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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 (MANTA-RAy)

Primary Purpose

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Filgotinib
Placebo
Standard of Care
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male participants who are between the ages of 21 and 65 years (inclusive) on the day of signing informed consent
  • 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.

Sites / Locations

  • Medical center Medconsult Pleven OOD
  • UMHAT Pulmed OOD
  • UMHAT Sv. Georgi, EAD
  • MHAT "Eurohospital" - Plovdiv, OOD
  • Medical Center Teodora, EOOD
  • Medizinski Zentar-1-Sevlievo EOOD
  • Medical Center Excelsior, OOD
  • DCC Alexandrovska, EOOD
  • UMHAT Sv. Ivan Rilski, EAD
  • DCC 17 - Sofia EOOD
  • Meditsinski Centar - Izgrev EOOD
  • MC Synexus - Sofia, EOOD
  • CCR Brno S.r.o.
  • CCBR Ostrava s.r.o
  • Vesalion s.r.o.
  • MUDr. Rosypalova s.r.o.
  • Bioclinica Pardubice
  • CLINTRIAL s.r.o.
  • Revmatologicky Ustav
  • Thomayerova nemocnice
  • MUDr Zuzana Stejfova Revmatologicka ambulance
  • Affidea Praha s.r.o.
  • MEDICAL PLUS s.r.o.
  • OÜ Innomedica
  • Center for Clinical and Basic Research
  • North Estonia Medical Centre Foundation
  • Clinical Research Centre
  • Meditrials OU
  • Chapidze Emergency Cardiology Center
  • Institute of Clinical Cardiology Ltd
  • National Institute of Endocrinology
  • Tbilisi Heart and Vascular Clinic Ltd
  • Aversi ClinicLtd.
  • Clinic on Mtskheta Street
  • Consilium Medulla-multiprofile clinic Ltd
  • Medicore Ltd.
  • M&M center
  • Nasz Lekarz Osrodek Badan Klinicznych
  • Szpital Uniwersytecki nr 2 im. dr J. Biziela
  • Silmedic sp. z o.o
  • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Zespol Poradni Specjalistycznych REUMED
  • SOLUMED Centrum Medyczne
  • Centrum Badan Klinicznych S.C.
  • Ai Centrum Medyczne Sp. Z O.O. Sp.K.
  • RCMed
  • Medycyna Kliniczna
  • Centrum Medyczne AMED
  • Centrum Medyczne AMED
  • Clinica GAIAS
  • CI Dnipropetrovsk CMCH #4 RC
  • Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
  • GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
  • CHI Kharkiv City Clinical Hospital #13
  • CI A.and O. Tropiny City Clinical Hospital
  • Medical Center of Limited Liability Company Medical Clinic Blagomed
  • Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
  • SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
  • Limited Liability Company Medical Center Concilium Medical
  • LLC Treatment-Diagnostic Center ADONIS plus
  • Volyn Regional Clinical Hospital
  • Lviv Regional Clinical Hospital Dept of Rheumatology NMU
  • Mil&Med Cl C of Lviv of the St Border Service of Ukraine
  • Center of Reconstructive & Restorative Medicine of Odessa National Medical University
  • M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
  • Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
  • Private Small Enterprise Medical Center Pulse
  • Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
  • MCIC Health Clinic BO LTD TDC Slaomed
  • CI CCH #6 Dept of Therapy ZSMU
  • CI Zaporizhzhia Regional Clinical Hospital of ZRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Filgotinib

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change From Baseline in Sperm Total Motility at Week 13
The normal range for sperm total motility is ≥40%.
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%.
Change From Baseline in Total Sperm Count at Week 13
The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
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.
Change From Baseline in Sperm Concentration at Week 13
The normal range for sperm concentration is ≥15 million sperms/mL.
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.
Change From Baseline in Ejaculate Volume at Week 13
The normal range for ejaculate volume is ≥1.5 mL.
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.
Change From Baseline in Percent Normal Sperm Morphology at Week 13
The normal range for percent normal sperm morphology is ≥30% normal sperms.
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.

