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Tracking Information | |||||
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First Received Date † | February 8, 2007 | ||||
Last Updated Date | December 20, 2007 | ||||
Start Date † | December 2002 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00433875 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Phase 2 AMG 714 in Rheumatoid Arthritis | ||||
Official Title † | A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs | ||||
Brief Summary | Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a 3 month observational period. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Parallel Assignment | ||||
Condition † | Rheumatoid Arthritis | ||||
Intervention † | Drug: AMG 714 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 180 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria: Diagnosis of RA - Exclusion Criteria: No prior biologic treatment for RA - |
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00433875 | ||||
Responsible Party | Global Development Leader, Amgen Inc. | ||||
Secondary IDs †† | |||||
Study Sponsor † | Amgen | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Amgen | ||||
Verification Date | December 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |