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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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 identifier NCT03926195

Recruitment Status Active, not recruiting

First Posted April 24, 2019

Last update posted August 5, 2020

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. The total planned number of participants in both studies combined will be up to approximately 250 participants.

  • Condition or Disease:Rheumatoid Arthritis
    Psoriatic Arthritis
    Ankylosing Spondylitis
    Non-Radiographical Axial Spondyloarthritis
  • Intervention/Treatment: Drug: Filgotinib
    Drug: Placebo
    Drug: Standard of Care
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: October 2024
Arms and interventions
Arm Intervention/treatment
Experimental: Double-Blind Phase: Filgotinib
Filgotinib up to Week 13
Drug: Filgotinib
200-mg tablet administered orally once daily
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.
Drug: Filgotinib
200-mg tablet administered orally once daily
Placebo Comparator: Double-Blind Phase: Placebo
Placebo up to Week 13
Drug: Placebo
Placebo to match filgotinib tablet administered orally once daily
Other: 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.
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.
Other: 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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Percentage of Participants with a ≥ 50% Decrease from Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
  • Secondary Outcome Measures: 1. Percentage of Participants with a ≥ 50% Decrease from Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
  • 2. Change from Baseline in Percent Motile Sperm at Week 13 [ Time Frame: Week 13 ]
  • 3. Change from Baseline in Percent Motile Sperm at Week 26 [ Time Frame: Week 26 ]
  • 4. Change from Baseline in Total Sperm Count at Week 13 [ Time Frame: Week 13 ]
  • 5. Change from Baseline in Total Sperm Count at Week 26 [ Time Frame: Week 26 ]
  • 6. Change from Baseline in Sperm Concentration at Week 13 [ Time Frame: Week 13 ]
  • 7. Change from Baseline in Sperm Concentration at Week 26 [ Time Frame: Week 26 ]
  • 8. Change from Baseline in Ejaculate Volume at Week 13 [ Time Frame: Week 13 ]
  • 9. Change from Baseline in Ejaculate Volume at Week 26 [ Time Frame: Week 26 ]
  • 10. Change from Baseline in Percent Normal Sperm Morphology at Week 13 [ Time Frame: Week 13 ]
  • 11. Change from Baseline in Percent Normal Sperm Morphology at Week 26 [ Time Frame: Week 26 ]
Eligibility Criteria
  • Ages Eligible for Study: 21 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.

Contacts and Locations
Contacts
Locations
Show 73 Study Locations
Sponsors and Collaborators

Galapagos NV

Gilead Sciences

Investigators

Study Director: Robin Besuyen, MD Galapagos NV

More Information
  • Responsible Party: Galapagos NV
  • ClinicalTrials.gov Identifier: NCT03926195 History of Changes
  • Other Study ID Numbers: GLPG0634-CL-227, 2018-003933-14
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: August 5, 2020
  • Last Verified: August 2020
  • 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: Spondylitis
    Arthritis
    Arthritis, Rheumatoid
    Arthritis, Psoriatic
    Spondylitis, Ankylosing
    Spondylarthritis