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

PHASE2CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

May 28, 2019

Primary Completion Date

August 14, 2020

Study Completion Date

May 10, 2023

Conditions
Rheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisNon-Radiographical Axial Spondyloarthritis
Interventions
DRUG

Filgotinib

200-mg tablet administered orally once daily

DRUG

Placebo

Placebo to match filgotinib tablet administered orally once daily

DRUG

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.

Trial Locations (71)

1407

Medical Center Excelsior, OOD, Sofia

1431

DCC Alexandrovska, EOOD, Sofia

UMHAT Sv. Ivan Rilski, EAD, Sofia

1504

DCC 17 - Sofia EOOD, Sofia

1606

Meditsinski Centar - Izgrev EOOD, Sofia

1784

MC Synexus - Sofia, EOOD, Sofia

4000

UMHAT Pulmed OOD, Plovdiv

UMHAT Sv. Georgi, EAD, Plovdiv

4002

"MHAT Eurohospital - Plovdiv, OOD", Plovdiv

5400

Medizinski Zentar-1-Sevlievo EOOD, Sevlievo

5800

Medical center Medconsult Pleven OOD, Pleven

7000

Medical Center Teodora, EOOD, Rousse

10000

CLINTRIAL s.r.o., Prague

10117

OÜ Innomedica, Tallinn

10128

Center for Clinical and Basic Research, Tallinn

13419

North Estonia Medical Centre Foundation, Tallinn

14000

MUDr Zuzana Stejfova Revmatologicka ambulance, Prague

14800

Affidea Praha s.r.o., Prague

15702

Clinica GAIAS, Santiago

21001

Private Small Enterprise Medical Center Pulse, Vinnytsia

21018

Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU, Vinnytsia

21029

MCIC Health Clinic BO LTD TDC Slaomed, Vinnytsia

36011

M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA, Poltava

43005

Volyn Regional Clinical Hospital, Lutsk

46002

Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU, Ternopil

49102

CI Dnipropetrovsk CMCH #4 RC, Dnipro

50106

Clinical Research Centre, Tartu

50406

Meditrials OU, Tartu

60200

CCR Brno S.r.o., Brno

61039

GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine, Kharkiv

61124

CHI Kharkiv City Clinical Hospital #13, Kharkiv

65000

Center of Reconstructive & Restorative Medicine of Odessa National Medical University, Odesa

68601

MEDICAL PLUS s.r.o., Uherské Hradiště

69035

CI CCH #6 Dept of Therapy ZSMU, Zaporizhzhya

69600

CI Zaporizhzhia Regional Clinical Hospital of ZRC, Zaporizhzhya

73000

CI A.and O. Tropiny City Clinical Hospital, Kherson

76008

Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU, Ivano-Frankivsk

79000

Lviv Regional Clinical Hospital Dept of Rheumatology NMU, Lviv

79049

Mil&Med Cl C of Lviv of the St Border Service of Ukraine, Lviv

702 00

CCBR Ostrava s.r.o, Ostrava

Vesalion s.r.o., Ostrava

708 00

MUDr. Rosypalova s.r.o., Ostrava

530 02

Bioclinica Pardubice, Pardubice

128 52

Revmatologicky Ustav, Prague

140 59

Thomayerova nemocnice, Prague

0159

Chapidze Emergency Cardiology Center, Tbilisi

Institute of Clinical Cardiology Ltd, Tbilisi

National Institute of Endocrinology, Tbilisi

Tbilisi Heart and Vascular Clinic Ltd, Tbilisi

0160

Aversi ClinicLtd., Tbilisi

0179

Clinic on Mtskheta Street, Tbilisi

0186

Consilium Medulla-multiprofile clinic Ltd, Tbilisi

Medicore Ltd., Tbilisi

LV2164

M&M center, Ādaži

85-065

Nasz Lekarz Osrodek Badan Klinicznych, Bydgoszcz

85-168

Szpital Uniwersytecki nr 2 im. dr J. Biziela, Bydgoszcz

40-282

Silmedic sp. z o.o, Katowice

44-190

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla, Knurów

91-363

Centrum Medyczne AMED, Lodz

20-607

Zespol Poradni Specjalistycznych REUMED, Lublin

60-529

SOLUMED Centrum Medyczne, Poznan

60-773

Centrum Badan Klinicznych S.C., Poznan

61-113

Ai Centrum Medyczne Sp. Z O.O. Sp.K., Poznan

96-500

RCMed, Sochaczew

00-874

Medycyna Kliniczna, Warsaw

03-291

Centrum Medyczne AMED, Warsaw

01023

Medical Center of Limited Liability Company Medical Clinic Blagomed, Kyiv

02091

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC, Kyiv

03680

SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU, Kyiv

04050

Limited Liability Company Medical Center Concilium Medical, Kyiv

LLC Treatment-Diagnostic Center ADONIS plus, Kyiv

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Galapagos NV

INDUSTRY

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 | Biotech Hunter | Biotech Hunter