The purpose of this study is to determine whether Rituximab is safe and effective as a maintenance strategy in individuals with stabilized systemic sclerosis in adults.
Adult patient (≥ 18 years old),
Patient with a diagnosis of SSc, as defined by the ACR/EULAR 2013 criteria (cf. Table 2) (6)
Patient with ILD identified on the basis of a HRCT, obtained within 12 months before screening, that showed fibrosis affecting at least 10% of the lungs,
SSc-ILD induction with RTX, either twice 1000 mg two weeks apart, or 375 mg/m2 four times 4 weeks apart.
Forced vital capacity < 40% of the predicted value
Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) < 30% of the predicted value.
Contra-indication or anaphylaxis toward RTX
Contra-indication to auxiliary medicinal products
Parallel
Rituximab
Drug500mg i.v at M0, M6 and M12
Placebo
Drug500mg i.v at M0, M6 and M12
changes in forced vital capacity (FVC) from baseline to Month 18 of randomisation.
PFTs: changes in forced vital capacity (FVC)
Mortality up to 18 months
Occurrence of Adverse Events
Occurrence of adverse events, overall and occurring at time of perfusion (day 0, and 6, 12 and 18 months)
Occurrence of Adverse Events
The number of adverse events, expressed according to the Common Terminology Criteria for Adverse Events (CTCAE): CTCAE toxicity grading system per patient-year at month 6, 12, and 18, for the following adverse events combined: death (all causes), grade 2 or higher leukopenia or thrombocytopenia, grade 3 or higher infections, hospitalization resulting either from the disease or from a complication due to the study treatment.
Occurrence of AE of specific interest previously mentioned at 6, 12 and 18 months
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Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
