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

July 9, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
      • Roeselare, Belgium, 8800
        • AZ Delta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are naïve to TNF antagonist treatment and who will be started on adalimumab for treatment of active refractory Crohn's disease. All patients should be in need for TNF antagonist therapy and should fulfill standard reimbursement criteria (Belgium).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single-group study
Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.
Drug: Adalimumab
160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients in clinical remission
Time Frame: week 12
As defined by a Harvey-Bradshaw index ≤4
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Filip Baert, MD, Filip.Baert@azdelta.be

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

May 25, 2016

Study Completion (Actual)

May 25, 2016

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimated)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S53297

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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