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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02450513
• Other study ID #: S53297
• Status: Recruiting
• Phase: N/A
• First received: May 12, 2015
• Last updated: May 23, 2016
• Start date: March 2012

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Filip Baert, MD
• Email: Filip.Baert[@]azdelta.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Adalimumab
160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
Belgium	AZ Delta	Roeselare

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in clinical remission	As defined by a Harvey-Bradshaw index =4	week 12	No