Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic Sclerosis

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

May 15, 2028

Study Completion Date

November 15, 2028

Conditions
Interstitial Lung Disease With Systemic Sclerosis
Interventions
DRUG

Rituximab

one course of IV rituximab consisting of an infusion of 1000 mg rituximab (diluted in 500 mL of saline 0.9 % sodium chloride) will be given at day 1, day 15 and an infusion of 500 mg rituximab (in 500 mL of saline 0.9 % sodium chloride) at week 24;

DRUG

Placebo

one course of intravenous placebo of rituximab consisting of an infusion of 500 mL of saline (0.9% sodium chloride) infusion will be given at day 1, day 15 and week 24;

All Listed Sponsors
lead

University Hospital, Tours

OTHER

NCT06549231 - Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic Sclerosis | Biotech Hunter | Biotech Hunter