An Open-label, Long-term Extension Study With Filgotinib in Active Psoriatic Arthritis.
- Registration Number
- NCT03320876
- Lead Sponsor
- Galapagos NV
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 122
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description filgotinib filgotinib -
- Primary Outcome Measures
Name Time Method Change in the proportion of subjects with adverse events Between entry visit and 4 weeks after the last dose. To asses safety and tolerability of filgotinib.
- Secondary Outcome Measures
Name Time Method Proportion of subjects achieving ACR50 response At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by ACR50 in PsA patients.
Proportion of subjects achieving ACR70 response At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by ACR70 in PsA patients
Proportion of subjects achieving minimal disease activity (MDA) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on MDA in PsA patients.
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by ACR20 in PsA patients.
Proportion of subjects with Psoriatic Arthritis Disease Activity Score (PASDAS) low disease activity (LDA, i.e. PASDAS ≤ 3.2) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by PASDAS in PsA patients.
Proportion of subjects with DAPSA remission (DAPSA ≤4) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.
Proportion of subjects with PASI90 At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PASI90 in PsA patients.
Percentage of patients subjects with PASDAS LDA (i.e. PASDAS ≤3.2) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PsA as assessed by DAPSA in PsA patients.
Proportion of subjects with DAPSA remission/LDA (DAPSA ≤14) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PASI in PsA patients.
Proportion of subjects with PASI50 At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PASI50 in PsA patients.
Proportion of subjects with PASI75 At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PASI75 in PsA patients.
Change from core baseline in Patient's Global Assessment of psoriasis At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on mNAPSI in PsA patients assessment of psoriasis in PsA patients.
Change from core baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on SPARCC enthesitis index in PsA patients.
Change from baseline in Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue scale) W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. To assess the effect of filgotinib on FACIT-Fatigue scale in PsA patients.
Proportion of subjects with PASI100 At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on PASI100 in PsA patients.
Change from core baseline in Psoriatic Arthritis Impact of Disease Questionnaire (PsAID). W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. To assess the effect of filgotinib on PsAID in PsA patients.
Change from core baseline in Physician's global assessment of psoriasis At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the affect of filgotinib on Physician's global assessment of psoriasis in PsA patients.
Change from core baseline in 36-item Short-Form Health Survey (SF-36) W4, W52, W100, W148, W172, W196, W220, W244, W268, W292, W304. To assess the effect of filgotinib on SF-36 in PsA patients
Change from core baseline in pruritis numeric rating scale (NRS) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. 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) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on NRS in PsA patients.
Change from core baseline in Leeds Dactylitis Index (LDI) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on Dactilytis in PsA patients.
Change from core baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on physical function in PsA patients.
Change from core baseline in individual components of the ACR response of improvement in multiple disease assessment criteria At each on-site visit until filgotinib is registered for PsA or until Week 304, whichever occurs first. To assess the effect of filgotinib on signs and symptoms of peripheral arthritis and physical function in PsA patients.
Trial Locations
- Locations (25)
UMHAT "Kaspela", EOOD
🇧🇬Plovdiv, Bulgaria
ULB Hopital Erasme, Service de Rheumatology
🇧🇪Brussels, Belgium
UMHAT "SofiaMed", OOD, Block 1
🇧🇬Sofia, Bulgaria
CCBR Czech, a.s
🇨🇿Pardubice, Czechia
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
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
Ai Centrum Medyczne sp. z o.o. sp.k.
🇵🇱Poznań, Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z, Przychodnia Specjalistyczna
🇵🇱Toruń, Poland
Centrum Medyczne AMED, Warszawa Targowek
🇵🇱Warsaw, Poland
Hospital Universitario de Fuenlabrada, Servicio de Reumatologia
🇪🇸Fuenlabrada, Spain
Hospital Infanta Luisa, Servicio de Reumatologia
🇪🇸Sevilla, Spain
CI of Healthcare Kharkiv CCH #8 Dept of Rheumatology Kharkiv MA of PGE of MOHU, Ch of Cardiology and Funct Diagnostics
🇺🇦Kharkiv, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Unit of Non-coronary HD&Rh
🇺🇦Kyiv, Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Ch of Family Medicine and Therapy
🇺🇦Poltava, 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.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, Ukraine
CI of TRC
🇺🇦Ternopil', Ukraine
MHAT - Ruse, AD
🇧🇬Ruse, Bulgaria
Twoja Przychodnia-Centrum Medyczne Nowa Sol
🇵🇱Nowa Sól, Poland
CNI Consultative and Diagnostic Center of Pecherskyi District of Kyiv, Department of Therapy
🇺🇦Kiev, Ukraine