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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
109
200-mg tablet administered orally once daily
Placebo to match filgotinib tablet administered orally once daily
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.
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
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 13
Baseline for sperm/semen parameters was the mean of 2 evaluable semen samples at screening. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 13 - baseline\] / baseline) × 100; value at Week 13 was the mean of 2 evaluable samples collected at Week 13.
Time frame: Baseline to Week 13
Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26
Arthritis responder: For rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nrAxSpA), a participant with an improvement in the Physician's Global Assessment of Disease Activity (PhGADA) of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a visual analogue scale (VAS) ranged from 0 (no disease)-100 (worst disease) millimeters (mm). Baseline value for sperm/semen parameters was the mean of 2 evaluable semen collections at the screening visit. The normal range for sperm concentration is ≥15 million sperms/mL. Percentage change = (\[mean at Week 26 - baseline\] / baseline) × 100; value at Week 26 was the mean of 2 evaluable samples collected at Week 26.
Time frame: Baseline to Week 26
Change From Baseline in Sperm Total Motility at Week 13
The normal range for sperm total motility is ≥40%.
Time frame: Baseline, Week 13
Change From Baseline in Sperm Total Motility at Week 26
Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm. The normal range for sperm total motility is ≥40%.
Time frame: Baseline, Week 26
Change From Baseline in Total Sperm Count at Week 13
The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
Time frame: Baseline, Week 13
Change From Baseline in Total Sperm Count at Week 26
Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm. The normal range for total sperm count is ≥ 39 million sperms/ejaculate.
Time frame: Baseline, Week 26
Change From Baseline in Sperm Concentration at Week 13
The normal range for sperm concentration is ≥15 million sperms/mL.
Time frame: Baseline, Week 13
Change From Baseline in Sperm Concentration at Week 26
Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm. The normal range for sperm concentration is ≥15 million sperms/mL.
Time frame: Baseline, Week 26
Change From Baseline in Ejaculate Volume at Week 13
The normal range for ejaculate volume is ≥1.5 mL.
Time frame: Baseline, Week 13
Change From Baseline in Ejaculate Volume at Week 26
Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm. The normal range for ejaculate volume is ≥1.5 mL.
Time frame: Baseline, Week 26
Change From Baseline in Percent Normal Sperm Morphology at Week 13
The normal range for percent normal sperm morphology is ≥30% normal sperms.
Time frame: Baseline, Week 13
Change From Baseline in Percent Normal Sperm Morphology at Week 26
Arthritis responder: For RA, PsA, AS, and nrAxSpA, a participant with an improvement in the PhGADA of at least 20% compared with baseline (Day 1) at the specified assessment time. Arthritis nonresponder: For RA, PsA, AS, or nrAxSpA, a participant who did not fulfill the definition of arthritis responder at the specified assessment timepoint. PhGADA: Physician measured the participant's disease severity on a VAS ranged from 0 (no disease)-100 (worst disease) mm. The normal range for percent normal sperm morphology is ≥30% normal sperms.
Time frame: Baseline, Week 26
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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
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