Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- AstraZeneca
- Study ID
- NCT01197534
- 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 disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.
Key Dates
- Start date
- Sep 30, 2010
- Status verified
- Mar 2014
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
Study Design
- Enrollment
- 913 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 (57)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | - | - |
| Research Site | Glendale | Arizona | - | - |
| Research Site | Mesa | Arizona | - | - |
| Research Site | Phoenix | Arizona | - | - |
| Research Site | Scottsdale | Arizona | - | - |
| Research Site | Tucson | Arizona | - | - |
| Research Site | Hot Springs | Arkansas | - | - |
| Research Site | Huntington Beach | California | - | - |
| Research Site | Torrance | California | - | - |
| Research Site | Trumbull | Connecticut | - | - |
| Research Site | Washington D.C. | District of Columbia | - | - |
| Research Site | Boca Raton | Florida | - | - |
| Research Site | Brandon | Florida | - | - |
| Research Site | Jacksonville | Florida | - | - |
| Research Site | Miami | Florida | - | - |
| Research Site | Orlando | Florida | - | - |
| Research Site | Tampa | Florida | - | - |
| Research Site | Venice | Florida | - | - |
| Research Site | Zephyrhills | Florida | - | - |
| Research Site | Canton | Georgia | - | - |
| Research Site | Decatur | Georgia | - | - |
| Research Site | Macon | Georgia | - | - |
| Research Site | Boise | Idaho | - | - |
| Research Site | South Bend | Indiana | - | - |
| Research Site | Elizabethtown | Kentucky | - | - |
| Research Site | Crofton | Maryland | - | - |
| Research Site | Cumberland | Maryland | - | - |
| Research Site | Hagerstown | Maryland | - | - |
| Research Site | Kalamazoo | Michigan | - | - |
| Research Site | Flowood | Mississippi | - | - |
| Research Site | St Louis | Missouri | - | - |
| Research Site | Kalispell | Montana | - | - |
| Research Site | Omaha | Nebraska | - | - |
| Research Site | Manalapan | New Jersey | - | - |
| Research Site | Las Cruces | New Mexico | - | - |
| Research Site | Brooklyn | New York | - | - |
| Research Site | Rochester | New York | - | - |
| Research Site | Roslyn | New York | - | - |
| Research Site | Syracuse | New York | - | - |
| Research Site | Charlotte | North Carolina | - | - |
| Research Site | Durham | North Carolina | - | - |
| Research Site | Dayton | Ohio | - | - |
| Research Site | Duncansville | Pennsylvania | - | - |
| Research Site | Philadelphia | Pennsylvania | - | - |
| Research Site | West Reading | Pennsylvania | - | - |
| Research Site | Greenville | South Carolina | - | - |
| Research Site | Orangeburg | South Carolina | - | - |
| Research Site | Memphis | Tennessee | - | - |
| Research Site | Amarillo | Texas | - | - |
| Research Site | Austin | Texas | - | - |
| Research Site | Dallas | Texas | - | - |
| Research Site | Houston | Texas | - | - |
| Research Site | Lubbock | Texas | - | - |
| Research Site | Mesquite | Texas | - | - |
| Research Site | San Antonio | Texas | - | - |
| Research Site | Chesapeake | Virginia | - | - |
| Research Site | Tacoma | Washington | - | - |
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