{"analyses":[{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG003"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.382","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG002"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"1.000","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG001"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"1.000","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG007"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.344","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG006"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.559","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"},{"groupDescription":"Efficacy analysis was based on the modified Intent-To-Treat-Efficacy (mITT-E) population for the maintenance period. The mITT-E population was a subpopulation of the mITT population, where participants in M-PL arm were excluded.","groupIds":["OG005"],"nonInferiorityComment":"one-sample two-sided Chi-square test","nonInferiorityType":"SUPERIORITY","pValue":"0.815","pValueComment":"Adjusted p-value from a sequentially rejective multiple test procedure, testing co-primary and ranked secondary endpoints 1st for M-SD+M-HD, then for individual adalimumab dose groups (M-HD, M-SD) against the respective external placebo rate (24.08%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.27","upperLimit":"85.34","value":"40.0"},{"groupId":"OG001","lowerLimit":"9.09","upperLimit":"61.43","value":"30.8"},{"groupId":"OG002","lowerLimit":"11.02","upperLimit":"58.66","value":"31.3"},{"groupId":"OG003","lowerLimit":"15.28","upperLimit":"50.83","value":"31.0"},{"groupId":"OG004","lowerLimit":"5.27","upperLimit":"85.34","value":"40.0"},{"groupId":"OG005","lowerLimit":"7.79","upperLimit":"55.10","value":"26.7"},{"groupId":"OG006","lowerLimit":"14.21","upperLimit":"61.67","value":"35.3"},{"groupId":"OG007","lowerLimit":"16.12","upperLimit":"50.01","value":"31.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"29"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"17"},{"groupId":"OG007","value":"32"}],"units":"Participants"}],"description":"The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). The PMS (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment). Negative changes indicate improvement. PMS responders are defined as those with a decrease in PMS ≥ 2 points and ≥ 30% from baseline. Among participants receiving systemic corticosteroids at Baseline, corticosteroid-free clinical remission per FMS at Week 52 is defined as having discontinued systemic corticosteroids prior to Week 52 and being in FMS clinical remission at Week 52 (defined as Mayo Score ≤ 2 and no individual subscore \\> 1).","dispersionType":"95% Confidence Interval","groups":[{"description":"(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.","id":"OG000","title":"Main Study: M-PL"},{"description":"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.","id":"OG001","title":"Main Study: M-SD"},{"description":"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.","id":"OG002","title":"Main Study: M-HD"},{"description":"Combined M-SD + M-HD arms (see above).","id":"OG003","title":"Main Study: M-SD + M-HD"},{"description":"(Prior to Amendment 4) participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to maintenance placebo. Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label adalimumab rescue therapy after the second flare.","id":"OG004","title":"Integrated Study (Main + Japan Sub-Study): M-PL"},{"description":"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance standard dose (0.6 mg/kg \\[maximum dose of 40 mg\\] eow). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.","id":"OG005","title":"Integrated Study (Main + Japan Sub-Study): M-SD"},{"description":"Participants demonstrating a clinical response per PMS (defined as a decrease in PMS ≥ 2 points and ≥ 30% from Baseline) at Week 8 randomized to adalimumab maintenance high dose (0.6 mg/kg \\[maximum dose of 40 mg\\] ew). Participants were to continue their blinded treatment during the maintenance period until Week 52 unless they had ≥ 2 flares and got open label rescue therapy after the second flare.","id":"OG006","title":"Integrated Study (Main + Japan Sub-Study): M-HD"},{"description":"Combined M-SD + M-HD arms (see above).","id":"OG007","title":"Integrated Study (Main + Japan Sub-Study): M-SD + M-HD"}],"paramType":"NUMBER","populationDescription":"mITT: all Week 8 PMS responders who were re-randomized at Week 8 and received at least 1 dose of study drug during the Maintenance period; analyzed as randomized at the beginning of the Maintenance phase. Participants receiving systemic corticosteroids at baseline. NRI: missing data is imputed as not having met the endpoint.","reportingStatus":"POSTED","timeFrame":"Week 52","title":"Ranked Secondary Endpoint 4: Percentage of Participants With Corticosteroid-Free Clinical Remission Per FMS at Week 52 in Week 8 Responders Per PMS - Maintenance Period","type":"SECONDARY","unitOfMeasure":"percentage of participants"}