Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT00076934
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2004-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of RG2077 in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D001259', 'term': 'Ataxia'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2004-02-06', 'studyFirstSubmitQcDate': '2004-02-06', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety assessment including a MRI, neurological and physical examinations', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI', 'timeFrame': 'Throughout study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ataxia', 'MRI', 'MS', 'CTLA4-IgG4m', 'Costimulatory Signals', 'Autoimmune Disorders'], 'conditions': ['Multiple Sclerosis', 'Multiple Sclerosis, Relapsing-Remitting']}, 'referencesModule': {'availIpds': [{'id': 'SDY661', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY661', 'type': 'Individual Participant Data Set', 'comment': 'ImmPort study identifier is SDY661'}, {'id': 'SDY661', 'url': 'http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY661', 'type': 'Study protocol synopsis, -summary, -design, -adverse events, -medications,-demographics, - lab tests, -files', 'comment': 'ImmPort study identifier is SDY661'}, {'id': 'ITN006AI/NMS02', 'url': 'http://www.itntrialshare.org/project/Studies/ITN006AIPUBLIC/Study%20Data/begin.view?', 'type': 'Individual Participant Data Set', 'comment': "TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available."}, {'id': 'ITN006AI/NMS02', 'url': 'http://www.itntrialshare.org/project/Studies/ITN006AIPUBLIC/Study%20Data/begin.view?', 'type': 'Study protocol synopsis; -schedule of assessments; data and reports; adverse event(s); -specimens availability; -manuscripts and abstracts', 'comment': "TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available."}], 'references': [{'pmid': '18794494', 'type': 'RESULT', 'citation': 'Viglietta V, Bourcier K, Buckle GJ, Healy B, Weiner HL, Hafler DA, Egorova S, Guttmann CR, Rusche JR, Khoury SJ. CTLA4Ig treatment in patients with multiple sclerosis: an open-label, phase 1 clinical trial. Neurology. 2008 Sep 16;71(12):917-24. doi: 10.1212/01.wnl.0000325915.00112.61.'}], 'seeAlsoLinks': [{'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute of Allergy and Infectious Diseases (NIAID) website'}, {'url': 'https://www.niaid.nih.gov/about/dait', 'label': 'Division of Allergy, Immunology, and Transplantation (DAIT) website'}, {'url': 'http://www.immunetolerance.org', 'label': 'Immune Tolerance Network (ITN) website'}]}, 'descriptionModule': {'briefSummary': "Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS.\n\nStudy hypothesis: RG2077 will arrest MS if administered early in the course of MS and decrease accumulation of lesions on MRI.", 'detailedDescription': 'Effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each patient participates in the study for 4 months.\n\nThe dose-escalation portion of this study evaluated the safety of a single infusion of RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the single infusion portion of the study were assigned to one of four groups. Each group received a different dose of RG2077. The second portion of the study will evaluate the safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all patients will receive the same dose of RG2077. Patients will be monitored for possible side effects of RG2077.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Confirmed diagnosis of MS, defined as an MRI consistent with MS plus two separate clinical events, or one clinical event and MRI consistent with demyelination plus a second MRI demonstrating new lesions\n* Have declined all FDA approved therapies for MS'}, 'identificationModule': {'nctId': 'NCT00076934', 'briefTitle': 'Safety of RG2077 in Patients With Multiple Sclerosis', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'DAIT ITN006AI'}, 'secondaryIdInfos': [{'id': 'NMS02', 'type': 'OTHER', 'domain': 'ITN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants receive Regimen 1 for 4 months', 'interventionNames': ['Drug: RG2077 (CTLA4-IgG4m)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants receive Regimen 2 for 4 months', 'interventionNames': ['Drug: RG2077 (CTLA4-IgG4m)']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants receive Regimen 3 for 4 months', 'interventionNames': ['Drug: RG2077 (CTLA4-IgG4m)']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Participants receive Regimen 4 for 4 months', 'interventionNames': ['Drug: RG2077 (CTLA4-IgG4m)']}], 'interventions': [{'name': 'RG2077 (CTLA4-IgG4m)', 'type': 'DRUG', 'description': 'RG2077', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital/Harvard Medical School", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Samia J. Khoury, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Immune Tolerance Network (ITN)', 'class': 'NETWORK'}, {'name': 'Repligen Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}