Imperial College London
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ProfessorDeborahAshby

Faculty of Medicine, School of Public Health

Dean of the Faculty of Medicine
 
 
 
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Contact

 

+44 (0)20 7594 8704deborah.ashby Website

 
 
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Location

 

2.15Faculty BuildingSouth Kensington Campus

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Summary

 

Publications

Citation

BibTex format

@article{Saunders:2017:10.1186/s13063-017-2016-2,
author = {Saunders, P and Tsipouri, V and Keir, GJ and Ashby, D and Flather, MD and Parfrey, H and Babalis, D and Renzoni, EA and Denton, CP and Wells, AU and Maher, TM},
doi = {10.1186/s13063-017-2016-2},
journal = {TRIALS},
title = {Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial},
url = {http://dx.doi.org/10.1186/s13063-017-2016-2},
volume = {18},
year = {2017}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Background:Interstitial lung disease (ILD) frequently complicates systemic autoimmune disorders resulting in considerable morbidity and mortality. The connective tissue diseases (CTDs) most frequently resulting in ILD include: systemic sclerosis, idiopathic inflammatory myositis (including dermatomyositis, polymyositis and anti-synthetase syndrome) and mixed connective tissue disease. Despite the development, over the last two decades, of a range of biological therapies which have resulted in significant improvements in the treatment of the systemic manifestations of CTD, the management of CTD-associated ILD has changed little. At present there are no approved therapies for CTD-ILD. Following trials in scleroderma-ILD, cyclophosphamide is the accepted standard of care for individuals with severe or progressive CTD-related ILD. Observational studies have suggested that the anti-CD20 monoclonal antibody, rituximab, is an effective rescue therapy in the treatment of refractory CTD-ILD. However, before now, there have been no randomised controlled trials assessing the efficacy of rituximab in this treatment population.Methods/design:RECITAL is a UK, multicentre, prospective, randomised, double-blind, double-dummy, controlled trial funded by the Efficacy and Mechanism Evaluation Programme of the Medical Research Council and National Institute for Health Research. The trial will compare rituximab 1 g given intravenously, twice at an interval of 2 weeks, with intravenously administered cyclophosphamide given monthly at a dose of 600 mg/m2 body surface area in individuals with ILD due to systemic sclerosis, idiopathic inflammatory myositis (including anti-synthetase syndrome) or mixed connective tissue disease. A total of 116 individuals will be randomised 1:1 to each of the two treatment arms, with stratification based on underlying CTD, and will be followed for a total of 48 weeks from first dose. The primary endpoint for the study will be change in forced vital capacity
AU  - Saunders,P
AU  - Tsipouri,V
AU  - Keir,GJ
AU  - Ashby,D
AU  - Flather,MD
AU  - Parfrey,H
AU  - Babalis,D
AU  - Renzoni,EA
AU  - Denton,CP
AU  - Wells,AU
AU  - Maher,TM
DO  - 10.1186/s13063-017-2016-2
PY  - 2017///
SN  - 1745-6215
TI  - Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial
T2  - TRIALS
UR  - http://dx.doi.org/10.1186/s13063-017-2016-2
UR  - http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000403844800001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
UR  - http://hdl.handle.net/10044/1/49885
VL  - 18
ER  -
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