Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Adalimumab

• Registration Number: NCT02450513
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

Detailed Description

Adalimumab (ADM), a fully human tumor necrosis factor (TNF) antagonist, is effective for treating patients with Crohn's disease (CD). A correlation between concentration and effect was observed at distinct time points.

The aim was to evaluate the correlation of early longitudinal measurements of ADM with different biological markers for disease activity and induction and maintenance of clinical remission.

This is a prospective two-center open-label observational study in anti-TNF naïve patients with moderate to severe CD induced with ADM 160/80 mg at week 0 and 2 and 40 mg every 2 weeks in monotherapy. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium). Serum samples were taken pre and post first injection and at weeks 1, 2, 3, 4, 12, 26 and 52. Following parameters were determined: C-reactive protein, albumin, TNF, ADM, antibodies to ADM, hemoglobin, platelet count and leukocyte count. Clinical response and remission was evaluated using the Harvey-Bradshaw index.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Primary Completion: 2016-05-25
• Study Completion: 2016-05-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with confirmed diagnosis of Crohn's disease, fulfilling the criteria for reimbursement (Belgium).
• Patients with active disease defined as a Harvey-Bradshaw index >4 and/or a C-reactive protein concentration >5 mg/l.
• Informed consent.

Exclusion Criteria

• Patients with ulcerative colitis.
• Patients treated in placebo controlled trials.
• Patients unwilling to participate or withdrawing informed consent for this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single-group study	Adalimumab	Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.

Primary Outcome Measures

Name	Time	Method
Proportion of patients in clinical remission	week 12	As defined by a Harvey-Bradshaw index ≤4

Trial Locations

Locations (2)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium