Crohn's Disease Crohn's Disease
Conditions
Interventions
The intervention consists of the administration of a biological that would also be given in routine practice. The 
only exception to routine practice is the number of biopsies that will be taken during endoscopy. 
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age >/= 18 years; • Male or non-pregnant, non-lactating females; • Females of child bearing potential must use appropriate contraception during the trial; • Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts* score >i2a) in the neoterminal ileum; • Negative tuberculosis (TB) screening per local protocol (see Section 8.3); • In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements; • The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion criteria
Exclusion criteria: • Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient*s ability to comply with study procedures; • Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association [NYHA], multiple sclerosis, active infections). • Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer. • Currently participating or planning to participate in a study involving an investigational product. • Current diagnosis of untreated tuberculosis (active or latent), human immunodeficiency virus (HIV) or active/chronic hepatitis B or C infection (HBV, HCV). • Active or planned pregnancy during the trial. • Prior diagnosis of dysplasia in the colon (excluding in resected adenomas). • History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer. • Received a biologic treatment between surgery and first endoscopy. • Positive Clostridium difficile toxin B in faeces. Patients who test positive can be treated per local practice and still enter the trial if no longer than 4 weeks after the screening visit, they test negative for Clostridium difficile toxin B. • Presence of a stoma without ileocolonic anastomosis or pouch. • Active perianal abscess or draining fistula • ALT or AST > 3x the upper limit of normal measured at screening • Increased risk of bleeding: coagulation disorder, use of anticoagulants and DOACs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunological changes in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Clinical, endoscopic and histological response to different targeted treatments given for postoperative CD. -Change from baseline in IL-23 pathway cytokines and mediators. -Differences in transcriptional signatures (single cell RNA sequencing) in ileal tissue. -Change in IL-23R+ cells, IL 23+ cells, FcγR+ cells, IL-23+ FcγR+ cells, and ILCs using single-cell RNA sequencing. | — |
Countries
Canada, Netherlands
Contacts
Public ContactL Oldenburg
Amsterdam UMC
Outcome results
None listed