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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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
18 and up
Critères de participation
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
Lieu de l'étude
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Centre Hospitalier Universitaire de Sherbrooke (CHUS)Sherbrooke, Quebec
Canada
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The University of British Columbia
The University of British ColumbiaVancouver, British Columbia
Canada
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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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- Étude parrainée par
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT03261102