We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00077870
First Posted: February 16, 2004
Last Update Posted: September 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Genentech, Inc.
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Drug: ocrelizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

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

Estimated Enrollment: 237
Study Start Date: February 2004
Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  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.
Investigators
Study Director: Wolfgang Dummer, M.D. Genentech, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00077870     History of Changes
Other Study ID Numbers: ACT2847g
First Submitted: February 12, 2004
First Posted: February 16, 2004
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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases