| Primary | Time to Relapse (ToR) of Takayasu Arteritis (TAK) According to Protocol-defined Criteria Through the End of Double-blind Period | ToR:time from randomization to 1st relapse through end of double-blind period (EDBP) per protocol-defined criteria with 5 categories:systemic (objective):body temperature >=38.0°C, weight loss >2kg in 4 weeks, arthralgia, swelling & tenderness =>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at >= grade 2, high inflammation markers (C-reactive protein >=1.0mg/dL, erythrocyte sedimentation rate >=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP <120/80mmHg risen to >=140/90mmHg, or if normal BP >=120/80mmHg, diastolic BP risen by >=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by >=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Relapse:>=2 categories met criteria. | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study intervention through double-blind period. Censored:death/discontinued drugs at last assessment through EDBP (before relapse)/before EDBP (no relapse). | Posted | | Median | 95% Confidence Interval | Weeks | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received placebo matched to ustekinumab as intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab | Participants received weight-range based ustekinumab (6 milligrams/kilogram [mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90 mg SC injection 8 weeks after initial IV dose, then q8w thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00012.64(12.14 to NA)Upper limit of 95% confidence interval (CI) was not estimable due to less number of participants with events due to early study termination.
- OG00111.14(4.14 to NA)Upper limit of 95% CI was not estimable due to less number of participants with events due to early study termination.
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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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| | | | | | Hazard Ratio (HR) | 1.86 | | | 2-Sided | 95 | 0.41 | 8.47 | | | | | Superiority | | |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs were defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose. | The safety analysis set included all participants who received at least 1 dose of study intervention through double-blind period and OLE period. | Posted | | Count of Participants | | Participants | | Double-blind period: Double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE period: OL Week 0 up to end of OLE treatment period (48.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Double-blind: Placebo | In double-blind period, participants received placebo matched to ustekinumab as intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab | Participants received weight-range based ustekinumab (6 milligrams/kilogram [mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90 mg SC injection 8 weeks after initial IV dose, then q8w thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. |
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| Secondary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) | SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were defined as SAEs with onset or worsening on or after date of first dose of study intervention through the day of last dose. | The safety analysis set included all participants who received at least 1 dose of study intervention through double-blind period and OLE period. | Posted | | Count of Participants | | Participants | | Double-blind period: Double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE: OL Week 0 up to end of OLE treatment period (48.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 |
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| Secondary | Time to Relapse of TAK According to Kerr's Criteria Through the End of Double-blind Period | ToR was defined from the date of randomization to the judged date of relapse through the EDBP based on Kerr's definition: participants who met 2 or more categories in the following 4 categories were considered as relapse: systemic (objective):body temperature >=38.0°C, weight loss >2kg in 4 weeks, arthralgia, swelling & tenderness =>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at >= grade 2, high inflammation markers (C-reactive protein >=1.0mg/dL, erythrocyte sedimentation rate >=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP <120/80mmHg risen to >=140/90mmHg, or if normal BP >=120/80mmHg, diastolic BP risen by >=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by >=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Median | 95% Confidence Interval | Weeks | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Time to Relapse of TAK Based on Clinical Symptoms Through the End of Double-blind Period | Time (in weeks) to relapse of TAK: time from randomization to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature >=38.0°C, weight loss >2kg in 4 weeks, arthralgia, swelling and tenderness =>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at >= grade 2, high inflammation markers (C-reactive protein >=1.0mg/dL, erythrocyte sedimentation rate >=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP <120/80mmHg risen to >=140/90mmHg, or if normal BP >=120/80mmHg, diastolic BP risen by >=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by >=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:>=2 categories met criteria. | FAS included all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Median | 95% Confidence Interval | weeks | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Time to Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | Time to relapse of TAK: time from randomization date to the 1st relapse through the EDBP according to protocol-defined criteria with 5 categories: systemic (objective):body temperature >=38.0°C, weight loss >2kg in 4 weeks, arthralgia, swelling and tenderness =>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at >= grade 2, high inflammation markers (C-reactive protein >=1.0mg/dL, erythrocyte sedimentation rate >=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP <120/80mmHg risen to >=140/90mmHg, or if normal BP >=120/80mmHg, diastolic BP risen by >=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by >=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms:abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. Time to relapse was calculated by each category independently. Relapse:>=2 categories met criteria. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field signifies that no participants were in relapse. | Posted | | Median | 95% Confidence Interval | weeks | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Percentage of Participants With Relapse of TAK in Each of the 5 Categories (Within Protocol-defined Criteria) Through the End of Double-blind Period | Percentage of participants with time to relapse of TAK through the EDBP were reported. Protocol-defined criteria consisted of 5 categories: systemic (objective):body temperature >=38.0°C, weight loss >2kg in 4 weeks, arthralgia, swelling & tenderness =>2 joints; systemic (subjective):malaise, myalgia, headache, dizziness/vertigo at >= grade 2, high inflammation markers (C-reactive protein >=1.0mg/dL, erythrocyte sedimentation rate >=30mm/hr), vascular symptoms:renovascular hypertension: if normal BP <120/80mmHg risen to >=140/90mmHg, or if normal BP >=120/80mmHg, diastolic BP risen by >=20mmHg, new bruits/loss of pulse/difference in systolic BP between left and right by >=10mmHg/tenderness/spontaneous pain in carotid artery/chest/back region, aortic valve incompetence; ischemic symptoms: abdominal pain, seizure, syncope, intermittent claudication, ischemic cardiac pain. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Number | | percentage of participants | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Cumulative Oral Glucocorticoid (GC) Dose Through the End of Double-blind Period | Cumulative oral GC dose (prednisolone or equivalent) through the end of double-blind period were reported. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Mean | Standard Deviation | milligrams (mg) | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab | |
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| Secondary | Change From Baseline in Oral GC Dose Through the End of Double-blind Period | Change from baseline in oral GC dose through the end of double-blind period were reported. Change from baseline was defined as the change between the GC dose at randomization and the last observed GC dose. If the participant had relapse, oral GC dose (prednisolone or equivalent) used from randomization date to last observed date prior to the date of relapse were included in the analysis and if the participant had no relapse then oral GC dose used from randomization to last observed date through the end of double-blind period were included in the analysis. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Mean | Standard Deviation | milligrams per day (mg/day) | | Baseline (double-blind Week 0) up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab |
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| Secondary | Number of Participants Achieving GC Dose of 5 mg/Day or Less Through the End of Double-blind Period | Number of participants who achieved GC dose of 5 mg/day or less through the end of double-blind period were reported. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. | Posted | | Count of Participants | | Participants | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab | Participants received weight-range based ustekinumab (6 milligrams/kilogram [mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90 mg SC injection 8 weeks after initial IV dose, then q8w thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. |
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| Secondary | Change From Baseline in Imaging Evaluation of Vessel Involvement (Average Percentage of Dilation) at the End of Double-blind Period | Change from baseline in average percentage of dilation for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using computed tomography angiography (CTA) or magnetic resonance angiography (MRA). For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number of participants analyzed field of arm 'Double-blind: Placebo' signifies that no participants were available for analysis because placebo group did not have abnormal dilation at double-blind relapse visit. Here, 'N' (number of participants analyzed): who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of Dilation | | Baseline (double-blind Week 0) and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Change From Baseline in Imaging Evaluation of Vessel Involvement (Average Percentage of Stenosis) Through the End of Double-blind Period | Change from baseline in average percentage of stenosis for abnormal vessel segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS: who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field of 'Double-blind: Placebo' arm signifies that no