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

Psoriatic Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03320876
• Other study ID #: GLPG0634-CL-225
• Secondary ID: 2017-000545-52
• Status: Terminated
• Phase: Phase 2
• Start date: July 26, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 122
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• filgotinib
one filgotinib oral tablet once daily.

Locations

Country	Name	City	State
Belgium	ULB Hopital Erasme, Service de Rheumatology	Brussels
Bulgaria	UMHAT "Kaspela", EOOD	Plovdiv
Bulgaria	MHAT - Ruse, AD	Ruse
Bulgaria	UMHAT "SofiaMed", OOD, Block 1	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Czechia	CCBR Czech, a.s	Pardubice
Czechia	MEDICAL PLUS s.r.o.	Uherské Hradište
Estonia	Center for Clinical and Basic Research	Tallinn
Estonia	North Estonia Medical Centre Foundation	Tallinn
Estonia	OÜ Innomedica	Tallinn
Poland	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
Spain	Hospital Universitario de Fuenlabrada, Servicio de Reumatologia	Fuenlabrada
Spain	Hospital Infanta Luisa, Servicio de Reumatologia	Sevilla
Ukraine	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 NS? 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	L'viv
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	SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy	Vinnytsia
Ukraine	MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology	Vinnytsya

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

Belgium,  Bulgaria,  Czechia,  Estonia,  Poland,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of subjects with adverse events	To asses safety and tolerability of filgotinib.	Between entry visit and 4 weeks after the last dose.
Secondary	Proportion of subjects achieving minimal disease activity (MDA)	To assess the effect of filgotinib on MDA in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects achieving ACR50 response	To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects achieving ACR70 response	To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with DAPSA remission/LDA (DAPSA =14)	To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with DAPSA remission (DAPSA =4)	To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Change from core baseline in Psoriasis Area and Severity Index (PASI)	To assess the effect of filgotinib on PASI in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with PASI50	To assess the effect of filgotinib on PASI50 in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with PASI75	To assess the effect of filgotinib on PASI75 in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with PASI90	To assess the effect of filgotinib on PASI90 in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Proportion of subjects with PASI100	To assess the effect of filgotinib on PASI100 in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Change from core baseline in pruritis numeric rating scale (NRS)	To assess the effect of filgotinib on NRS in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Change from core baseline in Leeds Dactylitis Index (LDI)	To assess the effect of filgotinib on Dactilytis in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)	To assess the effect of filgotinib on physical function in PsA patients.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Secondary	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.	W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Secondary	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	W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Secondary	Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).	To assess the effect of filgotinib on PsAID in PsA patients.	W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
Secondary	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.	At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.