A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate

Genentech, Inc.0 sites237 target enrollmentFebruary 2004

ConditionsRheumatoid Arthritis

Drugsocrelizumab

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Enrollment: 237
Primary Endpoint: Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

December 2006

Last Updated

16 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Genentech, Inc.

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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