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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926195
Other study ID # GLPG0634-CL-227
Secondary ID 2018-003933-14
Status Completed
Phase Phase 2
First received
Last updated
Start date May 28, 2019
Est. completion date May 10, 2023

Study information

Verified date April 2024
Source Galapagos NV
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date May 10, 2023
Est. primary completion date August 14, 2020
Accepts healthy volunteers No
Gender Male
Age group 21 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Bulgaria Medical center Medconsult Pleven OOD Pleven
Bulgaria MHAT "Eurohospital" - Plovdiv, OOD Plovdiv
Bulgaria UMHAT Pulmed OOD Plovdiv
Bulgaria UMHAT Sv. Georgi, EAD Plovdiv
Bulgaria Medical Center Teodora, EOOD Ruse
Bulgaria Medizinski Zentar-1-Sevlievo EOOD Sevlievo
Bulgaria DCC 17 - Sofia EOOD Sofia
Bulgaria DCC Alexandrovska, EOOD Sofia
Bulgaria MC Synexus - Sofia, EOOD Sofia
Bulgaria Medical Center Excelsior, OOD Sofia
Bulgaria Meditsinski Centar - Izgrev EOOD Sofia
Bulgaria UMHAT Sv. Ivan Rilski, EAD Sofia
Czechia CCR Brno S.r.o. Brno
Czechia CCBR Ostrava s.r.o Ostrava
Czechia MUDr. Rosypalova s.r.o. Ostrava
Czechia Vesalion s.r.o. Ostrava
Czechia Bioclinica Pardubice Pardubice
Czechia Affidea Praha s.r.o. Praha
Czechia CLINTRIAL s.r.o. Praha
Czechia MUDr Zuzana Stejfova Revmatologicka ambulance Praha
Czechia Revmatologicky Ustav Praha
Czechia Thomayerova nemocnice Praha
Czechia MEDICAL PLUS s.r.o. Uherské Hradište
Estonia Center for Clinical and Basic Research Tallinn
Estonia North Estonia Medical Centre Foundation Tallinn
Estonia OÜ Innomedica Tallinn
Estonia Clinical Research Centre Tartu
Estonia Meditrials OU Tartu
Georgia Aversi ClinicLtd. Tbilisi
Georgia Chapidze Emergency Cardiology Center Tbilisi
Georgia Clinic on Mtskheta Street Tbilisi
Georgia Consilium Medulla-multiprofile clinic Ltd Tbilisi
Georgia Institute of Clinical Cardiology Ltd Tbilisi
Georgia Medicore Ltd. Tbilisi
Georgia National Institute of Endocrinology Tbilisi
Georgia Tbilisi Heart and Vascular Clinic Ltd Tbilisi
Latvia M&M center Adaži
Poland 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 Lódz
Poland Zespol Poradni Specjalistycznych REUMED Lublin
Poland Ai Centrum Medyczne Sp. Z O.O. Sp.K. Poznan
Poland Centrum Badan Klinicznych S.C. Poznan
Poland SOLUMED Centrum Medyczne Poznan
Poland RCMed Sochaczew
Poland Medycyna Kliniczna Warsaw
Poland Centrum Medyczne AMED Warszawa
Spain Clinica GAIAS Santiago
Ukraine 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 GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine Kharkiv
Ukraine CI A.and O. Tropiny City Clinical Hospital Kherson
Ukraine Limited Liability Company Medical Center Concilium Medical Kyiv
Ukraine LLC Treatment-Diagnostic Center ADONIS plus Kyiv
Ukraine Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC Kyiv
Ukraine Medical Center of Limited Liability Company Medical Clinic Blagomed Kyiv
Ukraine SI NS? 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 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 MCIC Health Clinic BO LTD TDC Slaomed Vinnytsia
Ukraine Private Small Enterprise Medical Center Pulse Vinnytsia
Ukraine Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU Vinnytsia
Ukraine CI CCH #6 Dept of Therapy ZSMU Zaporizhzhya
Ukraine CI Zaporizhzhia Regional Clinical Hospital of ZRC Zaporizhzhya

Sponsors (2)

Lead Sponsor Collaborator
Galapagos NV Gilead Sciences

Countries where clinical trial is conducted

Bulgaria,  Czechia,  Estonia,  Georgia,  Latvia,  Poland,  Spain,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at 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.
Baseline to Week 13
Secondary Percentage of Participants With a = 50% Decrease From Baseline in Sperm Concentration at 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.
Baseline to Week 26
Secondary Change From Baseline in Sperm Total Motility at Week 13 The normal range for sperm total motility is =40%. Baseline, Week 13
Secondary Change From Baseline in Sperm Total Motility at 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%.
Baseline, Week 26
Secondary Change From Baseline in Total Sperm Count at Week 13 The normal range for total sperm count is = 39 million sperms/ejaculate. Baseline, Week 13
Secondary Change From Baseline in Total Sperm Count at 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.
Baseline, Week 26
Secondary Change From Baseline in Sperm Concentration at Week 13 The normal range for sperm concentration is =15 million sperms/mL. Baseline, Week 13
Secondary Change From Baseline in Sperm Concentration at 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.
Baseline, Week 26
Secondary Change From Baseline in Ejaculate Volume at Week 13 The normal range for ejaculate volume is =1.5 mL. Baseline, Week 13
Secondary Change From Baseline in Ejaculate Volume at 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.
Baseline, Week 26
Secondary Change From Baseline in Percent Normal Sperm Morphology at Week 13 The normal range for percent normal sperm morphology is =30% normal sperms. Baseline, Week 13
Secondary Change From Baseline in Percent Normal Sperm Morphology at 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.
Baseline, Week 26
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