IVIG Treatment in Systemic Sclerosis
Information source: Georgetown University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Systemic Sclerosis; Diffuse Scleroderma
Intervention: Privigen (Biological)
Phase: N/A
Status: Recruiting
Sponsored by: Georgetown University Official(s) and/or principal investigator(s): Virginia D Steen, MD, Principal Investigator, Affiliation: Georgetown University Hospital
Overall contact: Virginia D Steen, MD, Phone: 202-444-6200
Summary
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.
Clinical Details
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: To study the effects of IVIG on the skin in patients with scleroderma
Secondary outcome: To determine any toxicity of IVIG in sclerodermaTo evaluate the effects of IVIG on pulmonary function Muscle, joint, and inflammatory parameters
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Virginia D Steen, MD, Phone: 202-444-6200
Georgetown University Hospital, Washington, District of Columbia 20007, United States; Recruiting Virginia D Steen, MD, Phone: 202-444-6200 Maia Zulmatashvili, Phone: 202-444-6210, Email: mz381@georgetown.edu Virginia D Steen, MD, Principal Investigator
Johns Hopkins Hospital, Baltimore, Maryland 21224, United States; Recruiting Laura Hummers, MD, Phone: 410-550-2400 Gwendolyn Leatherman, Phone: 410-550-8582, Email: gleathe@jhmi.edu Laura Hummers, MD, Principal Investigator
Additional Information
Starting date: April 2013
Last updated: August 10, 2015
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