IVIG Treatment in Systemic Sclerosis



Status:Active, not recruiting
Conditions:Neurology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Neurology
Healthy:No
Age Range:18 - Any
Updated:7/19/2018
Start Date:April 2013
End Date:January 2019

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A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis

The purpose of this research is to study the effects of Privigen (intravenous immunoglobulin)
on the skin in patients with scleroderma. Approximately 24 subjects will take part in this
investigator-initiated study at Georgetown University Hospital and Johns Hopkins Hospital.
This study will last for one year (12 months). This research is being done because systemic
sclerosis can cause severe, progressive organ involvement. The investigators hope this study
treatment will improve the outcomes in this disease, including skin, muscle, joint,
gastrointestinal, and lung involvement.

The investigators propose a double-blind controlled trial of 24 patients with Privigen®
(Immune Globulin Intravenous (Human), 10% liquid treatment) with 3:1 randomization. Subjects
with scleroderma will be given 2 g/kg/mo of Privigen® or placebo (Albuminar®-5) for 6 months.
Scleroderma is generally a progressive disease, and while the skin does improve with time in
some patients, others have progressive disease in spite of aggressive treatment. Also,
spontaneous improvement in other organ systems is even less likely. Patients entered into the
trial will have failed to respond to standard of care treatment over the past 4 months. Thus,
the investigators feel that any actual improvement observed can be attributed to the IVIG
treatment. Since this is a pilot study, future larger controlled trials will be necessary to
clearly demonstrate the effectiveness, but the investigators are hoping that this study will
give us signals that will guide the future clinical trial.

Inclusion Criteria:

- Diffuse systemic sclerosis with active skin involvement as defined as a mRSS >12, with
no improvement or worsening in the previous 4 months in spite of treatment with
methotrexate, cellcept, imuran, or anti-TNF agent;

- 18 years of age or older;

- Disease duration of less than 5 years from the first non-Raynaud's symptom of
scleroderma.

Exclusion Criteria:

- Use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or
rituximab in the last 3 months;

- History of deep vein thrombosis (DVT), stroke, or other thromboembolic phenomenon;

- History of anaphylaxis or other serious reaction to human blood or blood products.

- Absolute IgA deficiency

- A prior receipt of IVIg treatment
We found this trial at
2
sites
3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Virginia D Steen, MD
Phone: 202-444-6200
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Laura Hummers, MD
Phone: 410-550-2400
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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