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

Sponsor
University Hospital, Tours
Study ID
NCT06549231
Phase
PHASE3
Status
Recruiting
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Conditions

  • Interstitial Lung Disease With Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    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;
  • Placebo — DRUG
    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;

Study Details

The goal of this clinical trial is to evaluate the efficacy on lung function after 24 weeks of rituximab + MMF combination comparatively to placebo + MMF combination in patients with SSc-ILD severe at the initial assessment or at high risk of progression.

Key Dates

Start date
Jan 8, 2025
Status verified
Jun 2026
Primary completion
Jul 8, 2028
Completion
Jan 8, 2029

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab
  • Placebo Comparator: Placebo

Primary Outcome Measure

Forced vital Capacity in % [ Time Frame: At 24 weeks ]

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