Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
- Conditions
- Rheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisNon-Radiographical Axial Spondyloarthritis
- Interventions
- Registration Number
- NCT03926195
- Lead Sponsor
- Galapagos NV
- Brief Summary
The primary objective of this study is to evaluate the effect of filgotinib on semen parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.
Results of this study may be pooled with the results of a separate study being conducted in participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the same objective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 109
- Diagnosis of active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or, non-radiographic axial spondyloarthritis for at least 12 weeks prior to screening, meeting the corresponding specific disease classification criteria as specified in the protocol
Key
- Previously documented problems with male reproductive health
- Prior diagnosis of male infertility
- Use of any prohibited concomitant medication as outlined by protocol
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Filgotinib Filgotinib Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. Filgotinib Standard of Care Participants received filgotinib 200 milligrams (mg) tablet, orally, once daily up to Week 13 in the double-blind (DB) phase. At Week 13, participants who were arthritis responders, were unblinded and received open-label (OL) treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the extension (EXT) phase and participants who were arthritis nonresponders discontinued blinded study drug and started standard of care (SOC) treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. Placebo Placebo Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. Placebo Standard of Care Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment.
- Primary Outcome Measures
Name Time Method Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 Baseline to Week 13 Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL.
Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Sperm Total Motility at Week 13 Baseline, Week 13 The normal range for sperm total motility is ≥40%.
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 Baseline to Week 26 Arthritis responder: For rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nrAxSpA), a participant with an improvement in the Physician's Global Assessment of Disease Activity (PhGADA) of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a visual analogue scale (VAS) ranged from 0 (no disease)-100 (worst disease) millimeters (mm).
Baseline value for sperm/semen parameters was the mean of 2 evaluable semen collections at the screening visit. The normal range for sperm concentration is ≥15 million sperms/mL.
Percentage change = (\[mean at Week 26 - baseline\] / baseline) × 100; value at Week 26 was the mean of 2 evaluable samples collected at Week 26.Change From Baseline in Sperm Total Motility at Week 26 Baseline, Week 26 Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.
The normal range for sperm total motility is ≥40%.Change From Baseline in Total Sperm Count at Week 13 Baseline, Week 13 The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
Change From Baseline in Total Sperm Count at Week 26 Baseline, Week 26 Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.
The normal range for total sperm count is ≥ 39 million sperms/ejaculate.Change From Baseline in Sperm Concentration at Week 13 Baseline, Week 13 The normal range for sperm concentration is ≥15 million sperms/mL.
Change From Baseline in Sperm Concentration at Week 26 Baseline, Week 26 Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.
The normal range for sperm concentration is ≥15 million sperms/mL.Change From Baseline in Ejaculate Volume at Week 13 Baseline, Week 13 The normal range for ejaculate volume is ≥1.5 mL.
Change From Baseline in Ejaculate Volume at Week 26 Baseline, Week 26 Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.
The normal range for ejaculate volume is ≥1.5 mL.Change From Baseline in Percent Normal Sperm Morphology at Week 13 Baseline, Week 13 The normal range for percent normal sperm morphology is ≥30% normal sperms.
Change From Baseline in Percent Normal Sperm Morphology at Week 26 Baseline, Week 26 Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time.
Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint.
PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm.
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Trial Locations
- Locations (70)
DCC 17 - Sofia EOOD
🇧🇬Sofia, Bulgaria
UMHAT Sv. Georgi, EAD
🇧🇬Plovdiv, Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
🇧🇬Plovdiv, Bulgaria
UMHAT Sv. Ivan Rilski, EAD
🇧🇬Sofia, Bulgaria
North Estonia Medical Centre Foundation
🇪🇪Tallinn, Estonia
Aversi ClinicLtd.
🇬🇪Tbilisi, Georgia
Medical center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
Medical Center Teodora, EOOD
🇧🇬Ruse, Bulgaria
MC Synexus - Sofia, EOOD
🇧🇬Sofia, Bulgaria
Clinic on Mtskheta Street
🇬🇪Tbilisi, Georgia
Center for Clinical and Basic Research
🇪🇪Tallinn, Estonia
Institute of Clinical Cardiology Ltd
🇬🇪Tbilisi, Georgia
National Institute of Endocrinology
🇬🇪Tbilisi, Georgia
Consilium Medulla-multiprofile clinic Ltd
🇬🇪Tbilisi, Georgia
UMHAT Pulmed OOD
🇧🇬Plovdiv, Bulgaria
DCC Alexandrovska, EOOD
🇧🇬Sofia, Bulgaria
Meditsinski Centar - Izgrev EOOD
🇧🇬Sofia, Bulgaria
Meditrials OU
🇪🇪Tartu, Estonia
Tbilisi Heart and Vascular Clinic Ltd
🇬🇪Tbilisi, Georgia
RCMed
🇵🇱Sochaczew, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
🇵🇱Knurów, Poland
Centrum Badan Klinicznych S.C.
