Assessments
|
Eligibility assessment
| ✓ | ✓ |
HSCT procedure (intervention) or continuation on current treatment (control)
| | | | | | | |
Consent
| ✓ | | | | | | | | |
Standard Pre-HSCT work (including chest x-ray and MUGA scan)
| ✓ | | | | | | | | |
Serology for HBV, HCV, HIV
| ✓ | | | | | | | | |
Demographics
| ✓ | | | | | | | | |
Medication history
| ✓ | | | | | | | | |
Concomitant medications
| ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Adverse events
| | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
General Medical History
| ✓ | | | | | | | | |
History of CD
| ✓ | | | | | | | | |
General Physical Examination
| ✓ | ✓ | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Urinalysis
| ✓ | ✓ | | | | | | | |
Pregnancy test
| ✓ | ✓ | | | | | | | |
Smoking History
| ✓ | | | | | | | | |
Crohn’s Disease Activity Index (CDAI)
| ✓ | ✓ | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Harvey Bradshaw Index
| ✓ | ✓ | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Karnofsky Performance Status
| ✓ | | | | | | | | ✓ |
Patient Reported Outcome 2 questionnaire (PRO2)
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Ileo-colonoscopy (Simple Endoscopic Score for Crohn’s Disease (SES CD)) / endoscopic assessment
| ✓ | | | | | ✓ | | | ✓ |
Biopsies2
| ✓ | | | | | ✓ | | | ✓ |
MRI Intestine
| ✓ | | ✓ | | | ✓ | | | ✓ |
MRI Pelvis
| ✓ | | | | | | | | |
Routine Clinical Care blood test
| | ✓ | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Serum3
| | ✓ | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Whole Blood3
| | ✓ | | ✓ | ✓ | ✓ | ✓ | | ✓ |
Peripheral Blood mononuclear cells (PBMCs)3
| | ✓ | | ✓ | ✓ | ✓ | ✓ | | ✓ |
Stool sample3
| | ✓ | | ✓ | ✓ | ✓ | ✓ | | ✓ |
Inflammatory Bowel Disease Questionnaire (IBDQ)
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Inflammatory Bowel Disease Control Questionnaire (IBD-Control)
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
100 day safety (collection of Adverse Events for transplant endpoint)
| | | | | ✓ | | | | |
EQ-5D-5 L
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Work Productivity and Activity Impairment questionnaire (WPAI)
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Health Care Resource Use Questionnaire
| ✓ | | | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Patient Global Impression of Change (PGIC)
| | | | | | | | | ✓ |
For participants in HSCTlite arm only:
|
JACIE and HTA recommended routine tests
| | ✓ |
HSCT procedure (intervention) or continuation on current treatment (control)
| | | | | | | |
Anti-TNF therapy initiated (if required)
| | | | | | ✓ | | | |
Adherence to re-vaccination policy
| | | | | ✓ | ✓ | ✓ | ✓ | ✓ |