Clinical trial NCT03320876: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the proportion of subjects with adverse events
timeFrame: Between entry visit and 4 weeks after the last dose.
Secondary outcomes:
measure: Proportion of subjects achieving minimal disease activity (MDA)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects achieving ACR50 response
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects achieving ACR70 response
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with PASDAS Very Low Disease Activity (VLDA) (i.e. PASDAS ≤1.9)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Percentage of patients subjects with PASDAS VLDA (i.e. PASDAS ≤1.9)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with DAPSA remission (DAPSA ≤4)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with PASI50
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with PASI75
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with PASI90
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects with PASI100
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Physician's global assessment of psoriasis
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Patient's Global Assessment of psoriasis
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in modified Nail Psoriasis Area and Severity Index (mNAPSI)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in pruritis numeric rating scale (NRS)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Proportion of subjects achieving a pruritis numeric rating scale (NRS) response(improvement in pruritus NRS score of ≥3)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Leeds Dactylitis Index (LDI)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
measure: Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale)
timeFrame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
measure: Change from core baseline in 36-item Short-Form Health Survey (SF-36)
timeFrame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
measure: Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID).
timeFrame: W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304.
measure: Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria
timeFrame: At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: ULB Hopital Erasme, Service de Rheumatology
city: Plovdiv
country: Bulgaria
facility: UMHAT "Kaspela", EOOD
city: Ruse
country: Bulgaria
facility: MHAT - Ruse, AD
city: Sofia
country: Bulgaria
facility: UMHAT "SofiaMed", OOD, Block 1
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Pardubice
country: Czechia
facility: CCBR Czech, a.s
city: Uherské Hradiště
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol
city: Poznań
country: Poland
facility: Ai Centrum Medyczne sp. z o.o. sp.k.
city: Toruń
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
city: Warsaw
country: Poland
facility: Centrum Medyczne AMED, Warszawa Targowek
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa, Servicio de Reumatologia
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
city: Kiev
country: Ukraine
facility: CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
city: Kyiv
country: Ukraine
facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
city: L'viv
country: Ukraine
facility: CH of State Border Service of Ukraine (Military Base 2522) Dept of Therapy, D.Halytskyi Lviv NMU, Ch of Family Medicine & Dermatology, Venereology
city: Poltava
country: Ukraine
facility: M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
city: Ternopil'
country: Ukraine
facility: CI of TRC
city: Vinnytsia
country: Ukraine
facility: M.I. Pyrogov VRCH Dept of Rheumatology M.I. Pyrogov VNMU, Ch of IM #1
city: Vinnytsia
country: Ukraine
facility: SRI of Invalid Rehabilitation (EST Complex) of Vinnytsia M.I.Pyrogov NMU MOHU, Un of Therapy and CRh Dept of Therapy
city: Vinnytsya
country: Ukraine
facility: MCIC MC LLC Health Clinic, Unit of Cardiology and Rheumatology
Study officials:
affiliation: Galapagos NV
name: Vijay Rajendran, MD
role: STUDY_DIRECTOR
References: