Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
NCT00634933
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- Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.
- Any prior use of rituximab or other B cell depleting agents.
- Any significant health problem other than rheumatoid arthritis
- Clinically significant laboratory abnormalities
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis | |||
Official Title ICMJE | A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate | |||
Brief Summary | This study will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Arthritis, Rheumatoid | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | Terminated | |||
Actual Enrollment ICMJE | 222 | |||
Original Estimated Enrollment ICMJE | 216 | |||
Actual Study Completion Date ICMJE | October 2012 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | Belgium, Canada, France, Germany, Hungary, Mexico, Netherlands, Romania, Serbia, United States | |||
Removed Location Countries | Austria | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00634933 | |||
Other Study ID Numbers ICMJE | 3206K1-2203 B2051001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Trubion Pharmaceuticals/Emergent BioSolutions Inc. | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |