Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02015793
• Date of registration: 13/12/2013
• Prospective Registration: No
• Primary sponsor: AbbVie
• Public title: Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease
• Scientific 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
• Date of first enrolment: December 2013
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02015793
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Anne Robinson
• Affiliation: AbbVie

Key inclusion & exclusion 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.



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

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Placebo for adalimumab

Biological: Adalimumab

Primary Outcome(s)

Mean Serum Adalimumab Concentration at Week 8 [Time Frame: Week 8]

Secondary Outcome(s)

High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26 [Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26]

Percentage of Participants Who Achieved Clinical Response (CDAI Decrease = 70 From Week 0) Every 2 Weeks up to Week 26 [Time Frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26]

Number of Participants With Potentially Significant Vital Signs Parameters During Administration of Adalimumab [Time Frame: 26 weeks]

Number of Participants With Adverse Events (AEs) [Time Frame: 35 weeks]

CDAI: Mean Change From Baseline to Each Visit [Time Frame: Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26]

Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab [Time Frame: From Week 0 to Week 26]

Fecal Calprotectin: Change From Baseline (Week 0) to Week 8 [Time Frame: Baseline (Week 0) and Weeks 4 and 8]

Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26 [Time Frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26]

Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab [Time Frame: 26 weeks]

Secondary ID(s)

M14-232

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02015793