Maher 2015.

Trial name or title	Rituximab Versus Cyclophosphamide in Connective Tissue Disease‐ILD (RECITAL)
Methods	Randomised parallel double‐blind controlled trial
Participants	Adults over 18 years with a diagnosis of connective tissue disease, based on internationally accepted criteria, in one of the following categories: • Systemic sclerosis • Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) • Mixed connective tissue disease With severe and/or progressive interstitial lung disease associated with underlying connective tissue disease
Interventions	Experimental: rituximab: 1 gram given at baseline and at 2 weeks Active comparator: cyclophosphamide: intravenous dose of 600 mg/m2 body surface area. 6 doses given 4‐weekly
Outcomes	Primary outcome measures • Absolute change in FVC at 48 weeks Secondary outcome measures • Change from baseline in diffusing capacity for carbon monoxide (DLCO) at 48 weeks • Change from baseline in health‐related quality of life scores at 48 weeks • Change from baseline in global disease activity score at 48 weeks • Progression‐free survival at 48 weeks • Composite endpoint of mortality, transplant, treatment failure, or decline in FVC > 10% compared with baseline • Adverse and serious adverse events (as defined in GCP) at 48 weeks
Starting date	May 2013
Contact information	Toby M Maher: Royal Brompton and Harefield Foundation NHS Trust
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