Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT05313061
Status:
UNKNOWN
Last Update Posted:
2022-04-06
First Post:
2021-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MTX Hold During Covid-19 Booster
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-12-28', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Covid-19 antibody titer before and after Covid-19 vacciation', 'timeFrame': '2 weeks', 'description': 'Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination'}], 'secondaryOutcomes': [{'measure': 'T cell activation after vaccination', 'timeFrame': '2, 4, 16 weeks', 'description': 'Percentage of activated T cells after vaccination'}, {'measure': 'B cell activation after vaccination', 'timeFrame': '2, 4, 16 weeks', 'description': 'Percentage of activated b cells after vaccination'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '29572291', 'type': 'BACKGROUND', 'citation': 'Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.'}, {'pmid': '28468794', 'type': 'BACKGROUND', 'citation': 'Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.'}, {'pmid': '34346564', 'type': 'BACKGROUND', 'citation': 'Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females ≥ 19 years of age at time of consent\n* Have a diagnosis of RA per ACR criteria\n* Require methotrexate for RA treatment\n* Subject to a Covid-19 booster vaccination\n* Must understand and voluntarily sign an informed consent form including writing consent for data protection\n\nExclusion Criteria:\n\n* Pregnant or lactating females\n* Previous anaphylactic response to the vaccine components\n* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease\n* Any condition including laboratory abnormality which places the subject at unacceptable risk\n* Subjects who decline to participate"}, 'identificationModule': {'nctId': 'NCT05313061', 'briefTitle': 'MTX Hold During Covid-19 Booster', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'H-2112-019-1279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MTX continue', 'description': 'Group will continue MTX after vaccination', 'interventionNames': ['Drug: MTX']}, {'type': 'EXPERIMENTAL', 'label': 'MTX 1 week hold', 'description': 'Group will continue MTX for 1 week after vaccination', 'interventionNames': ['Drug: MTX']}], 'interventions': [{'name': 'MTX', 'type': 'DRUG', 'description': 'MTX continuation', 'armGroupLabels': ['MTX 1 week hold', 'MTX continue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Eun Bong Lee, MD PhD', 'role': 'CONTACT', 'email': 'leb7616@snu.ac.kr', 'phone': '82-2-2072-3944'}, {'name': 'Jina Yeo, MD', 'role': 'CONTACT', 'email': 'hi.thinmint@gmail.com', 'phone': '82-2-2072-2957'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Bong Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}