IVIG Treatment in Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01785056
• Other study ID #: Pro00000052
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: January 2019

Study information

• Verified date: January 2018
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To study the effects of IVIG on the skin in patients with scleroderma	The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin	At the 6 month visit
Other	To determine any toxicity of IVIG in scleroderma	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.	At the 6 month visit
Other	To evaluate the effects of IVIG on pulmonary function	Pulmonary Function Tests (PFTs) will be performed to determine these changes.	At the 6 month visit
Other	To study the biologic effects of IVIG on gene arrays in skin biopsies	A skin biopsy will be taken at the Baseline and Month 6 visit to determine the biological effects of IVIG on the skin.	At the 6 month visit
Other	Muscle, joint, and inflammatory parameters	A physical exam will be performed to determine these changes	At the 6 month visit
Primary	To study the effects of IVIG on the skin in patients with scleroderma	The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin	At the 4 month visit
Secondary	To determine any toxicity of IVIG in scleroderma	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.	At the 4 month visit
Secondary	To evaluate the effects of IVIG on pulmonary function	Pulmonary Function Tests (PFTs) will be performed to determine these changes.	At the 4 month visit
Secondary	Muscle, joint, and inflammatory parameters	Done by performing a physical exam	At the 4 month visit