Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-25 @ 12:51 PM
Study NCT ID:
NCT01829295
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2013-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methotrexate and Mycophenolate Mofetil for UVEITIS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'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'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Nisha.Acharya@ucsf.edu', 'phone': '4154768131', 'title': 'Dr. Nisha Acharya', 'organization': 'F.I. Proctor Foundation, UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected through the primary endpoint (the first 6 months) for each enrolled patient; Phase I, 0-6 Months.', 'eventGroups': [{'id': 'EG000', 'title': 'Methotrexate', 'description': 'oral methotrexate\n\nPatients randomized to receive oral methotrexate in Phase I, 0-6 Months.\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 99, 'seriousNumAtRisk': 107, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil\n\nPatients randomized to receive oral mycophenolate mofetil in Phase I, 0-6 Months.\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.', 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 100, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suspected/confirmed glaucoma diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotony', 'notes': 'Intraocular pressure \\<5 mmHg without structural damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ocular hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 13}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral and/or central vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other ocular event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 26}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine', 'notes': '≥1.5 to \\<2 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin', 'notes': '\\>6.4 to \\<10 g/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukocytes', 'notes': '\\>1000 and \\<2500 µL lasting less than 1 month or absolute neutrophil count (ANC) \\<1000 but \\>500', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SGOT or SGPT', 'notes': '2 to 5 times the upper limit of normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild congestive heart failure or arrhythmia', 'notes': 'Not requiring therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 59}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'notes': '\\<103 degrees for 12 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hair loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 45}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-serious systemic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 27}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mood changes', 'notes': 'Not requiring therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle weakness', 'notes': 'No decrease in function', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Numbness/tingling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other systemic (no treatment required)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decrease in vision/defective vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SGOT and SGPT', 'notes': '≥5 times the upper limit of normal of the reference range', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Disability or permanent damage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Serious systemic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other serious/systemic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'oral methotrexate\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}, {'id': 'OG001', 'title': 'Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patient with a 6-month visit, or who were declared early treatment failures, are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Methotrexate', 'description': 'oral methotrexate Methotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week) Prednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}, {'id': 'OG001', 'title': 'Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil Mycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who were a treatment success at 6 months and continued in follow-up.