PsoriasisPhase 2NCT00329303
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
A Phase 2 study testing Certolizumab Pegol (Cimzia®) in people with Psoriasis, run by UCB Pharma at 14 sites in 2 countries.
Trial summary
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Certolizumab Pegol (Cimzia®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Apr 2006to May 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
- Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870
Who cannot join
- Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
- Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
- Positive human immunodeficiency virus (HIV) test result
- White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
Show all 9Show fewer
- Systemic Lupus Erythematosus
- Participation in a clinical study within the past 3 months except Study C87040
- Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Germany9 sites
Study site
Berlin
Study site
Bonn
Study site
Essen
Study site
Frankfurt
Study site
Hamburg
Study site
Kiel
Study site
Mahlow
Study site
Mainz
Study site
Münster
France5 sites
Study site
Besançon
Study site
Créteil
Study site
Nice
Study site
Paris
Study site
Pierre-Bénite
About this study
Official title: Follow-up of Study C87040: Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous at 2 Different Dose Regimens (400 mg Initial Dose at Week 0 With 200 mg Every 2 Weeks Thereafter and 400 mg Every 2 Weeks) or Placebo for 12 Weeks, in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy, Having Responded to Treatment in Study C87040 and Having Subsequently Relapsed
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.
- Conditions
- Psoriasis
- Being tested
- Certolizumab Pegol (Cimzia®)
- Keywords
- Moderate to severe chronic plaque psoriasis, anti TNF α, CDP 870, Cimzia®, certolizumab pegol, retreatment
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab Pegol (Cimzia®)Drug
- Pharmaceutical Form: Solution for injection in pre-filled syringe
- Route of Administration: Subcutaneous use
- Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by
- 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10
- 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10
| Study group | Role | What they receive |
|---|---|---|
| Certolizumab Pegol (CZP) 200 mg | Experimental | Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. Receives: Drug: Certolizumab Pegol (Cimzia®) |
| Certolizumab Pegol (CZP) 400 mg | Experimental | Subcutaneous injections of 400 mg every 2 weeks. Receives: Drug: Certolizumab Pegol (Cimzia®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.
Measured: Week 12 in C87040 [NCT00245765] and Week 12 in this study
Secondary outcomes (77)
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 75 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI75 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 75 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 50 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI50 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 50 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in study C87040 of at least 90 %.
Measured: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
PASI90 response at Week 12 of re-treatment is defined as a decrease in PASI score at Week 12 in this study from Baseline in this study of at least 90 %.
Measured: Week 12
Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: First treatment Baseline in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 1 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 2 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 3 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 4 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 6 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 8 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 10 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 12 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Re-treatment Baseline in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 2 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 4 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 6 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 8 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 10 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Week 12 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: Last re-treatment visit in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to re-treatment Baseline in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity. A positive value in percentage change from Baseline indicates an improvement from Baseline.
Measured: From re-treatment Baseline in this study to Week 12 of re-treatment in this study
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: 12 week first treatment Period in study C87040
Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: 12 week re-treatment Period in this study
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: 12 week first treatment Period in study C87040
Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study
Determining the PASI score involves the evaluation of erythema, infiltration, and desquamation and body surface area involvement over 4 body regions. These regions are the head, trunk, upper and lower extremities.
The score value ranges from 0 to 72, with higher scores indicating higher Psoriasis activity and severity.
Measured: 12 week re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Re-treatment Baseline in this study
Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 2 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 4 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 6 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 8 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 10 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 12 of re-treatment Period in this study
Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Last re-treatment visit in this study
Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study
The overall severity of the disease was evaluated using the following 6-point scale:
5 = Severe: Very marked plaque elevation, scaling, and/or erythema. 4 = Moderate to severe: Marked plaque elevation, scaling, and/or erythema. 3 = Moderate: Moderate plaque elevation, scaling, and/or erythema. 2 = Mild: Slight plaque elevation, scaling, and/or erythema
1 = Almost clear: Intermediate between mild and clear 0 = Clear: No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Measured: Week 12 of re-treatment in this study
BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Re-treatment Baseline in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 2 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 4 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 6 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 8 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 10 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Week 12 of re-treatment Period in this study
BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %)
Measured: Last re-treatment visit in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to re-treatment Baseline in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 2 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 4 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 6 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 8 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 10 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to Week 12 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From first treatment Baseline in C87040 to last re-treatment visit (up to Week 12) in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 2 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 4 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 6 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 8 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 10 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to Week 12 of re-treatment Period in this study
Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study
Two methods were used for the evaluation of BSA:
- The area of one side of a subject's flat closed hand was used to represent 1 % to the total body surface area (BSA) to estimate the extent of skin involvement in subjects with psoriasis
- The rule of nines method assumed that the total BSA comprises head (9 %), anterior trunk (upper, 9 %; lower, 9 %), posterior trunk (upper, 9 %; lower, 9 %), each leg (anterior, 9 %; posterior, 9 %), each arm (9 %) and genitalia (1 %) A positive value in Change from Baseline indicates an improvement from Baseline. The higher the positive value, the higher the change.
