A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
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
1 other identifier
interventional
237
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Feb 2004
Longer than P75 for phase_1 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 12, 2004
CompletedFirst Posted
Study publicly available on registry
February 16, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedSeptember 3, 2009
September 1, 2009
February 12, 2004
September 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
Secondary Outcomes (3)
Pharmacokinetics of ocrelizumab
Pharmacodynamics of ocrelizumab
Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Related 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 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.
PMID: 18759293RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wolfgang Dummer, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 12, 2004
First Posted
February 16, 2004
Study Start
February 1, 2004
Study Completion
December 1, 2006
Last Updated
September 3, 2009
Record last verified: 2009-09