Phase 2
Completed N=30
Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT02015793 ↗Enrolled (actual)
30
Serious AEs
8.8%
Results posted
May 2016
Primary outcomePrimary: Mean Serum Adalimumab Concentration at Week 8 — 7.99; 10.0 μg/mL
Summary
The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Serum Adalimumab Concentration at Week 8 |
7.99; 10.0 | — |
| SECONDARY Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab |
1; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab |
0; 1; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab |
7; 5; 8; 3; 3; 4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
6; 7; 7; 7; 1; 1 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 |
26.7; 46.7; 40.0; 66.7; 60.0; 73.3 | — |
| SECONDARY Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26 |
66.7; 80.0; 93.3; 93.3; 93.3; 86.7 | — |
| SECONDARY CDAI: Mean Change From Baseline to Each Visit |
-108.91; -143.79; -152.96; -163.21; -163.53; -178.23 | — |
| SECONDARY High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 |
-7.70; -24.51; -14.10; -25.37; -12.05; -21.12 | — |
| SECONDARY Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 |
-135.0; -207.0; -44.0; -274.0 | — |
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 confirmed by endoscopy, radiologic evaluation, and/or histology during the Screening Period.
- Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants.
- Subject has a negative Tuberculosis (TB) Screening Assessment.
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).
- Chronic recurring infections or active TB.
Data sourced from ClinicalTrials.gov (NCT02015793). 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.