Clinical trial NCT02450513: Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
Official title: Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: adalimumab
anti-TNF
pharmacokinetics
trough level
immunogenicity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of patients in clinical remission
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
Study officials:
affiliation: Filip.Baert@azdelta.be
name: Filip Baert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vande Casteele N, Baert F, Bian S, Dreesen E, Compernolle G, Van Assche G, Ferrante M, Vermeire S, Gils A. Subcutaneous Absorption Contributes to Observed Interindividual Variability in Adalimumab Serum Concentrations in Crohn's Disease: A Prospective Multicentre Study. J Crohns Colitis. 2019 Sep 27;13(10):1248-1256. doi: 10.1093/ecco-jcc/jjz050.