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.
The specific objectives of this study are to:
Determine whether rituximab/belimumab/mmf is safe and tolerable in the treatment of
patients with early diffuse cutaneous (dc)SSc when compared to patients treated with
placebo/placebo/mmf, as assessed by comparison of adverse and serious adverse effects.
In this study stand of care will be protocolized as mycophenolate mofetil.
Determine whether rituximab/belimumab/mmf is more effective than placebo/placebo/mmf, as
measured by change in CRISS, which is a composite outcome measure provisionally endorsed
by the ACR for scleroderma clinical trials. It incorporates change in the mRSS, FVC
percent predicted, physician and patient global assessments, and HAQ-DI. Additionally,
hemoglobin corrected diffusion capacity (DLCO), Medsger Severity Scale (MSS), and by
other physician and patient derived outcome measures will be used.
Determine the biological activity of rituximab/belimumab/mmf vs placebo/placebo/mmf as
assessed by effect on histology of skin, gene expression of skin and blood, change in
B-Cell profiles including assessment of B regulatory cells, and effect on serological
and cutaneous biomarkers of disease activity.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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