A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive

• Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  ACR 50 response is an improvement of greater than or equal to 50% in both tender and swollen joint count and in 3 to 5 assessments- patient's assessment of pain visual analog scale (VAS) (0 [no pain] to 10 [worst pain]); patient's and physician's global assessment of disease activity VAS scales: overall disease activity, (0 [very well] to 10 [very poor] and 0 [no arthritis activity] to 10 [extremely active], respectively); Health Assessment Questionnaire (HAQ): 20-questions on life activities (0 [no difficulty] to 3 [inability to perform a task];and assessment of C-reactive protein [CRP].
  
  
• Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.
  
  

• Number of Participants Who Achieved American College of Rheumatology (ACR) 20 Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  ACR 20 response is an improvement of greater than or equal to 20% in both tender and swollen joint count and in 3 to 5 assessments- patient's assessment of pain visual analog scale (VAS) (0 [no pain] to 10 [worst pain]); patient's and physician's global assessment of disease activity VAS scales: overall disease activity, (0 [very well] to 10 [very poor] and 0 [no arthritis activity] to 10 [extremely active], respectively); Health Assessment Questionnaire (HAQ): 20-questions on life activities (0 [no difficulty] to 3 [inability to perform a task];and assessment of C-reactive protein [CRP].
  
  
• Number of Patients With Abnormal Baseline C-reactive Protein (CRP) Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  ACR 50 response is an improvement of greater than or equal to 50% in both tender and swollen joint count and in 3 to 5 assessments- patient's assessment of pain visual analog scale (VAS) (0 [no pain] to 10 [worst pain]); patient's and physician's global assessment of disease activity VAS scales: overall disease activity, (0 [very well] to 10 [very poor] and 0 [no arthritis activity] to 10 [extremely active], respectively); Health Assessment Questionnaire (HAQ): 20-questions on life activities (0 [no difficulty] to 3 [inability to perform a task];and assessment of CRP.
  
  
• Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 in Patients With Abnormal C-reactive Protein (CRP Greater Than 1.0 mg/dL) at Baseline [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
  Total vdH-S score is sum of joint erosion score and joint-space narrowing (JSN) score. Joint erosion score summarizes erosion severity in 32 joints of hands and 12 joints of feet. Each joint scored from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Maximal erosion score is 280. JSN score summarizes severity of JSN in 30 joints of hands and 12 joints of feet. Assessment of JSN, including subluxation, is scored from 0 (normal) to 4 (bony ankylosis or complete luxation). Maximal JSN score is 168. Thus, the worst possible vdH-S score is 448.
  
  

Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFa). TNFa 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 TNFa (anti-TNFa 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-TNFa 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 Heide 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.