Skip to main content
. 2023 May 4;2023(5):CD013854. doi: 10.1002/14651858.CD013854.pub2

NCT04183608.

Methods RCT
Participants 238
Interventions Group1: adalimumab + patient education + calprotectin + e‐monitoring
Group 2: adalimumab
Group 3: e‐Monitoring, home fecal calprotectin testing and therapy education
Group 4: standard of care (patient only visits every 3 months the doctor so the optimisation of treatment can be done only at this frequency)
Outcomes Endoscopic remission (primary)
Clinical remission (defined as a total Mayo score ≤ 2 points, with no individual sub score > 1, and a Mayo endoscopy sub score of 0 or 1)
Remission without steroids
Endoscopic healing rate with Mayo score 0 or 1
UCEIS score
Histological healing (Nancy score)
Remission rate and remission rate without steroids at study visits and W48
Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48)
Patient satisfaction
Continuous response
Safety and tolerability
Anti‐TNF pharmacokinetics
Number of visits in trial
Number of UC‐related hospitalisations
Number of colectomies
Treatment compliance (questionnaire)
Patient adhesion (questionnaire)
Medico‐economic analysis
Notes We contacted authors about a full report of their results on 15 June 2021 and we received no response