Study Evaluating TMI-005 in Active Rheumatoid Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00095342 |
Recruitment Status :
Completed
First Posted : November 3, 2004
Last Update Posted : September 10, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: TMI-005 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | August 2005 |
Actual Study Completion Date : | August 2005 |


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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00095342
United States, Indiana | |
Indianapolis, Indiana, United States, 46250 | |
United States, New York | |
Syracuse, New York, United States, 13210 | |
United States, Pennsylvania | |
Duncansville, Pennsylvania, United States, 16635 | |
West Reading, Pennsylvania, United States, 19611 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H2L 1S6 | |
Ste-Foy, Quebec, Canada, G1W 4R4 | |
Trois-Rivieres, Quebec, Canada, G8Z 1Y2 | |
Canada, Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7K 0H6 |
Study Director: | Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer |
ClinicalTrials.gov Identifier: | NCT00095342 |
Other Study ID Numbers: |
3140A1-200 |
First Posted: | November 3, 2004 Key Record Dates |
Last Update Posted: | September 10, 2009 |
Last Verified: | September 2009 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |