A clinical study to demonstrate safety and efficacy data to support the development of R-TPR-015 (1422015) in Patients with active rheumatoid arthritis on stable dose of methotrexate

INTERVENTION: Intervention1: Infliximab code named as R TPR 015 & Methotrexate: Infliximab: Dosage: 3 mg/kg given as an intravenous infusion at Week 0, followed with similar doses at Weeks 2, 6, 14, 22, 30, 38 and 46. Methotrexate: Dose: 10‐20mg/week, Duration: 4 weeks prior to screening and for the entire duration of the study. Frequency : weekly Mode of admin: Oral Control Intervention1: Remicade & Methotrexate: Remicade: Dosage: 3 mg/kg given as an intravenous infusion at Week 0, followed with similar doses at Weeks 2, 6, 14, 22, 30, 38 and 46. Methotrexate: Dose: 10‐20mg/week, Duration: 4 weeks prior to screening and for the entire duration of the study. Frequency : weekly Mode of admin: Oral CONDITION: Active Rheumatoid Arthritis PRIMARY OUTCOME: The primary efficacy endpoint will be the proportion of patients achieving clinical response according to the ACR20 criteria‐‐‐‐‐‐Timepoint: Week 16 SECONDARY OUTCOME: ACR 20‐‐‐‐‐‐Timepoint: Weeks 30 38 and 54 ACR 50‐‐‐‐‐‐Timepoint: Weeks 16 30 38 and 54 ACR 70‐‐‐‐‐‐Timepoint: Weeks 16 30 38 and 54 Assess immunogenicity of R‐TPR‐015 (1422015)‐‐‐‐‐‐Timepoint: Week 16 and 30 Change from baseline in the Quality of Life Assessment Questionnaire‐‐‐‐‐‐Timepoint: Weeks 16 30 and 54 Incidence and severity of adverse events and clinical laboratory abnormalities‐‐‐‐‐‐Timepoint: Week 16 30 38 and 54 Mean decrease of DAS28 comparison with Baseline‐‐‐‐‐‐Timepoint: Weeks 16 30 38 and 54 Number of patients requiring salvage treatment‐‐‐‐‐‐Timepoint: Weeks 30 and 54 INCLUSION CRITERIA: 1 Male and female aged 18 to 65 inclusive 2 Diagnosis of RA according to the criteria based on the revised 2010 American College of Rheumatology (ACR)or EULAR RA Classification criteria The disease should have been diagnosed at least 2 years prior to screening 3 Patients must have ACR or EULAR diagnostic criteria score More than equal to 6 4 Patients must have active disease as defined by a More than equal to 6 swollen joints b More than equal to 6 tender joints and the following i ESR More than equal to 28 mm per h ii CRP More than equal to 10 mg per L 5 Patients must have been on treatment with methotrexate (10 to 20 mg per week) taken orally for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period and on stable dose between 10 and 20 mg per week for at least 4 weeks prior to screening and for the ent