The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: TMI-005	Phase II

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Meet American College of Rheumatology (ACR) criteria for RA.
• Disease duration of at least 6 months.
• Disease onset at > 16 years of age.
• Must be currently treated with a stable, well-tolerated dose of MTX (7.5 to 20 mg) given once weekly for at least 12 weeks before the baseline visit
• Women of childbearing potential, who have a negative pregnancy test result, as well as all male subjects, must agree to use a medically acceptable method of birth control during the study and for at least 12 weeks after the last dose of test article.
• Be able and willing to comply with study visits and procedures specified in this protocol.
• Understand, sign, and date the written voluntary informed consent form at the screening visit before any protocol-specific procedures are performed.

Exclusion Criteria:

• Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra).
• Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article.
• History of poor compliance or history of drug abuse/alcohol abuse, excessive alcohol beverage consumption or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
• Any condition that the physician judges could be detrimental to subjects participating in this study, including any clinically important deviations from normal clinical laboratory values or important concurrent medical events, as detailed in the protocol body.

Indiana
      Physicians Research Group, Indianapolis,  Indiana,  46250,  United States; Recruiting
New York
      Arthritis Health Associates, Syracuse,  New York,  13210,  United States; Recruiting
Pennsylvania
      Clinical Research Center of Reading LLP, West Reading,  Pennsylvania,  19611,  United States; Recruiting
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
Canada, Quebec
      Centre de Rhumatologie St-Louis, Ste Foy,  Quebec,  G1W 4R4,  Canada; Recruiting
      Institute de Rhumatologie de Montreal, Montreal,  Quebec,  H2L 1S6,  Canada; Recruiting
      Centre de Recherche Musculo-Squelettique, Trois-Rivieres,  Quebec,  G8Z 1Y2,  Canada; Recruiting
Canada, Saskatchewan
      Saskatoon  Osteoporosis  Centre, Saskatoon,  Saskatchewan,  S7K 0H6,  Canada; Recruiting

Study ID Numbers:  3140A1-200-WW
Record last reviewed:  November 2004
Last Updated:  November 3, 2004
Record first received:  November 2, 2004
ClinicalTrials.gov Identifier:  NCT00095342
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08