ISRCTN11808228CompletedPhase 4

PRedicting Outcomes For Crohn’s dIsease using a moLecular biomarkEr (PROFILE) trial

Cambridge University Hospitals NHS Foundation Trust0 sites390 target enrollmentStarted: November 3, 2017Last updated: March 25, 2024

Conditions

Trial Snapshot

2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30523133 protocol (added 04/11/2019) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38402895/ (added 26/02/2024)

•1. Crohn’s disease diagnosed within 3 months* using standard endoscopic, histologic or radiological criteria
•2. Clinical evidence of active Crohn’s disease (corresponding to an HBI > 7)
•3. Endoscopic evidence of at least moderately active Crohn’s disease (corresponding to an SES-CD > 6 or > 4 if limited to terminal ileum)
•4. CRP > upper limit of normal on local assay OR Calprotectin > 200 µg/g
•5. Immunomodulator and anti-TNFa naïve
•6. Aged 16-80 years old
•* Patients that have glucocorticoids in this period need to have discontinued this medication prior to screening assessments and still have active disease.

•1. Patients with ulcerative colitis or indeterminate colitis
•2. Patients with fistulating peri-anal Crohn’s disease or active perianal sepsis
•3. Patients with obstructive symptoms AND evidence of a fixed stricture on radiology or colonoscopy, which suggest that the subject is at high risk of requiring surgery over the following year. N.B. patients with modest degrees of stricturing on imaging but no obstructive symptoms may be included according to clinician judgement
•4. Patients with contra-indications to study medications including a history of hepatitis B or C, tuberculosis
•5. Patients with a history of malignancy
•6. Patients who are pregnant or breastfeeding at screening
•7. Other serious medical or psychiatric illness currently on going, or experienced in the last 3 months, that could compromise the study
•8. Patients unable to comply with protocol requirements (for reasons including alcohol and/or recreational drug abuse)

Sponsor