NDLI: Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Saunders, Peter Tsipouri, Vicky Keir, Gregory J. Ashby, Deborah Flather, Marcus D. Parfrey, Helen Babalis, Daphne Renzoni, Elisabetta A. Denton, Christopher P. Wells, Athol U. Maher, Toby M.
Abstract	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 (FVC) at 24 weeks. Key secondary endpoints include: safety, change in FVC at 48 weeks as well as survival, change in oxygen requirements, total 48-week corticosteroid exposure and utilisation of health care resources. Discussion This is the first randomised control trial to study the efficacy of rituximab as first-line treatment in CTD-associated ILD. The results generated should provide important information on the treatment of a life-threatening complication affecting a rare group of CTDs. Trial registration ClinicalTrials.gov, NCT01862926. Registered on 22 May 2013.
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-017-2016-2.pdf
Ending Page	11
Page Count	11
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-017-2016-2
Journal	Trials
Issue Number	1
Volume Number	18
Language	English
Publisher	BioMed Central
Publisher Date	2017-06-15
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Myositis Scleroderma Mixed connective tissue disease Pulmonary fibrosis Respiratory failure Biomarkers Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

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