Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

• ClinicalTrials.gov Identifier: NCT02065622
• Recruitment Status: Completed
• First Posted: February 19, 2014
• Results First Posted: October 8, 2020
• Last Update Posted: November 23, 2020
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Ulcerative Colitis (UC)
• Interventions: Drug: Adalimumab; Other: Placebo
• Enrollment: 952

Participant Flow

Recruitment Details	This study included a Main Study (120 sites in 19 countries) and a Japan Sub-Study (22 sites in Japan). After a 3-week screening period, participants were randomized 3:2 to an 8-week double-blind (DB) Induction Period with 2 adalimumab dosing regimens (Induction Standard Dose [I-SD] or Induction Higher Dose [I-HD]).
Pre-assignment Details	At Week 8, participants in Main Study were re-randomized (2:2:1) into 44-week DB Maintenance Period with 3 adalimumab dosing regimens (M-SD, M-HD, or an exploratory Therapeutic Drug Monitoring [TDM] Regimen). Participants in Japan Sub-study were re-randomized (1:1) into 44-week DB Maintenance Period with 2 adalimumab dosing regimens (M-SD, M-HD).

Arm/Group Title	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD	Maintenance (Main Study): TDM Regimen
Arm/Group Description	Induction Standard Dose (I-SD): Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose (I-HD): Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Maintenance Standard Dose (M-SD): Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose (M-HD): Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Exploratory Therapeutic Drug Monitoring (TDM) Regimen: Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore assessments.
Period Title: Induction Study
Started	379	573	0	0	0
Enrolled in Main Study	340	512	0	0	0
Enrolled in Japan Sub-Study	39	61	0	0	0
Completed	332	514	0	0	0
Not Completed	47	59	0	0	0
Reason Not Completed
Adverse Event	13	19	0	0	0
Withdrawal by Subject	3	5	0	0	0
Lost to Follow-up	1	0	0	0	0
Lack of Efficacy	22	27	0	0	0
Requires Alternative/Prohibited Therapy	4	5	0	0	0
Subject Noncompliance	1	1	0	0	0
Other, Not Specified	3	2	0	0	0
Period Title: Maintenance Study
Started	0	0	345	350	151
Completed	0	0	221	246	105
Not Completed	0	0	124	104	46
Reason Not Completed
Adverse Event	0	0	25	22	11
Withdrawal by Subject	0	0	11	5	7
Lost to Follow-up	0	0	4	1	1
Lack of Efficacy	0	0	70	55	19
Requires Alternative/Prohibited Therapy	0	0	7	3	4
Subject Non-Compliance	0	0	1	3	2
Other, Not Specified	0	0	6	14	2
Unknown Reason	0	0	0	1	0

Baseline Characteristics

Arm/Group Title		Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD	Total
Arm/Group Description		Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Total of all reporting groups
Overall Number of Baseline Participants		379	573	952
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	379 participants	573 participants	952 participants
		40.2 (13.14)	40.5 (12.89)	40.4 (12.98)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	379 participants	573 participants	952 participants
	Female	166 43.8%	239 41.7%	405 42.5%
	Male	213 56.2%	334 58.3%	547 57.5%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
White	Number Analyzed	379 participants	573 participants	952 participants
		326 86.0%	484 84.5%	810 85.1%
Black or African American	Number Analyzed	379 participants	573 participants	952 participants
		8 2.1%	16 2.8%	24 2.5%
Asian	Number Analyzed	379 participants	573 participants	952 participants
		44 11.6%	70 12.2%	114 12.0%
Native Hawaiian/Other Pacific Islander	Number Analyzed	379 participants	573 participants	952 participants
		0 0.0%	1 0.2%	1 0.1%
Multiracial	Number Analyzed	379 participants	573 participants	952 participants
		1 0.3%	1 0.2%	2 0.2%
Missing	Number Analyzed	379 participants	573 participants	952 participants
		0 0.0%	1 0.2%	1 0.1%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Hispanic or Latino	Number Analyzed	379 participants	573 participants	952 participants
		19 5.0%	28 4.9%	47 4.9%
Japanese	Number Analyzed	379 participants	573 participants	952 participants
		39 10.3%	61 10.6%	100 10.5%
Other, Not Specified	Number Analyzed	379 participants	573 participants	952 participants
		321 84.7%	484 84.5%	805 84.6%
Region; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	379 participants	573 participants	952 participants
		65 17.2%	113 19.7%	178 18.7%
Non-United States	Number Analyzed	379 participants	573 participants	952 participants
		314 82.8%	460 80.3%	774 81.3%
Full Mayo Score (FMS) [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	379 participants	570 participants	949 participants
		8.69 (1.509)	8.87 (1.571)	8.80 (1.548)
		[1] Measure Description: The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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).; [2] Measure Analysis Population Description: participants with an assessment
FMS: Rectal Bleeding Subscore [1] [2]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	379 participants	570 participants	949 participants
		1.68 (0.955)	1.75 (0.967)	1.72 (0.962)
		[1] Measure Description: The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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).; [2] Measure Analysis Population Description: participants with an assessment

