Table 1

Schedule of events—intervention arm

Intervention group visit#1234567891011121314
Prestudy medical screeningx
Consent by consultantx
Clinical lab (haematology)xxx
Clinical lab
Clinical lab (HCG)x
Clinical lab (stool culture & sensitivity (C&S)x
Blood drawn for GLM drug levels and ADAxxxxxxxxxxxx
FCP stool sample*xxxxxxxxxxxxx
Mayo scorexx
Partial Mayo scorex
Short Health Scalexxxxxxxxxxxxx
Modified partial Mayoxxxxxxxxxxxxx
GLM drug administration by research nursexx
  • *Initial FCP may done at screening or baseline visit.

  • †Colonoscopy/sigmoidoscopy (w/Mayo score) to be completed within 12 weeks (±4 weeks) of baseline visit. Window for week 46 colonoscopy/sigmoidoscopy is also ±4 weeks.

  • ADA, adalimumab; FCP, faecal calprotectin; GLM, golimumab.