Viewing Study NCT03030118

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Ignite Creation Date: 2025-12-25 @ 4:35 AM
Ignite Modification Date: 2026-03-02 @ 4:12 AM
Study NCT ID: NCT03030118
Status: COMPLETED
Last Update Posted: 2025-09-16
First Post: 2017-01-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study of Anti-Malarials in Incomplete Lupus Erythematosus
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nolsen@pennstatehealth.psu.edu', 'phone': '717-531-4921', 'title': 'Nancy J Olsen MD, Professor of Medicine', 'organization': 'Penn State Hershey College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The number of participants was lower than planned in part due to the restrictions that were in place during the COVID-19 pandemic; some sites were closed for a time.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 96 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.", 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 83, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.", 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 85, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'Maculo-papular rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalization Colitis', 'notes': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Uterine Fibroids', 'notes': 'Uterine Fibroids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Neuropathy', 'notes': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization COVID-19', 'notes': 'COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Radiculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Mastectomy', 'notes': 'Right mastectomy, benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization Bilateral capsulotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SLICC Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'SLICC score of 2 : baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 36 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 60 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 72 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 84 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 2 : 96 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 36 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 60 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 72 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 84 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 3 : 96 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 36 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 60 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 72 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 84 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SLICC score of 4 or more : 96 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For the primary outcome (SLICC classification criteria count \\[SLICC score\\]), measured every 12 weeks over a 96-week period, we used an ordinal logistic regression model to compare the estimated slopes over time for the intervention (HCQ) and placebo groups. The model accounted for the ordinal and non-decreasing properties of the SLICC score. Our null hypothesis was that the intervention slope equaled the placebo slope, with a corresponding hypothesis that the slopes were not equal.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Measured every 12 weeks for 96 weeks.', 'description': 'The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis at each timepoint includes only the number patients who were still active in the study.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Progression to SLE was defined as the number of subjects in whom a SLICC score of 4 was recorded, up to 96 weeks.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured up to 96 weeks.', 'description': 'The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed via survival method. TIme to progression, Kaplan Meier.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Meeting Disease Activity Scores Defined Below', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Week 60 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Week 84 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 Score 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 60 score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 84 Score 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 Sc ore 2-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'week 12 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 36 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 48 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 60 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 72 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 84 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 96 Score 4-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For the SLEDAI score, we combined responses to model the following groups:\n\n* Score of 0 or 1\n* Score of 2 or 3\n* Score of 4, 6, or 8', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured every 12 weeks for 96 weeks.', 'description': 'Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Count includes number of participants active at each visit. Groups: Score 0-1, Score 2-3, Score 4-8.