Outcome Measures

1. Primary Outcome

Title	Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	10.9	13.3	11.6	13.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.269
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	2.5
	Confidence Interval	(2-Sided) 95%; -2.0 to 7.0
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.447
	Comments	[Not Specified]
	Method	Breslow-Day test
	Comments	Breslow-Day test of homogeneity across strata.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.301
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; -2.0 to 6.6
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.502
	Comments	[Not Specified]
	Method	Breslow-Day test
	Comments	Breslow-Day test of homogeneity across strata.

2. Primary Outcome

Title	Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Responder population (I-ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	29.0	39.5	30.1	41.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.069
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; -0.8 to 20.6
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.085
	Comments	[Not Specified]
	Method	Breslow-Day test
	Comments	Breslow-Day test of homogeneity across strata.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.045
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 0.2 to 20.4
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.106
	Comments	[Not Specified]
	Method	Breslow-Day test
	Comments	Breslow-Day test of homogeneity across strata.

3. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	27.1	31.1	26.9	30.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.181
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95%; -2.0 to 10.5
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.200
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; -2.0 to 9.7
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

4. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8
Description	[Not Specified]
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	27.1	31.1	26.9	30.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.300
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -2.6 to 8.6
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.254
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; -2.2 to 8.4
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

5. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8
Description	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	60.9	67.2	60.7	65.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.050
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; -0.0 to 13.1
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.131
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	4.8
	Confidence Interval	(2-Sided) 95%; -1.4 to 11.0
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

6. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	40.0	47.1	38.8	47.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.035
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; 0.5 to 14.1
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	8.7
	Confidence Interval	(2-Sided) 95%; 2.3 to 15.1
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

7. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	10.0	13.1	10.0	12.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.160
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95%; -1.3 to 7.6
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.166
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; -1.2 to 7.1
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

8. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8
Description	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	63.2	71.3	63.1	69.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	8.3
	Confidence Interval	(2-Sided) 95%; 1.9 to 14.7
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.025
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 0.9 to 13.0
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

9. Secondary Outcome

Title	Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8
Description	The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Induction Study Intent-to-Treat (ITT) set: all participants who were randomized at Baseline. Non-responder imputation.

Arm/Group Title	Induction (Main Study): I-SD	Induction (Main Study): I-HD	Induction (Main Study + Japan Sub-study): I-SD	Induction (Main Study + Japan Sub-study): I-HD
Arm/Group Description:	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.	Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6.
Overall Number of Participants Analyzed	340	512	379	573
Measure Type: Number; Unit of Measure: percentage of participants
	57.1	61.1	57.5	59.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study): I-SD, Induction (Main Study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.218
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95%; -2.5 to 10.9
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction (Main Study + Japan Sub-study): I-SD, Induction (Main Study + Japan Sub-study): I-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel test adjusted for previous infliximab use and baseline corticosteroid use.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.456
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; -4.0 to 8.8
	Estimation Comments	Risk difference = (adalimumab higher induction dose - adalimumab standard induction dose).

10. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Responder population (I-ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	41.4	51.3	41.7	52.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.098
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	9.5
	Confidence Interval	(2-Sided) 95%; -1.7 to 20.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.066
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; -0.7 to 20.5
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

11. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

I-ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	92	95	103	108
Measure Type: Number; Unit of Measure: percentage of participants
	53.3	74.7	54.4	74.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	21.5
	Confidence Interval	(2-Sided) 95%; 7.6 to 35.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	19.7
	Confidence Interval	(2-Sided) 95%; 6.6 to 32.7
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

12. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders, per FMS, are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

I-ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	92	95	103	108
Measure Type: Number; Unit of Measure: percentage of participants
	27.2	38.9	28.2	39.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.093
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	11.5
	Confidence Interval	(2-Sided) 95%; -1.9 to 25.0
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.088
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	11.1
	Confidence Interval	(2-Sided) 95%; -1.7 to 23.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

13. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Remitter (ITT-RM) Population included all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	37	42	45	52
Measure Type: Number; Unit of Measure: percentage of participants
	40.5	57.1	44.4	55.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.161
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	15.9
	Confidence Interval	(2-Sided) 95%; -6.3 to 38.2
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.312
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	10.4
	Confidence Interval	(2-Sided) 95%; -9.8 to 30.6
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

14. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Remitter (ITT-RM) Population included all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	37	42	45	52
Measure Type: Number; Unit of Measure: percentage of participants
	51.4	64.3	55.6	61.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.272
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	12.3
	Confidence Interval	(2-Sided) 95%; -9.7 to 34.4
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.600
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	5.3
	Confidence Interval	(2-Sided) 95%; -14.6 to 25.2
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

15. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-RM Population: participants in ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid use at Baseline. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	26	27	32	35
Measure Type: Number; Unit of Measure: percentage of participants
	53.8	77.8	56.3	71.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.074
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	23.8
	Confidence Interval	(2-Sided) 95%; -2.3 to 49.9
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.210
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	15.0
	Confidence Interval	(2-Sided) 95%; -8.5 to 38.4
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

16. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-RM Population: all participants in the ITT population who achieved Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants with steroid usage. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	26	27	32	35
Measure Type: Number; Unit of Measure: percentage of participants
	34.6	55.6	37.5	51.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.151
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	20.0
	Confidence Interval	(2-Sided) 95%; -7.3 to 47.3
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.299
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	12.8
	Confidence Interval	(2-Sided) 95%; -11.3 to 36.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

17. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, the TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	62.1	66.4	62.6	65.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.422
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	4.5
	Confidence Interval	(2-Sided) 95%; -6.4 to 15.3
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.513
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.4
	Confidence Interval	(2-Sided) 95%; -6.8 to 13.6
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

18. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Non-Responder (ITT-NRP) Population: all participants in ITT who did not achieve Week 8 response based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	157	152	182	175
Measure Type: Number; Unit of Measure: percentage of participants
	12.1	15.8	12.1	16.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.351
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; -4.1 to 11.4
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.292
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; -3.3 to 11.1
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

19. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Non-Remitter (ITT-NRM) Population: all participants in ITT who did not achieve Week 8 remission based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	265	262	300	298
Measure Type: Number; Unit of Measure: percentage of participants
	17.4	22.9	17.0	23.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.121
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	5.4
	Confidence Interval	(2-Sided) 95%; -1.4 to 12.1
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.046
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	6.5
	Confidence Interval	(2-Sided) 95%; 0.1 to 12.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

20. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-RP: participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Participants who were remitters at Week 8. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	27.6	35.5	27.0	35.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.159
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	7.5
	Confidence Interval	(2-Sided) 95%; -2.9 to 17.9
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.109
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	8.0
	Confidence Interval	(2-Sided) 95%; -1.8 to 17.9
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

21. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Remitter (ITT-RM) Population: all participants in ITT who achieved Week 8 remission based on the Full Mayo Score utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	37	42	45	52
Measure Type: Number; Unit of Measure: percentage of participants
	45.9	47.6	42.2	44.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.903
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; -21.0 to 23.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.901
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -18.8 to 21.3
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

22. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	62.1	69.7	62.6	71.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.160
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	7.7
	Confidence Interval	(2-Sided) 95%; -3.0 to 18.4
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.076
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	9.1
	Confidence Interval	(2-Sided) 95%; -0.9 to 19.1
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

23. Secondary Outcome

Title	Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52
Description	The Mayo score is a tool designed to measure disease activity for ulcerative colitis. 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 [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.
Time Frame	Week 52

Outcome Measure Data

Analysis Population Description

ITT-Responder population (ITT-RP): all participants in the Induction ITT population who achieve Week 8 response based on the FMS utilizing the endoscopy subscore provided by the central reader. Non-responder imputation. Per protocol, TDM Regimen arm was used to analyze exploratory outcome measures only (and therefore is not included).

Arm/Group Title	Maintenance (Main Study): M-SD	Maintenance (Main Study): M-HD	Maintenance (Main Study + Japan Sub-study): M-SD	Maintenance (Main Study + Japan Sub-study): M-HD
Arm/Group Description:	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.	Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.	Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Overall Number of Participants Analyzed	145	152	163	175
Measure Type: Number; Unit of Measure: percentage of participants
	53.8	61.2	55.2	59.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study): M-SD, Maintenance (Main Study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.207
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; -4.0 to 18.6
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance (Main Study + Japan Sub-study): M-SD, Maintenance (Main Study + Japan Sub-study): M-HD
	Comments	Adjusted risk difference, 95% confidence interval for the difference in the proportions between the treatment groups and P-value were calculated using Cochran-Mantel-Haenszel (CMH) test adjusted for induction treatment regimen and week 8 remission status.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.440
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted risk difference
	Estimated Value	4.2
	Confidence Interval	(2-Sided) 95%; -6.4 to 14.8
	Estimation Comments	Risk difference = Adalimumab 40mg EW - Adalimumab 40mg EOW.

