A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis, Despite Existing Methotrexate Therapy

This is a randomized (patients assigned to treatment by chance), double-blind (study
personnel and patients will not know what treatment is being assigned to patients),
multicenter, placebo-controlled (a placebo is a treatment identical in appearance to the
study agent, but containing no active ingredient), dose-ranging study. Approximately 250
patients will be randomly assigned to 1 of 5 treatment groups. The maximum length of study
participation is 54 weeks, including a 6-week screening period. The end of the study will
be the last follow-up visit of the last patient. Study visits and evaluations will occur,
and patient safety will be monitored throughout the study.

Inclusion Criteria:

- Have had RA for at least 6 months prior to screening

- Have a diagnosis of RA according to the revised 1987 criteria of the American
Rheumatism Association - Be positive for either anti-cyclic citrullinated peptide
antibody or rheumatoid factor in serum at screening

- Have been treated with and tolerated MTX for at least 6 months prior to screening,
and have a MTX dose of >= 10 mg and <= 25 mg per week and stable for at least 12
weeks prior to first administration of study agent

- Have active RA, defined as persistent disease activity with both of the following
criteria: at least 6 swollen and 6 tender joints at the time of screening and
baseline; serum C-reactive protein (CRP) >= 0.80 mg/dL at screening. The investigator
may consider the patient eligible if the CRP value is at least 0.80 mg/dL in a single
repeat testing during the screening period

- If using oral corticosteroids, must be on a stable dose of <= 10 mg/day of prednisone
or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to
the first administration of study agent. If not using corticosteroids at Week 0, the
patient must not have received oral corticosteroids for at least 2 weeks prior to the
first administration of study agent

- If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics regularly
for RA, the patient must have been on a stable dose for at least 2 weeks prior to the
first administration of study agent. If not using NSAIDs or other analgesics for RA
at Week 0, the patient must have not received NSAIDs or other analgesics for RA for
at least 2 weeks prior to the first administration of study agent

Exclusion Criteria:

- Has other inflammatory diseases, including but not limited to psoriatic arthritis,
ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease, that
might confound the evaluation of the benefit of study agent therapy

- Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary,
gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic
disturbances that are severe, progressive, or uncontrolled

- Has any known malignancy or history of malignancy (with the exception of basal cell
carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ
that has been treated with no evidence of recurrence, or squamous cell carcinoma of
the skin that has been treated with no evidence of recurrence within 5 years prior to
the first administration of study agent)

- Has a history of lymphoproliferative disease, including lymphoma, or signs suggestive
of possible lymphoproliferative disease such as lymphadenopathy of unusual size or
location, or clinically significant splenomegaly

- Has known allergies, hypersensitivity, or intolerance to ustekinumab or CNTO 1959 or
its inactive ingredients

- Has ever received any approved or investigational biologic agent