🇵🇱Poznań, Poland
Centrum Medyczne AMED
🇵🇱Łódź, Poland
CCR Brno S.r.o.
🇨🇿Brno, Czechia
Medical Center Excelsior, OOD
🇧🇬Sofia, Bulgaria
CCBR Ostrava s.r.o
🇨🇿Ostrava, Czechia
Revmatologicky Ustav
🇨🇿Praha, Czechia
MUDr. Rosypalova s.r.o.
🇨🇿Ostrava, Czechia
CLINTRIAL s.r.o.
🇨🇿Praha, Czechia
Bioclinica Pardubice
🇨🇿Pardubice, Czechia
Affidea Praha s.r.o.
🇨🇿Praha, Czechia
MUDr Zuzana Stejfova Revmatologicka ambulance
🇨🇿Praha, Czechia
MEDICAL PLUS s.r.o.
🇨🇿Uherské Hradiště, Czechia
Thomayerova nemocnice
🇨🇿Praha, Czechia
OÜ Innomedica
🇪🇪Tallinn, Estonia
Clinical Research Centre
🇪🇪Tartu, Estonia
M&M center
🇱🇻Ādaži, Latvia
Medicore Ltd.
🇬🇪Tbilisi, Georgia
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
🇵🇱Poznań, Poland
Silmedic sp. z o.o
🇵🇱Katowice, Poland
Zespol Poradni Specjalistycznych REUMED
🇵🇱Lublin, Poland
Clinica GAIAS
🇪🇸Santiago, Spain
CI Dnipropetrovsk CMCH #4 RC
🇺🇦Dnipro, Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
🇺🇦Ivano-Frankivs'k, Ukraine
CHI Kharkiv City Clinical Hospital #13
🇺🇦Kharkiv, Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
🇺🇦Poltava, Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
🇺🇦Kyiv, Ukraine
LLC Treatment-Diagnostic Center ADONIS plus
🇺🇦Kyiv, Ukraine
CI CCH #6 Dept of Therapy ZSMU
🇺🇦Zaporizhzhya, Ukraine
Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
🇺🇦Vinnytsia, Ukraine
MCIC Health Clinic BO LTD TDC Slaomed
🇺🇦Vinnytsia, Ukraine
Medizinski Zentar-1-Sevlievo EOOD
🇧🇬Sevlievo, Bulgaria
Vesalion s.r.o.
🇨🇿Ostrava, Czechia
Chapidze Emergency Cardiology Center
🇬🇪Tbilisi, Georgia
Nasz Lekarz Osrodek Badan Klinicznych
🇵🇱Bydgoszcz, Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela
🇵🇱Bydgoszcz, Poland
SOLUMED Centrum Medyczne
🇵🇱Poznań, Poland
Medycyna Kliniczna
🇵🇱Warsaw, Poland
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
🇺🇦Kharkiv, Ukraine
CI A.and O. Tropiny City Clinical Hospital
🇺🇦Kherson, Ukraine
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
🇺🇦Kyiv, Ukraine
Limited Liability Company Medical Center Concilium Medical
🇺🇦Kyiv, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
🇺🇦Kyiv, Ukraine
Volyn Regional Clinical Hospital
🇺🇦Luts'k, Ukraine
Lviv Regional Clinical Hospital Dept of Rheumatology NMU
🇺🇦Lviv, Ukraine
Mil&Med Cl C of Lviv of the St Border Service of Ukraine
🇺🇦Lviv, Ukraine
Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
🇺🇦Ternopil, Ukraine
Center of Reconstructive & Restorative Medicine of Odessa National Medical University
🇺🇦Odesa, Ukraine
Private Small Enterprise Medical Center Pulse
🇺🇦Vinnytsia, Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
🇺🇦Zaporizhzhya, Ukraine