Table 3 Study assessment schedule
Screening1 | Baseline | Week 4 (HSCT only) | Week 8 | Week 14 | Week 24 | Week 32 | Week 40 | Week 48 | ||
|---|---|---|---|---|---|---|---|---|---|---|
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 | ✓ | ✓ | ✓ | ✓ | ✓ | |||||