Status:
UNKNOWN
Preemptive HLA Genotyping for the Safe Use of Infliximab-combination Therapy in Inflammatory Bowel Disease
Lead Sponsor:
Western University, Canada
Conditions:
Inflammatory Bowel Diseases
Ulcerative Colitis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Inflammatory bowel disease (IBD) is a common disease in Canada, leading to significant morbidity as a result of remitting and relapsing intestinal inflammation. Currently, tumor necrosis factor (TNF) ...
Detailed Description
Inflammatory bowel disease (IBD) affects over 250,000 individuals in Canada. It is comprised of ulcerative colitis (UC) and Crohn's disease (CD). The dysregulated inflammatory response targeting the g...
Eligibility Criteria
Inclusion
- Adults (\>17 years of age) with a histopathologic diagnosis of CD or UC being initiated on therapy with infliximab by their treating gastroenterologist
- Individuals with prior biologic exposure to a non-TNF-based therapy are eligible
- Individuals on prednisone are eligible
Exclusion
- Absence of histopathologic diagnosis of CD or UC
- Prior exposure to a TNF-based therapy (infliximab, golimumab, adalimumab)
- Pregnancy
- Known contraindication to both azathioprine and methotrexate
- Non-english speaking
- Being ineligible for infliximab based on insurance plan
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04109300
Start Date
September 1 2020
End Date
September 1 2023
Last Update
September 30 2019
Active Locations (1)
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1
Western University
London, Ontario, Canada, N6A 3K7