Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD
Status:
Completed
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
Interstitial lung disease (ILD) is characterised by inflammation and scarring of the lung and
is the leading cause of death in patients with systemic sclerosis, and contributes
significantly to morbidity and mortality in many other connective tissue diseases (CTDs) such
as polymyositis/dermatomyositis and mixed connective tissue disease. When ILD is extensive
and/or progressive, immunosuppressive medication is often required to stabilize lung disease
and alleviate symptoms. Current standard care for CTD associated ILD is extrapolated from
studies performed in individuals with systemic sclerosis and comprises low dose
corticosteroids and intravenous cyclophosphamide followed by oral azathioprine. In some
individuals even this intensive immunosuppression is insufficient to prevent deterioration,
and in a significant minority of affected individuals this results in respiratory failure and
death. Rituximab has recently been reported as an effective 'rescue therapy' for stabilizing
and even improving ILD in this patient group. Based on observations gained from this
experience, the investigators believe that rituximab is a potential important alternative to
current best therapy for this patient group. This study has therefore been initiated to
evaluate the efficacy of rituximab (compared with standard therapy) in patients with
progressive CTD related ILD.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborators:
Imperial College London University College London Hospitals University of East Anglia