A Study of Golimumab in Participants With Active Psoriatic Arthritis

• Status: Completed
• Trial end date: 2017-03-22
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: 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