Clinical trial NCT03926195: 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
Official title: A Randomized, Double-blind, Placebo-controlled Phase 2 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Psoriatic Arthritis
Ankylosing Spondylitis
Non-Radiographical Axial Spondyloarthritis
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2019-04-24
Enrollment: 109
Sex: MALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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 Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
timeFrame: Baseline to Week 13
Secondary outcomes:
measure: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
timeFrame: Baseline to Week 26
measure: Change From Baseline in Sperm Total Motility at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Sperm Total Motility at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Sperm Count at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Total Sperm Count at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Sperm Concentration at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Sperm Concentration at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Ejaculate Volume at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Ejaculate Volume at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Percent Normal Sperm Morphology at Week 13
timeFrame: Baseline, Week 13
measure: Change From Baseline in Percent Normal Sperm Morphology at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Medical center Medconsult Pleven OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed OOD
city: Plovdiv
country: Bulgaria
facility: UMHAT Sv. Georgi, EAD
city: Plovdiv
country: Bulgaria
facility: MHAT "Eurohospital" - Plovdiv, OOD
city: Ruse
country: Bulgaria
facility: Medical Center Teodora, EOOD
city: Sevlievo
country: Bulgaria
facility: Medizinski Zentar-1-Sevlievo EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior, OOD
city: Sofia
country: Bulgaria
facility: DCC Alexandrovska, EOOD
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski, EAD
city: Sofia
country: Bulgaria
facility: DCC 17 - Sofia EOOD
city: Sofia
country: Bulgaria
facility: Meditsinski Centar - Izgrev EOOD
city: Sofia
country: Bulgaria
facility: MC Synexus - Sofia, EOOD
city: Brno
country: Czechia
facility: CCR Brno S.r.o.
city: Ostrava
country: Czechia
facility: CCBR Ostrava s.r.o
city: Ostrava
country: Czechia
facility: Vesalion s.r.o.
city: Ostrava
country: Czechia
facility: MUDr. Rosypalova s.r.o.
city: Pardubice
country: Czechia
facility: Bioclinica Pardubice
city: Praha
country: Czechia
facility: CLINTRIAL s.r.o.
city: Praha
country: Czechia
facility: Revmatologicky Ustav
city: Praha
country: Czechia
facility: Thomayerova nemocnice
city: Praha
country: Czechia
facility: MUDr Zuzana Stejfova Revmatologicka ambulance
city: Praha
country: Czechia
facility: Affidea Praha s.r.o.
city: Uherské Hradiště
country: Czechia
facility: MEDICAL PLUS s.r.o.
city: Tallinn
country: Estonia
facility: OÜ Innomedica
city: Tallinn
country: Estonia
facility: Center for Clinical and Basic Research
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Tartu
country: Estonia
facility: Meditrials OU
city: Tbilisi
country: Georgia
facility: Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: Institute of Clinical Cardiology Ltd
city: Tbilisi
country: Georgia
facility: National Institute of Endocrinology
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd
city: Tbilisi
country: Georgia
facility: Aversi ClinicLtd.
city: Tbilisi
country: Georgia
facility: Clinic on Mtskheta Street
city: Tbilisi
country: Georgia
facility: Consilium Medulla-multiprofile clinic Ltd
city: Tbilisi
country: Georgia
facility: Medicore Ltd.
city: Ādaži
country: Latvia
facility: M&M center
city: Bydgoszcz
country: Poland
facility: Nasz Lekarz Osrodek Badan Klinicznych
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela
city: Katowice
country: Poland
facility: Silmedic sp. z o.o
city: Knurów
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych REUMED
city: Poznań
country: Poland
facility: SOLUMED Centrum Medyczne
city: Poznań
country: Poland
facility: Centrum Badan Klinicznych S.C.
city: Poznań
country: Poland
facility: Ai Centrum Medyczne Sp. Z O.O. Sp.K.
city: Sochaczew
country: Poland
facility: RCMed
city: Warsaw
country: Poland
facility: Medycyna Kliniczna
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Łódź
country: Poland
facility: Centrum Medyczne AMED
city: Santiago
country: Spain
facility: Clinica GAIAS
city: Dnipro
country: Ukraine
facility: CI Dnipropetrovsk CMCH #4 RC
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
city: Kharkiv
country: Ukraine
facility: GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv City Clinical Hospital #13
city: Kherson
country: Ukraine
facility: CI A.and O. Tropiny City Clinical Hospital
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
city: Kyiv
country: Ukraine
facility: SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
city: Kyiv
country: Ukraine
facility: Limited Liability Company Medical Center Concilium Medical
city: Kyiv
country: Ukraine
facility: LLC Treatment-Diagnostic Center ADONIS plus
city: Luts'k
country: Ukraine
facility: Volyn Regional Clinical Hospital
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital Dept of Rheumatology NMU
city: Lviv
country: Ukraine
facility: Mil&Med Cl C of Lviv of the St Border Service of Ukraine
city: Odesa
country: Ukraine
facility: Center of Reconstructive & Restorative Medicine of Odessa National Medical University
city: Poltava
country: Ukraine
facility: M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
city: Vinnytsia
country: Ukraine
facility: Private Small Enterprise Medical Center Pulse
city: Vinnytsia
country: Ukraine
facility: Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
city: Vinnytsia
country: Ukraine
facility: MCIC Health Clinic BO LTD TDC Slaomed
city: Zaporizhzhya
country: Ukraine
facility: CI CCH #6 Dept of Therapy ZSMU
city: Zaporizhzhya
country: Ukraine
facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References:
citation: 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.