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Defined Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Score 1', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 2', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Score 3 or higher', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'For analysis, we combined responses ≥3 to model the following groups:\n\n* Score of 0\n* Score of 1\n* Score of 2\n* Score of 3 or higher', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Ordinal logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured every 12 weeks for 96 weeks', 'description': 'Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data are shown for number of active patients at each timepoint. CLASI activity score is measured as 0,1,2 or 3 and higher. At some timepoints, Data are Missing.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcome Physical Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.5', 'spread': '8.26', 'groupId': 'OG000'}, {'value': '48.9', 'spread': '7.87', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '7.71', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '7.84', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.5', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '49.4', 'spread': '8.42', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.8', 'spread': '8.12', 'groupId': 'OG000'}, {'value': '49.2', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': '48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '49.9', 'spread': '7.89', 'groupId': 'OG001'}]}]}, {'title': '60 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '8.06', 'groupId': 'OG000'}, {'value': '49.4', 'spread': '7.92', 'groupId': 'OG001'}]}]}, {'title': '72 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.3', 'spread': '8.28', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '8.24', 'groupId': 'OG001'}]}]}, {'title': '84 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.7', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '8.55', 'groupId': 'OG001'}]}]}, {'title': '96 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.5', 'spread': '8.17', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '7.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.386', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Measured every 12 weeks for 96 weeks', 'description': 'The PROMIS 29 Adult Profile: Physical Function T Scores The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.\n\nHigher score indicates better physical function', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients active at each visit are measured.'}, {'type': 'SECONDARY', 'title': 'Patient Reported Outcomes Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.7', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '55.0', 'spread': '10.87', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.0', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '12.0', 'groupId': 'OG001'}]}]}, {'title': '36 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.3', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '51.8', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': '48 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.5', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '11.3', 'groupId': 'OG001'}]}]}, {'title': '60 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.1', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': '72 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.9', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': '84 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.7', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '51.1', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': '96 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.9', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '50.7', 'spread': '11.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.497', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Paired t-test'}], 'paramType': 'MEAN', 'timeFrame': 'Measured every 12 weeks for up to 96 weeks', 'description': 'Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items T Scores are reported. The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.\n\nHigher scores indicate more fatigue', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only active patients are recorded at each visit. Values represent Fatigue T-scores.'