Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-04 @ 3:11 AM
Study NCT ID:
NCT06000956
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2023-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583495', 'term': 'jitongning'}]}}, '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': 408}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASAS20', 'timeFrame': '8 weeks', 'description': 'Proportion of subjects who achieved improvement in ASAS20（Assessment of Spondylarthritis International Society） at week 8 of treatment.\n\nThe ASAS Improvement Criteria contains the following 4 assessment domains:\n\n1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);\n2. Spinal pain, by Spinal Pain Scale;\n3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)\n4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.\n\nASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.'}], 'secondaryOutcomes': [{'measure': 'ASAS20', 'timeFrame': '4 weeks', 'description': 'Proportion of subjects who achieved improvement in ASAS20 at week 4 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains:\n\n1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);\n2. Spinal pain, by Spinal Pain Scale;\n3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)\n4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.\n\nASAS 20% response criteria (ASAS 20): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 10 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 20% improvement from baseline.'}, {'measure': 'ASAS40', 'timeFrame': '8 weeks', 'description': 'Proportion of subjects who achieved improvement in ASAS40 at week 8 of treatment.The ASAS Improvement Criteria contains the following 4 assessment domains:\n\n1. Physical function, by BASFI (Bath Ankylosing Spondylitis Functional Index);\n2. Spinal pain, by Spinal Pain Scale;\n3. Overall assessment of the condition in the past week, by PGA (Patient Global Assessment)\n4. Inflammatory activity, by the last 2 items of BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) were averaged.\n\nASAS 40% response standard (ASAS 40): 1. 3 of the above 4 items have at least ≥20% improvement and improved ≥ 20 mm in 0-100mm score; 2. Moreover, there was no deterioration in 1 item that did not achieve a 40% improvement from baseline.'}, {'measure': 'spinal pain scale', 'timeFrame': '8 weeks', 'description': 'Change from baseline in score of spinal pain at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.'}, {'measure': 'BASFI', 'timeFrame': '8 weeks', 'description': 'Change from baseline in score of BASFI（Bath Ankylosing Spondylitis Functional Index） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.'}, {'measure': 'PGA', 'timeFrame': '8 weeks', 'description': 'Change from baseline in score of PGA（Patient Global Assessment） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.'}, {'measure': 'BASDAI', 'timeFrame': '8 weeks', 'description': 'Change from baseline in score of BASDAI（Bath Ankylosing Spondylitis Disease Activity Index） at week 8 of treatment.The highest score on the scale is 100mm and the lowest is 0mm, and the higher the score, the more severe the condition.'}, {'measure': 'Traditional Chinese medical Syndrome Points', 'timeFrame': '8 weeks', 'description': 'Change from baseline in score of traditional Chinese medical Syndrome at week 8 of treatment.The scale has a maximum score of 36 points and a minimum score of 0 points, with lower scores indicating milder TCM symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are:\n\n* Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.\n* Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.\n* Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will\n\n 1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.\n 2. Receive examinations and follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll of the following standards must be met:\n\n1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;\n2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI) ≥ 40mm (0-100mm, evaluated using VAS); Spinal pain score ≥ 40mm (0-100mm, evaluated using VAS);\n3. Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;\n4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);\n5. Human leukocyte antigen B27 (HLA-B27) is positive;\n6. Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);\n7. Voluntarily participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\nThose who meet any of the following criteria cannot be included in this experiment:\n\n1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;\n2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;\n3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;\n4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;\n5. Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;\n6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;\n7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;\n8. Those who have fertility requirements within six months;\n9. Pregnant or lactating women;\n10. Suspected or actual drug, substance, or alcohol abuse;\n11. Within 3 months prior to the trial or currently participating in clinical trials;\n12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;\n13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);\n14. The researchers believe that it is not suitable to participate in this experiment.'}, 'identificationModule': {'nctId': 'NCT06000956', 'briefTitle': 'A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tasly Pharmaceutical Group Co., Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)', 'orgStudyIdInfo': {'id': 'TSL-TCM-JTNP-Ⅲ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jitongning tablets', 'interventionNames': ['Drug: Jitongning tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'a simulated agent of Jitongning tablets', 'interventionNames': ['Drug: a simulated agent of Jitongning tablets']}], 'interventions': [{'name': 'Jitongning tablets', 'type': 'DRUG', 'description': 'The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.', 'armGroupLabels': ['Jitongning tablets']}, {'name': 'a simulated agent of Jitongning tablets', 'type': 'DRUG', 'description': 'The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.', 'armGroupLabels': ['a simulated agent of Jitongning tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100078', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenna Liu', 'role': 'CONTACT', 'email': 'dfjgb2019@126.com', 'phone': '010-67689923'}], 'facility': 'Dongfang Hospital, Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xueqi Zhu', 'role': 'CONTACT', 'email': 'bjzyyygcp@sina.com', 'phone': '010-52176813'}], 'facility': 'Beijing Hospital of Traditional Chinese Medicine, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Lanzhou', 'state': 'Gansu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ting Wang', 'role': 'CONTACT', 'email': 'ting_w6710@163.com', 'phone': '0931-8356748'}], 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenxiu Si', 'role': 'CONTACT', 'email': 'swxlbc@163.com', 'phone': '0311-87156671'}], 'facility': 'The First Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Luoyang', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuntong Zhai', 'role': 'CONTACT', 'email': '1652065260@qq.com', 'phone': '0379-64830815'}], 'facility': 'The First Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chang Shu', 'role': 'CONTACT', 'email': 'tongjigcp@163.com', 'phone': '027-83663940'}], 'facility': 'Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaofeng Zhu', 'role': 'CONTACT', 'email': 'szszyyyll@163.com', 'phone': '0512-67872186'}], 'facility': 'Suzhou Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Nanchong', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Zeng', 'role': 'CONTACT', 'email': '393241992@qq.com', 'phone': '0817-2608120'}], 'facility': 'Affiliated Hospital of North Sichuan Medical College', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hui Wang', 'role': 'CONTACT', 'email': 'yfyjdb@163.com', 'phone': '022-27986257'}], 'facility': 'The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'An Wang', 'role': 'CONTACT', 'email': 'ynzygcp1@163.com', 'phone': '0871-63623713'}], 'facility': 'Yunnan Province Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Wei Liu', 'role': 'CONTACT', 'email': 'fengshiliuwei@163.com', 'phone': '022-27432680'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tasly Pharmaceutical Group Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}