A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®)

The study employs an open-label "active switch" design that moves subjects from infliximab
to golimumab 2 mg/kg IV. In general, subjects eligible for the study include men or women
who are currently receiving infliximab in actual clinical practice who are at least 18 years
of age with active rheumatoid arthritis, and have previously demonstrated initial and/or
temporary improvement in disease signs and symptoms, but now exhibit a diminished response
and inadequate disease control despite continued treatment. Subjects must have received
infliximab in combination with methotrexate for a minimum of 9 months prior to the first
screening visit.

The screening visit will occur sometime between Week -12 and Week -10. Consenting subjects
who meet screening criteria will receive their final dose of infliximab at Week -8 as part
of actual clinical practice. Golimumab IV treatment, which will be supplied by the sponsor,
will be received at Weeks 0, 4, 12, 20, and 28. The primary endpoint is at Week 24, the
final efficacy assessment is at Week 32, and a follow-up safety assessment by telephone is
at Week 44. There will be a maximum of 36 weeks between the last infliximab infusion at Week
-8 and the last infusion of golimumab at Week 28. The duration of study participation is
expected to be a maximum of 56 weeks (including the Screening Period, 32 weeks of golimumab
treatment and assessment, and a 12-week safety follow-up).

Major Inclusion Criteria include (but not limited to):

- Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of
the American Rheumatism Association).

- Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of
methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy
with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg
every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).

- Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR)
at Week -8 and Week 0.

- Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at
Week 0.

- Prior response confirmed by physician.

Major Exclusion Criteria include (but not limited to):

- Have a history of latent or active granulomatous infection, including histoplasmosis,
or Have a history of latent or active granulomatous infection, including
histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during
the Screening Period.

- Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.

- Have a chest radiograph within 3 months prior to the first administration of study
agent that shows an abnormality suggestive of a malignancy or current active
infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.

- Have previously received more than 1 of the currently approved subcutaneous (SC)
administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or
adalimumab.

- Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months
after receiving the last administration of the study agent.

- Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than
242 pounds).