participant was available for analysis because all placebo group participants either relapsed or discontinued the study before Week 24. Here, 'N' (number of participants analyzed): who were evaluable for this outcome measure and 'n' (number analysed): number of participants analyzed at each specified timepoints. | Posted | | Mean | Standard Deviation | Percentage of Stenosis | | Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Change From Baseline in Imaging Evaluation of Average Arterial Wall Thickness Through the End of Double-blind Period | Change from baseline in average wall thickness for abnormal segments through the end of double-blind period was reported. Assessment was performed using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS: who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field of 'Double-blind: Placebo' arm signifies that no participant was available for analysis because all placebo group participants either relapsed or discontinued the study before Week 24. Here, 'N' (number of participants analyzed): who were evaluable for this outcome measure and 'n' (number analyzed):number of participants analyzed at each specified timepoints. | Posted | | Mean | Standard Deviation | millimeters | | Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind : Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Imaging Evaluation: Number of Participants With Mural Contrast Enhancement Through the End of Double-blind Period | Number of participants with mural contrast enhancement through the end of double-blind period were reported. The mural contrast enhancement were assessed for imaging evaluation using CTA or MRA. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS: who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field of Double-blind: Placebo arm signifies that no participant was available for analysis because all placebo group participants either relapsed or discontinued the study before Week 24. Here, 'N' (number of participants analyzed): who were evaluable for this outcome measure and 'n' (number analyzed): number of participants analyzed at each specified timepoints. | Posted | | Count of Participants | | Participants | | Baseline (double-blind Week 0), Week 24, Week 48, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Change From Baseline in C-reactive Protein (CRP) Through the End of Double-blind Period | Change from baseline in CRP (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field of arm 'Double-blind: Placebo', signifies that no participant was available for analysis because all placebo group participants either relapsed or discontinued the study before Week 24. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | | Baseline (double-blind Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Through the End of Double-blind Period | Change from baseline in ESR (as inflammatory marker) through the end of double-blind period were reported. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | FAS includes all randomized participants who received at least 1 dose of study intervention through double-blind period. Here, '0' in the number analyzed field of "Double-blind: Placebo" arm signifies that no participant was available for analysis because all placebo group participants either relapsed or discontinued the study before Week 24. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. | Posted | | Mean | Standard Deviation | millimeters per hour (mm/h) | | Baseline (double-blind Week 0), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, and double-blind relapse (up to 14 weeks for Placebo arm; up to 48 weeks for ustekinumab arm) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. |
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| Secondary | Serum Concentrations of Ustekinumab in Participants Receiving Ustekinumab During Double-blind Phase | Serum concentrations of ustekinumab was reported during double-blind Phase. For a participant, the time point at which the 1st relapse developed or discontinuation from double-blind period was considered as the end of double-blind period. | The pharmacokinetic (PK) analysis set was defined as participants who received at least 1 complete dose of ustekinumab and had at least 1 valid postdose PK data. Here, 'n' (number analyzed) signifies number of participants analyzed at each specified timepoints. For this outcome measure, as pre-planned, data collection and analysis was not performed for the placebo arm. | Posted | | Mean | Standard Deviation | micrograms per millilitres (mcg/mL) | | Pre-dose (double-blind Week 0), Post-dose: Week 0, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, double-blind relapse (up to 48 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Ustekinumab | Participants received weight-range based ustekinumab (6 milligrams/kilogram [mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90 mg SC injection 8 weeks after initial IV dose, then q8w thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. |
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| Secondary | Serum Concentrations of Ustekinumab in Participants Receiving Ustekinumab During Open-label Extension Phase | Serum concentrations of ustekinumab was reported during OLE Phase. | PK analysis set: who experienced relapse in double-blind period and received at least 1 complete dose of ustekinumab and had at least 1 valid postdose PK data from OL Week 0 to end of OLE period. Here, '0' in the number analyzed field of second arm signifies that no participant was available for analysis because all participants were relapsed before OL Week 48. Here, 'n' (number analyzed): number of participants analyzed at each specified timepoints. | Posted | | Mean | Standard Deviation | mcg/mL | | Pre-dose (OL Week 0), Post-dose: OL Week 0, OL Weeks 8, 16, 24, 32, 40, 48, 52, and 56 | | | | ID | Title | Description |
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| OG000 | OLE: Placebo Then Ustekinumab | Participants who had relapse during the double-blind period, received rescue medication of >=doubled oral GC dose. These participants were assessed whether they achieved remission at the next scheduled dose administration visit (OL Week 0) from the relapse to enter OLE period and received ustekinumab 90 mg IV infusion at OL Week 0 followed by ustekinumab 90 mg SC injection at OL Week 8 and thereafter q8w in OLE period (maximum exposure: 48.1 weeks). Rest of the participants entered OLE period after end of double blind period and then they received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 (maximum exposure: 48.1 weeks). Participants who received placebo (up to 8.1 weeks) in double-blind period received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 till end of OLE period (maximum exposure: 48.1 weeks). |
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| Secondary | Number of Participants With Positive Anti-ustekinumab Antibodies Through End of Double-blind Period | Number of participants with positive anti-ustekinumab antibodies were reported. | The immunogenicity analysis set was defined as all participants who received at least 1 dose of ustekinumab and had at least 1 postdose valid immunogenicity data. For this outcome measure, as pre-planned, data collection and analysis was not performed for the placebo arm. | Posted | | Count of Participants | | Participants | | From double-blind Week 0 up to end of double-blind period (up to 71.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Ustekinumab | Participants received weight-range based ustekinumab (6 milligrams/kilogram [mg/kg]) as IV infusion at Week 0 followed by ustekinumab 90 mg SC injection 8 weeks after initial IV dose, then q8w thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. |
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| Secondary | Number of Participants With Positive Anti-ustekinumab Antibodies Through End of OLE Period | Number of participants with positive anti-ustekinumab antibodies were reported. | The immunogenicity analysis set was defined as all participants who received at least 1 dose of ustekinumab and had at least 1 postdose valid immunogenicity data. In ustekinumab arm N included all participants who were initially randomized to ustekinumab arm. | Posted | | Count of Participants | | Participants | | From OL Week 0 up to end of OLE period (up to 63.1 weeks) | | | | ID | Title | Description |
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| OG000 | OLE: Placebo Then Ustekinumab | Participants who had relapse during the double-blind period, received rescue medication of >=doubled oral GC dose. These participants were assessed whether they achieved remission at the next scheduled dose administration visit (OL Week 0) from the relapse to enter OLE period and received ustekinumab 90 mg IV infusion at OL Week 0 followed by ustekinumab 90 mg SC injection at OL Week 8 and thereafter q8w in OLE period (maximum exposure: 48.1 weeks). Rest of the participants entered OLE period after end of double blind period and then they received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 (maximum exposure: 48.1 weeks). Participants who received placebo (up to 8.1 weeks) in double-blind period received ustekinumab 90 mg SC injection (maintenance dosing) q8w from OL Week 0 till end of OLE period (maximum exposure: 48.1 weeks). | | OG001 | OLE: Ustekinumab Then Ustekinumab | |
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| Secondary | Number of Participants With TEAEs by System Organ Class (SOC) With a Frequency Threshold of 5 Percent (%) or More | An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study intervention. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study intervention through the day of last dose. If same participant had more than one AE within the same SOC, that participant is counted only once in the below data table. | The safety analysis set included all participants who received at least 1 dose of study intervention through double-blind period and OLE period. | Posted | | Count of Participants | | Participants | | Double-blind period: double-blind Week 0 up to end of double-blind treatment period (56.1 weeks); OLE period: OL Week 0 up to end of OLE treatment period (48.1 weeks) | | | | ID | Title | Description |
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| OG000 | Double-blind: Placebo | In double-blind period, participants received body weight-range placebo intravenous (IV) infusion at Week 0 followed by placebo subcutaneous (SC) injection administration, 8 weeks after the initial IV dose, then every 8 weeks (q8w) thereafter until developing relapse or end of double-blind period, with starting the protocol defined oral GC taper regimen from Week 2. Participants who received placebo in double-blind period and reached oral GC dose of 5 mg/day or less were terminated from study intervention administration and underwent early-term visit after completion of double-blind period. | | OG001 | Double-blind: Ustekinumab |
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