TDM Guided Early Optimization of ADAL in Crohn's Disease
Inflammatory Bowel Diseases | Crohn Disease | Drug MonitoringTo investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* Age 18 or older.
* Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
* Active disease based on Harvey Bradshaw Index (HBI \>5) and elevated C-reactive protein (CRP) (\>normal reference range for local laboratory) OR fecal calprotectin (FCP) (\>250 µg/g)
* Due to commence treatment with ADAL.
Exclusion Criteria:
* Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
* History of active HIV, hepatitis B or C infection,
* Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
* Pregnancy
* Prior exposure to ADAL
Study Location
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Centre Hospitalier Universitaire de Sherbrooke (CHUS)Sherbrooke, Quebec
Canada
Contact Study Team
The University of British Columbia
The University of British ColumbiaVancouver, British Columbia
Canada
Contact Study Team
University of Calgary Medical Center (UCMC)
University of Calgary Medical Center (UCMC)Calgary, Alberta
Canada
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McGill University Hospital Center (MUHC)
McGill University Hospital Center (MUHC)Montréal, Quebec
Canada
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London Health Sciences Centre (LHSC) University Hospital
London Health Sciences Centre (LHSC) University HospitalLondon, Ontario
Canada
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The Ottawa Hospital, IBD Centre of Excellence
The Ottawa Hospital, IBD Centre of ExcellenceOttawa, Ontario
Canada
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- Study Sponsored By
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Participants Required
- More Information
- Study ID:
NCT03261102