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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