A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases

• Conditions: A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease; MedDRA version: 14.1Level: PTClassification code 10012503Term: DermatomyositisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 14.1Level: PTClassification code 10022611Term: Interstitial lung diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10027754Term: Mixed connective tissue diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: PTClassification code 10039710Term: SclerodermaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: PTClassification code 10036102Term: PolymyositisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003633-42-GB
• Lead Sponsor: Royal Brompton and Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-22
• Last Update Posted: 11 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subjects will be recruited prospectively from rheumatology or interstitial lung disease units at 6 UK centres. Prior to enrolment potential study subjects will be assessed according to the following inclusion and exclusion criteria; Inclusion Criteria: • A diagnosis of connective tissue disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease • Severe and/or progressive interstitial lung disease associated with the underlying connective tissue disease. • Chest HRCT performed within 12 months of randomisation • 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 • Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

Exclusion Criteria: • Age <18 or >80 years. • Previous treatment with Rituximab and/or intravenous Cyclophosphamide • Known hypersensitivity to Rituximab or Cyclophosphamide or their components • Significant (in the opinion of the investigator) other organ co-morbidity including cardiac, hepatic or renal impairment • Co-existent obstructive pulmonary disease (e.g. asthma, COPD, emphysema) with pre bronchodilator FEV1/FVC < 70% • Patients at significant risk for infectious complications following immunosuppression including HIV positive or other immunodeficiency syndromes (including hypogammaglobulineamia) • Suspected or proven untreated tuberculosis • Viral hepatitis • Infection requiring antibiotic treatment in the preceding four weeks • Unexplained neurological symptoms (which may be suggestive of progressive mutifocal leukoencephalopathy; PML). Neurological symptoms arising as a consequence of the underlying CTD do not necessitate exclusion. • Other investigational therapy (participation in research trial) received within 8 weeks of randomisation • Immunosuppressive or CTD disease modifying therapy (other than corticosteroids) received within 2 weeks of randomisation • Pregnant or breast feeding women, or women of child-bearing potential, not using a reliable contraceptive method for up to 12 months following IMP • Unexplained haematuria, or previous bladder carcinoma • CT scan > 12 months from randomisation • Unable to provide informed written consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified