A Canadian Open-Label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriatic Arthritis (PsA) (ACCLAIM)
Phase 3
Completed
- Conditions
- Psoriatic Arthritis
- Registration Number
- NCT00427362
- Lead Sponsor
- Abbott
- Brief Summary
To further assess the safety and effectiveness of adalimumab 40mg in the treatment PsA who have had an unsatisfactory response or intolerance to prior or ongoing DMARDs
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- Active psoriatic arthritis defined by >= 3 tender or painful joints and >= 3 swollen joints despite standard psoriatic arthritis therapy
- Has had an unsatisfactory response or intolerance to at least two prior or ongoing DMARDs (one of which has to be methotrexate)
Exclusion Criteria
- Has a history of cancer or other than certain skin or cervical cancers
- Has a history of, or current acute inflammatory joint disease of origin other than PsA, e.g., systemic lupus erythematosus etc.
- Has other, unstable diseases, including congestive heart failure, inflammatory bowel disease, recent stroke, leg ulcers or other condition which would put the subject at risk
- History of active tuberculosis, history of histoplasmosis or listeriosis
- Latent TB or risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method ACR20 response Week 12
- Secondary Outcome Measures
Name Time Method DAS28 Week 12 PASI50/75 Week 12 HAQ-DI Week 12 ACR50 Week 12 PsAQoL Week 12 ACR70 Week 12 PsARC Week 12