Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
1 other identifier
observational
30
1 country
2
Brief Summary
Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2012
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 12, 2015
CompletedFirst Posted
Study publicly available on registry
May 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2016
CompletedJuly 10, 2024
July 1, 2024
4.2 years
May 12, 2015
July 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients in clinical remission
As defined by a Harvey-Bradshaw index ≤4
week 12
Study Arms (1)
Single-group study
Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.
Interventions
160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- Patients with ulcerative colitis.
- Patients treated in placebo controlled trials.
- Patients unwilling to participate or withdrawing informed consent for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospitals Leuven
Leuven, 3000, Belgium
AZ Delta
Roeselare, 8800, Belgium
Related Publications (1)
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.
PMID: 30820530DERIVED
Biospecimen
Serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Filip Baert, MD
Filip.Baert@azdelta.be
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2015
First Posted
May 21, 2015
Study Start
March 1, 2012
Primary Completion
May 25, 2016
Study Completion
May 25, 2016
Last Updated
July 10, 2024
Record last verified: 2024-07