Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease (NCT NCT02499783)

Results Overview

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

205 participants

Primary outcome timeframe

Week 4

Results posted on

2019-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Double-Blind (DB) Period: Adalimumab 160/80/40 mg Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.	DB Period: Placebo Followed by Adalimumab 160/80 mg Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.	Open-Label (OL) Period: Adalimumab 40 mg Open-label adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
DB Period/Placebo-Controlled: Weeks 0-4 STARTED	102	103	0
DB Period/Placebo-Controlled: Weeks 0-4 COMPLETED	98	98	0
DB Period/Placebo-Controlled: Weeks 0-4 NOT COMPLETED	4	5	0
DB Period: Weeks 0-8 STARTED	102	103	0
DB Period: Weeks 0-8 COMPLETED	92	96	0
DB Period: Weeks 0-8 NOT COMPLETED	10	7	0
Open Label Period: Weeks 8 to 26 STARTED	0	0	188
Open Label Period: Weeks 8 to 26 COMPLETED	0	0	159
Open Label Period: Weeks 8 to 26 NOT COMPLETED	0	0	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Double-Blind (DB) Period: Adalimumab 160/80/40 mg Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.	DB Period: Placebo Followed by Adalimumab 160/80 mg Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.	Open-Label (OL) Period: Adalimumab 40 mg Open-label adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.
DB Period/Placebo-Controlled: Weeks 0-4 Adverse Event	2	4	0
DB Period/Placebo-Controlled: Weeks 0-4 Withdrew Consent	1	0	0
DB Period/Placebo-Controlled: Weeks 0-4 Other	1	1	0
DB Period: Weeks 0-8 Adverse Event	8	6	0
DB Period: Weeks 0-8 Withdrew Consent	1	0	0
DB Period: Weeks 0-8 Other	1	1	0
Open Label Period: Weeks 8 to 26 Adverse Event	0	0	16
Open Label Period: Weeks 8 to 26 Withdrew Consent	0	0	2
Open Label Period: Weeks 8 to 26 Lack of Efficacy	0	0	9
Open Label Period: Weeks 8 to 26 Subject Noncompliance	0	0	2

Baseline Characteristics

Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double-Blind Period: Adalimumab 160/80/40 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.	Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg n=103 Participants Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.	Total n=205 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 10.24 • n=5 Participants	32.6 years STANDARD_DEVIATION 9.50 • n=7 Participants	32.9 years STANDARD_DEVIATION 9.85 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	30 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	73 Participants n=7 Participants	140 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Crohn's Disease Activity Index (CDAI)	272.05 units on a scale STANDARD_DEVIATION 48.117 • n=5 Participants	274.71 units on a scale STANDARD_DEVIATION 49.055 • n=7 Participants	273.38 units on a scale STANDARD_DEVIATION 48.490 • n=5 Participants
High Sensitivity C-Reactive Protein (Hs-CRP)	23.93 mg/L STANDARD_DEVIATION 24.595 • n=5 Participants	27.12 mg/L STANDARD_DEVIATION 31.526 • n=7 Participants	25.53 mg/L STANDARD_DEVIATION 28.266 • n=5 Participants
Fecal Calprotectin	1481.8 μg/g STANDARD_DEVIATION 809.29 • n=5 Participants	1435.4 μg/g STANDARD_DEVIATION 766.37 • n=7 Participants	1458.4 μg/g STANDARD_DEVIATION 786.20 • n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: Intention to Treat (ITT) Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4	6.8 percentage of participants	37.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=144 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8	64.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4	0 percentage of participants	33.3 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus at least 30% reduction in hs-CRP from Baseline at Week 8. Non-responder imputation.

Clinical response is defined as a decrease in CDAI ≥ 70 Points from Baseline CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=120 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8	55.0 percentage of participants	—

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=43 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8	62.8 percentage of participants	—

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus a reduction in hs-CRP of at least 30% from Baseline at Week 8. Non-responder imputation.

Percentage of participants who discontinued corticosteroid use and achieved clinical remission (CDAI \< 150) plus a reduction in hs-CRP of at least 50% from Baseline at Week 26 in participants who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI of ≥ 70 points from Baseline) plus a reduction in hs-CRP of ≥ 30% From Baseline at Week 8. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=33 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8	57.6 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4	27.2 percentage of participants	67.6 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4	11.7 percentage of participants	61.8 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4	0 percentage of participants	27.5 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=144 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8	36.8 percentage of participants	—

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

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.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4	20.4 percentage of participants	40.2 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.

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. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=144 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8	51.4 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: ITT Set: all participants who were randomized. Observed cases.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=93 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=91 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in Fecal Calprotectin Level at Week 4	-66.3 μg/g Standard Deviation 844.89	-499.5 μg/g Standard Deviation 868.62

SECONDARY outcome

Timeframe: Week 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4	0 percentage of participants	9.8 percentage of participants

