{"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 (18.37%)","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 (18.37%)","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":"0.382","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 (18.37%)","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 (18.37%)","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 (18.37%)","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":"0.344","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 (18.37%)","statisticalComment":"controlling familywise Type I error of 5% in a strong sense","statisticalMethod":"rejective multiple test procedure"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.92","upperLimit":"65.11","value":"33.3"},{"groupId":"OG001","lowerLimit":"14.22","upperLimit":"48.04","value":"29.0"},{"groupId":"OG002","lowerLimit":"27.32","upperLimit":"63.97","value":"45.2"},{"groupId":"OG003","lowerLimit":"25.16","upperLimit":"50.31","value":"37.1"},{"groupId":"OG004","lowerLimit":"9.92","upperLimit":"65.11","value":"33.3"},{"groupId":"OG005","lowerLimit":"13.30","upperLimit":"45.52","value":"27.3"},{"groupId":"OG006","lowerLimit":"26.32","upperLimit":"60.65","value":"42.9"},{"groupId":"OG007","lowerLimit":"24.08","upperLimit":"47.83","value":"35.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"62"},{"groupId":"OG004","value":"12"},{"groupId":"OG005","value":"33"},{"groupId":"OG006","value":"35"},{"groupId":"OG007","value":"68"}],"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. 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. NRI: missing data is imputed as not having met the endpoint.","reportingStatus":"POSTED","timeFrame":"Week 52","title":"Co-Primary Endpoint 2: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 52 in Week 8 Responders Per PMS - Maintenance Period","type":"PRIMARY","unitOfMeasure":"percentage of participants"}