Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-02 @ 3:56 AM
Study NCT ID:
NCT02467504
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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': 'D005492', 'term': 'Folic Acid'}, {'id': 'C040656', 'term': 'loxoprofen'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '13810001444@163.com', 'phone': '+86-13810001444', 'title': 'Prof. Zhanguo Li', 'organization': "Peking university People's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'deathsNumAffected': 11, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'deathsNumAffected': 9, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever after injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hospitalized not related to RA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving DAS28 Remission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.530', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 24', 'description': 'DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.315', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Change From Baseline of Clinical Disease Activity Index (CDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-17.5', 'groupId': 'OG000', 'lowerLimit': '-22', 'upperLimit': '-11'}, {'value': '-11', 'groupId': 'OG001', 'lowerLimit': '-17.5', 'upperLimit': '-7.0'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-15.0', 'groupId': 'OG000', 'lowerLimit': '-19.0', 'upperLimit': '-9.7'}, {'value': '-8.0', 'groupId': 'OG001', 'lowerLimit': '-16.9', 'upperLimit': '-3.5'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': 'Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome.\n\nThe change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Change From Baseline of Simplified Disease Activity Index (SDAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-19.0', 'groupId': 'OG000', 'lowerLimit': '-23.1', 'upperLimit': '-12.2'}, {'value': '-12.1', 'groupId': 'OG001', 'lowerLimit': '-19.3', 'upperLimit': '-6.3'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-16.9', 'groupId': 'OG000', 'lowerLimit': '-19.1', 'upperLimit': '-9.8'}, {'value': '-9.2', 'groupId': 'OG001', 'lowerLimit': '-17.2', 'upperLimit': '-3.9'}]}]}], 'analyses': [{'pValue': '0.015', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': 'Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome.\n\nThe change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.474', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Chi'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 24', 'description': 'adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of CD4+ Treg Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '6.94', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '13.77'}, {'value': '6.46', 'groupId': 'OG001', 'lowerLimit': '3.71', 'upperLimit': '12.30'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6.84', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '10.61'}, {'value': '5.37', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '7.86'}]}]}], 'analyses': [{'pValue': '0.665', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'description of Treg cells in CD4+ T cells'}], 'paramType': 'MEAN', 'timeFrame': 'week 12, week 24', 'description': 'analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values\\<0.05 are considered statistically significant.', 'unitOfMeasure': 'percentage of CD4+ T cells', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving DAS28 Low Disease Activity.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.616', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': 'Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.616', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': 'Good response is defined as: DAS28-ESR ≤ 3.2 and decrease from Baseline by \\> 1.2.\n\nmoderate response is defined as achievement of one of the following: DAS28-ESR ≤ 3.2 and decrease from Baseline \\> 0.6 and ≤ 1.2 DAS28-ESR \\> 3.2 and ≤ 5.1 and decrease from Baseline \\> 0.6 DAS28-ESR \\> 5.1 and decrease from Baseline \\>1.2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'weed 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.200', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.373', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.565', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 12, week 24', 'description': "The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-0.63', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '-0.13'}, {'value': '-0.38', 'groupId': 'OG001', 'lowerLimit': '-0.75', 'upperLimit': '0'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000', 'lowerLimit': '-0.88', 'upperLimit': '-0.19'}, {'value': '-0.25', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '0.00'}]}]}], 'analyses': [{'pValue': '0.221', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': 'The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability.