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

AbbVie0 sites30 target enrollmentDecember 2013

ConditionsCrohn's Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: AbbVie
Enrollment: 30
Primary Endpoint: Mean Serum Adalimumab Concentration at Week 8
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

February 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Mean Serum Adalimumab Concentration at Week 8

Time Frame: Week 8

Blood samples were drawn prior to drug administration. Adalimumab concentrations in serum were determined using a validated enzyme-linked immunosorbent assay (ELISA) method.

Secondary Outcomes

Number of Participants With Potentially Significant Hematology Parameters During Administration of Adalimumab(26 weeks)
Number of Participants With Adverse Events (AEs)(35 weeks)
Number of Participants With Potentially Significant Clinical Chemistry Parameters During Administration of Adalimumab(From Week 0 to Week 26)
High-sensitivity C-reactive Protein (hsCRP): Median Change From Baseline (Week 0) to Week 26(Baseline (Week 0) and Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and 26)
CDAI: Mean Change From Baseline to Each Visit(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 Vital Signs Parameters During Administration of Adalimumab(26 weeks)
Percentage of Participants Who Achieved Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) Every 2 Weeks up to Week 26(Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26)
Percentage of Participants Who Achieved Clinical Response (CDAI Decrease ≥ 70 From Week 0) Every 2 Weeks up to Week 26(Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26)
Fecal Calprotectin: Change From Baseline (Week 0) to Week 8(Baseline (Week 0) and Weeks 4 and 8)