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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT02450513 |
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Date of registration:
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12/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study
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Scientific title:
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Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study |
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Date of first enrolment:
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March 2012 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02450513 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Karolien Van den Broek |
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Address:
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Telephone:
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Email:
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karolien.vandenbroeck@uzleuven.be |
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Affiliation:
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Name:
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Filip Baert, MD |
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Address:
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Telephone:
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Email:
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Filip.Baert@azdelta.be |
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Affiliation:
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Name:
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Filip Baert, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Filip.Baert@azdelta.be |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Adalimumab
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Primary Outcome(s)
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Proportion of patients in clinical remission
[Time Frame: week 12]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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