Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04326894
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2013-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methorexate and Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2013-08-08', 'studyFirstSubmitQcDate': '2020-03-27', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '8 months', 'description': 'The primary outcome measure was pain reduction.Pain was assessed using the Visual Analogue pain Scale, (VAS, 0-100 mm).'}], 'secondaryOutcomes': [{'measure': 'Physical function improvement', 'timeFrame': '8 months', 'description': 'Functional assessment was performed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Activities of daily living (ADL) scores.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['methotrxate, knee osteoarthritis, inflammation, pain, function'], 'conditions': ['Pain Reduction', 'Physical Function Improvement']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis (OA) is considered a complex, multifactorial disease leading to considerable pain and functional disability amongst older adults in particular.Synovial inflammation and proliferation has emerged as a key component of OA and as a potential predictor of worsening disease. Methotrexate (MTX) is widely used in the treatment of all inflammatory rheumatic diseases. Accordingly, the aim of the present study is to assess the efficacy of methotrexate (MTX) in decreasing pain and inflammation in symptomatic knee OA.\n\n128 patients with clinical and radiographic criteria of primary knee OA pain,were recruited. Patients meeting the eligibility criteria are randomized in a 1:1 ratio to receive either 25mg/week oral MTX (n=64) or placebo (n=64) together with their usual therapy provided the dosages are kept constant for 32 weeks. The primary outcome measure is pain reduction and secondary outcome measures is improvement in physical function scores.\n\nKeywords:\n\nmethotrexate knee osteoarthritis inflammation pain reduction physical funtion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* primary knee osteoarthritis\n* synovitis\n* pain\n\nExclusion Criteria:\n\n* other inflammatory conditions\n* hepatic insufficiency\n* renal insufficiency'}, 'identificationModule': {'nctId': 'NCT04326894', 'briefTitle': 'Methorexate and Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'orgStudyIdInfo': {'id': 'alexmed1391963211966'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': '25mg oral MTX tablets', 'interventionNames': ['Drug: 25 mg/week oral methotrexate tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '25 mg/week placebo tablets', 'interventionNames': ['Drug: 25mg/week oral placebo tablets']}], 'interventions': [{'name': '25 mg/week oral methotrexate tablets', 'type': 'DRUG', 'otherNames': ['interventional drug'], 'armGroupLabels': ['Methotrexate']}, {'name': '25mg/week oral placebo tablets', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00203', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Anna Abou-Raya', 'investigatorAffiliation': 'University of Alexandria'}}}}