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.
Summary
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-03
- Completion
- 2013-03
Outcome
Met primary endpoint
registry NUMBER FOSTA 100 MG BID PO: 39.6 Percentage of responders NCT01197534 ↗
registry NUMBER PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO: 24.5 Percentage of responders NCT01197534 ↗
registry p <0.001; Weighted difference in proportions 0.15 (95% CI 0.08 to 0.22) NCT01197534 ↗
release “OSKIRA-2 study of patients inadequately responding to disease modifying anti-rheumatic drugs (DMARDs), fostamatinib in combination with DMARDs showed statistically significant improvements” astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fostamatinib | Small molecule | 100 mg | Oral |
| Subject | Fostamatinib | Small molecule | 150 mg | Oral |