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

Primary Purpose

Psoriatic Arthritis

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

filgotinib

About this trial

This is an interventional treatment trial for Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

ULB Hopital Erasme, Service de Rheumatology
UMHAT "Kaspela", EOOD
MHAT - Ruse, AD
UMHAT "SofiaMed", OOD, Block 1
UMHAT "Sv. Ivan Rilski", EAD
CCBR Czech, a.s
MEDICAL PLUS s.r.o.
Center for Clinical and Basic Research
North Estonia Medical Centre Foundation
OÜ Innomedica
Twoja Przychodnia-Centrum Medyczne Nowa Sol
Ai Centrum Medyczne sp. z o.o. sp.k.
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
Centrum Medyczne AMED, Warszawa Targowek
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
Hospital Infanta Luisa, Servicio de Reumatologia
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
CI of TRC
M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

filgotinib

Arm Description

Outcomes

Primary Outcome Measures

Change in the proportion of subjects with adverse events

To asses safety and tolerability of filgotinib.

Secondary Outcome Measures

Proportion of subjects achieving minimal disease activity (MDA)

To assess the effect of filgotinib on MDA in PsA patients.

Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response

To assess the effect of filgotinib on PsA as assessed by ACR20 in PsA patients.

Proportion of subjects achieving ACR50 response

To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.

Proportion of subjects achieving ACR70 response

To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients

Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Proportion of subjects with DAPSA remission (DAPSA ≤4)

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Change from core baseline in Psoriasis Area and Severity Index (PASI)

To assess the effect of filgotinib on PASI in PsA patients.

Proportion of subjects with PASI50

To assess the effect of filgotinib on PASI50 in PsA patients.

Proportion of subjects with PASI75

To assess the effect of filgotinib on PASI75 in PsA patients.

Proportion of subjects with PASI90

To assess the effect of filgotinib on PASI90 in PsA patients.

Proportion of subjects with PASI100

To assess the effect of filgotinib on PASI100 in PsA patients.

Change from core baseline in Physician's global assessment of psoriasis

To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.

Change from core baseline in Patient's Global Assessment of psoriasis

To assess the affect of filgotinib on patient's global assessment of psoriasis in PsA patients.

Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)

To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.

Change from core baseline in pruritis numeric rating scale (NRS)

To assess the effect of filgotinib on NRS in PsA patients.

Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)

To assess the effect of filgotinib on NRS in PsA patients.

Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index

To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.

Change from core baseline in Leeds Dactylitis Index (LDI)

To assess the effect of filgotinib on Dactilytis in PsA patients.

Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

To assess the effect of filgotinib on physical function in PsA patients.

Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)

To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.

Change from core baseline in 36-item Short-Form Health Survey (SF-36)

To assess the effect of filgotinib on SF-36 in PsA patients

Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).

To assess the effect of filgotinib on PsAID in PsA patients.

Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria

To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical function in PsA patients.

Full Information

NCT ID

NCT03320876

First Posted

October 20, 2017

Last Updated

April 20, 2022

Sponsor

Galapagos NV

1. Study Identification

Unique Protocol Identification Number

NCT03320876

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Terminated

Why Stopped

development program for filgotinib for participants with psoriatic arthritis has been stopped

Study Start Date

July 26, 2017 (Actual)

Primary Completion Date

June 30, 2021 (Actual)

Study Completion Date

June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galapagos NV

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

filgotinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

filgotinib

Intervention Description

one filgotinib oral tablet once daily.

Primary Outcome Measure Information:

Title

Change in the proportion of subjects with adverse events

Description

To asses safety and tolerability of filgotinib.

Time Frame

Between entry visit and 4 weeks after the last dose.

Secondary Outcome Measure Information:

Title

Proportion of subjects achieving minimal disease activity (MDA)

Description

To assess the effect of filgotinib on MDA in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response

Description

To assess the effect of filgotinib on PsA as assessed by ACR20 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects achieving ACR50 response

Description

To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects achieving ACR70 response

Description

To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)

Description

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)

Description

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)

Description

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)

Description

To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)

Description

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)

Description

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with DAPSA remission (DAPSA ≤4)

Description

To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Psoriasis Area and Severity Index (PASI)

Description

To assess the effect of filgotinib on PASI in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with PASI50

Description

To assess the effect of filgotinib on PASI50 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with PASI75

Description

To assess the effect of filgotinib on PASI75 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with PASI90

Description

To assess the effect of filgotinib on PASI90 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects with PASI100

Description

To assess the effect of filgotinib on PASI100 in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Physician's global assessment of psoriasis

Description

To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Patient's Global Assessment of psoriasis

Description

To assess the affect of filgotinib on patient's global assessment of psoriasis in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)

Description

To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in pruritis numeric rating scale (NRS)

Description

To assess the effect of filgotinib on NRS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)

Description

To assess the effect of filgotinib on NRS in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index

Description

To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Leeds Dactylitis Index (LDI)

Description

To assess the effect of filgotinib on Dactilytis in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)

Description

To assess the effect of filgotinib on physical function in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

Title

Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)

Description

To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.

Time Frame

W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.

Title

Change from core baseline in 36-item Short-Form Health Survey (SF-36)

Description

To assess the effect of filgotinib on SF-36 in PsA patients

Time Frame

W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.

Title

Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).

Description

To assess the effect of filgotinib on PsAID in PsA patients.

Time Frame

W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.

Title

Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria

Description

To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical function in PsA patients.

Time Frame

At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vijay Rajendran, MD

Organizational Affiliation

Galapagos NV

Official's Role

Study Director

Facility Information:

Facility Name

ULB Hopital Erasme, Service de Rheumatology

City

Brussels

Country

Belgium

Facility Name

UMHAT "Kaspela", EOOD

City

Plovdiv

Country

Bulgaria

Facility Name

MHAT - Ruse, AD

City

Ruse

Country

Bulgaria

Facility Name

UMHAT "SofiaMed", OOD, Block 1

City

Sofia

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski", EAD

City

Sofia

Country

Bulgaria

Facility Name

CCBR Czech, a.s

City

Pardubice

Country

Czechia

Facility Name

MEDICAL PLUS s.r.o.

City

Uherské Hradiště

Country

Czechia

Facility Name

Center for Clinical and Basic Research

City

Tallinn

Country

Estonia

Facility Name

North Estonia Medical Centre Foundation

City

Tallinn

Country

Estonia

Facility Name

OÜ Innomedica

City

Tallinn

Country

Estonia

Facility Name

Twoja Przychodnia-Centrum Medyczne Nowa Sol

City

Nowa Sól

Country

Poland

Facility Name

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

City

Poznań

Country

Poland

Facility Name

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

City

Toruń

Country

Poland

Facility Name

Centrum Medyczne AMED, Warszawa Targowek

City

Warsaw

Country

Poland

Facility Name

Hospital Universitario de Fuenlabrada, Servicio de Reumatologia

City

Fuenlabrada

Country

Spain

Facility Name

Hospital Infanta Luisa, Servicio de Reumatologia

City

Sevilla

Country

Spain

Facility Name

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

City

Kharkiv

Country

Ukraine

Facility Name

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

City

Kiev

Country

Ukraine

Facility Name

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

City

Kyiv

Country

Ukraine

Facility Name

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

City

L'viv

Country

Ukraine

Facility Name

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

City

Poltava

Country

Ukraine

Facility Name

CI of TRC

City

Ternopil'

Country

Ukraine

Facility Name

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

City

Vinnytsia

Country

Ukraine

Facility Name

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

City

Vinnytsia

Country

Ukraine

Facility Name

MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology

City

Vinnytsya

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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