Belimumab and Rituximab for Diffuse Cutaneous Systemic Sclerosis
This study is testing if a combination of two approved medications, Belimumab and Rituximab, along with Mycophenolate Mofetil (MMF), can help people with diffuse cutaneous systemic sclerosis (dcSSc). dcSSc is a condition where your immune system attacks your own body. Belimumab works by decreasing certain immune cells called B-cells, and Rituximab also targets B-cells. You might be able to join if you are between 18 and 80 years old and have been diagnosed with dcSSc. The researchers will look at how much your skin fibrosis (thickening) improves and if there are any serious side effects over 12 months. The current status of this study is unclear.
- Study design
- This is a 52-week, single-center study where participants are randomly assigned to receive either the study drugs or a placebo (inactive treatment). About 30 people are expected to participate.
- What's involved
- You would take Mycophenolate Mofetil (MMF) throughout the study. You would receive Belimumab as an injection under the skin and Rituximab through an IV, or receive placebo injections and IVs.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main results will be measured at 12 months, which suggests you would be followed for at least that long after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Robert Spiera, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
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What this trial measures
- Primary Efficacy Outcome: Change in the ACR Revised CRISS at 12 months12 months
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 to 1.00, where a higher score indicates a better outcome.
- Primary Safety Outcome: The proportion of participants who experience at least one Grade 3 or higher adverse event at or before 12 months12 months
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.Grade 3 = Severe and undesirable adverse event