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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-05-25

Brief Summary

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

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Detailed Description

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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.

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single-group study

Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.

Adalimumab

Intervention Type DRUG

160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards

Interventions

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Adalimumab

160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards

Intervention Type DRUG

Other Intervention Names

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Humira

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No