Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist
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 methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.
Timeline
- Start
- 2010-09
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry FOSTA 100 MG BID PO vs PLACEBO PO; p = 0.004; Weighted difference in proportion 0.17 (95% CI 0.05 to 0.28) reads as mixed primary results NCT01197755 ↗
registry FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO vs PLACEBO PO; p = 0.168; Weighted difference in proportion 0.07 (95% CI -0.03 to 0.18) reads as mixed primary results NCT01197755 ↗
release “OSKIRA-3 study of patients inadequately responding to methotrexate (MTX) and a single TNF-alpha antagonist, fostamatinib in combination with MTX showed statistically significant improvements” reads as met primary endpoint astrazeneca.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fostamatinib | Small molecule | 100 mg | Oral |
| Subject | Fostamatinib | Small molecule | 150 mg | Oral |