Monitoring of Vedolizumab Infusion Therapy (MOVE-IT) Response With Fecal Inflammation Markers, Ultrasound, and Trough Serum Level in Patients With Ulcerative Colitis: Protocol for a Multicentric, Prospective, Noninterventional Study.
ulcerative colitis
ultrasound
vedolizumab
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
08 Nov 2019
08 Nov 2019
Historique:
received:
10
04
2019
accepted:
27
08
2019
revised:
23
08
2019
entrez:
9
11
2019
pubmed:
9
11
2019
medline:
9
11
2019
Statut:
epublish
Résumé
Vedolizumab has been shown to induce clinical remission in patients with active ulcerative colitis. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. However, in clinical practice, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest. The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate-to-severe ulcerative colitis by calculating the probability of clinical response at week 14, on the basis of the data from week 6. This is a prospective, single-arm, multicentric, noninterventional, observational study with no interim analyses and a sample size of 35 evaluable patients. The enrollment started in August 2018 and was still open at the date of submission. The study is expected to complete in September 2020. The early identification of patients who are responding to an integrin antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or nonresponders can thus help prescribing physicians avoid ineffective treatments and stop these very early.
Sections du résumé
BACKGROUND
BACKGROUND
Vedolizumab has been shown to induce clinical remission in patients with active ulcerative colitis. Treatment with anti-integrin vedolizumab leads to clinical remission in 16.9% and clinical response in 47.1% of cases after 6 weeks. However, in clinical practice, no decision to discontinue or continue vedolizumab therapy is made until 14 weeks at the earliest.
OBJECTIVE
OBJECTIVE
The aim of this study is to develop an algorithm for optimizing vedolizumab administration in patients with moderate-to-severe ulcerative colitis by calculating the probability of clinical response at week 14, on the basis of the data from week 6.
METHODS
METHODS
This is a prospective, single-arm, multicentric, noninterventional, observational study with no interim analyses and a sample size of 35 evaluable patients.
RESULTS
RESULTS
The enrollment started in August 2018 and was still open at the date of submission. The study is expected to complete in September 2020.
CONCLUSIONS
CONCLUSIONS
The early identification of patients who are responding to an integrin antibody is therapeutically beneficial. At the same time, patients who are not responding can be identified earlier. The development of a therapeutic algorithm for identifying patients as responders or nonresponders can thus help prescribing physicians avoid ineffective treatments and stop these very early.
Identifiants
pubmed: 31702563
pii: v8i11e14335
doi: 10.2196/14335
pmc: PMC6874801
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e14335Informations de copyright
©Jimmi Cording, Margit Blömacher, Berit Inga Wiebe, Jost Langhorst, Torsten Kucharzik, Andreas Sturm, Stefan Schreiber, Ulf Helwig. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 08.11.2019.
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