The trial involves adults with a stable form of systemic sclerosis combined with interstitial lung disease, referred to as SSc‑ILD. After an initial course of the medication Rituximab, participants are randomly assigned to receive either additional Rituximab infusions or a placebo solution of sodium chloride.
The purpose of the study is to demonstrate the efficacy of maintaining RTX as a maintenance strategy in individuals with stabilized SSc‑ILD following RTX induction treatment. Participants receive the assigned infusion every few months for a total period of about 18 months, with clinic visits scheduled at regular intervals to monitor health.
During the study, lung function is checked using measurements such as FVC, which assesses the amount of air a person can forcefully exhale, and DLCO, which evaluates how well oxygen passes from the lungs into the blood. Imaging of the chest is performed with a HRCT scan, and physical capacity is measured with a 6‑min walk test that records the distance walked in six minutes. Additional assessments include questionnaires about quality of life and safety checks.



France