Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-23 @ 12:04 PM
Study NCT ID:
NCT00889694
Status:
UNKNOWN
Last Update Posted:
2009-04-29
First Post:
2009-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
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': 'D012460', 'term': 'Sulfasalazine'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-27', 'studyFirstSubmitDate': '2009-04-27', 'studyFirstSubmitQcDate': '2009-04-27', 'lastUpdatePostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ASAS20', 'timeFrame': '12th week'}], 'secondaryOutcomes': [{'measure': 'BASDAI20/50/70', 'timeFrame': '12th week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Early Ankylosing Spondylitis']}, 'descriptionModule': {'briefSummary': 'This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondylitis. The investigators expect that the tripterygium capsule is more effective than placebo and has few adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and inflammatory bowel disease associated arthritis.\n2. Disease is in active status defined by BASDAI\\>=40mm.\n3. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs dose must be stable for at least 4 weeks before screening.\n\nExclusion Criteria:\n\n1. Intra-articular injection of glucocorticoid within 3 months.\n2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.\n3. Accompanied by fibromyalgia syndrome or other rheumatic diseases.\n4. Female of pregnancy or breast-feeding.\n5. Poor compliance or with mental diseases.'}, 'identificationModule': {'nctId': 'NCT00889694', 'briefTitle': 'Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '[2008]2-4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tripterygium', 'type': 'DRUG', 'description': 'Tripterygium: 2 capsules per time, 3 times per day for 12 weeks.'}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'description': 'Sulfasalazine: 0.75 gram per time, 2 times per day for 12 weeks.'}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo: 2 capsules per time, 3 times per day for 12 weeks.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jieruo Gu', 'oldOrganization': 'Rheumatology Department of Third Affiliated Hospital of Sun Yat-sen University'}}}}