Digestive System Diseases

All Conditions

Immune System Diseases

Symptoms and General Pathology

Crohn Disease

Hypersensitivity

Necrosis

Intestinal Diseases

Inflammatory Bowel Diseases

Gastroenteritis

Gastrointestinal Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

All Drugs and Chemicals

Adalimumab

Tumor Necrosis Factor Inhibitors

Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6.

Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.

Double-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6.

Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24.

adalimumab

placebo

AbbVie Inc.

This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

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

A Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction and Maintenance of Clinical Remission in Chinese Patients With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein

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.

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.

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.

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.

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.

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.

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.)

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.

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.)

AbbVie

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.

Double-Blind Placebo Weeks 0-4

Double-blind adalimumab 160/80 mg at Weeks 0 and 2.

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

Any adalimumab, from first dose of adalimumab to last dose at Week 24.

Any Adalimumab

Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6.

Double-Blind Period: Adalimumab 160/80/40 mg

Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.

Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg

Total

Age, Continuous

Sex: Female, Male

Chinese

Race/Ethnicity, Customized

CDAI is used to quantify the symptoms of subjects with Crohn's Disease. It generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.

Crohn's Disease Activity Index (CDAI)

High Sensitivity C-Reactive Protein (Hs-CRP)

Fecal Calprotectin

Global Medical Services

Double-Blind Period, Weeks 0 to 4: Placebo

Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2

Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg

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

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4

Double-blind period: placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6, OR Double-blind period: adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Weeks 4 and 6.

Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24.

All Participants

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

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

Double-blind adalimumab 160 mg at Week 0 and 80 mg at Week 2.

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

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4

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.

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

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.

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

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 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

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4

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

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4

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

Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4

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

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

Change From Baseline in Fecal Calprotectin Level at Week 4

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4

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

Week 2

Week 4

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4

Baseline

Week 6

Week 8

Week 10

Week 12

Week 14

Week 16

Week 18

Week 20

Week 22

Week 24

Week 26

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

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)

Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2

Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4

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

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)

Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2

Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)

Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2

Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4

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

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)

Change From Baseline in CDAI Over Double-Blind Weeks 0-4

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

Change From Baseline in CDAI Over Time (Any Adalimumab Set)

Change From Baseline in hs-CRP Level at Week 2

Change From Baseline in hs-CRP Level at Week 4

Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4

Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)

Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)

Double-Blind (DB) Period: Adalimumab 160/80/40 mg

DB Period: Placebo Followed by Adalimumab 160/80 mg

Open-label adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24.

Spots Global Cancer Trial Database for Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

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