Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

Summary

The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active RA as measured by change from baseline in Disease Activity Score for 28 joint count using C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.

Timeline

Start

2016-09-21

Primary completion

2017-08-22

Completion

2017-09-20

Outcome

Missed primary endpoint

registry analysis (superiority test); GS-9876 30 mg vs Placebo; p = 0.978; Least Squares (LS) Means of Differences 0.01 (95% CI - 0.74 to 0.76); NCT02885181 ↗

registry analysis (superiority test); GS-9876 10 mg vs Placebo; p = 0.300; LS Means of Differences 0.40 (95% CI - 0.36 to 1.16); NCT02885181 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Filgotinib	Small molecule	—	Oral
Subject	GS-9876	Unknown	10 mg	Oral
Subject	GS-9876	Unknown	30 mg	Oral
Background	Methotrexate	Small molecule	—	Oral

Indications