}, {'type': 'SECONDARY', 'title': 'Physician Global Asssessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Missing data', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Score 0', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': 'Score 0.25', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Score 0.50', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Score 0.75 or higher', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Ordinal logistic regression'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured every 12 weeks for up to 96 weeks', 'description': 'Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of active patients at each time point are measured.'}, {'type': 'SECONDARY', 'title': 'Fluorescence Intensity (FI) of Autoantibodies in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Baseline CENP-A', 'categories': [{'measurements': [{'value': '1319', 'spread': '869', 'groupId': 'OG000'}, {'value': '1243', 'spread': '1222', 'groupId': 'OG001'}]}]}, {'title': 'Baseline CENP-B', 'categories': [{'measurements': [{'value': '5461', 'spread': '2703', 'groupId': 'OG000'}, {'value': '5454', 'spread': '3029', 'groupId': 'OG001'}]}]}, {'title': 'Baseline dsDNA', 'categories': [{'measurements': [{'value': '2838', 'spread': '2766', 'groupId': 'OG000'}, {'value': '2582', 'spread': '4289', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Genomic DNA', 'categories': [{'measurements': [{'value': '4484', 'spread': '7821', 'groupId': 'OG000'}, {'value': '3362', 'spread': '2458', 'groupId': 'OG001'}]}]}, {'title': 'Baseline HIstone', 'categories': [{'measurements': [{'value': '2349', 'spread': '2118', 'groupId': 'OG000'}, {'value': '2145', 'spread': '1703', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IFN-alpha', 'categories': [{'measurements': [{'value': '1813', 'spread': '1619', 'groupId': 'OG000'}, {'value': '2049', 'spread': '1960', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IFN-gamma', 'categories': [{'measurements': [{'value': '9092', 'spread': '6184', 'groupId': 'OG000'}, {'value': '9373', 'spread': '7330', 'groupId': 'OG001'}]}]}, {'title': 'Baseline IL-17A', 'categories': [{'measurements': [{'value': '9991', 'spread': '6075', 'groupId': 'OG000'}, {'value': '9953', 'spread': '5816', 'groupId': 'OG001'}]}]}, {'title': 'Baseline KU. (P70/P80)', 'categories': [{'measurements': [{'value': '3933', 'spread': '5283', 'groupId': 'OG000'}, {'value': '3967', 'spread': '5697', 'groupId': 'OG001'}]}]}, {'title': 'Baseline La/SSB', 'categories': [{'measurements': [{'value': '4682', 'spread': '9508', 'groupId': 'OG000'}, {'value': '4703', 'spread': '10076', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Laminin', 'categories': [{'measurements': [{'value': '16234', 'spread': '17545', 'groupId': 'OG000'}, {'value': '15573', 'spread': '16455', 'groupId': 'OG001'}]}]}, {'title': "Baseline Liver Baseline Cytosol '", 'categories': [{'measurements': [{'value': '3563', 'spread': '3632', 'groupId': 'OG000'}, {'value': '3267', 'spread': '3074', 'groupId': 'OG001'}]}]}, {'title': 'baseline LKM 1', 'categories': [{'measurements': [{'value': '3067', 'spread': '1321', 'groupId': 'OG000'}, {'value': '2903', 'spread': '1151', 'groupId': 'OG001'}]}]}, {'title': 'Baseline MDA5', 'categories': [{'measurements': [{'value': '3725', 'spread': '4064', 'groupId': 'OG000'}, {'value': '3483', 'spread': '3476', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Mi-2', 'categories': [{'measurements': [{'value': '1140', 'spread': '760', 'groupId': 'OG000'}, {'value': '1067', 'spread': '679', 'groupId': 'OG001'}]}]}, {'title': 'Baseline NRP1', 'categories': [{'measurements': [{'value': '23735', 'spread': '20781', 'groupId': 'OG000'}, {'value': '24296', 'spread': '21025', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Nucleolin', 'categories': [{'measurements': [{'value': '3108', 'spread': '2148', 'groupId': 'OG000'}, {'value': '2748', 'spread': '1576', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Nucleosome', 'categories': [{'measurements': [{'value': '3017', 'spread': '1661', 'groupId': 'OG000'}, {'value': '2800', 'spread': '1255', 'groupId': 'OG001'}]}]}, {'title': 'Baseline NXP2', 'categories': [{'measurements': [{'value': '3765', 'spread': '2275', 'groupId': 'OG000'}, {'value': '3584', 'spread': '2228', 'groupId': 'OG001'}]}]}, {'title': 'Baseline PL-7', 'categories': [{'measurements': [{'value': '2681', 'spread': '1335', 'groupId': 'OG000'}, {'value': '2352', 'spread': '973', 'groupId': 'OG001'}]}]}, {'title': 'Baseline PL-12', 'categories': [{'measurements': [{'value': '6040', 'spread': '2533', 'groupId': 'OG000'}, {'value': '5672', 'spread': '1905', 'groupId': 'OG001'}]}]}, {'title': 'Baseline PM/SCL-100', 'categories': [{'measurements': [{'value': '2967', 'spread': '2631', 'groupId': 'OG000'}, {'value': '2650', 'spread': '1919', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Ro/SSA 60 KDA', 'categories': [{'measurements': [{'value': '1800', 'spread': '4705', 'groupId': 'OG000'}, {'value': '1879', 'spread': '5617', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Scl-70', 'categories': [{'measurements': [{'value': '1596', 'spread': '1499', 'groupId': 'OG000'}, {'value': '1569', 'spread': '1231', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Sm', 