The purpose of this study is to determine whether rituximab is safe and effective for treatment of patients with active rheumatoid arthritis who continue to have symptoms despite treatment with disease-modifying anti-rheumatic drugs and who currently have an inadequate clinical response to methotrexate.

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: rituximab	Phase II

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

Criteria

Eligibility criteria include, but are not limited to the following:

• Are between the ages of 18 and 80 years
• Have been diagnosed with rheumatoid arthritis for at least 6 months
• Have failed treatment (lack of efficacy) with at least one but no more than five disease-modifying anti-rheumatic drugs or biologics (other than methotrexate)

*Please note that there is a re-treatment study available (WA16855/U2653g) for patients currently enrolled in the U2644g study.*

California
      UCLA, Los Angeles,  California,  90025,  United States
      Desert Medical Advances, Palm Desert,  California,  92260,  United States
Florida
      RASF-Clinical Research Center, Boca Raton,  Florida,  33486,  United States
      Rheumatology Associates of Central Florida, Orlando,  Florida,  32806,  United States
      Arthritis and Rheumatic Disease Specialties, Aventura,  Florida,  33180,  United States
Illinois
      University of Chicago Hospitals, Chicago,  Illinois,  60637,  United States
      Rheumatology Associates, Chicago,  Illinois,  60612,  United States
      Northwestern Medical Faculty Foundation, Chicago,  Illinois,  60611,  United States
Indiana
      Indiana University-Outpatient Clinical Research Facility, Indianapolis,  Indiana,  46202,  United States
Louisiana
      LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      Northern Michigan Hosptial-Nisus Research Department, Petoskey,  Michigan,  49770,  United States
Minnesota
      St. Lukes Hospital, Duluth,  Minnesota,  55805,  United States
Missouri
      Washington University-Center for Advanced Medicine, St. Louis,  Missouri,  63110,  United States
North Carolina
      Physicians East, Greenville,  North Carolina,  27834,  United States
      CARE Center, Raleigh,  North Carolina,  27609,  United States
Ohio
      University Hospitals of Cleveland, Beachwood,  Ohio,  44122,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States
Texas
      Presbyterian Hospital-Arthritis Consultation Center, Dallas,  Texas,  75231,  United States
      Radiant Research-Dallas, Dallas,  Texas,  75235,  United States
      Houston Institute for Clinical Research, Houston,  Texas,  77074,  United States
Wisconsin
      Marshfield Clinic Wausau Center, Wausau,  Wisconsin,  54401,  United States
      Rheumatic Disease Center, Glendale,  Wisconsin,  53217,  United States

Study ID Numbers:  WA17043/U2644g; WA16855/U2653g; (Re-treatment extension study)
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  December 12, 2003
ClinicalTrials.gov Identifier:  NCT00074438
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08