Estudio internacional, randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab en combinación con metotrexato (MTX) comparado con MTX como único tratamiento, en pacientes con artritis reumatoide activa no tratados previamente con metotrexato

INTERVENTION: Product Name: ocrelizumab Product Code: RO 496‐4913 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: ocrelizumab Current Sponsor code: RO 496‐4913 Other descriptive name: RhuMAb 2H7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30‐ Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Rheumatoid arthritis PRIMARY OUTCOME: Main Objective: To determine the efficacy of ocrelizumab versus placebo, when used in combination with methotrexate (MTX), to reduce or inhibit progression of joint damage in MTX‐naïve patients. Primary end point(s): The treatment difference in change from baseline of the modified total Sharp score (TSS) at 52 Weeks. Secondary Objective: • To assess the efficacy of ocrelizumab to prevent disability; • To determine the efficacy of ocrelizumab versus placebo, in; combination with methotrexate (MTX) in reducing signs and symptoms; • To assess the safety of ocrelizumab versus placebo, in; combination with MTX; • To investigate the pharmacokinetics, immunogenicity and; pharmacodynamic parameters of ocrelizumab; • To explore the long‐term efficacy and safety of further; courses of ocrelizumab; INCLUSION CRITERIA: Men and women =18 years old, with active RA of at least 3 months and less than 5 years duration who are naive to methotrexate (MTX) Patients must meet the following criteria to be eligible for study entry: 1. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol 2. Age =18 years 3. Have active disease defined as: A) Diagnosis of RA of at least 3 months and less than 5 years duration using the ACR criteria for the classification of RA. B) Swollen joint count (SJC) =8 (66 joint count) and tender joint count (TJC) =8 (68 joint count) at screening and baseline. C) CRP =1.0 mg/dL using a high‐sensitivity assay. D) Positive rheumatoid factor or positive anti‐CCP antibody or both. 4. Previous and current treatments: A) Patients naïve to and considered to be candidates for treatment with MTX. B) Patients who are to receive, or who are currently receiving treatment for RA on a