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)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Adalimumab

Criteria

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