A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFalfa Monoclonal Antibody, Administered Subcutaneously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy

INTERVENTION:

Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed

INN:

Golimumab Other descriptive name: Human Anti‐TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti‐TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and‐100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: Methotrexate sodium tablets 2.5 mg Product Code: NA Pharmaceutical Form: Tablet INN or Proposed

INN:

Methotrexate sodium Other descriptive name: Methylaminopterin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Golimumab Pre‐Filled Syringe Product Code: CNTO 148 Pharmaceutical Form: Solution for injection INN or Proposed

INN:

Golimumab Other descriptive name: Human Anti‐TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti‐TNFalfa Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50 and‐100 Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use

CONDITION:

Active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy

PRIMARY OUTCOME:

Main Objective: to assess the efficacy of golimumab in subjects with active RA despite MTX therapy as measured by the reduction of the signs and symptoms of RA at Week 14 and improvement in physical function at Week 24. Primary end point(s): ACR 20 response at Week 14 and change from baseline in health assessment questionnaire at Week 24. Secondary Objective: to assess the safety, the effects of golimumab on structural damage and quality of life, and the population pharmacokinetics of golimumab in subjects with active RA despite MTX therapy.

INCLUSION CRITERIA:

1. Are women or men 18 years of age or older. 2. Have a diagnosis of RA for at least 3 months prior to screening. 3. Must have been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have a MTX dose of equal to or more than 15 mg/week and equal to or less than 25 mg/week and stable for at least 4 weeks prior to screening. 4. Have active RA as defined, for the purpose of this study, by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and at baseline and at least 2 of the following 4 criteria: a. CRP equal to or more than 1.5 mg/dL at screening or ESR by Westergren method of equal to or greater than 28 mm in the first hour at screening or baseline. b. Morning stiffness of equal to or more than 30 minutes at screening and baseline. c. Bone erosion by x‐ray and/or by MRI prior to the first administration of study agent. d. Anti‐cyclic citr