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 |