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An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis. | Clinical Trials | Clareo Health

TERMINATEDPHASE2

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

A Multicenter, Open-label, Long-term Extension Safety and Efficacy Study of Filgotinib Treatment in Subjects With Moderately to Severely Active Psoriatic Arthritis.

NCT03320876•Galapagos NV

View on ClinicalTrials.gov

Summary

This is a Phase 2, multicenter, open-label, single arm, Long Term Extension (LTE) safety, tolerability and efficacy study of filgotinib in subjects with moderately to severely active PsA. It is estimated that approximately 105 subjects will be rolled-over after they have completed the 16 weeks of double-blind treatment in core study GLPG0634-CL-224. Subjects will be administered filgotinib in this study until filgotinib is registered for PsA or until Week 304, whichever occurs first. The LTE study is concluded with a follow-up visit approximately 4 weeks after the last intake of study treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects who are ≥18 years of age, having completed the 16 weeks of treatment in the qualifying core study GLPG0634-CL-224 and who may benefit from filgotinib long-term treatment according to the investigator's judgment.
•Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to continue to use highly effective methods of contraception as described in the protocol.
•Able and willing to sign the informed consent form (ICF), as approved by the Independent Ethics Committee (IEC) and agree to the schedule of assessments.

Exclusion Criteria

•Subjects who are deemed not to be benefitting from the study drug based upon lack of improvement or worsening of their symptoms. Local guidelines for subject treatment need to be followed.
•Persistent abnormal laboratory values associated with the use of the study drug (including and not limited to hematology, liver and renal function values), according to the investigator's clinical judgment.
•Subjects who discontinued the qualifying core study GLPG0634-CL-224 due to safety or tolerability issues.
•Subjects who require immunization with live/live attenuated vaccine.
•Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than psoriatic arthritis, except for Sjögren's syndrome.
•Subjects with symptoms suggestive of uncontrolled hypertension, congestive heart failure, uncontrolled diabetes, cerebrovascular accident, myocardial infarction, unstable angina, unstable arrhythmia or any other cardiovascular condition since the inclusion to the GLPG0634- CL-224 study.
•Subjects with symptoms suggestive of gastrointestinal tract ulceration and/or active diverticulitis since the inclusion to the GLPG0634-CL-224 study.
•Subjects with symptoms suggestive of possible lymphoproliferative disease including lymphadenopathy or splenomegaly since the inclusion to the GLPG0634-CL-224 study.
•Subjects with symptoms suggestive of malignancy since the inclusion to the GLPG0634-CL-224 study.

Locations (25)

ULB Hopital Erasme, Service de Rheumatology

Brussels, Belgium

UMHAT "Kaspela", EOOD

Plovdiv, Bulgaria

MHAT - Ruse, AD

Rousse, Bulgaria

UMHAT "SofiaMed", OOD, Block 1

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, Bulgaria

CCBR Czech, a.s

Pardubice, Czechia

MEDICAL PLUS s.r.o.

Uherské Hradiště, Czechia

Center for Clinical and Basic Research

Tallinn, Estonia

North Estonia Medical Centre Foundation

Tallinn, Estonia

OÜ Innomedica

Tallinn, Estonia

Key Dates

Start Date

July 26, 2017

Primary Completion Date

June 30, 2021

Completion Date

June 30, 2021

Last Updated

April 21, 2022

Enrollment

122

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

filgotinib

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

View study

RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

View study

RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

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Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis