- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00646178
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
March 26, 2008 updated by: Abbott
Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy
Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Moderate to severe PsA
- Inadequate response to DMARD therapy
- Corticosteroid stable dose <=10 mg QD
- DMARDs must have been taken for 3 months and stable dose for 4 weeks
- MTX maximum dose = <=30 mg/week
- Active chronic plaque PS or documented history of chronic plaque PS
Exclusion Criteria:
- No other active skin disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
|
40 mg adalimumab eow Week 0 - Week 12
Other Names:
|
Placebo Comparator: B
|
placebo eow Week 0 - Week 12
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ACR20
Time Frame: Week 12
|
Week 12
|
Adverse Events
Time Frame: Throughout the Study
|
Throughout the Study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ACR50/70
Time Frame: Week 12
|
Week 12
|
Modified Psoriatic Arthritis Response Criteria
Time Frame: Week 12
|
Week 12
|
Multiple QOL Assessments
Time Frame: Week 12
|
Week 12
|
Physicians Global Assessment for Psoriasis
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
March 1, 2004
Study Registration Dates
First Submitted
March 26, 2008
First Submitted That Met QC Criteria
March 26, 2008
First Posted (Estimate)
March 28, 2008
Study Record Updates
Last Update Posted (Estimate)
March 28, 2008
Last Update Submitted That Met QC Criteria
March 26, 2008
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M02-570
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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