Adverse Events

Time Frame	See time frame specifics detailed for each reporting group in their respective descriptions below. Participants were contacted 70 days following study drug discontinuation for an assessment of any new or ongoing adverse events, except those participants who continued on adalimumab therapy after the end of study participation.
Adverse Event Reporting Description	Treatment-emergent adverse events (TEAEs) are presented.
Arm/Group Title	Induction (Main Study + Japan Sub-study): I-SD		Induction (Main Study + Japan Sub-study): I-HD		Maintenance (Main Study + Japan Sub-study): M-SD		Maintenance (Main Study + Japan Sub-study): M-HD		Maintenance (Main Study): TDM Regimen
Arm/Group Description	Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 57.5 days.		Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4 and 40 mg at Week 6. TEAEs during induction period: events with an onset date on or after first dose date of study drug in induction period and up to 70 days after last dose date of the study drug in induction period and prior to first dose date of study drug in maintenance period. Mean duration of treatment was 55.0 days.		Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 251.5 days.		Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 263.1 days.		Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments. TEAEs during maintenance period: events with an onset date on or after first dose date of study drug in maintenance period and up to 70 days after the last dose date of the study drug in maintenance period. Mean duration of treatment was 255.9 days.
All-Cause Mortality
	Induction (Main Study + Japan Sub-study): I-SD		Induction (Main Study + Japan Sub-study): I-HD		Maintenance (Main Study + Japan Sub-study): M-SD		Maintenance (Main Study + Japan Sub-study): M-HD		Maintenance (Main Study): TDM Regimen
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	2/379 (0.53%)		4/573 (0.70%)		2/345 (0.58%)		2/350 (0.57%)		0/151 (0.00%)
Serious Adverse Events
	Induction (Main Study + Japan Sub-study): I-SD		Induction (Main Study + Japan Sub-study): I-HD		Maintenance (Main Study + Japan Sub-study): M-SD		Maintenance (Main Study + Japan Sub-study): M-HD		Maintenance (Main Study): TDM Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/379 (5.01%)		22/573 (3.84%)		44/345 (12.75%)		44/350 (12.57%)		15/151 (9.93%)
Blood and lymphatic system disorders
ANAEMIA † 1	3/379 (0.79%)	3	2/573 (0.35%)	2	1/345 (0.29%)	2	3/350 (0.86%)	4	0/151 (0.00%)	0
IRON DEFICIENCY ANAEMIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
LYMPHADENOPATHY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
THROMBOCYTOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
CARDIAC ARREST † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
CARDIAC FAILURE CONGESTIVE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
CORONARY ARTERY DISEASE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
MYOCARDIAL ISCHAEMIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Eye disorders
EYELID PTOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
OPTIC ATROPHY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Gastrointestinal disorders
ABDOMINAL PAIN † 1	1/379 (0.26%)	1	1/573 (0.17%)	1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
ABDOMINAL PAIN UPPER † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
ANOGENITAL DYSPLASIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
COLITIS † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	2/345 (0.58%)	2	0/350 (0.00%)	0	0/151 (0.00%)	0
COLITIS ULCERATIVE † 1	12/379 (3.17%)	17	13/573 (2.27%)	13	16/345 (4.64%)	16	18/350 (5.14%)	21	6/151 (3.97%)	6
DIARRHOEA † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
DUODENAL ULCER PERFORATION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
HAEMORRHOIDS † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
LARGE INTESTINAL STENOSIS † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
MALLORY-WEISS SYNDROME † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
NAUSEA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PANCREATITIS ACUTE † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
RECTAL HAEMORRHAGE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
SMALL INTESTINAL OBSTRUCTION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
UPPER GASTROINTESTINAL HAEMORRHAGE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
VOMITING † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
General disorders
GAIT DISTURBANCE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PYREXIA † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Hepatobiliary disorders
BILE DUCT STONE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
HEPATITIS † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
PORTOSPLENOMESENTERIC VENOUS THROMBOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
Infections and infestations
APPENDICITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
BRONCHITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
CLOSTRIDIUM DIFFICILE INFECTION † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	3/345 (0.87%)	3	0/350 (0.00%)	0	0/151 (0.00%)	0
CYTOMEGALOVIRUS COLITIS † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
ERYSIPELAS † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
EXTERNAL EAR CELLULITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
GASTROENTERITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
GASTROINTESTINAL INFECTION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
HERPES ZOSTER † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
INFECTION † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
OTITIS EXTERNA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PELVIC INFLAMMATORY DISEASE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
PERINEAL ABSCESS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PERITONSILLAR ABSCESS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
PNEUMONIA † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	2/345 (0.58%)	2	4/350 (1.14%)	4	0/151 (0.00%)	0
SEPSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
STERNITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
TUBERCULOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	1/151 (0.66%)	1
TUBERCULOSIS OF INTRATHORACIC LYMPH NODES † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
VARICELLA † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
VIRAL INFECTION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Injury, poisoning and procedural complications
HUMERUS FRACTURE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	2	0/151 (0.00%)	0
MENISCUS INJURY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
PATELLA FRACTURE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
POST PROCEDURAL HAEMORRHAGE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
RADIUS FRACTURE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
RIB FRACTURE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
UPPER LIMB FRACTURE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Investigations
ALANINE AMINOTRANSFERASE INCREASED † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
ASPARTATE AMINOTRANSFERASE INCREASED † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
NEUTROPHIL COUNT DECREASED † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
WEIGHT DECREASED † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Metabolism and nutrition disorders
DEHYDRATION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	1/350 (0.29%)	1	0/151 (0.00%)	0
DIABETES MELLITUS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
HYPONATRAEMIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
HYPOVOLAEMIA † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	2/350 (0.57%)	2	0/151 (0.00%)	0
OSTEOARTHRITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PAIN IN EXTREMITY † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
FIBROMATOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	4	0/151 (0.00%)	0
MALIGNANT MELANOMA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
MALIGNANT MELANOMA IN SITU † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
NON-SMALL CELL LUNG CANCER † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
OESOPHAGEAL ADENOCARCINOMA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
SQUAMOUS CELL CARCINOMA OF THE CERVIX † 1	1/379 (0.26%)	1	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
UTERINE LEIOMYOMA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
HYPOAESTHESIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
ISCHAEMIC STROKE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
MONONEUROPATHY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Psychiatric disorders
BINGE DRINKING † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
BIPOLAR DISORDER † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Renal and urinary disorders
HAEMATURIA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
NEPHROTIC SYNDROME † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
RENAL FAILURE † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
URINARY RETENTION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
Reproductive system and breast disorders
PROSTATOMEGALY † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
NASAL POLYPS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
NASAL SEPTUM DEVIATION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
PULMONARY EMBOLISM † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	2/350 (0.57%)	2	0/151 (0.00%)	0
SINUS POLYP † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
Skin and subcutaneous tissue disorders
ERYTHEMA NODOSUM † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
EXCESSIVE SKIN † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
LINEAR IGA DISEASE † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
NIGHT SWEATS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
PEMPHIGOID † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	0/350 (0.00%)	0	1/151 (0.66%)	1
SUBCORNEAL PUSTULAR DERMATOSIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
Surgical and medical procedures
WOUND DRAINAGE † 1	0/379 (0.00%)	0	1/573 (0.17%)	1	0/345 (0.00%)	0	0/350 (0.00%)	0	0/151 (0.00%)	0
Vascular disorders
HYPERTENSION † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	1/345 (0.29%)	1	0/350 (0.00%)	0	0/151 (0.00%)	0
THROMBOPHLEBITIS † 1	0/379 (0.00%)	0	0/573 (0.00%)	0	0/345 (0.00%)	0	1/350 (0.29%)	1	0/151 (0.00%)	0
1 Term from vocabulary, MedDRA 22.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Induction (Main Study + Japan Sub-study): I-SD		Induction (Main Study + Japan Sub-study): I-HD		Maintenance (Main Study + Japan Sub-study): M-SD		Maintenance (Main Study + Japan Sub-study): M-HD		Maintenance (Main Study): TDM Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/379 (19.53%)		112/573 (19.55%)		140/345 (40.58%)		141/350 (40.29%)		47/151 (31.13%)
Gastrointestinal disorders
COLITIS ULCERATIVE † 1	20/379 (5.28%)	22	18/573 (3.14%)	18	60/345 (17.39%)	70	47/350 (13.43%)	58	23/151 (15.23%)	29
Infections and infestations
NASOPHARYNGITIS † 1	16/379 (4.22%)	18	29/573 (5.06%)	34	47/345 (13.62%)	61	46/350 (13.14%)	57	11/151 (7.28%)	20
UPPER RESPIRATORY TRACT INFECTION † 1	3/379 (0.79%)	3	6/573 (1.05%)	6	22/345 (6.38%)	25	19/350 (5.43%)	20	9/151 (5.96%)	10
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	11/379 (2.90%)	11	18/573 (3.14%)	19	23/345 (6.67%)	27	23/350 (6.57%)	27	5/151 (3.31%)	5
Nervous system disorders
HEADACHE † 1	23/379 (6.07%)	32	48/573 (8.38%)	62	17/345 (4.93%)	19	22/350 (6.29%)	36	8/151 (5.30%)	9
Skin and subcutaneous tissue disorders
RASH † 1	11/379 (2.90%)	11	10/573 (1.75%)	10	11/345 (3.19%)	13	20/350 (5.71%)	24	4/151 (2.65%)	6
1 Term from vocabulary, MedDRA 22.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie
• Phone: 800-633-9110
• EMail: abbvieclinicaltrials@abbvie.com

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02065622
• Other Study ID Numbers: M14-033; 2013-001682-16 ( EudraCT Number )
• First Submitted: February 17, 2014
• First Posted: February 19, 2014
• Results First Submitted: August 19, 2020
• Results First Posted: October 8, 2020
• Last Update Posted: November 23, 2020