A randomized, double-blind, double-dummy, parallel group study to determine the efficacy and safety of RO4402257 monotherapy in comparison to methotrexate monotherapy in patients with active rheumatoid arthritis RA . - ND

• Conditions: rheumatoid arthritis; MedDRA version: 6.1Level: PTClassification code 10039073

• Registration Number: EUCTR2005-003694-25-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Able and willing to give written informed consent and to comply with the study protocol 2. Active RA as diagnosed by the 1987 American College of Rheumatology ACR; formerly American Rheumatism Association criteria Appendix 2 3. Age 18 years 4. Receiving treatment for RA on an outpatient basis 5. Swollen joint count 6 66 joint count and tender joint count TJC 8 68 joint count at screening and baseline 6. At screening, either high sensitivity C-reactive protein hs-CRP 0.6 mg/dL 6 mg/L or erythrocyte sedimentation rate ESR 28 mm/h or morning stiffness 45 minutes 7. Females of child-bearing potential and nonsterilized males with female partners of child-bearing potential only if willing to use a reliable means of contraception e.g., physical barrier, contraceptive pill, patch, or IUD during the study and for 4 weeks following the last dose of study drug. 8. If female and of childbearing potential, must have a negative pregnancy test within 3 weeks prior to randomization and at baseline prior to administration of study drug on Day 1 .
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Major surgery including joint surgery within 8 weeks prior to screening or planned surgery within 3 months after randomization 2. Rheumatic autoimmune disease other than RA including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis or significant systemic involvement secondary to RA e.g., vasculitis, pulmonary fibrosis, Felty s syndrome ; Sj gren s Syndrome with RA is allowed 3. Bed-ridden or confined to a wheelchair 4. Prior history of or current inflammatory joint disease other than RA e.g., tophaceous gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified