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

This study has been completed.

First Received: February 12, 2004 Last Updated: September 1, 2009 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00077870

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 I Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Ocrelizumab

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:

Genovese MC, Kaine JL, Lowenstein MB, Giudice JD, 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.

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

Keywords provided by Genentech:

Moderate to severe rheumatoid arthritis

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 09, 2009