NCT05596786 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
| NCT ID | NCT05596786 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Tours |
| Condition | Lung Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2023-01-16 |
| Primary Completion | 2026-07-16 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥ 18 years old 2. Who meet at least one of the following criteria for worsening ILD within 24 months: 1. a relative decline in the FVC of \>= 10% of the predicted value 2. 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. 3. worsening of respiratory symptoms AND an increased extent of ILD on high-resolution CT 3. AND presence of an inflammatory component defined by 1. 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…) 2. OR a previous alveolar lymphocytosis \>20% on Bronchoalveolar lavage fluid (BALF) 4. Su