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TDM Guided Early Optimization of ADAL in Crohn's Disease

Inflammatory Bowel Diseases | Crohn Disease | Drug Monitoring

To 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

Primary Contact

Chantal Guillet

[email protected]
(819) 346-1110
The University of British Columbia
The University of British Columbia
Vancouver, British Columbia
Canada

Contact Study Team

University of Calgary Medical Center (UCMC)
University of Calgary Medical Center (UCMC)
Calgary, Alberta
Canada

Contact Study Team

McGill University Hospital Center (MUHC)
McGill University Hospital Center (MUHC)
Montréal, Quebec
Canada

Contact Study Team

Primary Contact

Carolyne Lemieux, BN, RN

[email protected]
(514) 934-1934
Backup Contact

Meaghan Smith, RN

[email protected]
(514) 934-1934
London Health Sciences Centre (LHSC) University Hospital
London Health Sciences Centre (LHSC) University Hospital
London, Ontario
Canada

Contact Study Team

The Ottawa Hospital, IBD Centre of Excellence
The Ottawa Hospital, IBD Centre of Excellence
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Melissa Tessier

[email protected]
(613) 737-8899
Study Sponsored By
McGill University Health Centre/Research Institute of the McGill University Health Centre
Participants Required
More Information
Study ID: NCT03261102