A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

The purpose of this study is to evaluate the effectiveness and safety of subcutaneous (under the skin) administration of anti-interleukin-6 monoclonal antibody (CNTO 136) in reducing signs and symptoms of participants with active rheumatoid arthritis (RA) with methotrexate (MTX) therapy.

Key facts

Study ID

NCT00718718

Run by

Centocor, Inc.

People needed

187

Starts

2008-08-11

Expected to finish

2011-03-03

Last updated by the study team

2018-01-23

Who can join

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

You may qualify if…

• Diagnosed with rheumatoid arthritis (RA) for at least 4 months prior to screening
• Have been treated and having an inadequate response with the tolerated dose of methotrexate (MTX) (at least 15mg/week) for at least 4 months prior to screening. MTX doses of 10 or 12.5 mg/week are allowed if participant had intolerance of 15 mg/week
• MTX route of administration and dose (not to exceed 25 mg/week) should be stable for at least 6 weeks prior to the start of the study medication
• Have active RA as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and baseline, and either anti-cyclic citrullinated peptide antibody-positive or rheumatoid factor positive at screening
• C-reactive protein greater than or equal to 1.0 mg/dL (10 mg/L)
• Agree to use one of the contraception methods defined in the protocol

You may not qualify if…

• Have inflammatory diseases other than RA that might confound the evaluation of the benefit of CNTO 136 therapy in arthritis
• Family history of/ have long QT syndrome; or a history of second or third-degree heart block
• Received systemic immunosuppressives or disease modifying antirheumatic drug other than MTX, sulfasalazine, hydroxychloroquine or chloroquine within 4 weeks prior to the start of study medication
• Received intra articular (into joints), intramuscular, or intravenous corticosteroids within 4 weeks prior to the start of study medication
• Positive human immunodeficiency virus test, hepatitis B or hepatitis C
• History of / have chronic or recurrent infectious disease, history of / active tuberculosis
• Have serious infection within 2 months prior to start of study medication

Where it is running

• Study site — Aventura, Florida, United States
• Study site — Lexington, Kentucky, United States
• Study site — Frederick, Maryland, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Anderson, South Carolina, United States
• Study site — Budapest, Hungary
• Study site — Győr, Hungary
• Study site — Kecskemét, Hungary
• Study site — Goshogawara, Japan
• Study site — Hitachi, Japan
• Study site — Kawagoe, Japan
• Study site — Kitakyushu, Japan
• Study site — Miyazaki, Japan
• Study site — Sasebo, Japan
• Study site — Shinjuku-Ku, Japan
• Study site — Tomigusuku, Japan
• Study site — Guadalajara, Mexico
• Study site — Mexico City, Mexico
• Study site — México, Mexico
• Study site — Bialystok, Poland
• Study site — Bydgoszcz, Poland
• Study site — Elblag, Poland

Full record on ClinicalTrials.gov

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