\n\nThe change from baseline of HAQ-DI, minimum is -3, the maximum is 3. higher scores mean a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Scores of SF-36 Quetionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '15.29', 'groupId': 'OG000', 'lowerLimit': '8.73', 'upperLimit': '29.65'}, {'value': '6.90', 'groupId': 'OG001', 'lowerLimit': '1.39', 'upperLimit': '16.61'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '24.32', 'groupId': 'OG000', 'lowerLimit': '11.89', 'upperLimit': '40.85'}, {'value': '27.25', 'groupId': 'OG001', 'lowerLimit': '16.58', 'upperLimit': '41.47'}]}]}], 'analyses': [{'pValue': '0.085', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': 'Score ranging from 0 to 100 with higher scores a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'rate of Arthritis interference', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '6.75'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.5'}]}]}, {'title': 'Rate of arthritis interference with household work', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2.25', 'upperLimit': '6'}]}]}], 'analyses': [{'pValue': '0.740', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 24', 'description': 'The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).higher scores mean a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '43.3', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '24.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '29.6', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '21.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.881', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'week 12, week 24', 'unitOfMeasure': 'millimeter/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '21.6', 'spread': '20.83', 'groupId': 'OG000'}, {'value': '15.32', 'spread': '14.74', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '9.5', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.422', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'week 12, week 24', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-57.5', 'groupId': 'OG000', 'lowerLimit': '-76.4', 'upperLimit': '-29.5'}, {'value': '-33.3', 'groupId': 'OG001', 'lowerLimit': '-66.7', 'upperLimit': '0'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-57.1', 'groupId': 'OG000', 'lowerLimit': '-75.0', 'upperLimit': '-35.4'}, {'value': '-33.3', 'groupId': 'OG001', 'lowerLimit': '-62.5', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.055', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Patient's Global Assessment of Disease Activity Higher scores mean a worse outcome. The change from baseline of PtGADA, the minimum is -100, the maximum is 100. Higher scores mean a worse outcome.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-58.3', 'groupId': 'OG000', 'lowerLimit': '-76.4', 'upperLimit': '-47.2'}, {'value': '-44.4', 'groupId': 'OG001', 'lowerLimit': '-57.1', 'upperLimit': '0.0'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-57.1', 'groupId': 'OG000', 'lowerLimit': '-66.7', 'upperLimit': '-33.3'}, {'value': '-25.0', 'groupId': 'OG001', 'lowerLimit': '-44.4', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.039', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Physician's Global Assessment of Disease Activity higher scores mean a worse outcome. The change from baseline, the minimum is -100, the maximum is 100.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'week 24', 'categories': [{'measurements': [{'value': '-57.5', 'groupId': 'OG000', 'lowerLimit': '-76.4', 'upperLimit': '-29.5'}, {'value': '-33.3', 'groupId': 'OG001', 'lowerLimit': '-66.7', 'upperLimit': '0.0'}]}]}, {'title': 'week 12', 'categories': [{'measurements': [{'value': '-57.1', 'groupId': 'OG000', 'lowerLimit': '-69.6', 'upperLimit': '-41.5'}, {'value': '-27.3', 'groupId': 'OG001', 'lowerLimit': '-42.7', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.156', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Patient's Assessment of Arthritis Pain higher scores mean a worse outcome. The change from baseline of PtAAP, the minimum is -100, the maximum is 100.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'classes': [{'title': 'number of work days with reduced productivity', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '18'}]}]}, {'title': 'number of work days missed', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'Household work days missed due to arthritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.5'}]}]}, {'title': 'Days with household work productivity reduced', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '30'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '30'}]}]}, {'title': 'Days with activities missed due to arthritis', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Days with outside help hired due to arthritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'week 24', 'description': 'In the last month, number of work days missed, number of work days with reduced productivity. In the last month, number of days with no household work, number of days with reduced household work productivity, number of days with hired outside help, number of days missed of family/social/leisure activities in the last month.higher scores mean a worse outcome.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'FG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 active: hrIL-2 active (1 million U doses of hrIL-2s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'BG001', 'title': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen\n\nhrIL-2 placebo: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)\n\nMTX: Methotrexate (oral administration)\n\nFolic Acid: Folic Acid (oral administration)\n\nLoxoprofen: Loxoprofen (oral administration)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.6', 'spread': '10.9', 'groupId': 'BG000'}, {'value': '56.4', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-31', 'studyFirstSubmitDate': '2015-06-04', 'resultsFirstSubmitDate': '2018-09-09', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-31', 'studyFirstPostDateStruct': {'date': '2015-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving DAS28 Remission.', 'timeFrame': 'week 24', 'description': 'DAS 28 remission is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 2.6'}, {'measure': 'Percentage of Participants Meeting the American College of Rheumatology 20% Response Criteria', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 20% or greater improvement from Baseline in the number of tender joints, a 20%, or more improvement in the number of swollen joints, and a 20% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP)."