Rheumatoid ArthritisPhase 2MANTA-RAyNCT03926195
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
A Phase 2 study testing Filgotinib in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 71 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 21 to 65 years, men only
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 71 sitesin 8 countries
- Study dates
- 28 May 2019to 10 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
71 sites in 8 countries.
71 sites in 8 countries
Ukraine21 sites
CI Dnipropetrovsk CMCH #4 RC
Dnipro, 49102
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
Ivano-Frankivsk, 76008
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
Kharkiv, 61039
CHI Kharkiv City Clinical Hospital #13
Kharkiv, 61124
CI A.and O. Tropiny City Clinical Hospital
Kherson, 73000
Medical Center of Limited Liability Company Medical Clinic Blagomed
Kyiv, 01023
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, 02091
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
Kyiv, 03680
Limited Liability Company Medical Center Concilium Medical
Kyiv, 04050
LLC Treatment-Diagnostic Center ADONIS plus
Kyiv, 04050
Volyn Regional Clinical Hospital
Lutsk, 43005
Lviv Regional Clinical Hospital Dept of Rheumatology NMU
Lviv, 79000
Mil&Med Cl C of Lviv of the St Border Service of Ukraine
Lviv, 79049
Center of Reconstructive & Restorative Medicine of Odessa National Medical University
Odesa, 65000
M.V. Sklifosovskyi Poltava RCH Dept of Rheumatology HSEIU UMSA
Poltava, 36011
Ternopil University Hospital, Dept. of Rheumatology, SHEI I.Ya.Horbachevskyi Ternopil SMU
Ternopil, 46002
Private Small Enterprise Medical Center Pulse
Vinnytsia, 21001
Vinnytsia M.I.Pyrogov RCH Dept of cardiology NMU
Vinnytsia, 21018
MCIC Health Clinic BO LTD TDC Slaomed
Vinnytsia, 21029
CI CCH #6 Dept of Therapy ZSMU
Zaporizhzhya, 69035
CI Zaporizhzhia Regional Clinical Hospital of ZRC
Zaporizhzhya, 69600
Bulgaria12 sites
Medical center Medconsult Pleven OOD
Pleven, 5800
UMHAT Pulmed OOD
Plovdiv, 4000
UMHAT Sv. Georgi, EAD
Plovdiv, 4000
MHAT "Eurohospital" - Plovdiv, OOD
Plovdiv, 4002
Medical Center Teodora, EOOD
Rousse, 7000
Medizinski Zentar-1-Sevlievo EOOD
Sevlievo, 5400
Medical Center Excelsior, OOD
Sofia, 1407
DCC Alexandrovska, EOOD
Sofia, 1431
UMHAT Sv. Ivan Rilski, EAD
Sofia, 1431
DCC 17 - Sofia EOOD
Sofia, 1504
Meditsinski Centar - Izgrev EOOD
Sofia, 1606
MC Synexus - Sofia, EOOD
Sofia, 1784
Poland12 sites
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-065
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, 85-168
Silmedic sp. z o.o
Katowice, 40-282
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Knurów, 44-190
Centrum Medyczne AMED
Lodz, 91-363
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-607
SOLUMED Centrum Medyczne
Poznan, 60-529
Centrum Badan Klinicznych S.C.
Poznan, 60-773
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
Poznan, 61-113
RCMed
Sochaczew, 96-500
Medycyna Kliniczna
Warsaw, 00-874
Centrum Medyczne AMED
Warsaw, 03-291
Czechia11 sites
CCR Brno S.r.o.
Brno, 60200
CCBR Ostrava s.r.o
Ostrava, 702 00
Vesalion s.r.o.
Ostrava, 702 00
MUDr. Rosypalova s.r.o.
Ostrava, 708 00
Bioclinica Pardubice
Pardubice, 530 02
CLINTRIAL s.r.o.
