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

NCT ID: NCT00077870

Last Updated: 2009-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-12-31

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

Conditions

Rheumatoid Arthritis

Study Design

• Primary Study Purpose: TREATMENT

Interventions

ocrelizumab

Intervention Type: DRUG

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

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Wolfgang Dummer, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

References

Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, Sweiss NJ, Spaniolo G, Dummer W; ACTION Study Group. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Sep;58(9):2652-61. doi: 10.1002/art.23732.

Reference Type: RESULT

PMID: 18759293 (View on PubMed)

Other Identifiers

ACT2847g

Identifier Type: -

Identifier Source: org_study_id