Phase 2
Completed N=109
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 · Ankylosing Spondylitis · Non-Radiographical Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT03926195 ↗
Enrolled (actual)
109
Serious AEs
5.4%
Results posted
Aug 2023
Primary outcomePrimary: Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 — 13.0; 7.5 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13 |
13.0; 7.5 | — |
| SECONDARY Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26 |
10.3; 8.0; 14.3; 0 | — |
| SECONDARY Change From Baseline in Sperm Total Motility at Week 13 |
-2.3; -1.7 | — |
| SECONDARY Change From Baseline in Sperm Total Motility at Week 26 |
-2.4; 0.9; -1.4; -2.8 | — |
| SECONDARY Change From Baseline in Total Sperm Count at Week 13 |
-2.1; -9.6 | — |
| SECONDARY Change From Baseline in Total Sperm Count at Week 26 |
-0.2; 16.8; 32.2; -29.9 | — |
| SECONDARY Change From Baseline in Sperm Concentration at Week 13 |
3.7; -0.4 | — |
| SECONDARY Change From Baseline in Sperm Concentration at Week 26 |
1.7; 9.6; 10.3; -5.8 | — |
| SECONDARY Change From Baseline in Ejaculate Volume at Week 13 |
-0.3; -0.2 | — |
| SECONDARY Change From Baseline in Ejaculate Volume at Week 26 |
-0.2; -0.6; 0.2; -0.3 | — |
| SECONDARY Change From Baseline in Percent Normal Sperm Morphology at Week 13 |
1; 1 | — |
| SECONDARY Change From Baseline in Percent Normal Sperm Morphology at Week 26 |
1; 3; 3; 4 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03926195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.