Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

Summary

The purpose of the study is to evaluate the effectiveness of four 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 12 weeks.

Timeline

Start

2012-04

Primary completion

2013-07

Completion

2013-07

Outcome

Missed primary endpoint

Stopped: “AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.”

registry FOSTA 100 MG BID PO vs PLACEBO PO; p = 0.059 NCT01569074 ↗

registry FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO vs PLACEBO PO; p = 0.054 NCT01569074 ↗

registry FOSTA 75 MG BID PO vs PLACEBO PO; p = 0.570 NCT01569074 ↗

registry FOSTA 50 MG BID PO vs PLACEBO PO; p = 0.262 NCT01569074 ↗

Publications

• Tanaka Y, Millson D, Iwata S, Nakayamada S. Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study. Rheumatology (Oxford). 2021 Jun 18;60(6):2884-2895. doi: 10.1093/rheumatology/keaa732.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fostamatinib	Small molecule	50 mg	Oral
Subject	Fostamatinib	Small molecule	75 mg	Oral
Subject	Fostamatinib	Small molecule	100 mg	Oral
Subject	Fostamatinib	Small molecule	150 mg	Oral

Indications