IVIG Treatment in Systemic Sclerosis

NCT ID: NCT01785056

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2019-01-31

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 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.

Conditions

Systemic Sclerosis; Diffuse Scleroderma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Privigen

Privigen is a ready-to-use, sterile, 10% protein liquid preparation of polyvalent human immunoglobulin G (IgG) for intravenous administration. Subjects will be given 2 g/kg/month of IVIGfor 6 months. Each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.

Group Type: EXPERIMENTAL

Privigen

Intervention Type: BIOLOGICAL

Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.

Placebo (Albuminar-5)

Albuminar-5 is a sterile solution of albumin obtained from large pools of adult human venous plasma and used as the placebo in this study. Albuminar-5 will be administered by the intravenous route and each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.

Group Type: PLACEBO_COMPARATOR

Privigen

Intervention Type: BIOLOGICAL

Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.

Interventions

Privigen

Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginia D Steen, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Locations

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

Pro00000052

Identifier Type: -

Identifier Source: org_study_id