Candidates for Systemic Therapy for PsoriasisPhase 4NCT00287118
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
A Phase 4 study testing Efalizumab in people with Candidates for Systemic Therapy for Psoriasis and Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.
Trial summary
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks. Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Candidates for Systemic Therapy for Psoriasis, Psoriasis
- What is being tested?
- Efalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Oct 2004to 30 May 2006
- Phase
- Phase 4
- 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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A) In the opinion of the investigator, candidate for systemic therapy for psoriasis could include:
- Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10
- Patients with the following may also be deemed to require systemic therapy in the judgement of the physician:
- Severe psychosocial disability (in the judgement of the physician), or
- Nail psoriasis, or
- Scalp psoriasis, or
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- Palmar plantar psoriasis etc OR
- B) Subjects who have completed the CLEAR study investigational medicinal product (IMP) 24011 (NCT00256139) and who wish to continue Raptiva (efalizumab) therapy.
- Body weight of 120 kg
- 18 to 75 years old
- For women of childbearing potential and for men whose partner can become pregnant, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study up to 3 months after the last dose of Raptiva
- Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other ultraviolet (UV) light sources during the study
- Agreement to participate in the study
- Signed informed consent
- Discontinuation of any systemic psoriasis treatment prior to commencement of the study drug. No washout period is required for these agents prior to starting study and receiving first dose of study drug (Raptiva)
- Discontinuation of all biologic agents (other than Raptiva) 3 months prior to receiving first dose of study drug (Raptiva)
- Discontinuation of Psoralen-ultraviolet light A (PUVA), Ultraviolet light B (UVB) treatment 28 days prior to commencement of receiving first dose of study drug.
- Discontinuation of any investigational drug or treatment 3 months prior to study Day 0 or as per washout requirements from previous protocol
- No vaccinations (e.g., tetanus, booster, influenza vaccine) at least 14 days prior to first dose of study drug
- Treatment regimens of b-blockers, Angiotensin-converting enzyme (ACE) inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to first dose of study drug
Who cannot join
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Active rebound of psoriasis during or following discontinuation of the previous Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due to another non drug reason (vaccination, or infection) then the patient can be included in this study.
- History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- History of opportunistic infections (e.g., systemic fungal infections, parasites)
- Seropositivity for human immunodeficiency virus (HIV). Patients will undergo mandatory testing at screening. Patients who are positive for HIV will be excluded.
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- Pregnancy or lactation
- White blood cell (WBC) count <4000 per Liter (L) or >14,000/L
- Patient with a history of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 00,000 cells/L
- Seropositivity for hepatitis B or C virus Patients will undergo testing at screening. Patients who are positive for hepatitis B antigen or hepatitis C antibody will be excluded.
- Hepatic enzymes >3 times the upper limit of normal
- History of active tuberculosis (TB) or currently undergoing treatment for TB within one year prior to study Day 0. Chest X-ray (within 3 months prior to Study Day 0) is required for high-risk patients. Patients with a positive chest X-ray will be excluded.
- Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
- Diagnosis of hepatic cirrhosis, regardless of cause or severity
- Serum creatinine >2 times the upper limit of normal
- Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- History of substance abuse within the last 5 years
- Any medical condition that, in the judgment of the investigator, would jeopardize the patient's safety following exposure to study drug
Trial locations and contacts
1 site in 1 country.
About this study
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
- Being tested
- Efalizumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfalizumabDrug
Also called Raptiva
Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Efalizumab | Experimental | Not described Receives: Drug: Efalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study start27 Oct 2004
- Primary completion30 May 2006
- Study completion30 May 2006
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 Candidates for Systemic Therapy 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287118
- Sponsor's protocol ID
- 25161
- Other IDs
- CONTROL I Study
- Status last verified
- Aug 2017
- First submitted
- 2 Feb 2006
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Stengel FM, Petri V, Campbell GA, Dorantes GL, Lopez M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D; International IMP25161 Study Group. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x.
PubMed 20098510
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT00287118
- Acronym / sponsor ID
- 25161
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2004 (actual)
- Primary completion
- 30 May 2006 (actual)
- Study completion
- 30 May 2006 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Posted 3 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efalizumab | Experimental | Drug: Efalizumab |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- A) In the opinion of the investigator, candidate for systemic therapy for psoriasis could include:
- Patients with moderate to severe plaque psoriasis defined by Psoriasis Area and Severity Index (PASI) less than (>) 10 and body surface area (BSA) greater than (>) 10
- Patients with the following may also be deemed to require systemic therapy in the judgement of the physician:
- Severe psychosocial disability (in the judgement of the physician), or
- Nail psoriasis, or
Key exclusion criteria (18 listed)
- Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- Active rebound of psoriasis during or following discontinuation of the previous Raptiva treatment( PASI >125% from baseline and/or new predominant morphology of psoriasis) when reason was adverse event or lack of efficacy of Raptiva. If it was due to another non drug reason (vaccination, or infection) then the patient can be included in this study.
- History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- History of opportunistic infections (e.g., systemic fungal infections, parasites)
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 |
|---|---|---|
| EfalizumabAlso: RaptivaSubjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks. | Drug | Efalizumab |
Primary outcome
Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24
Time frame: Week 24
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20098510Stengel FM, Petri V, Campbell GA, Dorantes GL, Lopez M, Galimberti RL, Valdez RP, de Arruda LF, Guerra MA, Chouela EN, Licu D; International IMP25161 Study Group. Control of Moderate-to-Severe Plaque Psoriasis with Efalizumab: 24-Week, Open-Label, Phase IIIb/IV Latin American Study Results. Arch Drug Inf. 2009 Dec;2(4):71-78. doi: 10.1111/j.1753-5174.2009.00024.x.
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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.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efalizumab in people with Candidates for Systemic Therapy for Psoriasis and Psoriasis, run by Merck KGaA, Darmstadt, Germany at 1 site in Switzerland.
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 20 inclusion and 18 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 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 Apr 2018). 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?
Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24 (time frame: Week 24). 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 NCT00287118, 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 3 Apr 2018.