TY - JOUR
T1 - The role of anti-IgE (omalizumab/Xolair) in the management of severe recalcitrant paediatric atopic eczema (ADAPT)
T2 - Statistical analysis plan
AU - Chen, Tao
AU - Chan, Susan
AU - Lack, Gideon
AU - Cro, Suzie
AU - Cornelius, Victoria R.
PY - 2017/5/23
Y1 - 2017/5/23
N2 - 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.
AB - 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.
KW - Anti-IgE
KW - Atopic dermatitis
KW - Eczema
KW - Omalizumab
KW - Paediatric
KW - Randomised controlled trial
KW - Statistical analysis plan
KW - Xolair
UR - http://www.scopus.com/inward/record.url?scp=85019850509&partnerID=8YFLogxK
U2 - 10.1186/s13063-017-1976-6
DO - 10.1186/s13063-017-1976-6
M3 - Article
AN - SCOPUS:85019850509
SN - 1745-6215
VL - 18
JO - Trials
JF - Trials
IS - 1
M1 - 231
ER -