Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-01 @ 9:21 AM
Study NCT ID:
NCT01719159
Status:
COMPLETED
Last Update Posted:
2016-11-22
First Post:
2012-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-18', 'studyFirstSubmitDate': '2012-10-25', 'studyFirstSubmitQcDate': '2012-10-29', 'lastUpdatePostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immunological markers in blood', 'timeFrame': 'At 3,6,9,12 month after treatment', 'description': 'I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset'}, {'measure': 'Immunological markers in cerebrospinal fluid (CSF)', 'timeFrame': 'At 3, 6, 9 12 month after treatment', 'description': 'I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset'}], 'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'One year after completed treatment', 'description': 'Feasibility of IT administered monoclonal antibodies'}], 'secondaryOutcomes': [{'measure': 'Stabilisation of the neurological deterioration', 'timeFrame': 'At 3,6,9,12 month after completed treatment', 'description': 'Questionaires regarding MS quality of life, symptom inventory and fatigue will be used.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Progressive multiple sclerosis', 'Monoclonal antibodies', 'Mabthera', 'Intrathecal treatment'], 'conditions': ['Progressive Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '30305449', 'type': 'DERIVED', 'citation': 'Bergman J, Burman J, Gilthorpe JD, Zetterberg H, Jiltsova E, Bergenheim T, Svenningsson A. Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study. Neurology. 2018 Nov 13;91(20):e1893-e1901. doi: 10.1212/WNL.0000000000006500. Epub 2018 Oct 10.'}, {'pmid': '27536708', 'type': 'DERIVED', 'citation': 'Bergman J, Dring A, Zetterberg H, Blennow K, Norgren N, Gilthorpe J, Bergenheim T, Svenningsson A. Neurofilament light in CSF and serum is a sensitive marker for axonal white matter injury in MS. Neurol Neuroimmunol Neuroinflamm. 2016 Aug 2;3(5):e271. doi: 10.1212/NXI.0000000000000271. eCollection 2016 Oct.'}]}, 'descriptionModule': {'briefSummary': 'This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.', 'detailedDescription': 'There is presently no efficient therapy available in progressive MS, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. There are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. One specific feature of long-standing MS is that inflammatory cells accumulate in the central nervous system(CNS) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. Administration of substances via the Intrathecal (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)\n* Progressive MS since at least three years\n* Some kind of documented progression of neurological symptoms during the previous two years.\n* Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)\n* Conventional therapy not indicated, contraindicated or failed\n* Judged as compliant with the protocol\n\nExclusion Criteria:\n\n* Eligible for any of the conventional MS therapies\n* Relapsing remitting multiple sclerosis (RRMS)\n* Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture\n* Cognitive defect making informed consent unreliable\n* Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist\n* Severe, uncontrolled heart disease\n* Pregnant or lactating women\n* Patients having contraindication for or otherwise not compliant with MRI investigations\n* Documented vulnerability to infections\n* Simultaneous treatment with other immunosuppressive drugs\n* Documented allergy or intolerance to Rituximab\n* Severe psychiatric condition'}, 'identificationModule': {'nctId': 'NCT01719159', 'acronym': 'ITT-PMS', 'briefTitle': 'Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'ITT-PMS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rituximab', 'description': 'Rituximab, 25 mg, is administrated intrathecal three times one week apart', 'interventionNames': ['Drug: Rituximab']}], 'interventions': [{'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['Mabthera'], 'description': '25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.', 'armGroupLabels': ['Rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Department of neurology, Umeå University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': 'SE-751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Dept of neurology, Uppsala University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Anders Svenningsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umea university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD will be shared upon request from the researcher or scientific journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anders Svenningsson', 'class': 'OTHER'}, 'collaborators': [{'name': 'Västerbotten County Council, Sweden', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Assoc Prof', 'investigatorFullName': 'Anders Svenningsson', 'investigatorAffiliation': 'Umeå University'}}}}