A Study of Golimumab in Participants With Active Psoriatic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Psoriatic

In brief

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).

Key facts

Study ID

NCT02181673

Run by

Janssen Research & Development, LLC

People needed

480

Starts

2014-09-08

Expected to finish

2017-03-22

Last updated by the study team

2017-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Mesa, Arizona, United States
• Study site — Huntington Beach, California, United States
• Study site — Lakewood, California, United States
• Study site — Granger, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Monroe, Louisiana, United States
• Study site — Tupelo, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Orchard Park, New York, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Austin, Texas, United States
• Study site — Daw Park, Australia
• Study site — Maroochydore, Australia
• Study site — Grodno, Belarus
• Study site — Homyel, Belarus
• Study site — Minsk, Belarus
• Study site — Vitebsk, Belarus
• Study site — St. John's, Newfoundland and Labrador, Canada
• Study site — Waterloo, Ontario, Canada
• Study site — Burlington, Canada
• Study site — Bad Doberan, Germany
• Study site — Berlin, Germany
• Study site — Cologne, Germany
• Study site — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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