'categories': [{'measurements': [{'value': '1347', 'spread': '1677', 'groupId': 'OG000'}, {'value': '1135', 'spread': '1087', 'groupId': 'OG001'}]}]}, {'title': 'Baseline thyroglobulin', 'categories': [{'measurements': [{'value': '4211', 'spread': '7237', 'groupId': 'OG000'}, {'value': '2933', 'spread': '4782', 'groupId': 'OG001'}]}]}, {'title': 'Baseline TPO', 'categories': [{'measurements': [{'value': '7986', 'spread': '9281', 'groupId': 'OG000'}, {'value': '6769', 'spread': '7279', 'groupId': 'OG001'}]}]}, {'title': 'Baseline tTG', 'categories': [{'measurements': [{'value': '6966', 'spread': '4280', 'groupId': 'OG000'}, {'value': '6381', 'spread': '3164', 'groupId': 'OG001'}]}]}, {'title': 'Baseline U1-snRNPA', 'categories': [{'measurements': [{'value': '2372', 'spread': '2869', 'groupId': 'OG000'}, {'value': '2184', 'spread': '2701', 'groupId': 'OG001'}]}]}, {'title': 'Baseline U1-snRNP C', 'categories': [{'measurements': [{'value': '657', 'spread': '819', 'groupId': 'OG000'}, {'value': '602', 'spread': '821', 'groupId': 'OG001'}]}]}, {'title': 'Baseline U1-snRNP B/B', 'categories': [{'measurements': [{'value': '260', 'spread': '110', 'groupId': 'OG000'}, {'value': '252', 'spread': '94', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Vimentin', 'categories': [{'measurements': [{'value': '3160', 'spread': '1670', 'groupId': 'OG000'}, {'value': '3006', 'spread': '1140', 'groupId': 'OG001'}]}]}, {'title': 'Final CENP-A', 'categories': [{'measurements': [{'value': '1243', 'spread': '1222', 'groupId': 'OG000'}, {'value': '1889', 'spread': '7462', 'groupId': 'OG001'}]}]}, {'title': 'Final CENP-B', 'categories': [{'measurements': [{'value': '5454', 'spread': '3029', 'groupId': 'OG000'}, {'value': '6367', 'spread': '8328', 'groupId': 'OG001'}]}]}, {'title': 'Final dsDNA', 'categories': [{'measurements': [{'value': '2582', 'spread': '4289', 'groupId': 'OG000'}, {'value': '2496', 'spread': '2472', 'groupId': 'OG001'}]}]}, {'title': 'Final Genomic DNA', 'categories': [{'measurements': [{'value': '3362', 'spread': '2458', 'groupId': 'OG000'}, {'value': '3595', 'spread': '3971', 'groupId': 'OG001'}]}]}, {'title': 'Final Histone', 'categories': [{'measurements': [{'value': '2145', 'spread': '1703', 'groupId': 'OG000'}, {'value': '2304', 'spread': '2636', 'groupId': 'OG001'}]}]}, {'title': 'Final IFN-alpha', 'categories': [{'measurements': [{'value': '2049', 'spread': '1960', 'groupId': 'OG000'}, {'value': '2150', 'spread': '2096', 'groupId': 'OG001'}]}]}, {'title': 'Final IFN-gamma', 'categories': [{'measurements': [{'value': '9373', 'spread': '7330', 'groupId': 'OG000'}, {'value': '10235', 'spread': '6071', 'groupId': 'OG001'}]}]}, {'title': 'Final IL-17A', 'categories': [{'measurements': [{'value': '9953', 'spread': '5816', 'groupId': 'OG000'}, {'value': '11656', 'spread': '6798', 'groupId': 'OG001'}]}]}, {'title': 'Final Ku P70/P80', 'categories': [{'measurements': [{'value': '3967', 'spread': '5697', 'groupId': 'OG000'}, {'value': '4209', 'spread': '4440', 'groupId': 'OG001'}]}]}, {'title': 'Final La/SS-B', 'categories': [{'measurements': [{'value': '4703', 'spread': '10076', 'groupId': 'OG000'}, {'value': '2881', 'spread': '1677', 'groupId': 'OG001'}]}]}, {'title': 'Final Laminin', 'categories': [{'measurements': [{'value': '15573', 'spread': '16455', 'groupId': 'OG000'}, {'value': '18192', 'spread': '19262', 'groupId': 'OG001'}]}]}, {'title': 'Final Liver Cytosol 1', 'categories': [{'measurements': [{'value': '3267', 'spread': '3074', 'groupId': 'OG000'}, {'value': '3538', 'spread': '3506', 'groupId': 'OG001'}]}]}, {'title': 'Final LKM 1', 'categories': [{'measurements': [{'value': '2903', 'spread': '1151', 'groupId': 'OG000'}, {'value': '3323', 'spread': '1549', 'groupId': 'OG001'}]}]}, {'title': 'Final MDA5', 'categories': [{'measurements': [{'value': '3483', 'spread': '3476', 'groupId': 'OG000'}, {'value': '4262', 'spread': '2636', 'groupId': 'OG001'}]}]}, {'title': 'Final Mi-2', 'categories': [{'measurements': [{'value': '1067', 'spread': '679', 'groupId': 'OG000'}, {'value': '1299', 'spread': '736', 'groupId': 'OG001'}]}]}, {'title': 'Final Nrp1', 'categories': [{'measurements': [{'value': '24296', 'spread': '21025', 'groupId': 'OG000'}, {'value': '25597', 'spread': '22237', 'groupId': 'OG001'}]}]}, {'title': 'Final Nucleolin', 'categories': [{'measurements': [{'value': '2748', 'spread': '1576', 'groupId': 'OG000'}, {'value': '3721', 'spread': '2291', 'groupId': 'OG001'}]}]}, {'title': 'Final Nucleosome', 'categories': [{'measurements': [{'value': '2800', 'spread': '1255', 'groupId': 'OG000'}, {'value': '3292', 'spread': '1595', 'groupId': 'OG001'}]}]}, {'title': 'Final NXP2', 'categories': [{'measurements': [{'value': '3584', 'spread': '2228', 'groupId': 'OG000'}, {'value': '4598', 'spread': '2627', 'groupId': 'OG001'}]}]}, {'title': 'Final PL-7', 'categories': [{'measurements': [{'value': '2352', 'spread': '973', 'groupId': 'OG000'}, {'value': '2861', 