}, {'measure': 'The Change From Baseline of Clinical Disease Activity Index (CDAI)', 'timeFrame': 'week 12, week 24', 'description': 'Clinical Disease Activity Index(CDAI), the minimum is 0, the maximum is 76. higher scores mean a worse outcome.\n\nThe change of from baseline of CDAI, the minimum is -76, the maximum is 76. higher scores mean a worse outcome.'}, {'measure': 'The Change From Baseline of Simplified Disease Activity Index (SDAI)', 'timeFrame': 'week 12, week 24', 'description': 'Simplified Disease Activity Index(SDAI). the minimum is 0, the maximum is 96. higher scores mean worse outcome.\n\nThe change from baseline of SDAI. the minimum is -96, the maximum is 96. higher scores mean worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Up to week 24', 'description': 'adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event, drug-induced liver and kidney damage.'}, {'measure': 'Percentage of CD4+ Treg Cells', 'timeFrame': 'week 12, week 24', 'description': 'analysis regulatory CD4+ T(Treg) cells before and during IL-2 treatment. P values\\<0.05 are considered statistically significant.'}, {'measure': 'Percentage of Participants Achieving DAS28 Low Disease Activity.', 'timeFrame': 'week 12, week 24', 'description': 'Low disease activity is defined by a disease activity score (28 joint) calculated using the erythrocyte sedimentation rate (DAS28-ESR) of less than 3.2'}, {'measure': 'Percentage of Participants Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response', 'timeFrame': 'week 12, week 24', 'description': 'Good response is defined as: DAS28-ESR ≤ 3.2 and decrease from Baseline by \\> 1.2.\n\nmoderate response is defined as achievement of one of the following: DAS28-ESR ≤ 3.2 and decrease from Baseline \\> 0.6 and ≤ 1.2 DAS28-ESR \\> 3.2 and ≤ 5.1 and decrease from Baseline \\> 0.6 DAS28-ESR \\> 5.1 and decrease from Baseline \\>1.2.'}, {'measure': 'Percentage of Participants Meeting the American College of Rheumatology 50% Response Criteria', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 50% or greater improvement from Baseline in the number of tender joints, a 50%, or more improvement in the number of swollen joints, and a 50% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP)."}, {'measure': 'Percentage of Participants Meeting the American College of Rheumatology 70% Response Criteria', 'timeFrame': 'week 12, week 24', 'description': "The assessments are based on a 70% or greater improvement from Baseline in the number of tender joints, a 70%, or more improvement in the number of swollen joints, and a 70% or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP)."}, {'measure': 'Percentage of Participants Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice', 'timeFrame': 'week 12, week 24', 'description': "The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:Tender Joint Count (TJC) ≤ 1, Swollen Joint Count (SJC) ≤ 1 and Patient's Global Assessment of Disease Activity (PtGADA) ≤ 1."}, {'measure': 'The Change From Baseline of a Health Assessment Questionnaire- Disability Index (HAQ-DI)', 'timeFrame': 'week 12, week 24', 'description': 'The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. The total score ranges from 0 to 3 with lower scores meaning lower disability.\n\nThe change from baseline of HAQ-DI, minimum is -3, the maximum is 3. higher scores mean a worse outcome.'}, {'measure': 'The Scores of SF-36 Quetionnaire', 'timeFrame': 'week 12, week 24', 'description': 'Score ranging from 0 to 100 with higher scores a better outcome.'}, {'measure': 'Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]', 'timeFrame': 'week 24', 'description': 'The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference). The Arthritis interference in the last month with household work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).higher scores mean a worse outcome.'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'week 12, week 24'}, {'measure': 'C Reactive Protein (CRP)', 'timeFrame': 'week 12, week 24'}, {'measure': "The Change From Baseline of Patient's Global Assessment of Disease Activity (PtGADA)", 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Patient's Global Assessment of Disease Activity Higher scores mean a worse outcome. The change from baseline of PtGADA, the minimum is -100, the maximum is 100. Higher scores mean a worse outcome."}, {'measure': "The Change From Baseline of Physician's Global Assessment of Disease Activity (PhGADA)", 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Physician's Global Assessment of Disease Activity higher scores mean a worse outcome. The change from baseline, the minimum is -100, the maximum is 100."