NCT02885181

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

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Proof-of-Concept Study to Evaluate Safety, Tolerability, and Efficacy of GS-9876 in Subjects With Active Rheumatoid Arthritis on Background Therapy With Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GS-9876	One tablet administered orally once daily
DRUG	Filgotinib	Two tablets administered orally once daily
DRUG	GS-9876 placebo	One tablet administered orally once daily
DRUG	Filgotinib placebo	Two tablets administered orally once daily
DRUG	Methotrexate	Background therapy with methotrexate administered orally or parenterally once weekly

Timeline

• Start date: 2016-09-21
• Primary completion: 2017-08-22
• Completion: 2017-09-20
• First posted: 2016-08-31
• Last updated: 2018-09-19
• Results posted: 2018-09-19

Locations

19 sites across 7 countries: United States, Bulgaria, Czechia, Georgia, Moldova, Poland, Ukraine

Regulatory

• FDA-regulated drug study