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Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

NCT03025308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2731

Last updated 2025-07-03

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

Filgotinib

Tablet(s) administered orally once daily

DRUG

Placebo to match filgotinib

Tablet(s) administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Alfasigma Study Director · Alfasigma S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2025-05-16
Completion
2025-05-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • 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 NCT03025308 on ClinicalTrials.gov