Autologous stem cell transplantation in refractory Crohn’s disease – low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study

John A. Snowden; Chris Hawkey; Daniel Hind; Lizzie Swaby; Katie Mellor; Richard Emsley; Laura Mandefield; Ellen Lee; Manuela Badoglio; Emmanuelle Polge; Myriam Labopin; John Gribben; A. Graham Pockley; Gemma A. Foulds; Alan Lobo; Simon Travis; Miles Parkes; Jack Satsangi; Diana Papaioannou; James O. Lindsay

doi:10.1186/s12876-019-0992-2

Table 3 Study assessment schedule

From: Autologous stem cell transplantation in refractory Crohn’s disease – low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study

	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						✓	✓	✓	✓	✓

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