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
Verified date | January 2018 |
Source | Georgetown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Georgetown University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Georgetown University | CSL Behring |
United States,
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 |
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