Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT07261306
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C479163', 'term': 'tofacitinib'}], '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-07-23', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Achievement', 'timeFrame': 'Baseline to Week 12 of treatment', 'description': 'The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as "Achieved" if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and "Not Achieved" if this threshold is not met.'}], 'secondaryOutcomes': [{'measure': 'Percentage Reduction in PASI Score', 'timeFrame': 'From Baseline to Week 12', 'description': 'This outcome will quantify the degree of improvement by calculating the percentage reduction in PASI score from baseline to Week 12. Percentage reduction will be computed using the formula:\n\n\\[(Baseline PASI - Week-12 PASI) ÷ Baseline PASI\\] × 100.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MtX', 'Tofacitinib'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study', 'detailedDescription': 'Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18- 70 years of either gender.\n* Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included.\n* Duration of plaque psoriasis for at least 6 months prior to the study.\n* Psoriasis that has not shown adequate response to topical therapies\n\nExclusion Criteria:\n\n* Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis.\n* Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded.\n* Known hypersensitivity or contraindications to either methotrexate or tofacitinib.\n* History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy.\n* Pregnant or lactating women will not be eligible for the study.'}, 'identificationModule': {'nctId': 'NCT07261306', 'acronym': 'MTX', 'briefTitle': 'Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lahore General Hospital'}, 'officialTitle': 'Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'Derma LGH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group mTX', 'description': 'Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase', 'interventionNames': ['Drug: Methotrexate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tofacitinib', 'description': 'Tofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis', 'interventionNames': ['Drug: Tofacitinib']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment', 'armGroupLabels': ['Group mTX']}, {'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'Tofacitinib is janus kinase inhibitor and have role in psoriasis', 'armGroupLabels': ['Tofacitinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Dr Ayesha Wahid, Fcps', 'role': 'CONTACT', 'email': 'zaeemakanwal@hotmail.com', 'phone': '+92 323 4822177'}], 'facility': 'Lahore general hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'centralContacts': [{'name': 'Maryam Fatima, Mbbs', 'role': 'CONTACT', 'email': 'maryamfatima726@yahoo.com', 'phone': '03361409014'}], 'overallOfficials': [{'name': 'Maryam Fatima', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lahore General Hospital, Lahore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lahore General Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maryam Fatima', 'investigatorAffiliation': 'Lahore General Hospital'}}}}