Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Status:
Recruiting
Trial end date:
2022-02-28
Target enrollment:
Participant gender:
Summary
This is a 52 week, single center, randomized, double-blind, placebo-controlled study.
After patients maintain a stable dose of Mycophenolate Mofetil (MMF) for at least 1 month,
they will be randomized to treatment with either Belimumab & Rituximab or placebo.Patients in
both groups will be on background MMF for the entirety of the study. Belimumab will be
administered subcutaneously and Rituximab intravenously. Placebo injections and infusions
will be of normal saline. Randomization will be done in a 2:1 manner to favor the treatment
group. It is hypothesized that that Rituximab and Belimumab combination therapy with
Mycophenolate Mofetil background therapy will improve fibrosis in SSc skin when compared to
treatment with placebo and Mycophenolate Mofetil in a group of patients with early dcSSc.