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

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ClinicalTrials.gov Identifier: NCT00077870
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : September 3, 2009
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ocrelizumab Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 237 participants
Primary Purpose: Treatment
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
Study Start Date : February 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability of ocrelizumab in subjects with moderate to severe RA

Secondary Outcome Measures :
  1. Pharmacokinetics of ocrelizumab
  2. Pharmacodynamics of ocrelizumab
  3. Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077870

Sponsors and Collaborators
Genentech, Inc.
Study Director: Wolfgang Dummer, M.D. Genentech, Inc.
More Information

ClinicalTrials.gov Identifier: NCT00077870     History of Changes
Other Study ID Numbers: ACT2847g
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: September 3, 2009
Last Verified: September 2009

Keywords provided by Genentech, Inc.:
Moderate to severe rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases