A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis

INTERVENTION: Trade Name: RoActemra® Product Code: Ro 487‐7533/F01 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tocilizumab CAS Number: 375823‐41‐9 Current Sponsor code: RO4877533 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002‐9893/F02 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Methotrexate Disodium CAS Number: 7413345 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: Rheumatoid Arthritis ; MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis PRIMARY OUTCOME: Main Objective: To assess the efficacy of treatment with TCZ monotherapy and TCZ + MTX combination therapy, versus MTX monotherapy, with regard to the following primary endpoint in patients with early, moderate to severe rheumatoid arthritis (RA):; • Proportion of patients who achieve DAS28 remission (DAS28 < 2.6) at 6 months.; Primary end point(s): The primary endpoint is the proportion of patients with a DAS28 remission response (DAS28 < 2.6) at Week 24. Secondary Objective: • Prevention of structural joint damage over 12 months and maintenance of this effect at 24 months.; • Improvement in physical function over 12 months and maintenance of this effect at 24 months.; • Pharmacokinetics, immunogenicity and pharmacodynamics of TCZ in patients with early RA; • Safety and efficacy of TCZ administration in patients with early RA.; INCLUSION CRITERIA: ‐ adult patients at least 18 years of age with moderate to severe active RA of <2 years disease duration. ‐ no previous methotrexate or biologic agent. ‐ DMARDs should be withdrawn at least 2 weeks prior to baseline. ‐ weight = 150kg. ‐ patients of reproductive potential must be using reliable methods of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range