PROFILE - personalised medicine in Crohn's disease

Phase 4

Completed

• Conditions: Crohn’s disease; Digestive System; Crohn disease, unspecified

• Registration Number: ISRCTN11808228
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-03
• Study Completion: 2023-02-01
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 390

Inclusion Criteria

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.

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Sustained surgery free remission is measured using questionnaires from steroid induction treatment (screening) through weeks 4, 16, 32 and 48.<br>2. Steroid free remission is measured using questionnaires from steroid induction treatment (screening) through weeks 4, 16, 32 and 48.<br><br>The primary outcomes are measured using the sustained surgery and steroid free remission from completion of steroid induction treatment through to week 48 based upon information we collected at each trial time point.

Secondary Outcome Measures

Name	Time	Method
1. Mucosal healing is measured using local and central reading of colonoscopy and MRE from baseline to week 48.<br>2. Quality of life is measured using the IBDQ questionnaire from screening through weeks 16, 32 and 48.<br>3. Quality of life is measured using the EuroQol questionnaire from screening through weeks 16, 32 and 48.<br>4. Quality of life is measured using the IBDQ questionnaire from screening through weeks 16, 32 and 48.<br>5. Health resource usage is measured using the resource usage questionnaire from screening through weeks 16, 32 and 48.<br><br>Secondary outcomes are measured using the local and central reading of colonoscopy/MRE over 1 year and the quality of life assessment (IBDQ) provided over the duration of the study and the patient rated resource usage / quality of life assessment (EuroQol) questionnaires provided over the duration of the study.