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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02499783
• Date of registration: 14/07/2015
• Prospective Registration: Yes
• Primary sponsor: AbbVie
• Public title: Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
• Scientific 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
• Date of first enrolment: August 17, 2015
• Target sample size: 205
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02499783
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: AbbVie Inc.
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: adalimumab

Other: placebo

Primary Outcome(s)

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 [Time Frame: Week 4]

Secondary Outcome(s)

Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) [Time Frame: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26]

Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 [Time Frame: Baseline, Weeks 2, 4]

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 [Time Frame: Weeks 2, 4]

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 [Time Frame: Week 26]

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) [Time Frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26]

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) [Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26]

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 [Time Frame: Week 26]

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 [Time Frame: Weeks 2, 4]

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 [Time Frame: Week 26]

Change From Baseline in CDAI Over Double-Blind Weeks 0-4 [Time Frame: Baseline, Weeks 2, 4]

Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4 [Time Frame: 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 Time (Any Adalimumab Set) [Time Frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26]

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 [Time Frame: Week 26]

Change From Baseline in Fecal Calprotectin Level at Week 4 [Time Frame: Baseline, Week 4]

Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) [Time Frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26]

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

Change From Baseline in CDAI Over Time (Any Adalimumab Set) [Time Frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26]

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 [Time Frame: 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 [Time Frame: Week 26]

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) Over Time (Any Adalimumab Set) [Time Frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26]

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

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) at Week 4 [Time Frame: Week 4]

Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI = 70 Points From Baseline) Over Double-Blind Weeks 0-4 [Time Frame: Weeks 2, 4]

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 [Time Frame: Week 26]

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 [Time Frame: Weeks 2, 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 [Time Frame: Week 26]

Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ = 170 Points) at Week 4 [Time Frame: Week 4]

Secondary ID(s)

M14-233

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02499783