Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-01-06 @ 9:19 AM
Study NCT ID:
NCT06574594
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of MTX Discontinuation on Shingrix Response in RA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)', 'timeFrame': 'baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination'}], 'secondaryOutcomes': [{'measure': ', Humoral immunity (anti-VZV antibody, anti-gE antibody)', 'timeFrame': 'baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['herpes zoster', 'Shingrix', 'methotrexate'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:\n\nDiscontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?\n\nResearchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups.\n\nParticipants will:\n\nVaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination.\n\nVisit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \\& 6 months later from baseline to achieve blood sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis\n* age over 19 years\n* methotrexate user\n* agree for vaccination with shingrix\n\nExclusion Criteria:\n\n* have other form of inflammatory arthritis or autoimmune-mediated disease\n* malignancy, current infection, pregnancy'}, 'identificationModule': {'nctId': 'NCT06574594', 'briefTitle': 'Effect of MTX Discontinuation on Shingrix Response in RA', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Effect of Methotrexate Discontinuation on Immunogenicity of Shingrix in Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '2024-02-038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTX discontinuation', 'description': 'methotrexate stop for 2 weeks after each shingrix vaccination', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTX continuation', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination', 'armGroupLabels': ['MTX discontinuation']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'methotrexate continuation group : keep methotrexate', 'armGroupLabels': ['MTX continuation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hong Ki Min, MD, PhD', 'role': 'CONTACT', 'email': 'alsghdrl1921@naver.com', 'phone': '+82-10-9977-5455'}], 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hong Ki Min, MD, PhD', 'role': 'CONTACT', 'email': 'alsghdrl1921@naver.com', 'phone': '+82-10-9977-5455'}], 'overallOfficials': [{'name': 'Hong Ki Min, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Konkuk University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD can be shared with reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hong Ki Min', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}