Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis.

Phase 2

• Conditions: Rheumatoid Arthritis

• Registration Number: JPRN-jRCT2080220627
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of RA for >=6 months according to the revised 1987 ACR criteria for the classification of RA.

- Receiving methotrexate at a dose of 6 to 8 mg/week(oral) for >=12 weeks, with a stable dose for the last 4 weeks before treatment.

- Positive serum RF.

Exclusion Criteria

- Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA. Patients with secondary Sjogren's syndrome or secondary limited cutaneous vasculitis with RA are eligible.

- Functional Class IV as defined by the ACR Classification of Functional Status in RA.

- History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder.

- Any surgical procedure within 12 weeks prior to or planned within 24 weeks after baseline.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ACR20 response at week 24.