Clinical trial NCT02015793: Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease
Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Two Adalimumab Dosing Regimens in Chinese Subjects With Moderately to Severely Active Crohn's Disease and Elevated High-Sensitivity C-reactive Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 30
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: 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects of Chinese descent with full Chinese parentage.
2. 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.
3. Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants.
4. Subject has a negative Tuberculosis (TB) Screening Assessment.

Exclusion Criteria:

1. Subject with ulcerative colitis or indeterminate colitis.
2. 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.
3. Subject with an ostomy or ileoanal pouch.
4. Subject who has short bowel syndrome.
5. Subject with symptomatic known obstructive strictures.
6. Subject with an internal or external fistula (with the exception of an anal fistula without abscess).
7. Chronic recurring infections or active TB.

Primary outcomes:
measure: Mean Serum Adalimumab Concentration at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab
timeFrame: 26 weeks
measure: Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab
timeFrame: From Week 0 to Week 26
measure: Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab
timeFrame: 26 weeks
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 35 weeks
measure: Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26
timeFrame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: CDAI: Mean Change From Baseline to Each Visit
timeFrame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
measure: High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26
timeFrame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26
measure: Fecal Calprotectin: Change From Baseline (Week 0) to Week 8
timeFrame: Baseline (Week 0) and Weeks 4 and 8
Other outcomes:
measure: Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 8
timeFrame: Baseline (Week 0) to Week 8
Locations:
Study officials:
affiliation: AbbVie
name: Anne Robinson
role: STUDY_DIRECTOR
References:
citation: Wu KC, Ran ZH, Gao X, Chen M, Zhong J, Sheng JQ, Kamm MA, Travis S, Wallace K, Mostafa NM, Shapiro M, Li Y, Thakkar RB, Robinson AM. Adalimumab induction and maintenance therapy achieve clinical remission and response in Chinese patients with Crohn's disease. Intest Res. 2016 Apr;14(2):152-63. doi: 10.5217/ir.2016.14.2.152. Epub 2016 Apr 27.