Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02288520
Status:
COMPLETED
Last Update Posted:
2016-06-02
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 854}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-01', 'studyFirstSubmitDate': '2014-11-07', 'studyFirstSubmitQcDate': '2014-11-10', 'lastUpdatePostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic options and Impact on the progression of the disease (EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28)', 'timeFrame': 'Patients are included at the time of the change in the treatment of the RA and followed up to 6 months', 'description': 'The distribution of the various therapeutic options will be described overall. Their impact on the progression of the RA will be assessed at 6 months according to the EULAR (European League Against Rheumatism) criteria (change in DAS28 (Disease Activity Score 28) score during the study)'}], 'secondaryOutcomes': [{'measure': "Patient's satisfaction using a 4-point verbal scale", 'timeFrame': '6 months after inclusion', 'description': 'Satisfaction will be assessed using a 4-point verbal scale.'}, {'measure': 'Medical economic aspect (cost/benefit ratio)', 'timeFrame': '6 months after inclusion', 'description': 'The cost/benefit ratio of each therapeutic strategy will be described.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Methotrexate', 'Therapeutic strategy'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '33774669', 'type': 'DERIVED', 'citation': 'Gaujoux-Viala C, Hudry C, Zinovieva E, Herman-Demars H, Flipo RM. MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE. Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.'}]}, 'descriptionModule': {'briefSummary': 'This is a longitudinal, observational, prospective, multicentre study conducted in metropolitan France, among a representative sample of office-based or mixed practice rheumatology doctors.\n\nThe aim of this study is to describe in real life, the therapy strategy when faced with a patient treated with methotrexate as a monotherapy consulting for rheumatoid arthritis and the impact on the progression of the disease at 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Rheumatoid arthritis (RA) patients with clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA will be asked to participate from RA treatment change (inclusion visit) up to 6 months after inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient, ambulatory, seen in a rheumatology consultation.\n* With a confirmed diagnosis of RA (ACR 1987 or ACR/EULAR 2010 criteria) receiving a disease-modifying treatment with methotrexate as a monotherapy.\n* With clinical, functional, structural and/or therapeutic disease progression, for whom the rheumatologist intends to change the therapeutic treatment of the RA .\n* Informed about the computer processing of their medical data and their right of access and correction.\n\nExclusion Criteria:\n\n* Patient not treated with methotrexate for their RA.\n* Already treated with a biotherapy or receiving other synthetic DMARDs (disease-modifying antirheumatic drugs) in combination with methotrexate .\n* Participating in a clinical trial in rheumatology.'}, 'identificationModule': {'nctId': 'NCT02288520', 'acronym': 'STRATEGE', 'briefTitle': 'Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Pharma SAS'}, 'officialTitle': 'Therapeutic Strategy in Rheumatology When Faced With a Patient Treated With Methotrexate (MTX) for Rheumatoid Arthritis (RA).', 'orgStudyIdInfo': {'id': 'STRATEGE'}}, 'contactsLocationsModule': {'locations': [{'zip': '75007', 'city': 'Paris', 'country': 'France', 'facility': 'Nordic Pharma', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Hélène HERMAN DEMARS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nordic Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Pharma SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}