Table 2

Schedule of events—SMPC arm

SMPC arm visit#1234567891011121314
Week−402610141822263034384246
Prestudy medical screening x
Consent by consultant x
Clinical lab (haematology) x x x
Clinical lab
(biochemistry)
x x x
Clinical lab (HCG) x
Clinical lab (stool C&S) x
x
Blood drawn for GLM drug levels and ADA x x x
FCP stool sample*x x x
Mayo score x x
Partial Mayo score x
Colonoscopy/sigmoidoscopy† x x
Short Health Scale x x x x x x x x x x x x x
Modified partial Mayo x x x x x x x x x x x x x
GLM drug administration by research nurse x x
  • *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.