Multi-centre, randomized, double-blind, two-arm, parallel group, comparative clinical study to evaluate pharmacokinetic, efficacy and safety of Etanercept in Patients with Active Rheumatoid Arthritis

INTERVENTION: Intervention1: Etanercept coded as R‐TPR‐018 and Methotrexate: Strength: 25mg/ml vial Dose: 50 mg Route: Subcutaneous injection Frequency: Weekly Methotrexate: Dose:10‐25mg/week Duration: 4 weeks prior to screening and for the entire duration of the study Frequency : weekly Route of admin: Oral or intramuscular Control Intervention1: Enbrel® (Etanercept)and Methotrexate: Strength: 25mg/ml vial Dose: 50mg Route: Subcutaneous injection Frequency: Weekly Methotrexate: Dose:10‐25mg/week Duration: 4 weeks prior to screening and for the entire duration of the study Frequency : weekly Route of admin: Oral or intramuscular CONDITION: In Patients with Active Rheumatoid Arthritis on a stable dose of Methotrexate PRIMARY OUTCOME: The primary efficacy endpoint will be the proportion of subjects achieving clinical response ; according to the ACR 20 criteria‐‐‐‐‐‐Timepoint: Week 12 SECONDARY OUTCOME: Absolute values and changes from baseline in Acute Phase ; Reactant.‐‐‐‐‐‐Timepoint: Week 12 and Week 24 Absolute values and changes from baseline in Rheumatoid ; Factor.‐‐‐‐‐‐Timepoint: Week 12 and Week 24 Absolute values and changes from baseline in the DAS28‐‐‐‐‐‐Timepoint: Week 12 and Week 24 Absolute values and changes from baseline in the HAQ‐DI‐‐‐‐‐‐Timepoint: Week 12 and Week 24 ACR20‐‐‐‐‐‐Timepoint: Week 24 ACR50‐‐‐‐‐‐Timepoint: Week 12 and Week 24 ACR70‐‐‐‐‐‐Timepoint: Week 12 and Week 24 Immunogenicity assessment‐‐‐‐‐‐Timepoint: Baseline, at 12 Weeks and at 24 Weeks Pharmacokinetic parameters assessment after first dose: Cmax, AUC0‐t, AUC0‐â??, T1/2, ; Tmax,Kel‐‐‐‐‐‐Timepoint: Week 12 Safety evaluation ‐ Incidence of adverse events (AEs) and Serious Adverse Events(SAEs)‐‐‐‐‐‐Timepoint: Week 12 and Week 24 INCLUSION CRITERIA: 1. Males and females, aged 18 to 65, inclusive. 2. Diagnosis of Rheumatoid Arthritis according to the criteria based on the revised 2010 American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for Rheumatoid Arthritis. 3. Subjects must have ACR/EULAR diagnostic criteria score â?¥6. 4. Subjects must have active disease as defined by: a. â?¥6 swollen joints b. â?¥6 tender joints and c. Acute phase reactant values (CRP >8 mg/L or ESR >28 mm/h) 5. Subjects must have been on treatment with methotrexate (10 to 25 mg/week) (oral or injectable) for at least 3 months with no break(s) in treatment of more than 2 weeks in total during this period and stable dose between 10 and 25mg/week for at least 4 weeks prior to screening and it is planned that the same dose will continue for the entire duration of the study