Study Evaluating TMI-005 in Active Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00095342

Purpose

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	Intervention	Phase
Rheumatoid Arthritis	Drug: TMI-005	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meet American College of Rheumatology (ACR) criteria for RA
Have active RA
Disease duration of at least 6 months
Disease onset at > 16 years of age.

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)
Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095342

Locations

United States, Indiana

Indianapolis, Indiana, United States, 46250
United States, New York

Syracuse, New York, United States, 13210
United States, Pennsylvania

West Reading, Pennsylvania, United States, 19611

Duncansville, Pennsylvania, United States, 16635
Canada, Quebec

Ste-Foy, Quebec, Canada, G1W 4R4

Montreal, Quebec, Canada, H2L 1S6

Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan

Saskatoon, Saskatchewan, Canada, S7K 0H6

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor, MD

Wyeth

More Information

Study ID Numbers:	3140A1-200
Study First Received:	November 2, 2004
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00095342
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009