Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05966467
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2023-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009471', 'term': 'Neuromyelitis Optica'}], 'ancestors': [{'id': 'D009188', 'term': 'Myelitis, Transverse'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009902', 'term': 'Optic Neuritis'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate (ARR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'The ARR is defined as the total number of relapses divided by the total number of participant-years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Neuromyelitis Optica Spectrum Disorder', 'NMOSD', 'C5 Inhibitor Therapies', 'AQP4+ NMOSD', 'Patient Registry', 'Alexion C5IT', 'Soliris'], 'conditions': ['Neuromyelitis Optica Spectrum Disorder', 'NMOSD', 'AQP4+ NMOSD']}, 'descriptionModule': {'briefSummary': 'Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.', 'detailedDescription': "At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participant's medical history and AQP4+ NMOSD treatment history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry enrollment. The duration of data collection for the Registry will be approximately 5 years from the day the last participant is enrolled."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the time of enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is ≥ 18 years of age at the time of enrollment in the Registry.\n* Participant must have a confirmed diagnosis of AQP4+ NMOSD.\n* At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.\n* Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.\n\nExclusion Criteria:\n\n* Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.'}, 'identificationModule': {'nctId': 'NCT05966467', 'briefTitle': 'Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)', 'orgStudyIdInfo': {'id': 'D9282C00003'}}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Osborne', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irena Dujmovic-Basuroski', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacqueline Nicholas', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75024', 'city': 'Plano', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Annette Okai', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bhupendra Khatri', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Pablo Lopez', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Daniel Munoz, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Andres Villa, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Veronica Tkachuk', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Burnaby', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Galina Vorobeychik, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fudong Shi', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Qiu', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yue Huang', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.92189, 'lon': 112.22494}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qian Cao', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Tan', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Wuhan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daishi Tian, MD', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tjalf Ziemssen', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Refik Pul', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'München', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Achim Berthele', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Naples', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberta Lanzillo', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}, {'city': 'Fukuoka', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Katsuhisa Masaki', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kawasaki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kenzo Sakurai', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Miyagi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Ichiro Nakashima', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'city': 'Tokyo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Jin Nakahara', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Daejeon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Hee Sohn', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ho Jin Kim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jeeyoung Oh', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Young-Min Lim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Min Kim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byoung Joon Kim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woojun Kim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jun-Soon Kim', 'role': 'CONTACT'}], 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Alexion Pharmaceuticals, Inc. (Sponsor)', 'role': 'CONTACT', 'email': 'clinicaltrials@alexion.com', 'phone': '1-855-752-2356'}], 'overallOfficials': [{'name': 'Pablo Lopez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Aleman'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}