| Primary | 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. | The Semen Analysis Set included all randomized and treated (≥ 1 dose of double-blind study drug) participants who had 2 semen samples that were eligible for mean calculation at baseline and at the Week 13 analysis visit with the date of the first chronologic semen sample used for purposes of assigning analysis visit windows. | Posted | | Number | | percentage of participants | | Baseline to Week 13 | | | | ID | Title | Description |
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| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | Difference in Percentage | 5.8 | | | 2-Sided | 95 | -7.5 | 19.2 | | | Difference in percentage and 95% confidence interval (CI) was based on a stratified Mantel-Haenszel test. | | Other | | |
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| Secondary | 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. | The Week 26 Semen Analysis Set included all participants treated (≥ 1 dose of open-label filgotinib or SOC in the extension phase) who had 2 evaluable samples at baseline and at Week 26. | Posted | | Number | | percentage of participants | | Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. |
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| Secondary | Change From Baseline in Sperm Total Motility at Week 13 | The normal range for sperm total motility is ≥40%. | Participants in the Semen Analysis Set with available data were analyzed. | Posted | | Median | 95% Confidence Interval | percentage of motile sperms | | Baseline, Week 13 | | | | ID | Title | Description |
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| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| Secondary | 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%. | Participants in the Week 26 Semen Analysis Set with available data were analyzed. | Posted | | Median | 95% Confidence Interval | percentage of motile sperms | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. | | OG001 | Placebo/SOC (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). |
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| Secondary | Change From Baseline in Total Sperm Count at Week 13 | The normal range for total sperm count is ≥ 39 million sperms/ejaculate. | Participants in the Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | million sperms/ejaculate | | Baseline, Week 13 | | | | ID | Title | Description |
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| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| Secondary | 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. | Participants in the Week 26 Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | million sperms/ejaculate | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. | | OG001 | Placebo/SOC (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). |
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| Secondary | Change From Baseline in Sperm Concentration at Week 13 | The normal range for sperm concentration is ≥15 million sperms/mL. | Participants in the Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | million sperms/mL | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| Secondary | 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. | Participants in the Week 26 Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | million sperms/mL | | Baseline, Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. | | OG001 | Placebo/SOC (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). |
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| Secondary | Change From Baseline in Ejaculate Volume at Week 13 | The normal range for ejaculate volume is ≥1.5 mL. | Participants in the Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | mL | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| Secondary | 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. | Participants in the Week 26 Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | mL | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. | | OG001 | Placebo/SOC (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). | |
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| Secondary | Change From Baseline in Percent Normal Sperm Morphology at Week 13 | The normal range for percent normal sperm morphology is ≥30% normal sperms. | Participants in the Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | percentage of normal sperms | | Baseline, Week 13 | | | | ID | Title | Description |
|---|
| OG000 | Filgonitib | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase and participants who were arthritis nonresponders discontinued blinded study drug and started SOC treatment in the EXT phase. Participants on DB treatment or OL filgotinib who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) discontinued the study drug and started SOC for up to 52 weeks. | | OG001 | Placebo | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). Participants who entered the monitoring phase (if their sperm parameters met ≥50% decrease threshold in pre-specified semen parameters) continued on SOC treatment. |
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| Secondary | 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. | Participants in the Week 26 Semen Analysis Set were analyzed. | Posted | | Median | 95% Confidence Interval | percentage of normal sperms | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Filgotinib/OL Filgotinib (Responder) | Participants received filgotinib 200 mg tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and received OL treatment filgotinib 200 mg, tablet, orally, once daily up to approximately 143 weeks (until Week 156) in the EXT phase. | | OG001 | Placebo/SOC (Responder) | Participants received placebo (matched to filgotinib) tablet, orally, once daily up to Week 13 in the DB phase. At Week 13, participants who were arthritis responders, were unblinded and started SOC treatment in the EXT phase for up to approximately 143 weeks (until Week 156). |
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