Clinical trial NCT03261102: TDM Guided Early Optimization of ADAL in Crohn's Disease
Official title: Therapeutic Drug Monitoring Guided Early Optimization of Adalimumab in Crohn's Disease; A Randomized Open Label Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Drug Monitoring
Inflammatory Bowel Diseases
Keywords: IBD
Crohn
adalimumab
ADAL
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2017-08-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.

Detailed description: This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level early in the treatment course would lead to better outcomes for patients as compared to the standard doses.

Eligibility 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

Primary outcomes:
measure: Proportion of subjects who achieved remission
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of subjects who achieved clinical response
timeFrame: From Week 0 to Week 12
measure: Therapeutic drug monitoring
timeFrame: At Week 8, 12
measure: Proportion of steroid free subjects
timeFrame: At Week 12
measure: Subjects well-being
timeFrame: From Week 0 to Week 12
measure: Rates of complications
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Medical Center (UCMC)
state: Alberta
city: Vancouver
country: Canada
facility: The University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre (LHSC) University Hospital
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital, IBD Centre of Excellence
state: Ontario
city: Montréal
country: Canada
facility: McGill University Hospital Center (MUHC)
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Waqqas Afif, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: