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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00077870
First received: February 12, 2004
Last updated: September 1, 2009
Last verified: September 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Genentech:

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077870

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

Publications:

ClinicalTrials.gov Identifier: NCT00077870     History of Changes
Other Study ID Numbers: ACT2847g
Study First Received: February 12, 2004
Last Updated: September 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
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

ClinicalTrials.gov processed this record on May 23, 2013