Trial intelligence / Profile preview

Precision vs Conventional Infliximab Dosing in IBD

NCT02453776Phase 4

Key facts

Status
Completed
Start
May 2015
Primary completion
Dec 2018
Countries
1
Sponsor
University of Amsterdam
Modality
Monoclonal Antibodies
Conditions
inflammatory bowel disease (IBD)Crohn's diseaseulcerative colitis (UC)
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Overview

Phase 4, randomised, open-label trial of infliximab in inflammatory bowel disease (IBD), Crohn's disease and ulcerative colitis (UC), sponsored by University of Amsterdam. Primary endpoint: Sustained clinical remission at 52 weeks. Started May 2015; status: completed.

02

Design

Study design
RandomizedOpen-label
03

Who it enrols

Adults with CD or UC in clinical remission (HBI <=4 or PM <=2) receiving scheduled infliximab maintenance for at least 14 weeks.

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Endpoints

Primary

  • Sustained clinical remission

Secondary

  • Annual costs of infliximab treatment

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