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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077870
• Other study ID #: ACT2847g
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 12, 2004
• Last updated: September 1, 2009
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: September 2009
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ocrelizumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

References & Publications (1)

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 pati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
Secondary	Pharmacokinetics of ocrelizumab
Secondary	Pharmacodynamics of ocrelizumab
Secondary	Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria