• The primary outcomes are American College of Rheumatology (ACR) 50 response at Week 24, and the change from baseline in van der Heijde Modified Sharp (vdH-S) score at Week 52. [ Time Frame: Week 24 and Week 52 ] [ Designated as safety issue: No ]
  

• The secondary outcomes are change from baseline in HAQ at Week52, ACR20 response at Week24, change from baseline in vdH-S score at Week52 in subjects with abnormal CRP at baseline, and ACR50 response at Week24 in subjects with abnormal CRP at baseline. [ Time Frame: Week 24 and Week 52 ] [ Designated as safety issue: No ]
  

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFα). TNFα is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pain, swelling, and damage from RA. Other marketed drugs that target TNFα (anti-TNFα drugs) have been shown to be effective in reducing the symptoms, signs, and joint damage of RA, but have limitations with respect to safety and ease of use. This is a randomized, double-blind, placebo-controlled trial of the efficacy and safety of a new anti-TNFα drug, golimumab, at 2 doses, injected under the skin every 4 weeks, alone or in combination with methotrexate, compared with methotrexate alone, in subjects with active RA who have not been previously treated with methotrexate. The study hypothesis is that golimumab, alone or in combination with methotrexate, will be more effective in treatment of RA than methotrexate alone, as measured by the American College of Rheumatology (ACR) response criteria and change from baseline in van der Heijde Modified Sharp (vdH-S) score, without causing unacceptable significant adverse effects. The ACR response criteria were designed to determine the percentage of subjects who have achieved a certain level of improvement in their signs and symptoms of rheumatoid arthritis. The vdH-S score is a measurement of the amount of joint damage in a subject as seen by x-ray. Other secondary measures of effectiveness include the Health Assessment Questionnaire (HAQ), which is a series of questions that measure a subject's impairment in physical function caused by RA.

Golimumab 50 mg or 100 mg, or placebo injections under the skin every 4 weeks until Week52. Methotrexate (MTX) or placebo capsules will be given in addition. At Week52, subjects on MTX alone with joint pain or swelling get golimumab 50mg, and all subjects receive golimumab for about 4 more years.