Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission

What is the Purpose of this Study?

The purpose of this study is to collect and analyze data in patients with inflammatory bowel disease (IBD) who are currently receiving IBD medication(s) that targets their immune system (targeted immunomodulator- TIM) in routine clinical care and are feeling well but have active inflammation on colonoscopy. The study aims to determine whether switching to an alternative IBD medication will improve disease outcome without increasing the burden of treatment. IBD, including ulcerative colitis and Crohn’s disease, is a chronic condition that causes inflammation of the intestinal tract. Treatment of IBD often involves long-term use of TIM therapies. This study is proposing a “treat-to-target” approach, in which treatment strategies aim to resolve bowel inflammation by switching to another TIM in patients without symptoms but with bowel inflammation in the hope of achieving endoscopic remission. Endoscopic remission may, in turn, decrease the risk of relapse, unplanned healthcare utilization, IBD-related disability, and improve quality of life, versus continuing current TIM therapy.


Eligibility

  • Male or nonpregnant, nonlactating females, aged 18 to 80 years (inclusive).
  • An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.
  • Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., tumour necrosis factor α [TNFα] antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission: The QUOTIENT Trial

Study Details
Disease Type/Condition

Inflammatory Bowel Disease

Principal Investigator

Melmed, Gil

Co-Investigators

Andrea Banty, Gaurav Syal, Susie Lee

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002062

ClinicalTrials.gov ID

NCT05230173

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Details
Disease Type/Condition

Inflammatory Bowel Disease

Principal Investigator

Melmed, Gil

Age Group

Adult

Phase

N/A

IRB Number

RCT01519

ClinicalTrials.gov ID

NCT05230173

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org