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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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 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

NCT03926195•Galapagos NV

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 65 years

Sex

MALE

Healthy Volunteers

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

Exclusion Criteria

•Previously documented problems with male reproductive health
•Prior diagnosis of male infertility
•Use of any prohibited concomitant medication as outlined by protocol

Locations (71)

Medical center Medconsult Pleven OOD

Pleven, Bulgaria

UMHAT Pulmed OOD

Plovdiv, Bulgaria

UMHAT Sv. Georgi, EAD

Plovdiv, Bulgaria

MHAT "Eurohospital" - Plovdiv, OOD

Plovdiv, Bulgaria

Medical Center Teodora, EOOD

Rousse, Bulgaria

Medizinski Zentar-1-Sevlievo EOOD

Sevlievo, Bulgaria

Medical Center Excelsior, OOD

Sofia, Bulgaria

DCC Alexandrovska, EOOD

Sofia, Bulgaria

UMHAT Sv. Ivan Rilski, EAD

Sofia, Bulgaria

DCC 17 - Sofia EOOD

Sofia, Bulgaria

Key Dates

Start Date

May 28, 2019

Primary Completion Date

August 14, 2020

Completion Date

May 10, 2023

Last Updated

April 30, 2024

Enrollment

109

ACTUAL participants

Conditions

Rheumatoid ArthritisPsoriatic ArthritisAnkylosing SpondylitisNon-Radiographical Axial Spondyloarthritis

Interventions

Filgotinib

DRUG

Placebo

DRUG

Standard of Care

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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