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Switched Over to Methotrexate', 'description': 'oral methotrexate\n\nPatients were randomized to mycophenolate but were a treatment failure in Phase I, 0-6 Months and switched over to received methotrexate.\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}, {'id': 'OG001', 'title': 'Switched Over to Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil\n\nPatients were randomized to methotrexate but were a treatment failure in Phase I, 0-6 Months and switched over to received mycophenolate mofetil.\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who switched to the other medication following treatment failure at 6 months (or earlier). Patients were analyzed by the medication that they received in this second phase (Phase II, 0-6 Months).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methotrexate Only', 'description': 'oral methotrexate\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg twice a day (BID) once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.\n\nThese patients never switched over to receive mycophenolate mofetil as they were a treatment success at Month 6.'}, {'id': 'FG001', 'title': 'Mycophenolate Mofetil Only', 'description': 'oral mycophenolate mofetil\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.\n\nThese patients never switched over to receive mycophenolate mofetil as they were a treatment success at Month 6.'}, {'id': 'FG002', 'title': 'Methotrexate, Then Mycophenolate Mofetil', 'description': 'first received oral methotrexate\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.\n\nthen switched over to receive oral mycophenolate mofetil after failing with oral methotrexate\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nFollowed the same prednisone schedule as described in the Methotrexate only and Mycophenolate Mofetil only groups.'}, {'id': 'FG003', 'title': 'Mycophenolate Mofetil, Then Methotrexate', 'description': 'first received oral mycophenolate mofetil\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.\n\nthen switched over to receive oral mycophenolate mofetil after failing with oral mycophenolate mofetil\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nFollowed the same prednisone schedule as described in the Methotrexate only and Mycophenolate Mofetil only groups.'}], 'periods': [{'title': '0-6 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': '6-12 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '64 patients were a treatment success on methotrexate at 6 mo and had the option to continue', 'groupId': 'FG000', 'numSubjects': '64'}, {'comment': '56 patients were a treatment success on mycophenolate mofetil at 6 mo and had the option to continue', 'groupId': 'FG001', 'numSubjects': '56'}, {'comment': '32 patients failed methotrexate within the first 6 months', 'groupId': 'FG002', 'numSubjects': '32'}, {'comment': '42 patients failed on mycophenolate mofetil within the first 6 months', 'groupId': 'FG003', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Did not want to switch antimetabolites', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Methotrexate', 'description': 'oral methotrexate\n\nMethotrexate: For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}, {'id': 'BG001', 'title': 'Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil\n\nMycophenolate mofetil: For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.\n\nPrednisone: All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '50'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '51'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '51'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Indian Subcontinent', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Middle Eastern', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients could list more than one race.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Anatomic Location of Uveitis', 'classes': [{'categories': [{'title': 'Intermediate', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Anterior + Intermediate', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Posterior', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Panuveitis', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized patients are included in baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-04', 'size': 9456599, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-03T14:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-05', 'studyFirstSubmitDate': '2013-04-08', 'resultsFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2013-04-10', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-03', 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)', 'timeFrame': '6 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)', 'timeFrame': '12 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate in patients who were a treatment success at the primary outcome of 6 months.'}, {'measure': 'Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)', 'timeFrame': '6 Months', 'description': 'Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate for patients who crossed over to other medication following treatment failure at 6 months (or earlier).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antimetabolite, noninfectious'], 'conditions': ['Uveitis']}, 'referencesModule': {'references': [{'pmid': '18579209', 'type': 'BACKGROUND', 'citation': 'Galor A, Jabs DA, Leder HA, Kedhar SR, Dunn JP, Peters GB 3rd, Thorne JE. Comparison of antimetabolite drugs as corticosteroid-sparing therapy for noninfectious ocular inflammation. Ophthalmology. 2008 Oct;115(10):1826-32. doi: 10.1016/j.ophtha.2008.04.026. Epub 2008 Jun 25.'}, {'pmid': '16163494', 'type': 'BACKGROUND', 'citation': 'Siepmann K, Huber M, Stubiger N, Deuter C, Zierhut M. Mycophenolate mofetil is a highly effective and safe immunosuppressive agent for the treatment of uveitis : a retrospective analysis of 106 patients. Graefes Arch Clin Exp Ophthalmol. 2006 Jul;244(7):788-94. doi: 10.1007/s00417-005-0066-8. Epub 2005 Sep 15.'}, {'pmid': '18455143', 'type': 'BACKGROUND', 'citation': 'Teoh SC, Hogan AC, Dick AD, Lee RW. Mycophenolate mofetil for the treatment of uveitis. Am J Ophthalmol. 2008 Nov;146(5):752-60, 760.e1-3. doi: 10.1016/j.ajo.2008.03.004. Epub 2008 May 2.'}, {'pmid': '16061096', 'type': 'BACKGROUND', 'citation': 'Thorne JE, Jabs DA, Qazi FA, Nguyen QD, Kempen JH, Dunn JP. Mycophenolate mofetil therapy for inflammatory eye disease. Ophthalmology. 2005 Aug;112(8):1472-7. doi: 10.1016/j.ophtha.2005.02.020.'}, {'pmid': '9951492', 'type': 'BACKGROUND', 'citation': 'Larkin G, Lightman S. Mycophenolate mofetil. A useful immunosuppressive in inflammatory eye disease. Ophthalmology. 1999 Feb;106(2):370-4. doi: 10.1016/S0161-6420(99)90078-7.'}, {'pmid': '12750115', 'type': 'BACKGROUND', 'citation': 'Baltatzis S, Tufail F, Yu EN, Vredeveld CM, Foster CS. Mycophenolate mofetil as an immunomodulatory agent in the treatment of chronic ocular inflammatory disorders. Ophthalmology. 2003 May;110(5):1061-5. doi: 10.1016/S0161-6420(03)00092-7.'}, {'pmid': '16808677', 'type': 'BACKGROUND', 'citation': 'Choudhary A, Harding SP, Bucknall RC, Pearce IA. Mycophenolate mofetil as an immunosuppressive agent in refractory inflammatory eye disease. J Ocul Pharmacol Ther. 2006 Jun;22(3):168-75. doi: 10.1089/jop.2006.22.168.'}, {'pmid': '11262666', 'type': 'BACKGROUND', 'citation': 'Bom S, Zamiri P, Lightman S. Use of methotrexate in the management of sight-threatening uveitis. Ocul Immunol Inflamm. 2001 Mar;9(1):35-40. doi: 10.1076/ocii.9.1.35.3983.'}, {'pmid': '9917790', 'type': 'BACKGROUND', 'citation': 'Dev S, McCallum RM, Jaffe GJ. Methotrexate treatment for sarcoid-associated panuveitis. Ophthalmology. 1999 Jan;106(1):111-8. doi: 10.1016/S0161-6420(99)90011-8.'}, {'pmid': '15693100', 'type': 'BACKGROUND', 'citation': 'Foeldvari I, Wierk A. Methotrexate is an effective treatment for chronic uveitis associated with juvenile idiopathic arthritis. J Rheumatol. 2005 Feb;32(2):362-5.'}, {'pmid': '19748676', 'type': 'BACKGROUND', 'citation': 'Gangaputra S, Newcomb CW, Liesegang TL, Kacmaz RO, Jabs DA, Levy-Clarke GA, Nussenblatt RB, Rosenbaum JT, Suhler EB, Thorne JE, Foster CS, Kempen JH; Systemic Immunosuppressive Therapy for Eye Diseases Cohort Study. Methotrexate for ocular inflammatory diseases. Ophthalmology. 2009 Nov;116(11):2188-98.e1. doi: 10.1016/j.ophtha.2009.04.020. Epub 2009 Sep 12.'}, {'pmid': '1483126', 'type': 'BACKGROUND', 'citation': 'Holz FG, Krastel H, Breitbart A, Schwarz-Eywill M, Pezzutto A, Volcker HE. Low-dose methotrexate treatment in noninfectious uveitis resistant to corticosteroids. Ger J Ophthalmol. 1992;1(3-4):142-4.'