NCT00195689
Completed
Phase 3
A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
ConditionsPsoriatic Arthritis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Psoriatic Arthritis
- Sponsor
- Abbott
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Safety parameters
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject completed study M02-518 or M02-570
Exclusion Criteria
- •Subject prematurely discontinued study M02-518 or M02-570
- •Female subject who is pregnant or breast-feeding or considering becoming pregnant
- •Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Outcomes
Primary Outcomes
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
Disease progression measurements
FACTIT Fatigue Scale
Secondary Outcomes
- Clinical response indicators
- Patient reported outcomes
Study Sites (1)
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