Clinical trial NCT02499783: Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: China
Tumor necrosis factor (TNF)-alpha
Biologic
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: 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
timeFrame: Week 26
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 26
measure: 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
timeFrame: Week 26
measure: 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
timeFrame: Week 26
measure: Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 4
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 26
measure: Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 26
measure: Change From Baseline in Fecal Calprotectin Level at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Week 26
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4
timeFrame: Weeks 2, 4
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)
timeFrame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
measure: 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
timeFrame: Weeks 2, 4
measure: 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)
timeFrame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
measure: Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4
timeFrame: Weeks 2, 4
measure: Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
measure: 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
timeFrame: Weeks 2, 4
measure: 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)
timeFrame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
measure: Change From Baseline in CDAI Over Double-Blind Weeks 0-4
timeFrame: Baseline, Weeks 2, 4
measure: Change From Baseline in CDAI Over Time (Any Adalimumab Set)
timeFrame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
measure: Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4
timeFrame: Baseline, Weeks 2, 4
measure: Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)
timeFrame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26
measure: Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)
timeFrame: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Chen B, Gao X, Zhong J, Ren J, Zhu X, Liu Z, Wu K, Kalabic J, Yu Z, Huang B, Kwatra N, Doan T, Robinson AM, Chen MH. Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial. Therap Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020.