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

Royal Brompton & Harefield NHS trust0 个研究点目标入组 104 人开始时间: 2015年4月2日最近更新: 2024年5月21日

适应症

试验速览

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)

•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).
•11. Other investigational therapy (participation in research trial) received within 8 weeks of randomisation
•12. Immunosuppressive or CTD disease modifying therapy (other than corticosteroids) received within 2 weeks of randomisation
•13. Pregnant or breast feeding women, or women of child-bearing potential, not using a reliable contraceptive method for up to 12 months following IMP
•14. Unexplained haematuria, or previous bladder carcinoma
•15. CT scan > 12 months from randomisation
•16. Unable to provide informed written consent

发起方

Royal Brompton & Harefield NHS trust