Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 7:06 PM
Study NCT ID:
NCT05749666
Status:
UNKNOWN
Last Update Posted:
2023-03-01
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013625', 'term': 'Takayasu Arteritis'}], 'ancestors': [{'id': 'D001015', 'term': 'Aortic Arch Syndromes'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001167', 'term': 'Arteritis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-19', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-19', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with complete response', 'timeFrame': 'week 24', 'description': 'Percentage of patients with complete response at week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with partial response', 'timeFrame': 'week 24', 'description': 'Percentage of patients with partial response at week 24'}, {'measure': 'Percentage of patients with adverse events due to treatment of tofacitinib', 'timeFrame': '24 weeks', 'description': 'Percentage of patients with adverse events due to treatment of tofacitinib at week 24'}, {'measure': 'Percentage of patients with adverse events due to treatment of prednisolone', 'timeFrame': '24 weeks', 'description': 'Percentage of patients with adverse events due to treatment of prednisolone at week 24'}, {'measure': 'Percentage of patients with progression, no change, and improvement in vessel image at the end of study', 'timeFrame': 'week 24', 'description': 'Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24'}, {'measure': 'Intervention procedures', 'timeFrame': '24 weeks', 'description': 'Percentage of patients who require intervention procedures during the study period'}, {'measure': "Complication of Takayasu's arteritis", 'timeFrame': '24 weeks', 'description': "Complication of Takayasu's arteritis happened during 24 weeks"}, {'measure': 'Glucocorticoid toxicity index', 'timeFrame': 'week 24', 'description': 'Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tofacitinib', 'prednisolone'], 'conditions': ['Takayasu Arteritis']}, 'descriptionModule': {'briefSummary': "This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.", 'detailedDescription': "In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.\n\nThe efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged between 18-65 years old;\n2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;\n3. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;\n4. Patients who signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients who failed or intolerant to either tofacitinib or its similar drugs;\n2. Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;\n3. Not well controlled diabetes;\n4. Moderate and severe hyperlipedimia;\n5. Patients with history of thrombus;\n6. Uncontrolled heart failure od renal dysfunction (eGFR \\<30ml/min);\n7. Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;\n8. Upper GI bleeding happened in 3 months before enrollment;\n9. Refractory hypertension;\n10. Pregnant or intended to be pregnant recently;\n11. Severe coronary artery involvement demonstrated by CTA;\n12. Severe cranial or cervical or renal artery diseases that need surgery;\n13. Patients that should not be included judged by the investigator."}, 'identificationModule': {'nctId': 'NCT05749666', 'acronym': 'TOFGCTAK', 'briefTitle': "Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis", 'organization': {'class': 'OTHER', 'fullName': 'Chinese SLE Treatment And Research Group'}, 'officialTitle': "A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis", 'orgStudyIdInfo': {'id': 'CSTAR-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tofacitinib group', 'description': 'Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period', 'interventionNames': ['Drug: Tofacitinib 5 MG', 'Other: Placebo of prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone group', 'description': 'Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks', 'interventionNames': ['Drug: Prednisolone', 'Other: Placebo of tofacitinib 5mg']}], 'interventions': [{'name': 'Tofacitinib 5 MG', 'type': 'DRUG', 'description': 'Tofacitinib 5 MG BID taken orally for 24 weeks', 'armGroupLabels': ['Tofacitinib group']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Prednisolone taken daily according to preset tapering protocol', 'armGroupLabels': ['Prednisolone group']}, {'name': 'Placebo of tofacitinib 5mg', 'type': 'OTHER', 'description': 'Placebo of tofacitinib 5mg BID taken orally for 24 weeks', 'armGroupLabels': ['Prednisolone group']}, {'name': 'Placebo of prednisolone', 'type': 'OTHER', 'description': 'Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks', 'armGroupLabels': ['Tofacitinib group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinping Tian, MD', 'role': 'CONTACT', 'email': 'tianxp6@126.com', 'phone': '86-13691165939'}, {'name': 'Shi Rong, MD', 'role': 'CONTACT', 'email': 'rongshipumch@126.com', 'phone': '86-13601248311'}, {'name': 'XInping Tian, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xinping Tian, MD', 'role': 'CONTACT', 'email': 'tianxp6@126.com', 'phone': '+86-13691165939'}, {'name': 'Jing Li, MD', 'role': 'CONTACT', 'email': 'lijing6515@pumch.cn', 'phone': '+86-13020061363'}], 'overallOfficials': [{'name': 'Xinping Tian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese SLE Treatment And Research Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Xinping Tian', 'investigatorAffiliation': 'Chinese SLE Treatment And Research Group'}}}}