Actively Recruiting
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
Led by University Hospital, Tours · Updated on 2024-07-24
126
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of the EvER-ILD2 study is to evaluate the efficacy on lung function at 6 months of one course rituximab (2 infusions) comparatively to one course of placebo (2 infusions) in a broad range of progressive ILD patients with inflammatory component.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Worsening interstitial lung disease within 24 months defined by one of the following: a relative decline in forced vital capacity (FVC) of 10% or more predicted; or a relative FVC decrease of 5% to 10% predicted plus worsening respiratory symptoms, increased ILD extent on high-resolution CT, or a relative decrease in DLCO of 15% or more predicted; or worsening respiratory symptoms and increased ILD extent on high-resolution CT
- Presence of an inflammatory component shown by previous lung tissue biopsy with lymphocyte infiltration or alveolar lymphocytosis greater than 20% on bronchoalveolar lavage fluid
- Covered by the French social security system
- Provided written informed consent
- Able to comply with study requirements
You will not qualify if you...
- Diagnosis of significant respiratory disorders such as asthma, tuberculosis, aspergillosis, cystic fibrosis, idiopathic pulmonary fibrosis, connective tissue diseases-ILD, sarcoidosis, desquamative interstitial pneumonia, or pulmonary hypertension with mean arterial pressure over 30 mmHg
- Significant severe heart failure or cardiomyopathy
- Unable to walk more than 100 meters in a 6-minute walk test
- High-resolution CT profile typical of usual interstitial pneumonia (UIP)
- Histological pattern of typical nonspecific interstitial pneumonia (NSIP) or definitive UIP
- New therapy initiation or therapy dose change within 6 weeks prior to first visit
- Previous treatment with rituximab
- Known hypersensitivity to rituximab, murine proteins, excipients, or sulfonamide antibiotics
- Treatment with monoclonal antibodies within 6 months prior to inclusion
- Listed for lung transplant
- Pregnant or breastfeeding or not using reliable contraception if of childbearing age
- High risk of infectious complications including HIV, hepatitis B or C, recent coronavirus infection, or recent infection requiring treatment
- Incomplete COVID-19 vaccination regimen without antibody treatment
- Under judicial protection or deprivation of liberty
- Participation in other interventional research with investigational drugs or devices
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chru Tours
Tours, France
Actively Recruiting
Research Team
S
Sylvain MARCHAND ADAM, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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