Phase 3
Completed N=205
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT02499783 ↗Enrolled (actual)
205
Serious AEs
9.6%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 — 6.8; 37.3 percentage of participants — p=<0.001
◆ Published Evidence
Established
51citations · ~9 / year
Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized 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.
Linked Publications
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Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 |
6.8; 37.3 | <0.001 sig |
| 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 |
64.6 | < 0.001 sig |
| 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 |
0; 33.3 | < 0.001 sig |
| 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 |
55.0 | — |
| 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 |
62.8 | — |
| 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 |
57.6 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4 |
27.2; 67.6 | < 0.001 sig |
| 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 |
11.7; 61.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4 |
0; 27.5 | < 0.001 sig |
| 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 |
36.8 | — |
| SECONDARY Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4 |
20.4; 40.2 | 0.002 sig |
| 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 |
51.4 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin Level at Week 4 |
-66.3; -499.5 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4 |
0; 9.8 | 0.001 sig |
| 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 |
16.0 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 |
7.8; 26.5; 6.8; 37.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) |
3.0; 31.5; 40.0; 48.0; 55.5; 45.5 | — |
| 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 |
1.0; 22.5; 0; 33.3 | < 0.001 sig |
| 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) |
27.5; 36.0; 26.0; 45.0; 43.5; 44.5 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 |
22.3; 44.1; 27.2; 67.6 | 0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) |
45.0; 59.0; 60.0; 64.5; 54.5; 58.0 | — |
| 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 |
8.7; 40.2; 11.7; 61.8 | < 0.001 sig |
| 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) |
41.5; 55.0; 35.5; 55.5; 49.5; 51.0 | — |
| SECONDARY Change From Baseline in CDAI Over Double-Blind Weeks 0-4 |
-30.97; -73.66; -38.22; -104.56 | < 0.001 sig |
| SECONDARY Change From Baseline in CDAI Over Time (Any Adalimumab Set) |
-67.31; -92.60; -103.62; -115.96; -122.51; -131.55 | — |
| SECONDARY Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 |
-4.149; -16.474; -1.131; -16.670 | < 0.001 sig |
| SECONDARY Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) |
-16.923; -17.064; -12.295; -14.565; -13.527; -13.504 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) |
-425.7; -529.6; -475.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02499783) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.