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IVIG Treatment in Systemic Sclerosis

Information source: Georgetown University
ClinicalTrials.gov processed this data on November 27, 2014
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 scleroderma

To 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 >16,

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 6 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.

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; Not yet 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: June 26, 2014

Page last updated: November 27, 2014

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