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

NCT02885181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2018-09-19

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-21
Primary Completion
2017-08-22
Completion
2017-09-20
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Georgia
  • Moldova
  • Poland
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02885181 on ClinicalTrials.gov