Ignite Creation Date:
2025-12-25 @ 3:15 AM
Ignite Modification Date:
2026-03-02 @ 4:04 PM
Study NCT ID:
NCT01961505
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2013-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-06-27', 'unreleaseDateUnknown': True}, {'resetDate': '2017-08-17', 'releaseDate': '2017-07-20'}], 'estimatedResultsFirstSubmitDate': '2017-06-27'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-27', 'studyFirstSubmitDate': '2013-09-23', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR20 criteria', 'timeFrame': 'Week 4', 'description': "To meet the criteria, a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level."}], 'secondaryOutcomes': [{'measure': 'ACR50 criteria', 'timeFrame': 'Week 4', 'description': "To meet the criteria, a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the ESR or serum C-reactive protein (CRP) level."}, {'measure': '28-joint count Disease Activity Score (DAS28)', 'timeFrame': 'Baselin and week 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Active Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).\n* Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.\n* If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.\n* If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.\n* 16 to 65 years old, having signed the informed consent.\n\nExclusion Criteria:\n\n* Patients who have skin burst or allergies.\n* Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.\n* Patients who have been treated by tripterygium, hormones or biological agents.\n* Patients who have not been treated by DMARDs before.\n* Patients who are unwilling to comply with all study procedures.'}, 'identificationModule': {'nctId': 'NCT01961505', 'briefTitle': 'Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}, 'officialTitle': 'A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.', 'orgStudyIdInfo': {'id': 'Z111107058811104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical Tripterygium group', 'description': 'Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml.', 'interventionNames': ['Drug: Topical compound tripterygium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Topical Placebo group', 'description': 'Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Topical compound tripterygium', 'type': 'DRUG', 'description': 'Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.', 'armGroupLabels': ['Topical Tripterygium group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group.', 'armGroupLabels': ['Topical Placebo group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Quan Jiang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guang'anmen Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director', 'investigatorFullName': 'Quan Jiang', 'investigatorAffiliation': "Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-06-27', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2017-07-20', 'type': 'RELEASE'}, {'date': '2017-08-17', 'type': 'RESET'}], 'unpostedResponsibleParty': "Quan Jiang, director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences"}}}}