Overview
A Study of Golimumab in Participants With Active Psoriatic Arthritis
Status:
Completed
Completed
Trial end date:
2017-03-22
2017-03-22
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active psoriatic arthritis (a chronic inflammatory arthritis that is associated with psoriasis).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Janssen Research & Development, LLCTreatments:
Antibodies, Monoclonal
Golimumab
Criteria
Inclusion Criteria:- Have had psoriatic arthritis (PsA) for at least 6 months prior to the first
administration of study agent
- Have a diagnosis of active PSA as defined by 5 or more swollen joints and 5 or more
tender joints at Screening and at Baseline and C-reactive protein >=0.6 milligram per
deciliter (mg/dL) at Screening
- Have active plaque psoriasis or a documented history of plaque psoriasis
- Have active PsA despite current or previous disease-modifying antirheumatic drugs
(DMARD) and/or nonsteroidal anti-inflammatory drug (NSAID) therapy. DMARD therapy is
defined as taking a DMARD for at least 3 months, or evidence of DMARD intolerance.
NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of NSAID
intolerance
Exclusion Criteria:
- Have other inflammatory diseases that might confound the evaluations of benefit of
Golimumab therapy, including but not limited to rheumatoid arthritis, ankylosing
spondylitis, systemic lupus erythematosus, or Lyme disease
- Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in
the study or within 4 months after receiving the last administration of study agent
- Have used any biologic agents that are targeted for reducing tumor necrosis factors
(TNF) alpha, including but not limited to Infliximab, Etanercept, Adalimumab,
Golimumab, and Certolizumab Pegol
- Have ever used cytotoxic drugs, including Chlorambucil, Cyclophosphamide, Nitrogen
mustard, or other Alkylating agents