'spread': '1790', 'groupId': 'OG001'}]}]}, {'title': 'Final PL-12', 'categories': [{'measurements': [{'value': '5672', 'spread': '1905', 'groupId': 'OG000'}, {'value': '6673', 'spread': '2873', 'groupId': 'OG001'}]}]}, {'title': 'Final PM/Scl 100', 'categories': [{'measurements': [{'value': '2650', 'spread': '1919', 'groupId': 'OG000'}, {'value': '2982', 'spread': '1768', 'groupId': 'OG001'}]}]}, {'title': 'Final Ro/SS-A 60 Kda', 'categories': [{'measurements': [{'value': '1879', 'spread': '5617', 'groupId': 'OG000'}, {'value': '1421', 'spread': '908', 'groupId': 'OG001'}]}]}, {'title': 'Final Scl-70', 'categories': [{'measurements': [{'value': '1569', 'spread': '1231', 'groupId': 'OG000'}, {'value': '2009', 'spread': '4108', 'groupId': 'OG001'}]}]}, {'title': 'Final Sm', 'categories': [{'measurements': [{'value': '1135', 'spread': '1087', 'groupId': 'OG000'}, {'value': '1858', 'spread': '5755', 'groupId': 'OG001'}]}]}, {'title': 'Final Thyroglobulin', 'categories': [{'measurements': [{'value': '2933', 'spread': '4782', 'groupId': 'OG000'}, {'value': '3651', 'spread': '6602', 'groupId': 'OG001'}]}]}, {'title': 'Final TPO', 'categories': [{'measurements': [{'value': '6769', 'spread': '7279', 'groupId': 'OG000'}, {'value': '6873', 'spread': '4793', 'groupId': 'OG001'}]}]}, {'title': 'Final tTg', 'categories': [{'measurements': [{'value': '6381', 'spread': '3164', 'groupId': 'OG000'}, {'value': '6356', 'spread': '2314', 'groupId': 'OG001'}]}]}, {'title': 'Final U1-snRNP A', 'categories': [{'measurements': [{'value': '2184', 'spread': '2701', 'groupId': 'OG000'}, {'value': '2845', 'spread': '7385', 'groupId': 'OG001'}]}]}, {'title': 'Final U1-snRNP C', 'categories': [{'measurements': [{'value': '657', 'spread': '819', 'groupId': 'OG000'}, {'value': '502', 'spread': '276', 'groupId': 'OG001'}]}]}, {'title': 'Final U1-snRNP B/B', 'categories': [{'measurements': [{'value': '260', 'spread': '110', 'groupId': 'OG000'}, {'value': '247', 'spread': '92', 'groupId': 'OG001'}]}]}, {'title': 'Final Vimentin', 'categories': [{'measurements': [{'value': '3160', 'spread': '1670', 'groupId': 'OG000'}, {'value': '3891', 'spread': '1542', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and final visit up to 96 weeks.', 'description': 'Fluorescence intensity of Autoantibodies will be measured using a slide array. Minimum score is 0.1 Maximum score \\>100 A higher score indicates higher level of the autoantibody being measured.', 'unitOfMeasure': 'Mean Fluorescence Intensity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients who completed or who had a defined final visit are included. Samples were measured at baseline and last visit.'}, {'type': 'SECONDARY', 'title': 'Ophthalmologic Toxicity as Measured by Snellen Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'title': 'Right Eye', 'categories': [{'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '15', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '20', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': '25', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': '30', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '50', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Left eye', 'categories': [{'title': 'Missing data', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '10', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '15', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '20', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'title': '25', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '30', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '50', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.5', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Outcome with hydroxychloroquine is hypothesized to be not inferior to outcome with placebo.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at up to 96 weeks or final visit', 'description': 'Snellen visual acuity measured in right and left eyes Scale 10 to 50 with higher numbers indicating lower visual acuity Number of participants with each level of visual acuity in right eye and left eye are counted in the two groups at the final visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients who completed the exams are analyzed.'}, {'type': 'SECONDARY', 'title': 'Ophthalmologic Toxicity by Humphrey Visual Field Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at final visit up to 96 weeks', 'description': 'Number of participants with abnormal visual field testing at the final visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only patients who completed the exams are shown.'