Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00634933 |
Recruitment Status :
Terminated
(The study was terminated on 21 June 2010 due to results not meeting the primary endpoint. No safety reasons contributed to the termination of the study.)
First Posted : March 13, 2008
Results First Posted : March 11, 2013
Last Update Posted : March 11, 2013
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Sponsor:
Pfizer
Collaborator:
Trubion Pharmaceuticals/Emergent BioSolutions Inc.
Information provided by (Responsible Party):
Pfizer
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Tracking Information | ||||
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First Submitted Date ICMJE | March 5, 2008 | |||
First Posted Date ICMJE | March 13, 2008 | |||
Results First Submitted Date ICMJE | December 27, 2012 | |||
Results First Posted Date ICMJE | March 11, 2013 | |||
Last Update Posted Date | March 11, 2013 | |||
Study Start Date ICMJE | March 2008 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24 [ Time Frame: Week 24 ] ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).
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Original Primary Outcome Measures ICMJE |
American College of Rheumatology (ACR) 50 response [ Time Frame: at week 24 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Secondary efficacy measures include ACR responses and DAS-28. MRI, cytokines and B cells subsets and pharmacogenomics substudies will be performed and reported. [ Time Frame: Week 24 through week 52 ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
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 |
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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. |
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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 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Pfizer | |||
Original Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Current Study Sponsor ICMJE | Pfizer | |||
Original Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of 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 |