A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; Placebo; Sirukumab; Sirukumab; Sirukumab
Intervention description: Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50.; Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 104.; Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 52 through Week 104.; Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 104.; Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 104.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1670.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy; Sirukumab; Human Anti-IL-6 monoclonal antibody

Summary:

      The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction
      of the signs and symptoms of rheumatoid arthritis (RA) and inhibition of radiographic
      progression in patients with active RA who are unresponsive to treatment with
      disease-modifying antirheumatic drugs (DMARD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of rheumatoid arthritis (RA) for at least 3 months before screening

          -  Have moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66
             swollen joints, at screening and at baseline

          -  Have been unresponsive to single-agent or combination disease-modifying antirheumatic
             drugs (DMARD) therapy that includes methotrexate (MTX) or sulfasalazine (SSZ) due to
             lack of benefit after at least 12 weeks of DMARD, as assessed by the treating
             physician

          -  If using oral corticosteroids, must be on a stable dose equivalent to less than or
             equal to 10 mg/day of prednisone for at least 2 weeks prior to the first
             administration of study agent. If currently not using corticosteroids, must not have
             received oral corticosteroids for at least 2 weeks prior to the first administration
             of study agent

          -  If using non nonsteroidal anti-inflammatory drug (NSAIDs) or other analgesics for RA,
             must be on a stable dose for at least 2 weeks prior to the first administration of
             study agent

          -  If using non-biologic DMARD such as MTX, SSZ, hydroxychloroquine, chloroquine, or
             bucillamine, must be on a stable dose for at least 4 weeks prior to the first
             administration of study agent and should have no serious toxic side effects
             attributable to the DMARD

        Exclusion Criteria:

          -  Has a history of intolerance to at least 2 or inadequate response to at least 1
             anti-tumor necrosis factor alpha agent after 3 months of therapy

          -  Has received infliximab, golimumab, adalimumab, or certolizumab pegol within 3 months
             of the first study agent administration

          -  Has received etanercept or yisaipu within 6 weeks of the first study agent
             administration

          -  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
             administration or have evidence during screening of abnormally low B cell level caused
             by previous B-cell depletion therapy

          -  Has used anakinra within 4 weeks of first study agent administration

          -  Has used any other biologic therapy for the treatment of RA within 3 months of the
             first study agent administration

          -  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 administration-

          -  Has received leflunomide within 24 months before the first study agent administration
             and have not undergone a drug elimination procedure, unless the M1 metabolite is
             measured and is undetectable. If a drug elimination procedure is performed during
             screening, the M1 metabolite should be measured and found to be undetectable

          -  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 the first study agent
             administration

          -  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 the first study agent administration