}, {'type': 'SECONDARY', 'title': 'Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'OG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured at up to 96 weeks or final visit', 'description': 'Number of participants with abnormal spectral domain ocular coherence tomography at final visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only patients who completed exams are shown'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'FG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Achieved SLE Diagnosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Concomitant Medications', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Achieved SLE and Concomitant Meds', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.\n\nHydroxychloroquine: Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis."}, {'id': 'BG001', 'title': 'Placebo Oral Capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.\n\nPlacebo Oral Capsule: An oral capsule placebo is made to match the active intervention medication hydroxychloroquine."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '9.75', 'groupId': 'BG000'}, {'value': '33.5', 'spread': '8.58', 'groupId': 'BG001'}, {'value': '33.1', 'spread': '9.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Systemic Lupus International Cooperating Clinics (SLICC) score baseline', 'classes': [{'title': '2 criteria', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}]}]}, {'title': '3 criteria', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'SLICC scores were determined using the defined list of 17 criteria for classification of SLE. At each visit the list was reviewed and any clinical or laboratory features that satisfied a criterion were counted. This is a cumulative score, which can only increase over time. A higher score indicates more features of lupus have been found. When a score of 4 is reached, then the participant satisfies the classification criteria for SLE. This mandates removal from the trial.', 'unitOfMeasure': 'Number of criteria'}], 'populationDescription': 'Baseline analysis population is 180 patients, after excluding 7 patients due to diagnosis of SLE confirmed after delayed labs became available.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-02', 'size': 26014667, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-30T13:23', 'hasProtocol': True}, {'date': '2024-05-02', 'size': 11731535, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-30T13:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2017-01-15', 'resultsFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2017-01-20', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-11', 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SLICC Score', 'timeFrame': 'Measured every 12 weeks for 96 weeks.', 'description': 'The 2012 Systemic Lupus International Collaborating Clinics classification criteria score erythematosus Minimum value = 0 Maximum value = 17 A score of 4 or greater satisfies classification for systemic lupus erythematosus.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Disease Progression', 'timeFrame': 'Measured up to 96 weeks.', 'description': 'The number of subjects who progressed from incomplete lupus to satisfaction of classification criteria for systemic lupus erythematosus using SLICC criteria.'}, {'measure': 'Number of Subjects Meeting Disease Activity Scores Defined Below', 'timeFrame': 'Measured every 12 weeks for 96 weeks.', 'description': 'Disease activity measured by the SLE Disease Activity Index Minimum score = 0 Maximum score = 105 Higher scores indicate greater activity of lupus disease'}, {'measure': 'Count of Participants With Defined Disease Activity', 'timeFrame': 'Measured every 12 weeks for 96 weeks', 'description': 'Disease activity measured by the Cutaneous Lupus Erythematosus Disease Activity Index Minimum score = 0 Maximum score = 70 Higher scores indicate greater cutaneous lupus activity'}, {'measure': 'Patient Reported Outcome Physical Function', 'timeFrame': 'Measured every 12 weeks for 96 weeks', 'description': 'The PROMIS 29 Adult Profile: Physical Function T Scores The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.\n\nHigher score indicates better physical function'}, {'measure': 'Patient Reported Outcomes Fatigue', 'timeFrame': 'Measured every 12 weeks for up to 96 weeks', 'description': 'Selected Patient-reported outcomes measurement information system (PROMIS) fatigue items T Scores are reported. The T-score has a mean of 50 and a standard deviation of 10 within the reference (healthy) population.\n\nHigher scores indicate more fatigue'}, {'measure': 'Physician Global Asssessment', 'timeFrame': 'Measured every 12 weeks for up to 96 weeks', 'description': 'Physician Global Visual Analogue Scale Minimum score = 0 Maximum score = 1.0 Higher scores indicate worse status'}, {'measure': 'Fluorescence Intensity (FI) of Autoantibodies in Serum', 'timeFrame': 'Measured at baseline and final visit up to 96 weeks.', 'description': 'Fluorescence intensity of Autoantibodies will be measured using a slide array. Minimum score is 0.1 Maximum score \\>100 A higher score indicates higher level of the autoantibody being measured.'