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)
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| ClinicalTrials.gov Identifier: NCT03926195 |
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Recruitment Status :
Active, not recruiting
First Posted : April 24, 2019
Last Update Posted : August 5, 2022
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Sponsor:
Galapagos NV
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Galapagos NV
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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. The total planned number of participants in both studies combined will be up to approximately 250 participants.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Non-Radiographical Axial Spondyloarthritis | Drug: Filgotinib Drug: Placebo Drug: Standard of Care | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 109 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 28, 2019 |
| Actual Primary Completion Date : | August 14, 2020 |
| Estimated Study Completion Date : | October 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Psoriatic arthritis
Rheumatoid arthritis
Ankylosing spondylitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Double-Blind Phase: Filgotinib
Filgotinib up to Week 13
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Drug: Filgotinib
200-mg tablet administered orally once daily |
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Placebo Comparator: Double-Blind Phase: Placebo
Placebo up to Week 13
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Drug: Placebo
Placebo to match filgotinib tablet administered orally once daily |
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Experimental: Extension Phase: Open-Label Filgotinib
Participants who received double-blind filgotinib and did not meet prespecified decreases in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) and were arthritis responders at Week 13 will enter the Extension Phase and receive open-label filgotinib up to Week 156. Participants who meet the criteria of prespecified decreases in sperm parameters anytime during the Extension Phase will enter the Monitoring Phase.
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Drug: Filgotinib
200-mg tablet administered orally once daily |
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Extension Phase: Standard of Care
Participants who received double-blind placebo and participants who received double-blind filgotinib and were arthritis non-responders who did not meet prespecified decreases in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) at Week 13 will enter the Extension Phase and receive standard of care up to Week 156. Participants who meet the criteria of prespecified decreases in sperm parameters anytime during the Extension Phase will enter the Monitoring Phase.
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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. |
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Monitoring Phase: Standard of Care
Participants with a prespecified decrease in sperm parameters (that is, ≥ 50% decrease from baseline in sperm concentration, and/or motility, and/or morphology) anytime at/after Week 13 will receive standard-of-care therapy as per investigator discretion in the Monitoring Phase for up to 52 weeks or until reversibility in semen parameters is met, whichever occurs first.
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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. |
Primary Outcome Measures :
- Percentage of Participants with a ≥ 50% Decrease from Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
Secondary Outcome Measures :
- Percentage of Participants with a ≥ 50% Decrease from Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Percent Motile Sperm at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Percent Motile Sperm at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Total Sperm Count at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Total Sperm Count at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Ejaculate Volume at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Ejaculate Volume at Week 26 [ Time Frame: Week 26 ]
- Change from Baseline in Percent Normal Sperm Morphology at Week 13 [ Time Frame: Week 13 ]
- Change from Baseline in Percent Normal Sperm Morphology at Week 26 [ Time Frame: Week 26 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926195
Locations
Show 73 study locations
Sponsors and Collaborators
Galapagos NV
Gilead Sciences
Investigators
| Study Director: | Robin Besuyen, MD | Galapagos NV |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Galapagos NV |
| ClinicalTrials.gov Identifier: | NCT03926195 |
| Other Study ID Numbers: |
GLPG0634-CL-227 2018-003933-14 ( EudraCT Number ) |
| First Posted: | April 24, 2019 Key Record Dates |
| Last Update Posted: | August 5, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Additional relevant MeSH terms:
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Spondylitis Arthritis Arthritis, Rheumatoid Spondylarthritis Arthritis, Psoriatic Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Bone Diseases, Infectious Infections Bone Diseases Spinal Diseases Spondylarthropathies Psoriasis Skin Diseases, Papulosquamous Skin Diseases Ankylosis |