}, {'pmid': '1407973', 'type': 'BACKGROUND', 'citation': 'Shah SS, Lowder CY, Schmitt MA, Wilke WS, Kosmorsky GS, Meisler DM. Low-dose methotrexate therapy for ocular inflammatory disease. Ophthalmology. 1992 Sep;99(9):1419-23. doi: 10.1016/s0161-6420(92)31790-7.'}, {'pmid': '19344827', 'type': 'BACKGROUND', 'citation': 'Taylor SR, Habot-Wilner Z, Pacheco P, Lightman SL. Intraocular methotrexate in the treatment of uveitis and uveitic cystoid macular edema. Ophthalmology. 2009 Apr;116(4):797-801. doi: 10.1016/j.ophtha.2008.10.033.'}, {'pmid': '20042178', 'type': 'BACKGROUND', 'citation': 'Daniel E, Thorne JE, Newcomb CW, Pujari SS, Kacmaz RO, Levy-Clarke GA, Nussenblatt RB, Rosenbaum JT, Suhler EB, Foster CS, Jabs DA, Kempen JH. Mycophenolate mofetil for ocular inflammation. Am J Ophthalmol. 2010 Mar;149(3):423-32.e1-2. doi: 10.1016/j.ajo.2009.09.026. Epub 2009 Dec 30.'}, {'pmid': '18221998', 'type': 'BACKGROUND', 'citation': 'Sobrin L, Christen W, Foster CS. Mycophenolate mofetil after methotrexate failure or intolerance in the treatment of scleritis and uveitis. Ophthalmology. 2008 Aug;115(8):1416-21, 1421.e1. doi: 10.1016/j.ophtha.2007.12.011. Epub 2008 Jan 25.'}, {'pmid': '16196117', 'type': 'BACKGROUND', 'citation': 'Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.'}, {'pmid': '11024423', 'type': 'BACKGROUND', 'citation': 'Jabs DA, Rosenbaum JT, Foster CS, Holland GN, Jaffe GJ, Louie JS, Nussenblatt RB, Stiehm ER, Tessler H, Van Gelder RN, Whitcup SM, Yocum D. Guidelines for the use of immunosuppressive drugs in patients with ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol. 2000 Oct;130(4):492-513. doi: 10.1016/s0002-9394(00)00659-0.'}, {'pmid': '37294447', 'type': 'RESULT', 'citation': 'Reddy AK, Miller DC, Sura AA, Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Murugan B, Vedhanayaki R, Lim LL, Suhler EB, Doan T, Al-Dhibi HA, Goldstein DA, Arellanes-Garcia L, Acharya NR. Risk of failing both methotrexate and mycophenolate mofetil from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) uveitis trial. J Ophthalmic Inflamm Infect. 2023 Jun 9;13(1):29. doi: 10.1186/s12348-023-00350-5.'}, {'pmid': '36749914', 'type': 'RESULT', 'citation': 'Chattopadhyay A, Rathinam SR, Gonzales JA, Kelly NK, Thundikandy R, Kanakath A, Murugan SB, Vedhanayaki R, Lim LL, Suhler EB, Al-Dhibi HA, Doan T, Ebert CD, Porco TC, Acharya NR; FAST Research Group. Association between Quality of Life and Visual Acuity in a Randomized Clinical Trial of Patients with Uveitis Taking Antimetabolites. Ocul Immunol Inflamm. 2024 Apr;32(3):301-309. doi: 10.1080/09273948.2023.2169714. Epub 2023 Feb 7.'}, {'pmid': '36701644', 'type': 'RESULT', 'citation': 'Sura AA, Sun Y, Reddy AK, Rathinam SR, Gonzales JA, Thundikandy R, Vedhanayaki R, Kanakath A, Murugan B, Doan TA, Lim LL, Suhler EB, Al-Dhibi HA, Acharya NR; FAST Research Group. Reduced Dose Methotrexate and Mycophenolate Mofetil in Noninfectious Uveitis: A Sub-Analysis from the First-Line Antimetabolites as Steroid Sparing Therapy (FAST) Trial. Ocul Immunol Inflamm. 2024 Aug;32(6):955-960. doi: 10.1080/09273948.2023.2165949. Epub 2023 Jan 26.'}, {'pmid': '35143800', 'type': 'RESULT', 'citation': 'Tsui E, Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Balamurugan S, Vedhanayaki R, Lim LL, Suhler EB, Al-Dhibi HA, Doan T, Keenan J, Ebert CD, Kim E, Madow B, Porco TC, Acharya NR; FAST Research Group. Outcomes of Uveitic Macular Edema in the First-line Antimetabolites as Steroid-Sparing Treatment Uveitis Trial. Ophthalmology. 2022 Jun;129(6):661-667. doi: 10.1016/j.ophtha.2022.02.002. Epub 2022 Feb 8.'}, {'pmid': '33675850', 'type': 'RESULT', 'citation': 'Kelly NK, Chattopadhyay A, Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Murugan SB, Vedhanayaki R, Cugley D, Lim LL, Suhler EB, Al-Dhibi HA, Ebert CD, Berlinberg EJ, Porco TC, Acharya NR; FAST Research Group. Health- and Vision-Related Quality of Life in a Randomized Controlled Trial Comparing Methotrexate and Mycophenolate Mofetil for Uveitis. Ophthalmology. 2021 Sep;128(9):1337-1345. doi: 10.1016/j.ophtha.2021.02.024. Epub 2021 Mar 4.'}, {'pmid': '32779952', 'type': 'RESULT', 'citation': 'Kong CL, Kelly NK, Sundararajan M, Rathinam SR, Gonzales JA, Thundikandy R, Vedhanayaki R, Kanakath A, Murugan B, Doan T, Goldstein D, Al-Dhibi HA, Acharya NR. Comparison of CD4 Counts with Mycophenolate Mofetil versus Methotrexate from the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial. Ocul Immunol Inflamm. 