Measured: From re-treatment Baseline in this study to last re-treatment visit in this study
Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: During the 12 week re-treatment Period in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329303
- Sponsor's protocol ID
- C87044
- Other IDs
- 2005-005525-63, 2005
- Status last verified
- Feb 2019
- First submitted
- 22 May 2006
- Last updated
- 6 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.
PubMed 22413944
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Study C87040: Multicentre, Double-blind Study to Describe the Efficacy and Safety of Re-treatment With CDP870 (Certolizumab Pegol) Subcutaneous at 2 Different Dose Regimens (400 mg Initial Dose at Week 0 With 200 mg Every 2 Weeks Thereafter and 400 mg Every 2 Weeks) or Placebo for 12 Weeks, in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy, Having Responded to Treatment in Study C87040 and Having Subsequently Relapsed
- ClinicalTrials.gov ID
- NCT00329303
- Acronym / sponsor ID
- C87044
- Conditions
- Psoriasis
- Keywords
- Moderate to severe chronic plaque psoriasis, anti TNF α, CDP 870, Cimzia®, certolizumab pegol, retreatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 24 May 2006 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certolizumab Pegol (CZP) 200 mg | Experimental | Drug: Certolizumab Pegol (Cimzia®)Subcutaneous injections of 400 mg initial dose at Week 0 with 200 mg every 2 weeks thereafter. |
| Certolizumab Pegol (CZP) 400 mg | Experimental | Drug: Certolizumab Pegol (Cimzia®)Subcutaneous injections of 400 mg every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
- Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870
Key exclusion criteria (9 listed)
- Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
- Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
- Positive human immunodeficiency virus (HIV) test result
- White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab Pegol (Cimzia®)* Pharmaceutical Form: Solution for injection in pre-filled syringe * Route of Administration: Subcutaneous use * Dose and Administration details : 2 x 1 mL Certolizumab Pegol at Week 0, followed by * 1 x 1 mL Certolizumab Pegol plus 1 x 1 mL Placebo (for blinding reasons) in the Certolizumab Pegol 200 mg arm at Weeks 2, 4, 6, 8 and 10 * 2 x 1 mL Certolizumab Pegol in the Certolizumab Pegol 400 mg arm at Weeks 2, 4, 6, 8 and 10 | Drug | Certolizumab Pegol (CZP) 200 mg, Certolizumab Pegol (CZP) 400 mg |
Primary outcome
Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study
Time frame: Week 12 in C87040 [NCT00245765] and Week 12 in this study
The PASI is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease. The difference was calculated by 'PASI score at re-treatment Week 12' minus 'PASI score at First Treatment Week 12'.
77 secondary outcomes
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040
Time frame: Week 12
Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study
Time frame: Week 12
Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040
Time frame: First treatment Baseline in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040
Time frame: Week 1 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040
Time frame: Week 2 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040
Time frame: Week 3 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040
Time frame: Week 4 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040
Time frame: Week 6 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040
Time frame: Week 8 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040
Time frame: Week 10 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040
Time frame: Week 12 of first treatment Period in study C87040
Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study
Time frame: Re-treatment Baseline in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study
Time frame: Week 2 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study
Time frame: Week 4 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study
Time frame: Week 6 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study
Time frame: Week 8 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study
Time frame: Week 10 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study
Time frame: Week 12 of re-treatment Period in this study
Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study
Time frame: Last re-treatment visit in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 1 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 2 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 3 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 4 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 6 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 8 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 10 of first treatment Period in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040
Time frame: From first treatment Baseline in study C87040 to Week 12 of first treatment in C87040
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study
Time frame: From first treatment Baseline in study C87040 to re-treatment Baseline in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 2 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 4 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 6 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 8 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 10 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study
Time frame: From first treatment Baseline in study C87040 to Week 12 of re-treatment Period in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study
Time frame: From first treatment Baseline in study C87040 to last re-treatment visit (up to Week 12) in this study
Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study
Time frame: From re-treatment Baseline in this study to Week 12 of re-treatment in this study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22413944Reich K, Ortonne JP, Gottlieb AB, Terpstra IJ, Coteur G, Tasset C, Mease P. Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomized, placebo-controlled trial with a re-treatment extension. Br J Dermatol. 2012 Jul;167(1):180-90. doi: 10.1111/j.1365-2133.2012.10941.x. Epub 2012 Jun 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
UCB Pharma
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Certolizumab Pegol (Cimzia®) in people with Psoriasis, run by UCB Pharma at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study (time frame: Week 12 in C87040 [NCT00245765] and Week 12 in this study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.