An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy

This is a randomized (study medication is assigned by chance), double-blind (neither
physician nor participants knows the treatment that the participant receives),
placebo-controlled (an inactive substance is compared with a medication to test whether the
medication has a real effect in a clinical study), multicenter, 2-arm (2 groups) study of
golimumab in participants with active RA despite concurrent MTX therapy. Approximately 564
participants will be randomly allocated to 1 of 2 treatment groups in a 2:1 ratio ie, Group
1(approximately 376 participants will receive golimumab + MTX) and Group 2 (approximately 188
participants will receive MTX + placebo). Total duration of study for each participant is 112
weeks. Safety will be evaluated by assessment of adverse events, tuberculosis testing and
blood testing.

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening

- Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15
mg/week for at least 3 months prior to screening, and have been on a stable MTX dose
of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening

- Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender
joints, at the time of screening and at baseline

- C-Reactive Protein greater than or equal to 1.0 mg/dL at screening

- No history of latent or active tuberculosis prior to screening

Exclusion Criteria:

- Other inflammatory diseases, including but not limited to psoriatic arthritis,
ankylosing spondylitis, systemic lupus erythematosus, or lyme disease

- Treated with disease modifying agents (other than methotrexate)/systemic
immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or
parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate
mofetil) during the 4 weeks prior to first administration of study agent

- Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous
corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to
first administration of study agent

- Known allergy to human immunoglobulin proteins or other components of golimumab

- Received any commercial or investigational anti-tumor necrosis factor alpha therapy
such as but not exclusively infliximab, golimumab, adalimumab or etanercept