IVIG Treatment in Systemic Sclerosis

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Systemic Sclerosis, Diffuse Scleroderma

In brief

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.

Key facts

Study ID

NCT01785056

Run by

Georgetown University

People needed

14

Starts

2013-04-01

Expected to finish

2019-01-01

Last updated by the study team

2018-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.