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

NCT ID: NCT03320876

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2021-06-30

Brief 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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

filgotinib

Group Type: EXPERIMENTAL

filgotinib

Intervention Type: DRUG

one filgotinib oral tablet once daily.

Interventions

filgotinib

one filgotinib oral tablet once daily.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vijay Rajendran, MD

Role: STUDY_DIRECTOR

Galapagos NV

Locations

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

Twoja Przychodnia-Centrum Medyczne Nowa Sol

Nowa Sól, , Poland

Ai Centrum Medyczne sp. z o.o. sp.k.

Poznan, , Poland

Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna

Torun, , Poland

Centrum Medyczne AMED, Warszawa Targowek

Warsaw, , Poland

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

Fuenlabrada, , Spain

Hospital Infanta Luisa, Servicio de Reumatologia

Seville, , Spain

CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics

Kharkiv, , Ukraine

CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy

Kiev, , Ukraine

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh

Kyiv, , Ukraine

CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology

Lviv, , Ukraine

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy

Poltava, , Ukraine

CI of TRC

Ternopil, , Ukraine

M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1

Vinnytsia, , Ukraine

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Vinnytsia, , Ukraine

SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy

Vinnytsia, , Ukraine

Countries

Belgium; Bulgaria; Czechia; Estonia; Poland; Spain; Ukraine

Other Identifiers

2017-000545-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0634-CL-225

Identifier Type: -

Identifier Source: org_study_id