Trials / Completed
CompletedNCT00665925
Efficacy and Safety Study of R935788 Tablets to Treat Rheumatoid Arthritis
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of Two Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 457 (actual)
- Sponsor
- Rigel Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether the Spleen Tyrosine Kinase (Syk) inhibitor, R935788 (R788), at a dose of 100 mg, orally, twice-a-day, and/or a dose of of 150 mg, orally, once-a-day is effective in the treatment of Rheumatoid Arthrits in patients who have had an inadequate clinical response to methotrexate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fostamatinib disodium (R935788) | 100 mg tablet, orally, twice-a-day |
| DRUG | Fostamatinib disodium (R935788) | 150 mg tablet, orally, once a day |
| DRUG | Placebo | Placebo, orally, either once a day, or twice a day |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2009-06-01
- Completion
- 2009-06-01
- First posted
- 2008-04-24
- Last updated
- 2016-09-16
- Results posted
- 2016-06-13
Locations
65 sites across 6 countries: United States, Bulgaria, Colombia, Mexico, Poland, Romania
Source: ClinicalTrials.gov record NCT00665925. Inclusion in this directory is not an endorsement.