SECONDARY outcome

Timeframe: Week 26

Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=144 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8	16.0 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 Week 2	7.8 percentage of participants	26.5 percentage of participants
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 Week 4	6.8 percentage of participants	37.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Baseline	3.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 2	31.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 4	40.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 6	48.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 8	55.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 10	45.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 12	56.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 14	51.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 16	56.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 18	48.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 20	53.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 22	52.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 24	49.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) Week 26	53.9 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 Week 4	0 percentage of participants	33.3 percentage of participants
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 Week 2	1.0 percentage of participants	22.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 2	27.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 4	36.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 6	26.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 8	45.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 12	43.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 16	44.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 20	42.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) Week 26	39.2 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 Week 2	22.3 percentage of participants	44.1 percentage of participants
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 Week 4	27.2 percentage of participants	67.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 2	45.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 4	59.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 6	60.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 8	64.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 10	54.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 12	58.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 14	54.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 16	58.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 18	49.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 20	54.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 22	50.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 24	52.9 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) Week 26	59.8 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 2, 4

Population: ITT Set: all participants who were randomized. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 Week 2	8.7 percentage of participants	40.2 percentage of participants
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 Week 4	11.7 percentage of participants	61.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 2	41.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 4	55.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 6	35.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 8	55.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 12	49.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 16	51.0 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 20	45.5 percentage of participants	—
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) Week 26	52.0 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4

Population: ITT Set: all participants who were randomized. Observed cases.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in CDAI Over Double-Blind Weeks 0-4 Week 4	-38.22 units on a scale Standard Deviation 60.918	-104.56 units on a scale Standard Deviation 67.325
Change From Baseline in CDAI Over Double-Blind Weeks 0-4 Week 2	-30.97 units on a scale Standard Deviation 53.699	-73.66 units on a scale Standard Deviation 63.267

SECONDARY outcome

Timeframe: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.

CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 2	-67.31 units on a scale Standard Deviation 67.268	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 4	-92.60 units on a scale Standard Deviation 74.666	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 6	-103.62 units on a scale Standard Deviation 79.094	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 8	-115.96 units on a scale Standard Deviation 83.900	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 10	-122.51 units on a scale Standard Deviation 82.991	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 12	-131.55 units on a scale Standard Deviation 76.754	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 14	-136.85 units on a scale Standard Deviation 76.459	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 16	-143.56 units on a scale Standard Deviation 72.597	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 18	-140.40 units on a scale Standard Deviation 77.473	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 20	-147.54 units on a scale Standard Deviation 72.352	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 22	-143.99 units on a scale Standard Deviation 77.972	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 24	-182.01 units on a scale Standard Deviation 54.588	—
Change From Baseline in CDAI Over Time (Any Adalimumab Set) Week 26	-178.74 units on a scale Standard Deviation 54.277	—

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4

Population: ITT Set: all participants who were randomized. Observed cases.

The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=103 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg n=102 Participants Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 Week 2	-4.149 mg/L Standard Deviation 22.1944	-16.474 mg/L Standard Deviation 25.5491
Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 Week 4	-1.131 mg/L Standard Deviation 18.8392	-16.670 mg/L Standard Deviation 19.9088

SECONDARY outcome

Timeframe: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.

The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=200 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 2	-16.923 mg/L Standard Deviation 23.8242	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 4	-17.064 mg/L Standard Deviation 21.8366	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 6	-12.295 mg/L Standard Deviation 20.9586	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 8	-14.565 mg/L Standard Deviation 18.5093	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 12	-13.527 mg/L Standard Deviation 19.9087	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 16	-13.504 mg/L Standard Deviation 18.1452	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 20	-11.921 mg/L Standard Deviation 18.4776	—
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) Week 26	-12.308 mg/L Standard Deviation 14.4531	—

SECONDARY outcome

Timeframe: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26

Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.

The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.

Outcome measures

Outcome measures
Measure	Double-Blind Period, Weeks 0 to 4: Placebo n=188 Participants Double-blind placebo at Weeks 0 and 2	Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) Week 4	-425.7 μg/g Standard Deviation 940.04	—
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) Week 8	-529.6 μg/g Standard Deviation 913.50	—
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) Week 26	-475.6 μg/g Standard Deviation 978.07	—

Adverse Events

Double-Blind Placebo Weeks 0-4

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Double-Blind Adalimumab 160/80 mg Weeks 0-4

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Any Adalimumab

Serious events: 36 serious events

Other events: 137 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Double-Blind Placebo Weeks 0-4 n=103 participants at risk Double-blind placebo at Weeks 0 and 2.	Double-Blind Adalimumab 160/80 mg Weeks 0-4 n=102 participants at risk Double-blind adalimumab 160/80 mg at Weeks 0 and 2.	Any Adalimumab n=200 participants at risk Any adalimumab, from first dose of adalimumab to last dose at Week 24.
Blood and lymphatic system disorders LEUKOPENIA	0.97% 1/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	2.9% 3/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	11.0% 22/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	0.00% 0/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	5.0% 10/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
General disorders PYREXIA	3.9% 4/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	0.98% 1/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	7.5% 15/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Infections and infestations INFLUENZA	0.97% 1/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	2.0% 2/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	6.5% 13/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.9% 5/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	0.98% 1/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	11.5% 23/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	2.9% 3/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	3.9% 4/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	10.0% 20/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Investigations MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE	2.9% 3/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	0.98% 1/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	6.5% 13/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.97% 1/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	5.9% 6/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	19.5% 39/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Nervous system disorders DIZZINESS	0.00% 0/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	3.9% 4/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	6.0% 12/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders COUGH	0.00% 0/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	4.9% 5/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	8.0% 16/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/103 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	2.9% 3/102 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.	5.5% 11/200 • Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days. A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4. A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.

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