Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01068405
Status:
UNKNOWN
Last Update Posted:
2011-12-09
First Post:
2010-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-02-12', 'lastUpdatePostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain assessed with EVA', 'timeFrame': 'at screening visit, inclusion visit, first month, and every month during one year'}], 'secondaryOutcomes': [{'measure': 'Quality of life survey : SF-36', 'timeFrame': 'at inclusion visit, first month, and every month during one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polyarthritis']}, 'referencesModule': {'references': [{'pmid': '34157578', 'type': 'DERIVED', 'citation': 'Ferrero S, Wittoek R, Allado E, Cruzel C, Fontas E, Breuil V, Ziegler L, Kremer J, Loeuille D, Roux CH. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum. 2021 Aug;51(4):831-838. doi: 10.1016/j.semarthrit.2021.04.016. Epub 2021 May 6.'}, {'pmid': '33501510', 'type': 'DERIVED', 'citation': 'Allado E, Wittoek R, Albuisson E, Ferrero S, Chenuel B, Chary-Valckenaere I, Roux C, Loeuille D. Topographical analysis of structural lesions between dominant and non-dominant hands in erosive osteoarthritis. Rheumatol Int. 2021 Mar;41(3):617-623. doi: 10.1007/s00296-020-04784-1. Epub 2021 Jan 27.'}]}, 'descriptionModule': {'briefSummary': 'Interest of methotrexate in inflammatory rheumatisms was demonstrated since several years.\n\nAt present time,there is no effective treatment against digital arthritis. The investigators purpose to measure the efficacy of methotrexate on digital arthritis.\n\nIn this aim, two groups were compared. The first group receive 10mg/week of methotrexate administered in one shot (every Monday for example)during 12 months. The second group receive 10mg/week of placebo according to the same procedure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hand arthritis\n* pain over 40/100\n* stable treatment since 4 weeks at least with non-steroid analgesic\n* between 45 et 85 years\n\nExclusion Criteria:\n\n* pregnancy or breast feeding women\n* hyaluronic acid injection within the past 6 months\n* cortisonic derivated injection within the past 3 months'}, 'identificationModule': {'nctId': 'NCT01068405', 'acronym': 'ADEM', 'briefTitle': 'Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Erosive Osteoarthritis of the Hands: Treatment by Methotrexate Versus Placebo - Assessment of Structural and Clinical Action of Magnetic Resonance Imaging', 'orgStudyIdInfo': {'id': '06-API-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': 'Patients with digital arthritis receiving methotrexate treatment at 10mg/week during 12 months', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients with digital arthritis receiving placebo at 10mg/week during 12 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months', 'armGroupLabels': ['Methotrexate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Christian H ROUX, PhD', 'role': 'CONTACT', 'email': 'roux.cr@chu-nice.fr', 'phone': '0492035491'}], 'facility': 'Nice University Hospital, Rheumatology Department', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Christian H ROUX, PhD', 'role': 'CONTACT', 'email': 'roux.cr@chu-nice.fr'}], 'overallOfficials': [{'name': 'Christian H ROUX, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nice University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}