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

U

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Crohn's Disease

Treatments

Drug: Adalimumab

Study type

Observational

Funder types

Other

Identifiers

NCT02450513
S53297

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

30 participants in 1 patient group

Single-group study
Description:
Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.
Treatment:
Drug: Adalimumab

Trial contacts and locations

0

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Central trial contact

Filip Baert, MD

Data sourced from clinicaltrials.gov

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