Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Systemic Sclerosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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...
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.
Tracking Information
- NCT #
- NCT03844061
- Collaborators
- GlaxoSmithKline
- Investigators
- Principal Investigator: Robert Spiera, MD Hospital for Special Surgery, New York