Crohn’s disease Digestive System Crohn disease, unspecified
Conditions
Interventions
This trial aims to test the prognostic capabilities of a new biomarker. Participants with Crohn’s disease are stratified using a biomarker, then randomised to receive either ‘Top down’ or ‘Step up’ tr
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sustained surgery free remission is measured using questionnaires from steroid induction treatment (screening) through weeks 4, 16, 32 and 48. 2. Steroid free remission is measured using questionnaires from steroid induction treatment (screening) through weeks 4, 16, 32 and 48. 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
| Measure | Time frame |
|---|---|
| 1. Mucosal healing is measured using local and central reading of colonoscopy and MRE from baseline to week 48. 2. Quality of life is measured using the IBDQ questionnaire from screening through weeks 16, 32 and 48. 3. Quality of life is measured using the EuroQol questionnaire from screening through weeks 16, 32 and 48. 4. Quality of life is measured using the IBDQ questionnaire from screening through weeks 16, 32 and 48. 5. Health resource usage is measured using the resource usage questionnaire from screening through weeks 16, 32 and 48. 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. | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed