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Completed

NCT Number: NCT03926195

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

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.

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Key information

Conditions

Rheumatoid Arthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Non-Radiographical Axial Spondyloarthritis Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Medical center Medconsult Pleven OOD, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Filgotinib

Drug

200-mg tablet administered orally once daily

Other names: GS-6034, Jyseleca®

Placebo

Drug

Placebo to match filgotinib tablet administered orally once daily

Standard of care

Drug

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.

Primary outcomes

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

    Time frame: Baseline to 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.

Secondary outcomes

  1. Percentage of Participants With a ≥ 50% Decrease From Baseline in Sperm Concentration at Week 26

    Time frame: Baseline to 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.

  2. Change From Baseline in Sperm Total Motility at Week 13

    Time frame: Baseline, Week 13

    The normal range for sperm total motility is ≥40%.

  3. Change From Baseline in Sperm Total Motility at Week 26

    Time frame: Baseline, 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%.

  4. Change From Baseline in Total Sperm Count at Week 13

    Time frame: Baseline, Week 13

    The normal range for total sperm count is ≥ 39 million sperms/ejaculate.

  5. Change From Baseline in Total Sperm Count at Week 26

    Time frame: Baseline, 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.

  6. Change From Baseline in Sperm Concentration at Week 13

    Time frame: Baseline, Week 13

    The normal range for sperm concentration is ≥15 million sperms/mL.

  7. Change From Baseline in Sperm Concentration at Week 26

    Time frame: Baseline, 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.

  8. Change From Baseline in Ejaculate Volume at Week 13

    Time frame: Baseline, Week 13

    The normal range for ejaculate volume is ≥1.5 mL.

  9. Change From Baseline in Ejaculate Volume at Week 26

    Time frame: Baseline, 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.

  10. Change From Baseline in Percent Normal Sperm Morphology at Week 13

    Time frame: Baseline, Week 13

    The normal range for percent normal sperm morphology is ≥30% normal sperms.

  11. Change From Baseline in Percent Normal Sperm Morphology at Week 26

    Time frame: Baseline, 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.

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Acronym: MANTA-RAy

Important dates

Study start
2019
Primary completion
2020
Study completion
2023
First posted
Apr 24, 2019
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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