A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease

Royal Brompton & Harefield NHS trust0 sites104 target enrollmentApril 2, 2015

Overview

Phase: 未知
Intervention: Not specified
Conditions: Interstitial lung disease in people with severe connective tissue disease, including systemic sclerosis, idiopathic interstitial myopathy (including polymyositis/dermatomyositis) and mixed connective tissue disease
Sponsor: Royal Brompton & Harefield NHS trust
Enrollment: 104
Status: Completed
Last Updated: last year

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28619061 protocol (added 23/07/2019) 2022 Results article in https://doi.org/10.1016/S2213-2600(22)00359-9 (added 14/11/2022) 2024 Results article in https://doi.org/10.3310/LYWQ8541 (added 10/05/2024)

Registry

who.int

Start Date

April 2, 2015

End Date

January 12, 2021

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Royal Brompton & Harefield NHS trust

•Subjects will be recruited prospectively from rheumatology or interstitial lung disease units at 6 UK centres.
•1\. A diagnosis of connective tissue disease, based on internationally accepted criteria, in one of the following categories:
•1\.1\. Systemic sclerosis
•1\.2\. Idiopathic interstitial myopathy (including polymyositis/dermatomyositis)
•1\.3\. Mixed connective tissue disease
•2\. Severe and/or progressive interstitial lung disease associated with the underlying connective tissue disease.
•3\. Chest HRCT performed within 12 months of randomisation
•4\. Intention of the caring physician to treat the ILD with intravenous cyclophosphamide (with treatment indications including deteriorating symptoms attributable to ILD, deteriorating lung function tests, worsening gas exchange or extent of ILD at first presentation)and where there is a reasonable expectation that immunosuppressive treatment will stabilize or improve CTD\-ILD
•5\. Written informed consent

•1\. Age \<18 or \>80 years.
•2\. Previous treatment with rituximab and/or intravenous cyclophosphamide
•3\. Known hypersensitivity to rituximab or cyclophosphamide or their components
•4\. Significant (in the opinion of the investigator) other organ co\-morbidity including cardiac, hepatic or renal impairment
•5, Co\-existent obstructive pulmonary disease (e.g. asthma, COPD, emphysema) with pre bronchodilator FEV1/FVC \<70%
•6, Patients at significant risk for infectious complications following immunosuppression including HIV positive or other immunodeficiency syndromes (including hypogammaglobulineamia)
•7\. Suspected or proven untreated tuberculosis
•8\. Viral hepatitis
•9\. Infection requiring antibiotic treatment in the preceding four weeks
•10\. Unexplained neurological symptoms (which may be suggestive of progressive mutifocal leukoencephalopathy; PML).