A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00077870
• Lead Sponsor: Genentech, Inc.

Brief Summary

This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2004-02-12
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Study Completion: 2006-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

Inclusion Criteria

• Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
• Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
• Positive serum RF
• Current treatment for RA on an outpatient basis
• Contact your local site that is listed for more inclusion criteria

Exclusion Criteria

• Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
• Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
• Functional Class IV as defined by the ACR classification of functional status in RA
• History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
• Contact your local site that is listed for more exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ocrelizumab in subjects with moderate to severe RA

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of ocrelizumab
Pharmacodynamics of ocrelizumab
Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria