A Study of CNTO 136 (Sirukumab), Administered Subcutaneously, in Patients With Active Rheumatoid Arthritis Despite Disease-Modifying Antirheumatic Drug (DMARD) Therapy (SIRROUND-D)

Patients will be randomly assigned to treatment groups, and they and study personnel will not
know the identity of the treatments given. Some patients will receive a placebo, which
resembles a medication, but does not contain an active substance. This helps to determine if
the study agent is effective. Patients will receive placebo or sirukumab by injection under
the skin. The expected duration of the study is 120 weeks, which includes 104 weeks of
treatment. Participants who complete participation in the study will be eligible for
inclusion into the long-term safety and efficacy study, if enrollment at a participating site
is available to them. If they do not participate in the long-term study, they will continue
into the safety follow-up for approximately 16 weeks. The placebo-controlled portion of the
study is through Week 52, when placebo patients will cross over to one of two sirukumab dose
regimens. Patient safety will be monitored throughout the study.

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