}, {'measure': 'Ophthalmologic Toxicity as Measured by Snellen Visual Acuity', 'timeFrame': 'Measured at up to 96 weeks or final visit', 'description': 'Snellen visual acuity measured in right and left eyes Scale 10 to 50 with higher numbers indicating lower visual acuity Number of participants with each level of visual acuity in right eye and left eye are counted in the two groups at the final visit'}, {'measure': 'Ophthalmologic Toxicity by Humphrey Visual Field Testing', 'timeFrame': 'Measured at final visit up to 96 weeks', 'description': 'Number of participants with abnormal visual field testing at the final visit.'}, {'measure': 'Ophthalmologic Toxicity as Measured by Spectral Domain Ocular Coherence Tomography.', 'timeFrame': 'Measured at up to 96 weeks or final visit', 'description': 'Number of participants with abnormal spectral domain ocular coherence tomography at final visit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hydroxychloroquine'], 'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '30369087', 'type': 'BACKGROUND', 'citation': 'Karp DR, Chong BF, James JA, Arriens C, Ishimori M, Wallace DJ, Liao D, Olsen NJ. Mock Recruitment for the Study of Antimalarials in an Incomplete Lupus Erythematosus Trial. Arthritis Care Res (Hoboken). 2019 Nov;71(11):1425-1429. doi: 10.1002/acr.23802.'}, {'pmid': '30572906', 'type': 'BACKGROUND', 'citation': 'Olsen NJ, James JA, Arriens C, Ishimori ML, Wallace DJ, Kamen DL, Chong BF, Liao D, Chinchilli VM, Karp DR. Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial. Trials. 2018 Dec 20;19(1):694. doi: 10.1186/s13063-018-3076-7.'}, {'pmid': '34897194', 'type': 'DERIVED', 'citation': 'Porta SV, Ugarte-Gil MF, Garcia-de la Torre I, Bonfa E, Gomez-Puerta JA, Arnaud L, Cardiel MH, Alarcon GS, Pons-Estel BA, Pons-Estel G. Controversies in Systemic Lupus Erythematosus: Are We Treating Our Patients Adequately? J Clin Rheumatol. 2022 Mar 1;28(2):e651-e658. doi: 10.1097/RHU.0000000000001803.'}]}, 'descriptionModule': {'briefSummary': 'This project is a multicenter, randomized, placebo-controlled, double-blind clinical trial that is designed to test whether treating patients who are at risk for development of lupus with hydroxychloroquine can slow accumulation of disease features. Effects on clinical progression of symptoms, patient-reported outcomes and changes in the immune markers of response will be measured and toxicity of the treatment will be assessed. This trial is a first step in testing a prevention strategy for lupus.', 'detailedDescription': 'Systemic lupus erythematosus (SLE) causes major organ damage and shortens lifespan in relatively young persons. Early diagnosis and treatment are essential to improving outcomes for SLE patients. However, evidenced-based approaches to early treatment interventions and the appropriate target population for these interventions are not available. We propose that individuals who have positivity for antinuclear antibodies (ANAs) and who also exhibit some of the other features that are used to classify SLE, are at high risk of progressing to the full systemic form of this disease. These individuals, who have significant levels of ANA with 1 or 2 additional items from the lupus classification criteria, are considered to have incomplete lupus erythematosus (ILE). We propose to treat ILE patients with hydroxychloroquine (HCQ) in the "Study of Anti-Malarials in Incomplete Lupus Erythematosus" or SMILE trial. The primary objective is to determine whether HCQ treatment can prevent acquisition of additional clinical and immunologic features that define SLE.\n\nThe major secondary objectives are to determine whether HCQ treatment: (1) lessens lupus disease activity as measured by standard scoring indices; (2) improves patient reported outcomes (3) prevents accumulation of immunologic abnormalities including autoantibodies and cytokines and (4) has an acceptable toxicity profile. The specific aims of this proposal are:\n\n1. To carry out a double-blind, placebo-controlled, multicenter, randomized trial of HCQ vs. placebo in patients with ILE. The study tests the hypothesis that early use of HCQ can modify disease features so that accumulation of abnormalities leading to a classification of SLE can be significantly slowed.\n2. To determine effects of HCQ on disease activity and patient-reported outcomes in patients with ILE.\n3. To characterize the immunologic profile of HCQ in ILE-treated patients. Autoantibodies, cytokines and chemokines will be measured on multiplex arrays for developing insights into underlying mechanisms.\n4. To quantitatively assess the incidence of ophthalmologic toxicity in HCQ-treated ILE patients. All enrolled patients will have standardized ophthalmologic examinations before and after study treatment. Recommendations for use and monitoring in this patient population will be developed.