Golimumab in Rheumatoid Arthritis Participants With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Arthritis, Rheumatoid, Autoimmune Diseases

In brief

The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) participants who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 milligram (mg) subcutaneous (SC) injection (a needle inserted under the skin in the back of upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching participants from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 milligram per kilogram (mg/kg) intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Key facts

Study ID

NCT01004432

Run by

Janssen Biotech, Inc.

People needed

433

Starts

2009-12-01

Expected to finish

2013-10-01

Last updated by the study team

2015-04-30

Who can join

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

You may qualify if…

• Have inadequate RA disease control prior to the first administration of study agent despite treatment with etanercept (Enbrel) + methotrexate or adalimumab (Humira) + methotrexate (MTX)
• Must have received a stable dose of MTX greater than or equal to (>=) 7.5 milligram (mg) per week to less than or equal to (<=) 25 mg per week for at least 4 consecutive weeks prior to the first screening visit and must plan to maintain that dose throughout the study
• Participants must have received etanercept or adalimumab in combination with MTX for a minimum of 3 months prior to the first visit
• Negative tuberculosis (TB) test
• Are capable of providing informed consent, which must be obtained prior to any study-related procedures

You may not qualify if…

• Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or are frequently in contact with individuals who carry active TB infection
• Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren's or Lyme disease
• Have demonstrated a discernible improvement in disease activity between screening and prior to the first golimumab injection at Week 0
• Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence)
• Have a history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Tuscaloosa, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Covina, California, United States
• Study site — Hemet, California, United States
• Study site — Loma Linda, California, United States
• Study site — Long Beach, California, United States
• Study site — Murrieta, California, United States
• Study site — Santa Maria, California, United States
• Study site — Santa Monica, California, United States
• Study site — Torrance, California, United States
• Study site — Van Nuys, California, United States
• Study site — Victorville, California, United States
• Study site — Whittier, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Hamden, Connecticut, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Aventura, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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