Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Privigen | Experimental | 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. |
|
| Placebo (Albuminar-5) | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Privigen | Biological | Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To evaluate the effects of IVIG on pulmonary function |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To determine any toxicity of IVIG in scleroderma |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Virginia D Steen, MD | Georgetown University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States | ||
| Johns Hopkins Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 3, 2019 | |
| Reset | Sep 24, 2019 | |
| Release | Feb 15, 2023 | |
| Reset | Mar 13, 2023 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 3, 2019 | Sep 24, 2019 | |||
| Feb 15, 2023 |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pulmonary Function Tests (PFTs) will be performed to determine these changes. |
| At the 4 month visit |
| Muscle, joint, and inflammatory parameters | Done by performing a physical exam | 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.
| At the 6 month visit |
| 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 |
| 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 |
| Muscle, joint, and inflammatory parameters | A physical exam will be performed to determine these changes | At the 6 month visit |
| Baltimore |
| Maryland |
| 21224 |
| United States |
| Mar 13, 2023 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |