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

Rheumatoid Arthritis Clinical Trial

— MANTA-RAy  

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Non-Radiographic Axial Spondyloarthritis
• Non-Radiographical Axial Spondyloarthritis
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

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