Intervention group visit# | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
Week | −4 | 0 | 2 | 6 | 10 | 14 | 18 | 22 | 26 | 30 | 34 | 38 | 42 | 46 |
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 culture & sensitivity (C&S) | x | |||||||||||||
Blood drawn for GLM drug levels and ADA | x | x | x | x | x | x | x | x | x | x | x | x | ||
FCP stool sample | *x | x | x | x | x | x | x | x | x | x | 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.