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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499783
• Other study ID #: M14-233
• Status: Completed
• Phase: Phase 3
• Start date: August 17, 2015
• Est. completion date: December 15, 2017

Study information

• Verified date: May 2018
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 15, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subjects of Chinese descent with full Chinese parentage.

• Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0.

• Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants.

• Subject has a negative Tuberculosis (TB) Screening Assessment.

• Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.

Exclusion Criteria:

• Subject with ulcerative colitis or indeterminate colitis.

• Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future.

• Subject with an ostomy or ileoanal pouch.

• Subject who has short bowel syndrome.

• Subject with symptomatic known obstructive strictures.

• Subject with an internal or external fistula (with the exception of an anal fistula without abscess).

• Active, or chronic or recurring infections, or active tuberculosis.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• adalimumab
subcutaneous injections of adalimumab

Other:
• placebo
subcutaneous injections of placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4	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.	Week 4
Secondary	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	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.	Week 26
Secondary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4	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.	Week 4
Secondary	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	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.	Week 26
Secondary	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	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.	Week 26
Secondary	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 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.	Week 26
Secondary	Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) at Week 4	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.	Week 4
Secondary	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	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.	Week 4
Secondary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4	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.	Week 4
Secondary	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	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.	Week 26
Secondary	Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ = 170 Points) at Week 4	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.	Week 4
Secondary	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	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.	Week 26
Secondary	Change From Baseline in Fecal Calprotectin Level at Week 4		Baseline, Week 4
Secondary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 µg/g at Week 4	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.	Week 4
Secondary	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	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.	Week 26
Secondary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4	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.	Weeks 2, 4
Secondary	Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)	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.)	Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Secondary	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	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.	Weeks 2, 4
Secondary	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)	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.)	Weeks 2, 4, 6, 8, 12, 16, 20, 26
Secondary	Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) Over Double-Blind Weeks 0-4	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.	Weeks 2, 4
Secondary	Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) Over Time (Any Adalimumab Set)	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.)	Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Secondary	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	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.	Weeks 2, 4
Secondary	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)	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.)	Weeks 2, 4, 6, 8, 12, 16, 20, 26
Secondary	Change From Baseline in CDAI Over Double-Blind Weeks 0-4	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.	Baseline, Weeks 2, 4
Secondary	Change From Baseline in CDAI Over Time (Any Adalimumab Set)	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.)	Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Secondary	Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4	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.	Baseline, Weeks 2, 4
Secondary	Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)	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.)	Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26
Secondary	Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)	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.	Baseline (Week 0 of adalimumab), Weeks 4, 8, 26