{"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":"< 0.001","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 (14.79%)","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":"< 0.001","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 (14.79%)","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":"0.292","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 (14.79%)","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":"< 0.001","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 (14.79%)","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":"< 0.001","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 (14.79%)","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":"0.292","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 (14.79%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.52","upperLimit":"75.51","value":"37.5"},{"groupId":"OG001","lowerLimit":"21.82","upperLimit":"65.98","value":"42.9"},{"groupId":"OG002","lowerLimit":"24.39","upperLimit":"67.79","value":"45.5"},{"groupId":"OG003","lowerLimit":"29.08","upperLimit":"60.12","value":"44.2"},{"groupId":"OG004","lowerLimit":"8.52","upperLimit":"75.51","value":"37.5"},{"groupId":"OG005","lowerLimit":"21.82","upperLimit":"65.98","value":"42.9"},{"groupId":"OG006","lowerLimit":"24.40","upperLimit":"65.07","value":"44.0"},{"groupId":"OG007","lowerLimit":"28.93","upperLimit":"58.89","value":"43.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"22"},{"groupId":"OG003","value":"43"},{"groupId":"OG004","value":"8"},{"groupId":"OG005","value":"21"},{"groupId":"OG006","value":"25"},{"groupId":"OG007","value":"46"}],"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 remitters are defined as those participants with a PMS ≤ 2 and no individual subscore \\> 1. Clinical remission per FMS is 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":"Modified intent-to-treat (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 who were also Week 8 remitters. NRI: missing data is imputed as not having met the endpoint.","reportingStatus":"POSTED","timeFrame":"Week 52","title":"Ranked Secondary Endpoint 3: Percentage of Participants With Clinical Remission Per FMS at Week 52 in Week 8 Remitters Per PMS - Maintenance Period","type":"SECONDARY","unitOfMeasure":"percentage of participants"}