2022 Jan 2;30(1):198-202. doi: 10.1080/09273948.2020.1774906. Epub 2020 Aug 11.'}, {'pmid': '31503307', 'type': 'RESULT', 'citation': 'Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Murugan SB, Vedhanayaki R, Lim LL, Suhler EB, Al-Dhibi HA, Doan T, Keenan JD, Rao MM, Ebert CD, Nguyen HH, Kim E, Porco TC, Acharya NR; FAST Research Group. Effect of Corticosteroid-Sparing Treatment With Mycophenolate Mofetil vs Methotrexate on Inflammation in Patients With Uveitis: A Randomized Clinical Trial. JAMA. 2019 Sep 10;322(10):936-945. doi: 10.1001/jama.2019.12618.'}, {'pmid': '35085661', 'type': 'RESULT', 'citation': 'Bui AD, Kong CL, Kelly NK, Rathinam SR, Gonzales JA, Thundikandy R, Kanakath A, Murugan B, Vedhanayaki R, Lim LL, Suhler EB, Al-Dhibi HA, Doan T, Acharya NR; First-Line Antimetabolites as Steroid-Sparing Treatment Research Group. Time to Uveitis Control with Methotrexate and Mycophenolate Mofetil. Ophthalmology. 2022 Jun;129(6):721-723. doi: 10.1016/j.ophtha.2022.01.020. Epub 2022 Jan 25. No abstract available.'}, {'pmid': '39190826', 'type': 'DERIVED', 'citation': 'Sundararajan M, Rathinam SR, Thundikandy R, Kanakath A, Balamurugan S, Vedhanayaki R, Miller DC, Lim LL, Suhler EB, Al-Dhibi HA, Arellanes-Garcia L, Reddy AK, Feng S, Doan T, Porco TC, Shantha JG, Acharya NR, Gonzales JA. Association Between Baseline Macular Morphologic Features on Optical Coherence Tomography and Visual Outcomes in Patients with Vogt-Koyanagi-Harada Disease. Ocul Immunol Inflamm. 2025 Feb;33(2):263-270. doi: 10.1080/09273948.2024.2391420. Epub 2024 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.', 'detailedDescription': 'This is a randomized comparative effectiveness trial to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as first-line corticosteroid-sparing treatment for patients with non-infectious intermediate, posterior and panuveitis requiring corticosteroid-sparing therapy. The primary outcome is treatment success assessed at the 6 month visit (Phase 1, 0-6 months). If patients are a treatment success, they continue on the medication for another 6 months (Phase 1, 6-12 months). Patients who are a treatment failure can crossover to the other medication (Phase 2, 0-6 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All the following criteria must be met at enrollment:\n\nHistorical non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye\n\nActive inflammation within the last 180 days, defined by the presence of any of the following (in at least one eye) according to Standardization of Uveitis Nomenclature (SUN) criteria:\n\n* ≥ 2+ anterior chamber cells\n* ≥ 2+ vitreous haze\n* active retinal or choroidal lesions\n\nActive inflammation at enrollment, defined by the presence of any of the following (in at least one eye) according to SUN criteria:\n\n* ≥1+ anterior chamber cells and/or\n* ≥1+ vitreous haze and/or\n* active retinal/choroidal lesions\n\nAt least one of the following criteria must be met before or at enrollment:\n\n* Active inflammation after 4 weeks of high-dose (1mg/kg prednisone equivalent) corticosteroid treatment or 4 weeks following a regional corticosteroid injection\n* Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by an increase in inflammation (of at least 1 grade in anterior chamber cells or vitreous haze or a change of non-active to active lesions) when corticosteroid is tapered, in the 180 weeks prior to enrollment\n* Active inflammation after long-acting corticosteroid injection 4 weeks to 180 days prior to enrollment\n* Active inflammation after treatment with \\>10mg/day oral prednisone for at least the past 90 days prior to enrollment\n* Known chronic condition necessitating corticosteroid-sparing immunosuppressive treatment: Behcet's disease with posterior segment involvement, multifocal choroiditis with panuveitis, serpiginous choroidopathy, birdshot retinochoroidopathy, diffuse retinal vasculitis, Vogt-Koyanagi-Harada with bullous serous retinal detachments and/or choroidal detachments, sympathetic ophthalmia. No prior therapy required for these patients\n\nWillingness to start corticosteroid treatment at 1mg/kg or 60mg a day of prednisone, whichever is less\n\nWillingness to limit alcohol consumption\n\nWillingness to use an acceptable method of contraception during the study period (i.e. pharmacologic medications, devices, barrier methods) or abstinence.