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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Study First Posted: 2007-01-29
• Primary Completion: 2007-05
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-30
• Last Update Posted: 2008-05-02

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
PsAQoL	Week 12
ACR70	Week 12
PsARC	Week 12
DAS28	Week 12
PASI50/75	Week 12
HAQ-DI	Week 12
ACR50	Week 12