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 patients with RA. The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients.

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

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

Criteria

Inclusion Criteria:

• Patients who have active rheumatoid arthritis and are receiving methotrexate

Exclusion Criteria:

• Used Enbrel, Remicaid, Kineret, or an experimental biologic agent within past 3 months
• Elevation of liver enzymes within past 6 months
• Tuberculosis
• Vertigo, inner ear, or vestibular abnormalities
• Cancer
• HIV-positive
• Abnormal electrocardiogram
• Chronic or acute infection
• Multiple sclerosis, neuropathy or encephalopathy

Alabama
      Rheumatology Associates of North Alabama, Huntsville,  Alabama,  35801,  United States
Arizona
      Arizona Research and Education, Phoenix,  Arizona,  85012,  United States
California
      Boling Clinical Trials, Rancho Cucamonga,  California,  91730,  United States
      University of California San Francisco, San Francisco,  California,  94143-0326,  United States
      Stanford, Palo Alto,  California,  94304,  United States
      UCSD, La Jolla,  California,  92037,  United States
      Pacific Arthritis Center Medical Group, Santa Maria,  California,  93454,  United States
      Harbor - UCLA Medical Center, Torrance,  California,  90502,  United States
      Wallace Rheumatic Study Center, Los Angeles,  California,  90048,  United States
Florida
      MIMA Century Research Associates, Melbourne,  Florida,  32901,  United States
      Ocala Rheumatology Research Center, Ocala,  Florida,  34474,  United States
      Sarasota Arthritis Research Center, Sarasota,  Florida,  34239,  United States
      Arthritis Center, Palm Harbor,  Florida,  34684,  United States
      Jacksonville Center for Clinical Research, Jacksonville,  Florida,  32216,  United States
      Miami Research Associates, Miami,  Florida,  33173,  United States
Illinois
      Rush - Presbyterian - St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States
Kentucky
      Kentuckiana Center for Better Bone & Joint Health, Louisville,  Kentucky,  40202,  United States
Maryland
      Arthritis & Osteoporosis Center of Maryland 2, Frederick,  Maryland,  2170,  United States
Missouri
      Arthritis Consultants, Inc., St. Louis,  Missouri,  63141,  United States
Ohio
      Radiant Research - Columbus, Columbus,  Ohio,  43212,  United States
Pennsylvania
      Radiant Research - Philadelphia, Philadelphia,  Pennsylvania,  19115,  United States
      Clinical Research Center of Reading, LLP, West Reading,  Pennsylvania,  19611,  United States
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States
Texas
      Protocare Trials San Antonio Center for Clinical Research, San Antonio,  Texas,  78217,  United States
      Austin Rheumatology Research, Austin,  Texas,  78705,  United States
      Amarillo Center for Clinical Research, LTD, Amarillo,  Texas,  79106,  United States
Utah
      University of Utah, Salt Lake City,  Utah,  84132,  United States
Washington
      Physicians Clinic of Spokane, Spokane,  Washington,  99204,  United States
      Seattle Rheumatology Associates, Seattle,  Washington,  98104,  United States
      South Puget Sound Clinical Research, Olympia,  Washington,  98502,  United States

Study ID Numbers:  782.344
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  August 12, 2002
ClinicalTrials.gov Identifier:  NCT00043732
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08