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Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Are Naive to Biologic DMARD Therapy

NCT04115748 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-05-16

Study results available
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Summary

The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE).

Conditions

Interventions

DRUG

Filgotinib

Tablets administered orally once daily with or without food

DRUG

Adalimumab

Injection administered subcutaneously once every 2 weeks

DRUG

Placebo to match filgotinib

Tablets administered orally once daily with or without food

DRUG

Placebo to match adalimumab

Injection administered subcutaneously once every 2 weeks

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
2019-12-03
Primary Completion
2021-01-19
Completion
2021-05-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Czechia
  • Hungary
  • Japan
  • New Zealand
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT04115748 on ClinicalTrials.gov