CompletedPhase 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

Bulgaria109 participantsStarted 2019-05-28

Plain-language 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.

Who can participate

Age range21 Years – 65 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13

Timeframe: Baseline to Week 13

Trial details

NCT IDNCT03926195

SponsorGalapagos NV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-14

Results submitted2023-05-26

View on ClinicalTrials.gov More Rheumatoid Arthritis trials