Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Scler… (NCT03844061) | Clinical Trial Compass
RecruitingPhase 2
Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
United States30 participantsStarted 2019-07-29
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age greater than or equal to eighteen years and less than or equal to 80.
✓. Classification of systemic sclerosis (SSc), as defined using the 2013 American College of Rheumatology/European Union League Against Rheumatism classification of SSc.
✓. Diagnosis of dcSSc, as defined by LeRoy and Medsger.
✓. Disease duration of less than or equal to 3 years as defined by the date of onset of the first non-Raynaud's symptom.
✓. A modified Rodnan Skin Score (mRSS) of \> 14
Exclusion criteria
✕. Inability to render informed consent in accordance with institutional guidelines.
✕. Disease duration of greater than 3 years.
✕. Patients with mixed connective tissue disease or "overlap" unless the dominant features of the illness are diffuse systemic sclerosis.
✕. Limited scleroderma.
What they're measuring
1
Primary Efficacy Outcome: Change in the ACR Revised CRISS at 12 months
Timeframe: 12 months
2
Primary Safety Outcome: The proportion of participants who experience at least one Grade 3 or higher adverse event at or before 12 months
. Systemic sclerosis-like illness associated with environmental or ingested agents such as toxic rapeseed oil, vinyl chloride, or bleomycin.
✕. The use of other anti-fibrotic agents including colchicine, D-penicillamine, or tyrosine kinase inhibitors (nilotinib, imatinib, dasatinib) in the month prior to enrollment.
✕. Use in the prior month of corticosteroids at doses exceeding the equivalent of prednisone 10 mg daily. Use of corticosteroid at \< 10 mg of prednisone can continue during the course of the study.
✕. Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for this study such as uncontrollable CHF, arrhythmia, severe pulmonary or systemic hypertension, severe GI involvement, hepatic impairment, serum creatinine of greater than 2.0, active infection, severe diabetes, unstable atherosclerotic cardiovascular disease, malignancy, HIV, or severe peripheral vascular disease.