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| Sponsors and Collaborators: |
Wyeth Trubion Pharmaceuticals |
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00634933 |
Purpose
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.
| Condition | Intervention | Phase |
|
Active Rheumatoid Arthritis |
Drug: TRU-015 Other: Placebo |
Phase II |
| MedlinePlus related topics: | Rheumatoid Arthritis |
| ChemIDplus related topics: | Methotrexate |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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 Background of Methotrexate |
| Estimated Enrollment: | 216 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Arm 1: Experimental | Drug: TRU-015 |
| Arm 2: Experimental | Drug: TRU-015 |
| Arm 3: Placebo Comparator | Other: Placebo |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Trial Manager | clintrialparticipation@wyeth.com |
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Show 30 Study Locations |
| Wyeth |
| Trubion Pharmaceuticals |
| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3206K1-2203 |
| First Received: | March 5, 2008 |
| Last Updated: | August 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00634933 |
| Health Authority: | United States: Food and Drug Administration |
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