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
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ClinicalTrials.gov Identifier: NCT00646178 |
Recruitment Status
:
Completed
First Posted
: March 28, 2008
Last Update Posted
: March 28, 2008
|
Sponsor:
Abbott
Information provided by:
Abbott
- Study Details
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Brief Summary:
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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthritis Psoriatic | Drug: adalimumab Drug: placebo for adalimumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | June 2003 |
Actual Primary Completion Date : | March 2004 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Psoriatic arthritis
Drug Information available for:
Adalimumab
U.S. FDA Resources
Arm | Intervention/treatment |
---|---|
Active Comparator: A |
Drug: adalimumab
40 mg adalimumab eow Week 0 - Week 12
Other Names:
|
Placebo Comparator: B |
Drug: placebo for adalimumab
placebo eow Week 0 - Week 12
Other Name: placebo
|
Primary Outcome Measures
:
- ACR20 [ Time Frame: Week 12 ]
- Adverse Events [ Time Frame: Throughout the Study ]
Secondary Outcome Measures
:
- ACR50/70 [ Time Frame: Week 12 ]
- Modified Psoriatic Arthritis Response Criteria [ Time Frame: Week 12 ]
- Multiple QOL Assessments [ Time Frame: Week 12 ]
- Physicians Global Assessment for Psoriasis [ Time Frame: Week 12 ]
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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
No Contacts or Locations Provided
Responsible Party: | Beverly Paperiello / Director, Clinical Research Development, Abbott |
ClinicalTrials.gov Identifier: | NCT00646178 History of Changes |
Other Study ID Numbers: |
M02-570 |
First Posted: | March 28, 2008 Key Record Dates |
Last Update Posted: | March 28, 2008 |
Last Verified: | March 2008 |
Additional relevant MeSH terms:
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases |
Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Adalimumab Antirheumatic Agents Anti-Inflammatory Agents |