The Role of Anti-IgE (omalizumab/Xolair) in the Management of Severe Recalcitrant Paediatric Atopic Eczema (ADAPT): Statistical Analysis Plan

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2017 May 25

PMID 28535776

Citations 2

Authors

Tao Chen

Susan Chan

Gideon Lack

Suzie Cro

Victoria R Cornelius

Affiliations

Soon will be listed here.

Abstract

Background: The Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT) is a trial to determine the clinical efficacy and safety of omalizumab for children with severe atopic eczema. This article describes the detailed statistical analysis plan for the ADAPT as an update to the published protocol and is submitted prior to knowing all outcomes.

Method And Design: The ADAPT is a randomised, double-blind, placebo-controlled trial with a primary objective to determine whether anti-IgE reduces eczema severity as assessed by the validated eczema score (objective SCORAD) after 24 weeks of treatment in children with severe eczema. This articles outline the overall analysis principles including considerations on sample definition in each analysis, missing data, and adjusted covariates. Comparability and representativeness of the randomised groups, primary and sensitivity analyses of the primary and secondary outcomes as well as subgroup analysis are described.

Results: This prespecified statistical analysis plan has been developed to comply with international guidelines which will increase the transparency of the data analysis for the ADAPT.

Trial Registration: ISRCTN, identifier: ISRCTN15090567 . Registered on 3 December 2014; EU Clinical Trials Register, EudraCT Number: 2010-020841-29 . Registered on 14 May 2010. The first participant was enrolled on 15 January 2015.

Citing Articles

Current approaches to handling rescue medication in asthma and eczema randomized controlled trials are inadequate: a systematic review.

Chis Ster A, Cornelius V, Cro S J Clin Epidemiol. 2020; 125:148-157.

PMID: 32504781 PMC: 7482905. DOI: 10.1016/j.jclinepi.2020.05.027.

An evaluation of inverse probability weighting using the propensity score for baseline covariate adjustment in smaller population randomised controlled trials with a continuous outcome.

Raad H, Cornelius V, Chan S, Williamson E, Cro S BMC Med Res Methodol. 2020; 20(1):70.

PMID: 32293286 PMC: 7092449. DOI: 10.1186/s12874-020-00947-7.

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