EvER-ILD 2: Evaluation of Efficacy and safety of Rituximab in patients with progressive Interstitial Lung Disease (ILD) with inflammatory component: a multicentre double-blind placebo-controlled randomized trial
- Conditions
- Interstitial lung diseaseMedDRA version: 21.1Level: PTClassification code: 10022611Term: Interstitial lung disease Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 126
Patients = 18 years old, Who meet at least one of the following criteria for worsening ILD within 24 months: a)a relative decline in the FVC of >= 10% of the predicted value b)a relative decrease in the FVC of >=5 to 10% of the predicted value AND i)worsening respiratory symptoms OR ii)an increased extent of ILD on high-resolution CT OR iii)a relative decrease in the DLCO of >= 15% of the predicted value. c)worsening of respiratory symptoms AND an increased extent of ILD on high-resolution CT, AND presence of an inflammatory component defined by: a)a previous histological pattern with lymphocyte infiltrations distant from pulmonary fibrosis to suggest an inflammatory component on pulmonary sample (for example: interstitial lymphoid aggregates with germinal centers, diffuse lympho-plasmocytic infiltrations, granulomas, giant cells or centrilobular inflammation…) b)OR a previous alveolar lymphocytosis > 20% on BALF, Subjects covered by the French social security system, Written informed consent obtained from subject, Ability for subject to comply with the requirements of the study.
Known diagnosis of significant respiratory disorders (asthma, tuberculosis, aspergillosis, cystic fibrosis, IPF, CTD-ILD, sarcoidosis, desquamative interstitial pneumonia, pulmonary hypertension (PAMp > 30mmHg)) or a significant severe heart failure, Patients on a lung transplant list, Pregnant or breastfeeding women, or women of childbearing age not using a reliable method of contraception during the study and for 12 months following the end of the study treatment, Patients at high risk of infectious complications: Human Immunodeficiency Virus (HIV) positive or other known immunodeficiency syndromes, hepatitis B and C (HBV, HCV), COVID (within 3 month) or other known viral infection, infection requiring anti-infective treatment within 4 weeks of inclusion, Patients with incomplete anti-SarsCoV2 vaccine regimen (according to current recommendations) or patient who has not receive treatment with therapeutic antibodies anti-SARSCov2 (ex: tixagévimab/cilgavimab), Patient under judicial protection, deprivation of liberty, Participation in other interventional research with an investigational drug or medical device., Concomitant medical or surgical disease, clinically significant as considered by the investigator, serious or unstable, acute or chronically progressive, or any condition that could affect the safety of the patient, in the opinion of the investigator, including severe cardiomyopathy or severe heart failure, Patient who cannot walk more than 100 meters at 6-minutes walk test, HRCT profile of definite usual interstitial pneumonia (UIP), Histological model of definite UIP, Initiation of a new therapy or with interruption/modification of therapy dosage within 6 weeks prior to visit 1, Patient who has already received a rituximab-based treatment line, Known hypersensitivity to rituximab, to murine proteins or other excipients or sulfonamide antibiotics, Treatment with monoclonal antibodies (such as, but not limited to, etanercept, adalimumab, efalizumab, infliximab, golimumab, certolizumab, tocilizumab) within 6 months (if 5 half-lives = 6 months) prior to inclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method