NCT00195689CompletedPhase 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
Abbott1 site in 1 country400 target enrollmentStarted: August 1, 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- HAQ
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Untitled Study
Intervention: Human anti-TNF monoclonal antibody/adalimumab (Biological)
Outcomes
Primary Outcomes
HAQ
Safety parameters
ACR 20/50/70
PsARC
SF-36
Disease progression measurements
FACTIT Fatigue Scale
Secondary Outcomes
- Clinical response indicators
- Patient reported outcomes
Investigators
Study Sites (1)
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