Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
Part of paid clinical trials in Anniston, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT01197521
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- fostamatinib — DRUGfostamatinib 100 mg twice daily
- fostamatinib — DRUGfostamatinib 100 mg twice daily/150 mg once daily
- placebo, fostamatinib — DRUGPlacebo for 24 weeks followed by fostamatinib 100 mg twice daily
Study Details
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Key Dates
- Start date
- Sep 30, 2010
- Status verified
- Feb 2014
- Primary completion
- Nov 30, 2012
- Completion
- Nov 30, 2012
Study Design
- Enrollment
- 923 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dosing Regimen AOral Treatment
- Experimental: Dosing Regimen BOral Treatment
- Placebo Comparator: Dosing Regimen COral Treatment
Primary Outcome Measure
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo. [ Time Frame: 24 weeks ]
Locations (41)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Anniston | Alabama | - | - |
| Research Site | Huntsville | Alabama | - | - |
| Research Site | Tuscaloosa | Alabama | - | - |
| Research Site | Tucson | Arizona | - | - |
| Research Site | Huntington Beach | California | - | - |
| Research Site | Long Beach | California | - | - |
| Research Site | Santa Maria | California | - | - |
| Research Site | Santa Monica | California | - | - |
| Research Site | Colorado Springs | Colorado | - | - |
| Research Site | Bridgeport | Connecticut | - | - |
| Research Site | Lewes | Delaware | - | - |
| Research Site | Daytona Beach | Florida | - | - |
| Research Site | Ocala | Florida | - | - |
| Research Site | Atlanta | Georgia | - | - |
| Research Site | Marietta | Georgia | - | - |
| Research Site | Idaho Falls | Idaho | - | - |
| Research Site | Springfield | Illinois | - | - |
| Research Site | Wichita | Kansas | - | - |
| Research Site | Bowling Green | Kentucky | - | - |
| Research Site | Flowood | Mississippi | - | - |
| Research Site | Florissant | Missouri | - | - |
| Research Site | Richmond Heights | Missouri | - | - |
| Research Site | St Louis | Missouri | - | - |
| Research Site | Kalispell | Montana | - | - |
| Research Site | Albuquerque | New Mexico | - | - |
| Research Site | Albany | New York | - | - |
| Research Site | Brooklyn | New York | - | - |
| Research Site | Olean | New York | - | - |
| Research Site | Asheville | North Carolina | - | - |
| Research Site | Greensboro | North Carolina | - | - |
| Research Site | Perrysburg | Ohio | - | - |
| Research Site | Lake Oswego | Oregon | - | - |
| Research Site | Erie | Pennsylvania | - | - |
| Research Site | Waxford | Pennsylvania | - | - |
| Research Site | Charleston | South Carolina | - | - |
| Research Site | Hixson | Tennessee | - | - |
| Research Site | Memphis | Tennessee | - | - |
| Research Site | Dallas | Texas | - | - |
| Research Site | Houston | Texas | - | - |
| Research Site | Mesquite | Texas | - | - |
| Research Site | San Antonio | Texas | - | - |
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