A Study of Effectiveness and Safety of CNTO 136 in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CNTO 136 100 mg; CNTO 136 50 mg; CNTO 136 25 mg; Placebo; Methotrexate
Intervention description: CNTO 136 100 mg will be administered subcutaneously (under the skin) every 2 or 4 weeks as per the appropriate randomized arm.; CNTO 136 50 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.; CNTO 136 25 mg will be administered subcutaneously every 4 weeks from Week 0 to Week 24.; Placebo will be adminstered subcutaneously as per the appropriate randomized arm.; Stable dose of methotrexate will be maintained through Week 24.
Intervention MeSH terms: Methotrexate; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Arthritis, Rheumatoid; Rheumatoid Arthritis; Active Rheumatoid Arthritis; CNTO 136; Interleukin-6; Anti-interleukin-6 monoclonal antibody; Methotrexate; Placebo

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 symptoms of participants with active rheumatoid arthritis (RA) with methotrexate
      (MTX) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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