Status:
COMPLETED
A Study of the Safety and Efficacy of Golimumab in Patients With Active Psoriatic Arthritis
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Schering-Plough
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy (improvement of signs and symptoms) of subcutaneous (under the skin) injections of golimumab for the treatment of active psoriatic arth...
Detailed Description
Anti-tumor necrosis factor (TNF) agents have been shown to be effective in improving arthritis and psoriasis symptoms in patients with active psoriatic arthritis. Golimumab is a new anti-TNFa agent. T...
Eligibility Criteria
Inclusion
- Psoriatic arthritis (PsA) diagnosed \> 6months prior
- Active PsA at the time of screening and at baseline visits, with \>= 3 swollen joints and \>= 3 tender joints
- Have at least 1 of the PsA subsets (DIP joint arthritis, polyarticular arthritis without rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis)
- Active plaque psoriasis with a lesion \>= 2cm in diameter
- Active arthritis despite current disease modifying anti-rheumatic drug (DMARD) or nonsteroidal anti-inflammatory drug (NSAID) therapy
- Stable doses of methotrexate, low-dose corticosteroids, and NSAIDs are permitted.
Exclusion
- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
- No treatment with alefacept or efalizumab within 3 months prior to the first study drug injection
- No DMARDs other than methotrexate, or immunosuppressive drugs within 4 weeks prior to the first study drug injection.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00265096
Start Date
December 1 2005
End Date
January 1 2012
Last Update
July 19 2013
Active Locations (51)
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1
Huntsville, Alabama, United States
2
La Jolla, California, United States
3
Upland, California, United States
4
Aventura, Florida, United States