Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate 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 methotrexate but not responding. The study will last for 1 year.

Timeline

Start

2010-09

Primary completion

2012-11

Completion

2012-11

Outcome

Mixed primary results

registry NUMBER FOSTA 100 MG BID PO: 49.0 Percentage of responders NCT01197521 ↗

registry NUMBER PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO: 34.2 Percentage of responders NCT01197521 ↗

registry analysis (superiority or other test); FOSTA 100 MG BID PO vs PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO; p <0.001 NCT01197521 ↗

registry analysis (superiority or other test); FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO vs PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO; p = 0.006 NCT01197521 ↗

registry analysis (superiority or other test); FOSTA 100 MG BID PO vs PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO; p = 0.252 NCT01197521 ↗

registry analysis (superiority or other test); FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO vs PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO; p = 0.170 NCT01197521 ↗

Publications

• Kjelgaard-Petersen CF, Platt A, Braddock M, Jenkins MA, Musa K, Graham E, Gantzel T, Slynn G, Weinblatt ME, Karsdal MA, Thudium CS, Bay-Jensen AC. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Sep;70(9):1419-1428. doi: 10.1002/art.40527. Epub 2018 Jul 24.

Drugs

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

Indications