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New treatment option for Systemic Sclerosis
Official title Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis
ClinicalTrials.gov ID: NCT03844061
What this study is testing
What is Belimumab?
Belimumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for systemic sclerosis.
Also referred to as Benlysta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
- 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...
See the full eligibility 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
- 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.
- 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...
- A positive pregnancy test at entry into this study. Men and women with reproductive potential will be required to use effective means of contraception through the course of the study, such as (1) surgical sterilization...
- Women not willing to use effective birth control for the duration of the study
- Breastfeeding.
- Participation in another clinical research study involving the evaluation of another investigational drug within ninety days of entry into this study.
- The presence of severe lung disease as defined by a diffusion capacity of less than 30% of predicted or requiring supplemental oxygen and forced vital capacity (FVC) of less than 45% of predicted.
- Grade 3 hypogammaglobulinemia
- Have a significant IgG deficiency (IgG level \< 400 mg/dL)
- Have an IgA deficiency (IgA level \< 10 mg/dL)
- Have a historically positive HIV test or test positive at screening for HIV
- Neutrophils \<1.5X10E9/L
- Hepatitis status:
- Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: 1\. Patients positive for HBsAg or HBcAb are excluded b) Positive test for Hepatitis C...
- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
- Hospitalization for treatment of infection within 60 days of Day 0.
- Use of parenteral (IV or IM) antibiotics (antibacterials, antivirals, anti-fungals, or anti-parasitic agents) within 60 days of Day 0 22. Suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.