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Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

NCT02886728 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1252

Last updated 2021-06-01

Study results available
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Summary

The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

Filgotinib

Tablet(s) administered orally once daily

DRUG

Placebo to match filgotinib

Tablet(s) administered orally once daily

DRUG

MTX

Capsule(s) administered orally once weekly

DRUG

Placebo to match MTX

Capsule(s) administered orally 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-08
Primary Completion
2018-10-05
Completion
2019-05-08
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • New Zealand
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

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 NCT02886728 on ClinicalTrials.gov