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| Sponsor: | Wyeth |
|---|---|
| Collaborator: |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, 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 |
| Enrollment: | 235 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | March 2010 (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
Show 40 Study Locations| Study Director: | Medical Monitor | Wyeth |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 3206K1-2203 |
| Study First Received: | March 5, 2008 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00634933 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Rheumatoid arthritis anti CD20 |
|
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |