The purpose of this study is to determine the safe dose of PRO70769 for subjects with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: PRO70769	Phase I Phase II

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

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

Arizona
      University of Arizona, Tucson,  Arizona,  85724,  United States; No longer recruiting
      Sun Valley Arthritis Center Ltd., Glendale,  Arizona,  85308,  United States; Recruiting
California
      San Diego Arthritis and Osteoporosis Medical Clinic, San Diego,  California,  92108,  United States; Recruiting
      Wallace Rheumatic Study Center, Los Angeles,  California,  90048,  United States; Recruiting
Florida
      Coastal Medical Research, Port Orange,  Florida,  32127,  United States; Recruiting
      Arthritis Associates, PA, Palm Harbor,  Florida,  34684,  United States; Recruiting
      CRIA Research, Ft. Lauderdale,  Florida,  33334,  United States; Recruiting
      Sarasota Arthritis Research Center, Sarasota,  Florida,  34239,  United States; Recruiting
      The Arthritis Center, Palm Harbor,  Florida,  34684,  United States; Recruiting
Illinois
      University of Chicago, Chicago,  Illinois,  60637,  United States; Recruiting
      The Arthritis Center, Springfield,  Illinois,  62704,  United States; Recruiting
Indiana
      Rheumatology Associates, P.C., Indianapolis,  Indiana,  46260,  United States; Recruiting
      Diagnostic Rheumatology and Research, Indianapolis,  Indiana,  46227,  United States; Recruiting
Kentucky
      Kentuckiana Center for Better Bone and Joint Health, Louisville,  Kentucky,  40202,  United States; No longer recruiting
Maryland
      Center for Rheumatology and Bone Research, Wheaton,  Maryland,  20902,  United States; Recruiting
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; No longer recruiting
Missouri
      Arthritis Consultants, Inc., St. Louis,  Missouri,  63141,  United States; Recruiting
New York
      NYU-Hospital for Joint Diseases, Seligman Center for Advanced Therapeutics, New York,  New York,  10003,  United States; Recruiting
      Rheumatology Associates of Long Island, Smithtown,  New York,  11787,  United States; Recruiting
Ohio
      STAT Research, Inc., Dayton,  Ohio,  45402,  United States; Recruiting
Oregon
      Portland Medical Associates, Portland,  Oregon,  97224,  United States; Recruiting
Pennsylvania
      Clinical Research Center of Reading LLP, West Reading,  Pennsylvania,  19611,  United States; Recruiting
      Altoona Center for Clinical Reserch, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
Texas
      Arthritis and Osteoporosis Associates, LLP, Lubbock,  Texas,  79410,  United States; Recruiting
      Austin Rheumatology Research, PA, Austin,  Texas,  78705,  United States; Recruiting
      Amarillo Center for Clinical Research, Ltd., Amarillo,  Texas,  79124,  United States; Recruiting
Utah
      Physician's Research Options, LLC, Ogden,  Utah,  84403,  United States; Recruiting

Study ID Numbers:  ACT2847g
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  February 12, 2004
ClinicalTrials.gov Identifier:  NCT00077870
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08