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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Observational
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02450513

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Universitaire Ziekenhuizen Leuven

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Belgium

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease
Additional Details

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.

Contact a Trial Team

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International Sites

University Hospitals Leuven, Leuven, Belgium

Status

Recruiting

Address

University Hospitals Leuven

Leuven, , 3000

Site Contact

Karolien Van den Broek

karolien.vandenbroeck@uzleuven.be

AZ Delta, Roeselare, Belgium

Status

Completed

Address

AZ Delta

Roeselare, , 8800

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