Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02248792
Status:
UNKNOWN
Last Update Posted:
2014-09-25
First Post:
2014-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-22', 'studyFirstSubmitDate': '2014-09-22', 'studyFirstSubmitQcDate': '2014-09-22', 'lastUpdatePostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in health related quality of life', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'comparison of improvement in health related quality of life between Group A and Group B', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Severe Plaque Type Psoriasis']}, 'descriptionModule': {'briefSummary': "Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA \\>10% or PASI \\>12) -\n\nExclusion Criteria:\n\nPregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02248792', 'briefTitle': 'Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.', 'organization': {'class': 'OTHER', 'fullName': 'Narayana Medical College & Hospital'}, 'officialTitle': 'Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.', 'orgStudyIdInfo': {'id': 'NMCHDer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Methotrexate 10mg orally once weekly', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Methotrexate 25mg orally once weekly', 'interventionNames': ['Drug: Methotrexate']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '524003', 'city': 'Nellore', 'state': 'Andhra Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Avisa Rao, MD', 'role': 'CONTACT'}], 'facility': 'Narayana Med College and Hospital', 'geoPoint': {'lat': 14.44992, 'lon': 79.98697}}], 'centralContacts': [{'name': 'C V Krishna, MD', 'role': 'CONTACT', 'email': 'vijay_postgradmed@yahoo.com', 'phone': '+91-0413-2655961'}], 'overallOfficials': [{'name': 'C V Krishna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Narayana Medical college and hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Narayana Medical College & Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'C V Krishna', 'investigatorFullName': 'C V Krishna', 'investigatorAffiliation': 'Narayana Medical College & Hospital'}}}}