Clinical Trials Directory

Trials / Completed

CompletedNCT01862926

Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD

A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
104 (actual)
Sponsor
Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGRituximab
DRUGCyclophosphamide

Timeline

Start date
2014-11-01
Primary completion
2021-01-01
Completion
2021-01-01
First posted
2013-05-27
Last updated
2021-10-07

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01862926. Inclusion in this directory is not an endorsement.