}, {'measure': "The Change From Baseline of Patient's Assessment of Arthritis Pain (PtAAP)", 'timeFrame': 'week 12, week 24', 'description': "VAS score from 0 to 100 for Patient's Assessment of Arthritis Pain higher scores mean a worse outcome. The change from baseline of PtAAP, the minimum is -100, the maximum is 100."}, {'measure': 'Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]-2', 'timeFrame': 'week 24', 'description': 'In the last month, number of work days missed, number of work days with reduced productivity. In the last month, number of days with no household work, number of days with reduced household work productivity, number of days with hired outside help, number of days missed of family/social/leisure activities in the last month.higher scores mean a worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '35250032', 'type': 'DERIVED', 'citation': 'Zhang X, Miao M, Zhang R, Liu X, Zhao X, Shao M, Liu T, Jin Y, Chen J, Liu H, Zhang X, Li Y, Zhou Y, Yang Y, Li R, Yao H, Liu Y, Li C, Li Y, Ren L, Su Y, Sun X, He J, Li Z. Efficacy and safety of low-dose interleukin-2 in combination with methotrexate in patients with active rheumatoid arthritis: a randomized, double-blind, placebo-controlled phase 2 trial. Signal Transduct Target Ther. 2022 Mar 7;7(1):67. doi: 10.1038/s41392-022-00887-2.'}]}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).', 'detailedDescription': 'Each RA patients (n=47) with DAS\\>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX + Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ≥18 and ≤70 years of age at time of screening\n* Diagnosed with rheumatoid arthritis\n* Must have active disease with DMARDs (Disease Modifying Anti-Rheumatic Drugs) except MTX, the doses had been stable for at least 3 months before baseline\n* Moderate or severe rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-ESR) \\> 3.2\n* Have given written informed consent\n\nExclusion Criteria:\n\n* Patient presenting or having a history of other inflammatory joint disease\n* Patient with ongoing or previous Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme\n* Patient with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes or other than active rheumatoid arthritis\n* Persistent infection or severe infection within 3 months before enrollment,\n* Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study,\n* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult\n* Severe hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin \\< 30 g/L\n* Moderate or severe impairment of renal function, as known by serum creatinine \\> 133μmol/L (or 1.5 mg/dl)\n* Patient with history of recent and clinically significant drug or alcohol abuse\n* Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold the upper limit of normal\n* Known HIV positive status\n* Known positive serology for hepatitis B or C\n* Patient with hypersensitivity to any of the excipients in the tablets of methotrexate\n* Pregnancy\n* Breastfeeding\n* Women of childbearing potential, except if they fulfill specific conditions,\n* Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 month with the washout procedure)\n* Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation.\n* Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research\n* Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose\n* BMI(body mass index) under 18.5 kg/m2 or more than 30 kg/m2\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02467504', 'briefTitle': 'Low-dose Recombinant Human IL-2 for the Treatment of Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Randomized, Double Blind, Placebo-controlled Pilot-study to Evaluate Efficacy and Safety of Low-dose hrIL-2 in the Treatment of Methotrexate (MTX)-Naive Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'hrIL-2 RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental', 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen', 'interventionNames': ['Drug: hrIL-2 active', 'Drug: MTX', 'Drug: Folic Acid', 'Drug: Loxoprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen', 'interventionNames': ['Drug: hrIL-2 placebo', 'Drug: MTX', 'Drug: Folic Acid', 'Drug: Loxoprofen']}], 'interventions': [{'name': 'hrIL-2 active', 'type': 'DRUG', 'otherNames': ['Human recombinant IL-2'], 'description': 'hrIL-2 active (1 million U doses of hrIL-2s.c.injection)', 'armGroupLabels': ['Experimental']}, {'name': 'hrIL-2 placebo', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)', 'armGroupLabels': ['Placebo Comparator']}, {'name': 'MTX', 'type': 'DRUG', 'description': 'Methotrexate (oral administration)', 'armGroupLabels': ['Experimental', 'Placebo Comparator']}, {'name': 'Folic Acid', 'type': 'DRUG', 'description': 'Folic Acid (oral administration)', 'armGroupLabels': ['Experimental', 'Placebo Comparator']}, {'name': 'Loxoprofen', 'type': 'DRUG', 'description': 'Loxoprofen (oral administration)', 'armGroupLabels': ['Experimental', 'Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Department of Rheumatology and Immunology, Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhanguo Li, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Institute of Rheuamotology and Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Monash University', 'class': 'OTHER'}, {'name': 'Beijing ShuangLu Pharmaceutical Co., Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Dept. Rheumatology and immunology,Peking University People's Hospital", 'investigatorFullName': 'Zhanguo Li', 'investigatorAffiliation': "Peking University People's Hospital"}}}}