A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sirukumab 100 mg; Sirukumab 50 mg; Placebo
Intervention description: Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.; Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.; Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine; Sirukumab; Human Anti-IL-6 Monoclonal Antibody

Summary:

      The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single
      therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who
      have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a Japanese man or woman with a diagnosis of rheumatoid arthritis (RA), according to
             the revised 1987 criteria of the American Rheumatism Association, for at least 3
             months before screening

          -  Has moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66
             swollen joints, at screening and at baseline

          -  Has been unresponsive to adequate treatment with methotrexate (MTX), sulfasalazine
             (SSZ), or combination of MTX or SSZ with other disease-modifying antirheumatic drugs
             (DMARDs) at screening due to lack of benefit after at least 12 weeks of marketed dose
             of MTX or SSZ, as assessed by the treating physician. Documented lack of benefit may
             include inadequate improvement in joint counts, physical function, or overall disease
             activity

          -  If using oral corticosteroids, must be on a stable dose equivalent to <=10 mg/day of
             prednisolone for at least 2 weeks prior to first dosing with study agent. If currently
             not using corticosteroids, the patient must not have received oral corticosteroids (by
             mouth) for at least 2 weeks prior to first dosing with study agent

          -  If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain
             relievers) for RA, must be on a stable dose for at least 2 weeks prior to first dosing
             with study agent

        Exclusion Criteria:

          -  Has a history of intolerance to at least 2 or inadequate response to at least one
             anti-tumor necrosis factor-alpha (anti-TNF-alpha) agent after 3 months of therapy; has
             received anti-TNF-alpha (eg, infliximab, golimumab, adalimumab, or etanercept) within
             3 months of first study agent dosing

          -  Has a history of intolerance to tocilizumab that precluded further treatment with it,
             or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy; has
             used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent
             dosing or has evidence during screening of abnormally low B-cell level caused by
             previous B-cell depletion therapy; has used any other biologic therapy for the
             treatment of RA within 3 months of first study agent dosing; has a history of
             sirukumab use

          -  Has received intra-articular (IA), intramuscular (IM), or intravenous (IV)
             corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks
             prior to first study agent dosing

          -  Has received leflunomide within 24 months before first study agent dosing and has not
             undergone a drug elimination procedure, unless the M1 metabolite is measured and is
             undetectable. Drug elimination procedure must be completed prior to obtaining informed
             consent

          -  Has a history of cyclophosphamide or cytotoxic agent use; has received cyclosporine A,
             azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or
             D-penicillamine within 4 weeks of first study agent dosing; has received an
             investigational drug (including investigational vaccines) or used an investigational
             medical device within 3 months or 5 half-lives, whichever is longer, before first
             study agent dosing