\n\nThe SMILE trial will determine whether or not HCQ should be given to ILE patients, will provide insights into the appropriate target population, and will propose candidate biomarkers to guide treatment decisions. While not part of the Precision Medicine Initiative®, SMILE is consistent with its goals. It will be the first step towards testing the feasibility of disease prevention studies in SLE and will accumulate biological samples in a repository that will be available to the lupus research community for further in-depth mechanistic studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '49 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Between 15 and 49 years of age, inclusive, at Visit 1.\n2. Anti-nuclear antibody (ANA) titer of 1:80, or greater, as determined by immunofluorescence assay (IFA).\n3. Participants must have at least one (but not three or more) additional clinical or laboratory criterion from the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria.\n4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. The subject meets the 2012 SLICC classification criteria for SLE at Visit 1 (i.e., ANA plus 3 other criteria, or ANA plus biopsy-proven lupus nephritis).\n2. The subject has been diagnosed with another autoimmune disorder, other than autoimmune thyroid conditions.\n3. The subject has fibromyalgia, based on clinical history and exam.\n4. The subject has previously been or is currently being treated with oral antimalarial agents including hydroxychloroquine, chloroquine, or quinacrine.\n5. The subject is currently or has been treated with immunosuppressive, immune modifying, or cytotoxic medications as listed in Section 7.2.\n6. Use of any investigational agent within the preceding 12 months.\n7. History of primary immunodeficiency.\n8. Active bacterial, viral, fungal, or opportunistic infection.\n9. Evidence of infection with human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.\n10. Concomitant malignancy or history of malignancy with the exception of adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n11. The subject has significant findings on ophthalmological examination that, in the opinion of the examining Ophthalmologist, prevent safe use of hydroxychloroquine.\n12. The subject has other contraindications to treatment with hydroxychloroquine including pre-existing ocular disease, hepatic impairment, psoriasis, porphyria, or allergy to the drug or class.\n13. Co-morbidities requiring systemic corticosteroid therapy greater than 10 mg of prednisone per day, or equivalent, or a change in corticosteroid dose within the 3 months prior to Visit 1.\n14. Starting, stopping, or changing the dose of over the counter or prescription non-steroidal anti-inflammatory drugs (NSAIDs) in the three months prior to Visit 1.\n15. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n16. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n17. Inability to comply with the study visit schedule and procedures."}, 'identificationModule': {'nctId': 'NCT03030118', 'acronym': 'SMILE', 'briefTitle': 'Study of Anti-Malarials in Incomplete Lupus Erythematosus', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Study of Anti-Malarials in Incomplete Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'STUDY00003506'}, 'secondaryIdInfos': [{'id': 'U01AR071077', 'link': 'https://reporter.nih.gov/quickSearch/U01AR071077', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxychloroquine', 'description': "Hydroxychloroquine will be administered as a once daily dose of 200 or 400 mg, based on the patient's weight. Treatment will be for 96 weeks.", 'interventionNames': ['Drug: Hydroxychloroquine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo oral capsule', 'description': "Placebo will be administered as one or two capsules as a single daily dose, based on the patient's weight. Treatment will be for 96 weeks.", 'interventionNames': ['Drug: Placebo Oral Capsule']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': 'Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.', 'armGroupLabels': ['Hydroxychloroquine']}, {'name': 'Placebo Oral Capsule', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.', 'armGroupLabels': ['Placebo oral capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Medical Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State MS Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Nancy J Olsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State MS Hershey Medical Center'}, {'name': 'David R Karp, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will be available after publication of the primary paper, anticipated in last quarter 2025.', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared with other investigators upon reasonable request. This will include all patient-level measurements and instruments, as well as the laboratory results.', 'accessCriteria': 'Reasonable request is defined as having a legitimate and specific purpose for use of the data and ability to accept it in a usable format.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Nancy Olsen', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}