A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis - Full Text View

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

MedlinePlus related topics:

Rheumatoid Arthritis

Drug Information available for:

Methotrexate Ocrelizumab Proline

U.S. FDA Resources

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

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

Study ID Numbers:	ACT2847g
First Received:	February 12, 2004
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00077870
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

Moderate to severe rheumatoid arthritis

Study placed in the following topic categories:

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Methotrexate

Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on November 19, 2008

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