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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02450513

Enrollment

Registered

2015-05-21

Start date

2012-03-31

Completion date

2016-05-25

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

adalimumab, anti-TNF, pharmacokinetics, trough level, immunogenicity

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.

Interventions

DRUGAdalimumab

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026