Arthritis, PsoriaticNCT00293722
Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists
An observational study of Arthritis, Psoriatic and Psoriasis, run by Pfizer at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic, Psoriasis, Skin Diseases, Papulosquamous
- What is being tested?
- Etanercept
- How many people
- 1,308 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Feb 2013
- Phase
- Observational
- 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
Study population: Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis
Who may be able to join
- Clinical diagnosis of psoriatic arthritis
Who cannot join
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists
The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.
Read the detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
- Being tested
- Etanercept
- Keywords
- Arthritis
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis, Skin Diseases, Papulosquamous, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Psoriatic Arthritis | Not described Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Measured: Baseline up to Week 52
Secondary outcomes (9)
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Measured: Baseline, Week 52
Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 100 mm; higher scores indicated greater affectation due to disease activity). DAS28 total score range: 0-10, where DAS28 less than or equal to (=<) 3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate disease activity and >5.1 = high disease activity.
Measured: Baseline, Week 52
Change From Baseline in Ritchie Index at Week 52
Ritchie index: the numerical measurement of joint tenderness (28 joints) in participants with arthritis. The number of quantitative evaluations of the pain experienced by the participants when the joints were subjected to firm pressure when exerted over the articular margin or in some instances by passive movement of the joint. Participant's reaction to pressure exerted by the physician were documented on 4-point scale, 0=not tender, 1=tender, 2=tender and caused wince, 3=reflexive effort to withdraw. Ritchie index was calculated as the total of the individual grades for all joints; ranged from 0 to 84, where higher score indicated higher tenderness.
Measured: Baseline, Week 52
Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Physician global assessment of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity to 100 mm = most possible disease activity.
Measured: Baseline, Week 52
Number of Participants With Nail Involvement
Number of participants with psoriatic arthritis affecting the nails are reported.
Measured: Baseline, Week 12, 52
Change From Baseline in C-reactive Protein (CRP) at Week 52
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Measured: Baseline, Week 52
Change From Baseline in Patient Assessment of Itching at Week 52
Participants rated the severity of their psoriasis itching on a 0 (none) to 100 (most possible) scale.
Measured: Baseline, Week 52
Change From Baseline in Patient Assessment of Pain at Week 52
Participants rated the severity of their psoriatic arthritis-related pain on a 0 (none) to 100 (most possible) scale.
Measured: Baseline, Week 52
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
SF-12 questionnaire was used to determine participants' quality of life (QoL). It comprised 12 items which covered 8 concepts: physical functionality, role impairment due to physical problems, physical pain, perception of general health, vitality, social functionality, role impairment due to emotional problems, and psychological wellbeing. Results were presented in the form of 2 meta-scores, the physical component and the mental component, each ranged from 0 to 100. Higher scores=better QoL, positive changes from baseline=improvement in QoL.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionFeb 2013
- Study completionFeb 2013
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 Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293722
- Sponsor's protocol ID
- 0881A6-102064
- Other IDs
- B1801127
- Status last verified
- Jan 2014
- First submitted
- 15 Feb 2006
- Last updated
- 26 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1.
PubMed 29606665
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists
- ClinicalTrials.gov ID
- NCT00293722
- Acronym / sponsor ID
- 0881A6-102064
- Keywords
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,308 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Feb 2006 (estimated)
- Results
- Posted 26 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with PsA treated by rheumatologists.
Detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Psoriatic Arthritis | – | Drug: Etanercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis
Key inclusion criteria (1 listed)
- Clinical diagnosis of psoriatic arthritis
Key exclusion criteria (3 listed)
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitivity against Etanercept
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 |
|---|---|---|
| EtanerceptThe patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. | Drug | Patients with Psoriatic Arthritis |
Primary outcome
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 52
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
9 secondary outcomes
Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Ritchie Index at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Physician Global Assessment of Disease Activity at Week 52
Time frame: Baseline, Week 52
Number of Participants With Nail Involvement
Time frame: Baseline, Week 12, 52
Change From Baseline in C-reactive Protein (CRP) at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Patient Assessment of Itching at Week 52
Time frame: Baseline, Week 52
Change From Baseline in Patient Assessment of Pain at Week 52
Time frame: Baseline, Week 52
Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52
Time frame: Baseline, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29606665Behrens F, Meier L, Prinz JC, Jobst J, Lippe R, Loschmann PA, Lorenz HM. Simultaneous Response in Several Domains in Patients with Psoriatic Disease Treated with Etanercept as Monotherapy or in Combination with Conventional Synthetic Disease-modifying Antirheumatic Drugs. J Rheumatol. 2018 Jun;45(6):802-810. doi: 10.3899/jrheum.170932. Epub 2018 Apr 1.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic and Psoriasis, run by Pfizer at 1 site in Germany.
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 1 inclusion and 3 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 26 Feb 2014. 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 Germany. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2014). 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 Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) (time frame: Baseline up to Week 52). 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 NCT00293722, 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 26 Feb 2014.