Crohn's Disease chronic intestinal inflammation that can occur throughout the digestive tract, from mouth to anus
Conditions
Interventions
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recommends treatment selections for 2 biologi
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Prior treatment with VDZ or UST. 2. Prior treatment with more than 1 advanced therapy (eg, any biologic [ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin]) or advanced oral small molecule [ie, Janus kinase inhibitor]) for CD. 3. CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to: • Ileorectal anastomosis (rectum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corticosteroid-free clinical remission (Harvey Bradshaw Index [HBI] score = 50% decrease from baseline in the Simple Endoscopic Score for Crohn*s Disease [SES-CD]) at Week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Receiver-operating characteristic curve area analysis will be used • Predicted likelihood of success of reaching corticosteroid-free clinical remission and endoscopic response at Week 26 • Endoscopic response (>= 50% decrease from baseline in SES-CD score) at Week 26 • Endoscopic remission (SES-CD = 3 points from baseline) at Week 26 • Corticosteroid-free deep remission (HBI | — |
Countries
Belgium, Hungary, Italy, Netherlands, Slovenia, United Kingdom
Contacts
Public ContactSarah Zon
Amsterdam UMC
Outcome results
None listed