Prague, 10000
Revmatologicky Ustav
Prague, 128 52
Thomayerova nemocnice
Prague, 140 59
MUDr Zuzana Stejfova Revmatologicka ambulance
Prague, 14000
Affidea Praha s.r.o.
Prague, 14800
MEDICAL PLUS s.r.o.
Uherské Hradiště, 68601
Georgia8 sites
Chapidze Emergency Cardiology Center
Tbilisi, 0159
Institute of Clinical Cardiology Ltd
Tbilisi, 0159
National Institute of Endocrinology
Tbilisi, 0159
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, 0159
Aversi ClinicLtd.
Tbilisi, 0160
Clinic on Mtskheta Street
Tbilisi, 0179
Consilium Medulla-multiprofile clinic Ltd
Tbilisi, 0186
Medicore Ltd.
Tbilisi, 0186
Estonia5 sites
OÜ Innomedica
Tallinn, 10117
Center for Clinical and Basic Research
Tallinn, 10128
North Estonia Medical Centre Foundation
Tallinn, 13419
Clinical Research Centre
Tartu, 50106
Meditrials OU
Tartu, 50406
About this study
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
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.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis
- Being tested
- Filgotinib, Placebo, Standard of Care
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called GS-6034, Jyseleca®
200-mg tablet administered orally once daily
PlaceboDrug
Placebo to match filgotinib tablet administered orally once daily
Standard of CareDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib | Experimental | 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. Receives: Drug: Filgotinib; Drug: Standard of Care |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 13
Secondary outcomes (11)
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.
Measured: Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 13
The normal range for sperm total motility is ≥40%.
Measured: Baseline, Week 13
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%.
Measured: Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
Measured: Baseline, Week 13
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.
Measured: Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
The normal range for sperm concentration is ≥15 million sperms/mL.
Measured: Baseline, Week 13
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.
Measured: Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 13
The normal range for ejaculate volume is ≥1.5 mL.
Measured: Baseline, Week 13
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.
Measured: Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 13
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Measured: Baseline, Week 13
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.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start28 May 2019
- Primary completion14 Aug 2020
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926195
- Sponsor's protocol ID
- GLPG0634-CL-227
- Other IDs
- 2018-003933-14, 2018
- Acronym
- MANTA-RAy
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2019
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.
PubMed 37137672Hellstrom 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.
PubMed 35614292
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03926195
- Acronym / sponsor ID
- MANTA-RAy / GLPG0634-CL-227
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographical Axial Spondyloarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Study start
- 28 May 2019 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filgotinib | Experimental | Drug: Filgotinib, Drug: Standard of CareParticipants 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Standard of CareParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgotinibAlso: GS-6034, Jyseleca®200-mg tablet administered orally once daily | Drug | Filgotinib |
| PlaceboPlacebo to match filgotinib tablet administered orally once daily | Drug | Placebo |
| Standard of CareLocally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity. | Drug | Filgotinib, Placebo |
Primary outcome
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Time frame: Baseline to 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.
11 secondary outcomes
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Time frame: Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Sperm Total Motility at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Total Sperm Count at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Sperm Concentration at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Ejaculate Volume at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 13
Time frame: Baseline, Week 13
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37137672Reinisch W, Hellstrom W, Dolhain RJEM, Sikka S, Westhovens R, Mehta R, Ritter T, Seidler U, Golovchenko O, Simanenkov V, Garmish O, Jeka S, Moravcova R, Rajendran V, Le Brun FO, Arterburn S, Watkins TR, Besuyen R, Vanderschueren D. Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies. Ann Rheum Dis. 2023 Aug;82(8):1049-1058. doi: 10.1136/ard-2023-224017. Epub 2023 May 3.
- Derived from this study: PubMed 35614292Hellstrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galapagos Study Director study director
Lakefront Biotherapeutics NV
71 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Filgotinib in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Lakefront Biotherapeutics NV at 71 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in Ukraine, Bulgaria, Poland, Czechia, Georgia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 (time frame: Baseline to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926195, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.