Status:
COMPLETED
A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Lead Sponsor:
Centocor, Inc.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 symptom...
Detailed Description
This is a multicenter, double-blind (neither physician nor participants knows the treatment that the participant receives), randomized (study medication is assigned by chance), placebo-controlled (an ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2011
Estimated Enrollment :
187 Patients enrolled
Trial Details
Trial ID
NCT00718718
Start Date
August 11 2008
End Date
March 3 2011
Last Update
January 23 2018
Active Locations (38)
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1
Aventura, Florida, United States
2
Lexington, Kentucky, United States
3
Frederick, Maryland, United States
4
Kalamazoo, Michigan, United States