\n\n* Exclusion Criteria: Any of the following\n\nAny infectious cause of uveitis\n\nPrior immunosuppressive therapy other than corticosteroids in the past 12 months\n\nPrior intolerability or safety issues with methotrexate or mycophenolate mofetil\n\nPrior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil\n\nPrior biologic therapy at any time\n\nMedia opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes\n\nChronic hypotony (IOP \\< 5 mm Hg for \\> 3 months) in both eyes\n\nPeriocular or intravitreal corticosteroid injection in the past 4 weeks\n\nFluocinolone acetonide implant in either eye in \\< 3 years\n\nIntraocular surgery in \\< 30 days, or planning on getting surgery within the next 6 months\n\nBest spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye\n\n\\< 16 years of age at enrollment\n\nPlanning to conceive during the study period, pregnant or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal is mandatory)\\*\n\nAny history of cancer (If a patient has a history of non-melanoma skin cancer they can still be considered for inclusion in this study, provided it is not currently active).\n\nSystemic autoimmune disease anticipated to dictate treatment course\n\nAbnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment\\*\n\nAbnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment\\*\n\nEvidence of active tuberculosis, HIV infection, syphilis, or hepatitis B or C (patients must have a tuberculin skin test, or interferon-gamma release assay, a chest radiograph, Rapid plasma reagin / Venereal disease research laboratory test (RPR/VDRL), fluorescent treponemal antibody absorption test (FTA-ABS), or other treponemal tests, Hepatitis B surface antigen, Hepatitis C antibody tests, and HIV test within 90 days prior to enrollment)\\*\\*\n\n\\*Testing required within 4 weeks prior to enrollment; \\*\\*Testing required within 90 days prior to enrollment."}, 'identificationModule': {'nctId': 'NCT01829295', 'acronym': 'FAST', 'briefTitle': 'Methotrexate and Mycophenolate Mofetil for UVEITIS', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial', 'orgStudyIdInfo': {'id': '11-08227'}, 'secondaryIdInfos': [{'id': '5U10EY021125', 'link': 'https://reporter.nih.gov/quickSearch/5U10EY021125', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate', 'description': 'oral methotrexate', 'interventionNames': ['Drug: Methotrexate', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Mycophenolate Mofetil', 'description': 'oral mycophenolate mofetil', 'interventionNames': ['Drug: Mycophenolate mofetil', 'Drug: Prednisone']}], 'interventions': [{'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': 'For the first two weeks, an introductory dose of 500 mg twice a day (BID) orally. After two weeks, the dose will be increased to 1.5 g BID.', 'armGroupLabels': ['Mycophenolate Mofetil']}, {'name': 'Methotrexate', 'type': 'DRUG', 'description': 'For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)', 'armGroupLabels': ['Methotrexate']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.', 'armGroupLabels': ['Methotrexate', 'Mycophenolate Mofetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Francis I Proctor Foundation', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University - Casey Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Victorian Eye and Ear Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}, {'city': 'Madurai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital', 'geoPoint': {'lat': 9.919, 'lon': 78.11953}}, {'city': 'Pondicherry', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Aravind Eye Hospital'}, {'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociacion Para Evita La Ceguera en Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Khaled Eye Specialist Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Nisha Acharya, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aravind Eye Hospitals, India', 'class': 'OTHER'}, {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, {'name': 'Royal Victoria Eye and Ear Hospital', 'class': 'OTHER_GOV'}, {'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'National Eye Institute (NEI)', 'class': 'NIH'}, {'name': 'King Khaled Eye Specialist Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}