Status:
WITHDRAWN
Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having a...
Detailed Description
Biologic therapy has revolutionized the treatment of IBD. Over the past 20 years, a significant amount of research has been done to optimize biologic therapy using therapeutic drug monitoring (TDM). E...
Eligibility Criteria
Inclusion
- Adult outpatients \>=18 y of age with a confirmed diagnosis of ulcerative colitis
- Patients beginning adalimumab for active disease as clinically indicated according to the treating physician's discretion, either biologic naïve or switching biologic due to failure of prior biologic therapy
- Have had a colonoscopy or flexible sigmoidoscopy within 12 weeks of study entry
- Any other concomitant therapies are allowed (including 5'ASA, corticosteroids, azathioprine, and methotrexate).
Exclusion
- Inability to provide informed consent
- Inability to provide a fecal calprotectin
- Contraindication to starting anti-TNF therapy
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03808506
Start Date
September 1 2019
End Date
July 19 2022
Last Update
March 9 2023
Active Locations (1)
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1
London Health Sciences Center
London, Ontario, Canada, N6A5W9