Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis (NCT NCT00385736)

Last Updated: 2011-04-11

Results Overview

Clinical remission per Mayo score is defined as a total Mayo score \<= 2 and no individual subscore \> 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

Week 8

Results posted on

2011-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 80/40 Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Efficacy Analysis Set - Induction STARTED	130	130	130
Efficacy Analysis Set - Induction COMPLETED	121	118	121
Efficacy Analysis Set - Induction NOT COMPLETED	9	12	9
Efficacy Analysis Set - Maintenance STARTED	222	130	223
Efficacy Analysis Set - Maintenance COMPLETED	153	86	143
Efficacy Analysis Set - Maintenance NOT COMPLETED	69	44	80
Safety Analysis Set STARTED	223	130	223
Safety Analysis Set COMPLETED	153	86	143
Safety Analysis Set NOT COMPLETED	70	44	80

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 80/40 Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Efficacy Analysis Set - Induction Adverse Event	5	6	4
Efficacy Analysis Set - Induction Withdrawal by Subject	0	2	1
Efficacy Analysis Set - Induction Lost to Follow-up	0	2	0
Efficacy Analysis Set - Induction Lack of Efficacy	4	2	1
Efficacy Analysis Set - Induction Protocol Violation	0	0	2
Efficacy Analysis Set - Induction Other	0	0	1
Efficacy Analysis Set - Maintenance Adverse Event	23	15	23
Efficacy Analysis Set - Maintenance Withdrawal by Subject	6	6	14
Efficacy Analysis Set - Maintenance Lost to Follow-up	0	2	2
Efficacy Analysis Set - Maintenance Lack of Efficacy	38	16	31
Efficacy Analysis Set - Maintenance Protocol Violation	2	1	6
Efficacy Analysis Set - Maintenance Other	0	4	4
Safety Analysis Set Adverse Event	23	15	23
Safety Analysis Set Withdrawal by Subject	6	6	14
Safety Analysis Set Lost to Follow-up	0	2	2
Safety Analysis Set Lack of Efficacy	38	16	31
Safety Analysis Set Protocol Violation	2	1	6
Safety Analysis Set Other	1	4	4

Baseline Characteristics

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 80/40 n=130 Participants Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Total n=390 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	125 Participants n=5 Participants	120 Participants n=7 Participants	124 Participants n=5 Participants	369 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Age Continuous	38.9 years STANDARD_DEVIATION 12.68 • n=5 Participants	41.6 years STANDARD_DEVIATION 13.99 • n=7 Participants	38.2 years STANDARD_DEVIATION 13.46 • n=5 Participants	39.5 years STANDARD_DEVIATION 13.43 • n=4 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	52 Participants n=7 Participants	47 Participants n=5 Participants	147 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	78 Participants n=7 Participants	83 Participants n=5 Participants	243 Participants n=4 Participants
Region of Enrollment United States	32 participants n=5 Participants	30 participants n=7 Participants	41 participants n=5 Participants	103 participants n=4 Participants
Region of Enrollment Slovakia	12 participants n=5 Participants	22 participants n=7 Participants	13 participants n=5 Participants	47 participants n=4 Participants
Region of Enrollment Austria	7 participants n=5 Participants	11 participants n=7 Participants	5 participants n=5 Participants	23 participants n=4 Participants
Region of Enrollment Italy	11 participants n=5 Participants	6 participants n=7 Participants	7 participants n=5 Participants	24 participants n=4 Participants
Region of Enrollment Czech Republic	23 participants n=5 Participants	11 participants n=7 Participants	18 participants n=5 Participants	52 participants n=4 Participants
Region of Enrollment Hungary	9 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants	19 participants n=4 Participants
Region of Enrollment Canada	26 participants n=5 Participants	25 participants n=7 Participants	20 participants n=5 Participants	71 participants n=4 Participants
Region of Enrollment Belgium	4 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment Poland	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Germany	3 participants n=5 Participants	14 participants n=7 Participants	9 participants n=5 Participants	26 participants n=4 Participants
Region of Enrollment Netherlands	1 participants n=5 Participants	4 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants
Region of Enrollment Sweden	0 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Population: All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used.

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Remission Per Mayo Score at Week 8	9.2 Proportion of participants	10.0 Proportion of participants	18.5 Proportion of participants

SECONDARY outcome

Timeframe: Week 8

Clinical response per Mayo score is defined as a decrease in Mayo score of \>= 3 points and \>= 30% from Baseline, plus either a decrease in rectal bleeding subscore of \>= 1 point or an absolute rectal bleeding subscore of 0 or 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo).	44.6 Proportion of participants	54.6 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo).	41.5 Proportion of participants	46.9 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).	66.2 Proportion of participants	77.7 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3)

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).	46.9 Proportion of participants	60.0 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo).	37.7 Proportion of participants	48.5 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo).	44.6 Proportion of participants	51.5 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration)

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo).	41.5 Proportion of participants	37.7 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).	66.2 Proportion of participants	70.0 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).	46.9 Proportion of participants	53.8 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo).	37.7 Proportion of participants	36.2 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a \>= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life).

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo).	57.7 Proportion of participants	60.8 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 8

Outcome measures

Outcome measures
Measure	Placebo n=130 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 n=130 Participants Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo).	57.7 Proportion of participants	53.8 Proportion of participants	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Remission Per Mayo Score at Week 52	24.2 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Clinical remission per partial Mayo score is defined as a partial Mayo score \<= 2 and no individual subscore \> 1. The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52	28.3 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Response Per Mayo Score at Week 52	42.6 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation.

Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of \>= 2 points and \>= 30% from Baseline, plus either a decrease in rectal bleeding subscore of \>= 1 point or an absolute rectal bleeding subscore of 0 or 1. The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52	41.6 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Mucosal Healing at Week 52	36.5 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52	47.0 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52	41.7 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Placebo n=575 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52	36.5 Proportion of participants	—	—

SECONDARY outcome

Timeframe: Week 52

Population: All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation.

Outcome measures

Outcome measures
Measure	Placebo n=316 Participants Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.	Adalimumab 160/80/40 Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52	41.5 Proportion of participants	—	—

Adverse Events

Placebo

Serious events: 17 serious events

Other events: 34 other events

Deaths: 0 deaths

Adalimumab 80/40

Serious events: 5 serious events

Other events: 30 other events

Deaths: 0 deaths

Adalimumab 160/80/40

Serious events: 9 serious events

Other events: 34 other events

Deaths: 0 deaths

Any Adalimumab

Serious events: 76 serious events

Other events: 210 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo n=223 participants at risk Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.	Adalimumab 80/40 n=130 participants at risk Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.	Adalimumab 160/80/40 n=223 participants at risk Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.	Any Adalimumab n=557 participants at risk Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
Gastrointestinal disorders Colitis ulcerative	3.6% 8/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	5.4% 7/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	4.0% 9/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	15.3% 85/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Nervous system disorders Headache	7.2% 16/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	6.9% 9/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	3.1% 7/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	8.4% 47/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Gastrointestinal disorders Nausea	1.8% 4/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	3.1% 4/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	1.8% 4/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	5.6% 31/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
General disorders Fatigue	2.2% 5/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	1.5% 2/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	4.0% 9/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	5.9% 33/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Infections and infestations Nasopharyngitis	1.8% 4/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	4.6% 6/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	2.7% 6/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	9.5% 53/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Infections and infestations Upper respiratory tract infection	2.7% 6/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	4.6% 6/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	1.3% 3/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	6.6% 37/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.45% 1/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	3.8% 5/130 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	1.8% 4/223 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.	7.7% 43/557 • Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group. Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER