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Adult Trials: 18+ Years
- 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.
- 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
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating TMI-005 in Active Rheumatoid Arthritis | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
| Condition ICMJE | Rheumatoid Arthritis | |||
| Intervention ICMJE | Drug: TMI-005 | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 390 | |||
| Original Enrollment ICMJE | Not Provided | |||
| Actual Study Completion Date ICMJE | August 2005 | |||
| Actual Primary Completion Date | August 2005 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00095342 | |||
| Other Study ID Numbers ICMJE | 3140A1-200 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||