Full Information

First Posted
April 19, 2019
Last Updated
July 13, 2023
Sponsor
Galapagos NV
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03926195
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2019 (Actual)
Primary Completion Date
August 14, 2020 (Actual)
Study Completion Date
May 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgotinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Other Intervention Name(s)
GS-6034, Jyseleca®
Intervention Description
200-mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match filgotinib tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Description
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.
Time Frame
Baseline to Week 13
Secondary Outcome Measure Information:
Title
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Description
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.
Time Frame
Baseline to Week 26
Title
Change From Baseline in Sperm Total Motility at Week 13
Description
The normal range for sperm total motility is ≥40%.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Sperm Total Motility at Week 26
Description
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%.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Total Sperm Count at Week 13
Description
The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Total Sperm Count at Week 26
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Sperm Concentration at Week 13
Description
The normal range for sperm concentration is ≥15 million sperms/mL.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Sperm Concentration at Week 26
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Ejaculate Volume at Week 13
Description
The normal range for ejaculate volume is ≥1.5 mL.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Ejaculate Volume at Week 26
Description
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.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Description
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Time Frame
Baseline, Week 13
Title
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Description
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.
Time Frame
Baseline, Week 26

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Medical center Medconsult Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
UMHAT Pulmed OOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Sv. Georgi, EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT "Eurohospital" - Plovdiv, OOD
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Medical Center Teodora, EOOD
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
Medizinski Zentar-1-Sevlievo EOOD
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Medical Center Excelsior, OOD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
DCC Alexandrovska, EOOD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UMHAT Sv. Ivan Rilski, EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
DCC 17 - Sofia EOOD
City
Sofia
ZIP/Postal Code
1504
Country
Bulgaria
Facility Name
Meditsinski Centar - Izgrev EOOD
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MC Synexus - Sofia, EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
CCR Brno S.r.o.
City
Brno
ZIP/Postal Code
60200
Country
Czechia
Facility Name
CCBR Ostrava s.r.o
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Vesalion s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
MUDr. Rosypalova s.r.o.
City
Ostrava
ZIP/Postal Code
708 00
Country
Czechia
Facility Name
Bioclinica Pardubice
City
Pardubice
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
CLINTRIAL s.r.o.
City
Praha
ZIP/Postal Code
10000
Country
Czechia
Facility Name
Revmatologicky Ustav
City
Praha
ZIP/Postal Code
128 52
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
MUDr Zuzana Stejfova Revmatologicka ambulance
City
Praha
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Affidea Praha s.r.o.
City
Praha
ZIP/Postal Code
14800
Country
Czechia
Facility Name
MEDICAL PLUS s.r.o.
City
Uherské Hradiště
ZIP/Postal Code
68601
Country
Czechia
Facility Name
OÜ Innomedica
City
Tallinn
ZIP/Postal Code
10117
Country
Estonia
Facility Name
Center for Clinical and Basic Research
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Clinical Research Centre
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Facility Name
Meditrials OU
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Chapidze Emergency Cardiology Center
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Institute of Clinical Cardiology Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
National Institute of Endocrinology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Tbilisi Heart and Vascular Clinic Ltd
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Facility Name
Aversi ClinicLtd.
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Clinic on Mtskheta Street
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Consilium Medulla-multiprofile clinic Ltd
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Medicore Ltd.
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
M&M center
City
Ādaži
ZIP/Postal Code
LV2164
Country
Latvia
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im. dr J. Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Silmedic sp. z o.o
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
City
Knurów
ZIP/Postal Code
44-190
Country
Poland
Facility Name
Zespol Poradni Specjalistycznych REUMED
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
SOLUMED Centrum Medyczne
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Centrum Badan Klinicznych S.C.
City
Poznań
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
City
Poznań
ZIP/Postal Code
61-113
Country
Poland
Facility Name
RCMed
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Centrum Medyczne AMED
City
Łódź
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Clinica GAIAS
City
Santiago
ZIP/Postal Code
15702
Country
Spain
Facility Name
CI Dnipropetrovsk CMCH #4 RC
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
City
Ivano-Frankivs'k
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
CHI Kharkiv City Clinical Hospital #13
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
CI A.and O. Tropiny City Clinical Hospital
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Medical Center of Limited Liability Company Medical Clinic Blagomed
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Limited Liability Company Medical Center Concilium Medical
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
LLC Treatment-Diagnostic Center ADONIS plus
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Volyn Regional Clinical Hospital
City
Luts'k
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Lviv Regional Clinical Hospital Dept of Rheumatology NMU
City
Lviv
ZIP/Postal Code
79000
Country
Ukraine
Facility Name
Mil&Med Cl C of Lviv of the St Border Service of Ukraine
City
Lviv
ZIP/Postal Code
79049
Country
Ukraine
Facility Name
Center of Reconstructive & Restorative Medicine of Odessa National Medical University
City
Odesa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Private Small Enterprise Medical Center Pulse
City
Vinnytsia
ZIP/Postal Code
21001
Country
Ukraine
Facility Name
Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
MCIC Health Clinic BO LTD TDC Slaomed
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
CI CCH #6 Dept of Therapy ZSMU
City
Zaporizhzhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
CI Zaporizhzhia Regional Clinical Hospital of ZRC
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35614292
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.
Results Reference
derived

Learn more about this trial

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

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