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

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ClinicalTrials.gov Identifier: NCT02450513
Recruitment Status : Unknown
Verified May 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : May 21, 2015
Last Update Posted : May 24, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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

Condition or disease Intervention/treatment
Crohn's Disease Drug: Adalimumab

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
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
Study Start Date : March 2012
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

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 Name: Humira




Primary Outcome Measures :
  1. Proportion of patients in clinical remission [ Time Frame: week 12 ]
    As defined by a Harvey-Bradshaw index ≤4


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450513


Contacts
Contact: Filip Baert, MD Filip.Baert@azdelta.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Karolien Van den Broek       karolien.vandenbroeck@uzleuven.be   
AZ Delta Completed
Roeselare, Belgium, 8800
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Filip Baert, MD Filip.Baert@azdelta.be

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02450513     History of Changes
Other Study ID Numbers: S53297
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Universitaire Ziekenhuizen Leuven:
adalimumab
anti-TNF
pharmacokinetics
trough level
immunogenicity

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents