Clinical Trial: IVIG Treatment in Systemic Sclerosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Georgetown University

Current Primary Outcome: To study the effects of IVIG on the skin in patients with scleroderma [ Time Frame: At the 4 month visit ]

The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To determine any toxicity of IVIG in scleroderma [ Time Frame: At the 4 month visit ]
    Laboratory assessments (Complete Blood Count (CBC) including liver and electrolytes with differentiation, Complete Metabolic Profile (CMP) including creatinine, and Coombs test) will be performed monthly to monitor toxicity.
  • To evaluate the effects of IVIG on pulmonary function [ Time Frame: At the 4 month visit ]
    Pulmonary Function Tests (PFTs) will be performed to determine these changes.
  • Muscle, joint, and inflammatory parameters [ Time Frame: At the 4 month visit ]
    Done by performing a physical exam


Original Secondary Outcome: Same as current

Information By: Georgetown University

Dates:
Date Received: January 28, 2013
Date Started: April 2013
Date Completion: December 2017
Last Updated: January 30, 2017
Last Verified: January 2017