Trial record 5 of 75 for:
Open Studies | "Scleroderma, Systemic"
IVIG Treatment in Systemic Sclerosis
This study is currently recruiting participants.
Verified April 2013 by Georgetown University
Sponsor:
Georgetown University
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT01785056
First received: January 28, 2013
Last updated: May 2, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Systemic Sclerosis Diffuse Scleroderma |
Biological: Privigen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
systemic scleroderma
MedlinePlus related topics:
Scleroderma
U.S. FDA Resources
Further study details as provided by Georgetown University:
Primary Outcome Measures:
- To study the effects of IVIG on the skin in patients with scleroderma [ Time Frame: At the 4 month visit ] [ Designated as safety issue: No ]The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin
Secondary Outcome Measures:
- To determine any toxicity of IVIG in scleroderma [ Time Frame: At the 4 month visit ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Pulmonary Function Tests (PFTs) will be performed to determine these changes.
- Muscle, joint, and inflammatory parameters [ Time Frame: At the 4 month visit ] [ Designated as safety issue: No ]Done by performing a physical exam
Other Outcome Measures:
- To study the effects of IVIG on the skin in patients with scleroderma [ Time Frame: At the 6 month visit ] [ Designated as safety issue: No ]The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin
- To determine any toxicity of IVIG in scleroderma [ Time Frame: At the 6 month visit ] [ Designated as safety issue: Yes ]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 6 month visit ] [ Designated as safety issue: No ]Pulmonary Function Tests (PFTs) will be performed to determine these changes.
- To study the biologic effects of IVIG on gene arrays in skin biopsies [ Time Frame: At the 6 month visit ] [ Designated as safety issue: No ]A skin biopsy will be taken at the Baseline and Month 6 visit to determine the biological effects of IVIG on the skin.
- Muscle, joint, and inflammatory parameters [ Time Frame: At the 6 month visit ] [ Designated as safety issue: No ]A physical exam will be performed to determine these changes
| Estimated Enrollment: | 24 |
| Study Start Date: | April 2013 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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 IVIG (or placebo) for 6 months. Each dose will be split into 2 to 4 infusions on consecutive days to achieve the total monthly dose.
|
Biological: Privigen
Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.
|
|
Placebo Comparator: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diffuse systemic sclerosis with active skin involvement as defined as a mRSS >16, 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 6 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01785056
Contacts
| Contact: Virginia D Steen, MD | 202-444-6200 | |
| Contact: Molly Lurie-Marino | 202-444-6210 | mfm84@georgetown.edu |
Locations
| United States, District of Columbia | |
| Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Virginia D Steen, MD 202-444-6200 | |
| Contact: Molly Lurie-Marino 202-444-6210 mfm84@georgetown.edu | |
| Principal Investigator: Virginia D Steen, MD | |
| United States, Maryland | |
| Johns Hopkins Hospital | Not yet recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Laura Hummers, MD 410-550-2400 | |
| Contact: Cynthia A Anderson, MS 410-550-8582 canderson@jhmi.edu | |
| Principal Investigator: Laura Hummers, MD | |
Sponsors and Collaborators
Georgetown University
CSL Behring
Investigators
| Principal Investigator: | Virginia D Steen, MD | Georgetown University Hospital |
More Information
No publications provided
| Responsible Party: | Georgetown University |
| ClinicalTrials.gov Identifier: | NCT01785056 History of Changes |
| Other Study ID Numbers: | Pro00000052 |
| Study First Received: | January 28, 2013 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Georgetown University:
|
Systemic Sclerosis Diffuse Scleroderma SSc |
Additional relevant MeSH terms:
|
Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Connective Tissue Diseases Skin Diseases Pathologic Processes |
Immunoglobulins Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013