Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis

Study 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.

Primary Outcome

The revised CRISS (rCRISS) is a proposed new composite endpoint developed in response to recent queries of the ACR CRISS (Composite Response Index in Systemic Sclerosis), showing concerns of high ceiling and floor effects and difficult interpretation. The exponential algorithm determines the predicted probability of change from baseline, incorporating change in 5 core items: the mRSS, FVC percent predicted, physician and patient global assessments, and HAQ-DI. The possible scores range from 0.00

Conditions Studied

Interventions

• DRUG Rituximab
• DRUG Belimumab
• OTHER Placebo Subcutaneous Injection
• OTHER Placebo Infusion
• DRUG MMF

Study Locations (1)