Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
|ClinicalTrials.gov Identifier: NCT02450513|
Recruitment Status : Unknown
Verified May 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : May 21, 2015
Last Update Posted : May 24, 2016
|Condition or disease||Intervention/treatment|
|Crohn's Disease||Drug: Adalimumab|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||July 2016|
Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.
160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards
Other Name: Humira
- Proportion of patients in clinical remission [ Time Frame: week 12 ]As defined by a Harvey-Bradshaw index ≤4
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450513
|Contact: Filip Baert, MD||Filip.Baert@azdelta.be|
|University Hospitals Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Karolien Van den Broek firstname.lastname@example.org|
|Roeselare, Belgium, 8800|
|Principal Investigator:||Filip Baert, MD||Filip.Baert@azdelta.be|