TDM Guided Early Optimization of ADAL in Crohn's Disease (NCT03261102) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TDM Guided Early Optimization of ADAL in Crohn's Disease
Canada200 participantsStarted 2017-01-17
Plain-language summary
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
Who can participate
Age range18 Years
SexALL
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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