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
NCT ID: NCT03926195
Last Updated: 2024-04-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2019-05-28
2023-05-10
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
200-mg tablet administered orally once daily
Standard of Care
Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
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
Placebo to match filgotinib tablet administered orally once daily
Standard of Care
Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Interventions
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Filgotinib
200-mg tablet administered orally once daily
Placebo
Placebo to match filgotinib tablet administered orally once daily
Standard of Care
Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior diagnosis of male infertility
* Use of any prohibited concomitant medication as outlined by protocol
21 Years
65 Years
MALE
No
Sponsors
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Gilead Sciences
INDUSTRY
Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Medical center Medconsult Pleven OOD
Pleven, , Bulgaria
UMHAT Pulmed OOD
Plovdiv, , Bulgaria
UMHAT Sv. Georgi, EAD
Plovdiv, , Bulgaria
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, , Bulgaria
Medical Center Teodora, EOOD
Rousse, , Bulgaria
Medizinski Zentar-1-Sevlievo EOOD
Sevlievo, , Bulgaria
Medical Center Excelsior, OOD
Sofia, , Bulgaria
DCC Alexandrovska, EOOD
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski, EAD
Sofia, , Bulgaria
DCC 17 - Sofia EOOD
Sofia, , Bulgaria
Meditsinski Centar - Izgrev EOOD
Sofia, , Bulgaria
MC Synexus - Sofia, EOOD
Sofia, , Bulgaria
CCR Brno S.r.o.
Brno, , Czechia
CCBR Ostrava s.r.o
Ostrava, , Czechia
Vesalion s.r.o.
Ostrava, , Czechia
MUDr. Rosypalova s.r.o.
Ostrava, , Czechia
Bioclinica Pardubice
Pardubice, , Czechia
CLINTRIAL s.r.o.
Prague, , Czechia
Revmatologicky Ustav
Prague, , Czechia
Thomayerova nemocnice
Prague, , Czechia
MUDr Zuzana Stejfova Revmatologicka ambulance
Prague, , Czechia
Affidea Praha s.r.o.
Prague, , Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, , Czechia
OÜ Innomedica
Tallinn, , Estonia
Center for Clinical and Basic Research
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Clinical Research Centre
Tartu, , Estonia
Meditrials OU
Tartu, , Estonia
Chapidze Emergency Cardiology Center
Tbilisi, , Georgia
Institute of Clinical Cardiology Ltd
Tbilisi, , Georgia
National Institute of Endocrinology
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, , Georgia
Aversi ClinicLtd.
Tbilisi, , Georgia
Clinic on Mtskheta Street
Tbilisi, , Georgia
Consilium Medulla-multiprofile clinic Ltd
Tbilisi, , Georgia
Medicore Ltd.
Tbilisi, , Georgia
M&M center
Ādaži, , Latvia
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, , Poland
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, , Poland
Silmedic sp. z o.o
Katowice, , Poland
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, , Poland
Centrum Medyczne AMED
Lodz, , Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, , Poland
SOLUMED Centrum Medyczne
Poznan, , Poland
Centrum Badan Klinicznych S.C.
Poznan, , Poland
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, , Poland
RCMed
Sochaczew, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
Clinica GAIAS
Santiago, , Spain
CI Dnipropetrovsk CMCH #4 RC
Dnipro, , Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, , Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, , Ukraine
CHI Kharkiv City Clinical Hospital #13
Kharkiv, , Ukraine
CI A.and O. Tropiny City Clinical Hospital
Kherson, , Ukraine
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, , Ukraine
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, , Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Kyiv, , Ukraine
Limited Liability Company Medical Center Concilium Medical
Kyiv, , Ukraine
LLC Treatment-Diagnostic Center ADONIS plus
Kyiv, , Ukraine
Volyn Regional Clinical Hospital
Lutsk, , 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
Center of Reconstructive & Restorative Medicine of Odessa National Medical University
Odesa, , Ukraine
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
Poltava, , Ukraine
Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
Ternopil, , Ukraine
Private Small Enterprise Medical Center Pulse
Vinnytsia, , Ukraine
Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
Vinnytsia, , Ukraine
MCIC Health Clinic BO LTD TDC Slaomed
Vinnytsia, , Ukraine
CI CCH #6 Dept of Therapy ZSMU
Zaporizhzhya, , Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, , Ukraine
Countries
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References
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Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.
Hellstrom WJG, Dolhain RJEM, Ritter TE, Watkins TR, Arterburn SJ, Dekkers G, Gillen A, Tonussi C, Gilles L, Oortwijn A, Van Beneden K, de Vries DE, Sikka SC, Vanderschueren D, Reinisch W. MANTA and MANTA-RAy: Rationale and Design of Trials Evaluating Effects of Filgotinib on Semen Parameters in Patients with Inflammatory Diseases. Adv Ther. 2022 Jul;39(7):3403-3422. doi: 10.1007/s12325-022-02168-4. Epub 2022 May 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003933-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG0634-CL-227
Identifier Type: -
Identifier Source: org_study_id
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