Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01785056
Status:
UNKNOWN
Last Update Posted:
2018-07-17
First Post:
2013-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IVIG Treatment in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-09-24', 'releaseDate': '2019-09-03'}, {'resetDate': '2023-03-13', 'releaseDate': '2023-02-15'}], 'estimatedResultsFirstSubmitDate': '2019-09-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-13', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-02-04', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'To study the effects of IVIG on the skin in patients with scleroderma', 'timeFrame': 'At the 6 month visit', 'description': 'The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin'}, {'measure': 'To determine any toxicity of IVIG in scleroderma', 'timeFrame': 'At the 6 month visit', 'description': '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.'}, {'measure': 'To evaluate the effects of IVIG on pulmonary function', 'timeFrame': 'At the 6 month visit', 'description': 'Pulmonary Function Tests (PFTs) will be performed to determine these changes.'}, {'measure': 'To study the biologic effects of IVIG on gene arrays in skin biopsies', 'timeFrame': 'At the 6 month visit', 'description': 'A skin biopsy will be taken at the Baseline and Month 6 visit to determine the biological effects of IVIG on the skin.'}, {'measure': 'Muscle, joint, and inflammatory parameters', 'timeFrame': 'At the 6 month visit', 'description': 'A physical exam will be performed to determine these changes'}], 'primaryOutcomes': [{'measure': 'To study the effects of IVIG on the skin in patients with scleroderma', 'timeFrame': 'At the 4 month visit', 'description': 'The modified Rodnan Skin Score (mRSS) will be used to determine the changes in skin'}], 'secondaryOutcomes': [{'measure': 'To determine any toxicity of IVIG in scleroderma', 'timeFrame': 'At the 4 month visit', 'description': '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.'}, {'measure': 'To evaluate the effects of IVIG on pulmonary function', 'timeFrame': 'At the 4 month visit', 'description': 'Pulmonary Function Tests (PFTs) will be performed to determine these changes.'}, {'measure': 'Muscle, joint, and inflammatory parameters', 'timeFrame': 'At the 4 month visit', 'description': 'Done by performing a physical exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Sclerosis', 'Diffuse Scleroderma', 'SSc'], 'conditions': ['Systemic Sclerosis', 'Diffuse Scleroderma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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;\n* 18 years of age or older;\n* Disease duration of less than 5 years from the first non-Raynaud's symptom of scleroderma.\n\nExclusion Criteria:\n\n* Use of more than 10 mg of prednisone, or any dose of cytoxan, d-penicillamine, or rituximab in the last 3 months;\n* History of deep vein thrombosis (DVT), stroke, or other thromboembolic phenomenon;\n* History of anaphylaxis or other serious reaction to human blood or blood products.\n* Absolute IgA deficiency\n* A prior receipt of IVIg treatment"}, 'identificationModule': {'nctId': 'NCT01785056', 'briefTitle': 'IVIG Treatment in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'A Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of Intravenous Immunoglobulin Treatment in Patients With Systemic Sclerosis', 'orgStudyIdInfo': {'id': 'Pro00000052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Privigen', 'description': '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.', 'interventionNames': ['Biological: Privigen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Albuminar-5)', 'description': '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.', 'interventionNames': ['Biological: Privigen']}], 'interventions': [{'name': 'Privigen', 'type': 'BIOLOGICAL', 'description': 'Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.', 'armGroupLabels': ['Placebo (Albuminar-5)', 'Privigen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Virginia D Steen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSL Behring', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-09-03', 'type': 'RELEASE'}, {'date': '2019-09-24', 'type': 'RESET'}, {'date': '2023-02-15', 'type': 'RELEASE'}, {'date': '2023-03-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Georgetown University'}}}}