Who can participate?
Inclusion criteria
- Aged 18 years or older at the time of informed consent.
- Documented diagnosis of ileal, ileocolonic, or colonic CD
- Active CD, as defined by HBI > 6 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.
- Eligible to receive either vedolizumab and/or ustekinumab therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.
- Must meet all eligibility criteria for biologic therapy initiation as per local standard of care
- Nonpregnant and nonlactating.
- If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening.
- If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:
- The dose is up to a maximum of prednisone ≤ 40 mg/day or budesonide ≤ 9 mg/day or equivalent.
- The dose has been stable for ≥ 2 weeks prior to screening.
- The participant is willing to initiate a corticosteroid taper within 2 weeks after initiating biologic treatment
Exclusion criteria
- Prior treatment with vedolizumab or ustekinumab
- Prior treatment with more than 1 advanced therapy for CD.
- CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to Ileorectal anastomosis or a proctocolectomy, short bowel syndrome, all ostomies, symptomatic strictures, active abscess.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, idiopathic colitis, microscopic colitis, or colonic mucosal dysplasia.
Study locations in Europe
Check with your treating gastroenterologist if you are eligibile for participation. Also check the website of your local Crohn’s Disease patient organisation.
- The Netherlands (more information)
- Belgium
- Hungary
- Italy
- Slovenia
- United Kingdom