Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT05716035
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-18', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2024-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)'}], 'secondaryOutcomes': [{'measure': 'Change in Quantitative Myasthenia Gravis (QMG) scores.', 'timeFrame': '16 weeks'}, {'measure': 'Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks', 'timeFrame': '16 weeks'}, {'measure': 'Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks', 'timeFrame': '16 weeks'}, {'measure': 'Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score', 'timeFrame': '16 weeks'}, {'measure': 'Change in Myasthenia Gravis Composite (MGC) score', 'timeFrame': '16 weeks'}, {'measure': 'Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Generalized Myasthenia Gravis', 'Tocilizumab', 'Open-label'], 'conditions': ['Myasthenia Gravis, Generalized']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).', 'detailedDescription': 'tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG.\n\nAfter receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG.\n\nStudy tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant has completed Study tMG.\n2. Participant has given written informed consent.\n3. MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study\n\nExclusion Criteria:\n\n1. Participants had clinically relevant active infections (such as sepsis, pneumonia, or abscess) or severe infections (resulting in hospitalization or requiring antibiotic treatment) in the past 4 weeks;\n2. Those with high-risk tuberculosis infection, acquired tuberculosis infection, and chronic hepatitis after the tMG study;\n3. planned thymectomy during RCP;\n4. Received IVIG or plasma exchange in the past 4 weeks;\n5. Any medical condition or circumstances that, in the opinion of the investigator, might have interfered with the participant's participation in the study, posed any added risk for the participant, or confounded the assessment of the participants."}, 'identificationModule': {'nctId': 'NCT05716035', 'acronym': 'tMG-E', 'briefTitle': 'Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)', 'orgStudyIdInfo': {'id': 'V1.0, 20221201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tocilizumab', 'description': 'Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.', 'interventionNames': ['Drug: Tocilizumab Injection']}], 'interventions': [{'name': 'Tocilizumab Injection', 'type': 'DRUG', 'description': 'Participants will receive IV tocilizumab', 'armGroupLabels': ['tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fudong Shi, MD,PHD', 'role': 'CONTACT', 'email': 'fshi@tmu.edu.cn', 'phone': '+86-22-60817429'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huan Yang, MD,PHD', 'role': 'CONTACT', 'email': 'yxyx69@gahoo.com.cn'}], 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '710038', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Chang', 'role': 'CONTACT', 'email': 'changting1981@163.com', 'phone': '02984778845'}, {'name': 'Zhe Ruan', 'role': 'CONTACT', 'email': 'ruanzhe573291596@126.com'}], 'facility': 'Tangdu Hospital, The Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chongbo Zhao, MD,PHD', 'role': 'CONTACT', 'email': 'zhao_chongbo@fudan.edu.cn', 'phone': '86-21-52889999'}], 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyu Zhou, MD,PHD', 'role': 'CONTACT', 'email': 'zhouhy@scu.edu.cn'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300052', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chao Zhang, MD,PHD', 'role': 'CONTACT', 'email': 'chaozhang@tmu.edu.cn', 'phone': '+86-22-60362255'}], 'facility': 'Tianjin medical university general hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'changting', 'investigatorAffiliation': 'Tang-Du Hospital'}}}}