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

Interstitial lung disease

The primary outcome is the change in Forced Vital Capacity (FVC) (in mL) from baseline to 6 months.

Change from baseline in FVC (in % of predicted) to 6 months, Progression free survival (PFS) at 6 months, defined as the time to (first event considered): a) a first acute exacerbation, or b) a relative decline in the FVC of ≥ 10% of the predicted value, or c) the need for new immunosuppressive therapy or/and anti-fibrotic therapies (excluding corticosteroids), or d) inclusion on a lung transplant list, or e) death., Changes from baseline to 6 months in the King’s Brief Interstitial Lung Disease (K-BILD) questionnaire and L-PF symptom and impact questionnaire, Difference in cumulative doses of corticosteroids at 6 months, Changes from baseline to 6 months in % of predicted diffusing capacity for carbon monoxide (DLCO), Changes from baseline to 6 months in the 6-minute walk test, Change from baseline to 6 months in accelerometer-assessed physical activity, Changes from baseline to 6 months of biological markers related to B-cell depletion: CD19 lymphocytes and gammaglobulins,, Changes from baseline to 6 months of serology by ELISA of 15 environmental antigens., Changes from baseline to 6 months in high-resolution computed tomography (HRCT) of chest images, All adverse events, especially serious infectious adverse events, occurring during the six-month treatment period, Pharmacokinetic parameters of rituximab: volume of distribution, rituximab clearance and half-life, Change from baseline to 6 months of SARS COV 2 antibodies

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