SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in subjects with rheumatoid arthritis.

The primary objective of this study is to determine the efficacy of oral SCIO-469 in subjects with rheumatoid arthritis who are not receiving hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs).

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: SCIO-469	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects have active rheumatoid arthritis and are not receiving DMARDs
• Subjects taking hydroxychloroquine (Plaquenil) must be on a stable dose

Exclusion Criteria:

• Used Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
• Elevation of liver enzymes within the past 6 months
• Tuberculosis
• Cancer
• HIV-positive
• Abnormal electrocardiogram
• Chronic or acute infection
• Multiple sclerosis, neuropathy, encephalopathy

Liezl Boehnlein      1-800-972-4670  Ext. 2485    Boehnlein@sciosinc.com
Suzette Warren, BS      1-800-972-4670  Ext. 2655    Warren@sciosinc.com

Alabama
      Coastal Clinical Research, Inc., Mobile,  Alabama,  36608,  United States; Recruiting
Arizona
      Arizona Arthritis and Rheumatology Associates, Paradise Valley,  Arizona,  85253,  United States; Recruiting
California
      Osteoporosis Diagnostic Imaging & Treatment Center, Riverside,  California,  92501,  United States; Recruiting
      Pacific Arthritis Center, Santa Maria,  California,  93454,  United States; Recruiting
      San Diego Arthritis Medical Clinic, San Diego,  California,  92120,  United States; Recruiting
      Valerius Medical Group & Research Center of Greater Long Beach, Inc., Long Beach,  California,  90802,  United States; Recruiting
      Wallace Rheumatic Study, Los Angeles,  California,  90048,  United States; Recruiting
      Arthritis Medical Clinic of North County Inc., Escondido,  California,  92025,  United States; Recruiting
      UCLA School of Medicine, Los Angeles,  California,  90095,  United States; Not yet recruiting
      Stanford University Medical Center, Palo Alto,  California,  94304,  United States; Not yet recruiting
Florida
      Radiant Research, Daytona Beach,  Florida,  32114,  United States; Not yet recruiting
      Rheumatology Associates of South Florida, Boca Raton,  Florida,  33486,  United States; Recruiting
      Jacksonville Center for Clinical Research, Jacksonville,  Florida,  32216,  United States; Recruiting
      Arthritis & Ostreoporosis Treatment Center, Orange Park,  Florida,  32073,  United States; Recruiting
      Arthritis Associates Inc., Orlando,  Florida,  32804,  United States; Recruiting
      Center for Rheumatology, Immunology and Arthritis, Ft. Lauderdale,  Florida,  33334,  United States; Recruiting
      Tampa Medical Group, PA, Tampa,  Florida,  33614,  United States; Recruiting
      International Medical Research, Ormond Beach,  Florida,  32174,  United States; Recruiting
Idaho
      Coeur d'Alene Arthritis Clinical Trials, Coeur D Alene,  Idaho,  83814,  United States; Recruiting
Illinois
      Quad City Rheumatology, Moline,  Illinois,  61265,  United States; Recruiting
      Springfield Clinic, LLP, Springfield,  Illinois,  62703,  United States; Recruiting
      The Arthritis Center, Springfield,  Illinois,  62704,  United States; Recruiting
Indiana
      Rheumatology Associates, Indianapolis,  Indiana,  46260,  United States; Recruiting
Maryland
      The Center of Rheumatology and Bone Research, Wheaton,  Maryland,  20902,  United States; Recruiting
      Center for Rheumatology and Bone Research, Wheaton,  Maryland,  20902,  United States; Recruiting
      Arthritis and Osteoporosis Center of Maryland, Frederick,  Maryland,  21702,  United States; Recruiting
Massachusetts
      Phase III Clinical Research, Fall River,  Massachusetts,  02720,  United States; Recruiting
Michigan
      Fiechtner Research, Inc., Lansing,  Michigan,  48910,  United States; Recruiting
Nebraska
      Arthritis Center of Nebraska, Lincoln,  Nebraska,  68516,  United States; Recruiting
      Westroads Medical Group, Omaha,  Nebraska,  68114,  United States; Recruiting
Nevada
      Arthritis Center of Reno, Reno,  Nevada,  89502,  United States; Recruiting
New Jersey
      Rheumatology & Arthritis Associates, PC, Medford,  New Jersey,  08055,  United States; Recruiting
New Mexico
      Albuquerque Rehabilitation & Rheumatology, Albuquerque,  New Mexico,  87109,  United States; Recruiting
New York
      The Center for Rheumatology, LLP, Albany,  New York,  12206,  United States; Recruiting
      Andrew J. Porges, MD PC, Roslyn,  New York,  11576,  United States; Recruiting
North Carolina
      Carolina Arthritis Allergy and Rheumatology Evaluation & Treatment Center, Raleigh,  North Carolina,  27609,  United States; Recruiting
Pennsylvania
      Clinical Research Center of Reading, LLP, West Reading,  Pennsylvania,  19611,  United States; Recruiting
      East Penn Rheumatology Associates, Bethlehem,  Pennsylvania,  18015,  United States; Recruiting
      Camp Hill Clinical Research Center, Camp Hill,  Pennsylvania,  17011,  United States; Recruiting
      Rheumatology Associates, PC, Colmar,  Pennsylvania,  18915,  United States; Not yet recruiting
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
South Carolina
      Low Country Rheumatology, Charleston,  South Carolina,  29406,  United States; Recruiting
      The Arthritis and Osteoporosis Center, PA, Orangeburg,  South Carolina,  29118,  United States; Recruiting
Tennessee
      Arthritis Clinic, Jackson,  Tennessee,  38305,  United States; Recruiting
      Arthritis Associates, Chattanooga,  Tennessee,  37404,  United States; Recruiting
      Memphis Medical Specialists, Memphis,  Tennessee,  38119,  United States; Recruiting
Texas
      Arthritis Care and Diagnostic Center, Dallas,  Texas,  75231,  United States; Recruiting
      Arthritis and Osteoporosis Associates, LLP, Lubbock,  Texas,  79410,  United States; Recruiting
      Radiant Research, Dallas,  Texas,  75235,  United States; Recruiting
      Austin Rheumatology & Osteoporosis, Austin,  Texas,  78705,  United States; Recruiting
Virginia
      Center for Arthritis and Rheumatic Disease, Chesapeake,  Virginia,  23320,  United States; Recruiting
Washington
      Physician's Clinic of Spokane, Spokane,  Washington,  99204,  United States; Recruiting
      Seattle Rheumatology Associates, PLLC, Seattle,  Washington,  98104,  United States; Recruiting
Wisconsin
      Rheumatic Disease Center, Glendale,  Wisconsin,  53217,  United States; Recruiting

Study ID Numbers:  SCIO-469/B007
Record last reviewed:  September 2004
Last Updated:  October 25, 2004
Record first received:  August 17, 2004
ClinicalTrials.gov Identifier:  NCT00089921
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08