ClinicaliQ Trial Snapshot
- A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN’s Disease — Recruiting • Non-phase study • Rheumatology • NCT07363044.
- What is being tested: Epigenome-guided treatment selection for biologic therapy in active Crohn's disease, comparing personalised epigenetic marker-based approaches against standard-of-care treatment protocols to determine efficacy, safety, and cost-effectiveness.
- Patient eligibility overview: Adults with active Crohn's disease who are initiating biologic therapy; participants are randomly assigned to either epigenome-guided selection or conventional treatment selection across multiple NHS centres.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).
Eligibility Snapshot
- : Participants must meet all of the following criteria for enrolment into the study: 1. Aged 18 years or older at the time of informed consent. 2. Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy). 3. Active CD, as defined by HBI > 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only. 4. Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician. 5. Must meet all eligibility criteria for biologic therapy initiation as per local SOC, including absence of chronic/opportunistic infections as demonstrated by local protocols for human immunodeficiency virus, tuberculosis, active cytomegalovirus, hepatitis B and C, and Clostridioides difficile infection. Local vaccination protocols apply as per SOC. 6. Nonpregnant and nonlactating. Participants of childbearing potential must agree to follow local SOC guidelines for use of biologics in pregnancy/lactation, including appropriate contraception, during the study; must agree to avoid becoming pregnant from the time of informed consent up until Week 26. 7. If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.