Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02429934
Status:
TERMINATED
Last Update Posted:
2021-05-13
First Post:
2015-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Abatacept for SLE Arthritis (IM101-330)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001168', 'term': 'Arthritis'}], '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'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bhahn@mednet.ucla.edu', 'phone': '8184869745', 'title': 'Dr. Bevra Hahn', 'phoneExt': '8184869745', 'organization': 'University of California at Los Angeles'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for 20 weeks after initial dose (visit 1)', 'description': 'We used clinicaltrials.gov definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 6, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 3, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin reaction at injection site', 'notes': 'soreness and tenderness around point of subcutaneous injection for 1-2 days post injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'flare of lupus nephritis', 'notes': 'Patient developed increased proteinuria, was removed from clinical trial and treated with increased immunosuppression and problem resolved, Judged not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'title': '8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': '16 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, 8 Weeks, 16 Weeks', 'description': 'Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'subjects that completed the 8 and 16 week study visits'}, {'type': 'SECONDARY', 'title': 'Change in SLEDAI 2K', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injections weekly for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4545', 'spread': '3.2669', 'groupId': 'OG000'}, {'value': '-3.4000', 'spread': '2.8363', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'completers at 16 weeks'}, {'type': 'SECONDARY', 'title': 'Change in the PGA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3650', 'spread': '3.7029', 'groupId': 'OG000'}, {'value': '-0.3350', 'spread': '2.2289', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': "Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome", 'unitOfMeasure': 'points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SLE subjects completing 16 weeks of treatment or placebo and attending the 16-week physician assessment visit.'}, {'type': 'SECONDARY', 'title': 'Clinical Disease Activity Index (CDAI) Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7850', 'spread': '12.0459', 'groupId': 'OG000'}, {'value': '14.5700', 'spread': '7.9701', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': "CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\\<=) 2.8 indicates disease remission, greater than (\\>) 2.8 to 10 = low disease activity, greater than (\\>) 10 to 22 = moderate disease activity, and \\>22 = high disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'sle subjects that completed 16 week assessment visit'}, {'type': 'SECONDARY', 'title': 'Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'title': 'baseline GSUS', 'categories': [{'measurements': [{'value': '17.50', 'spread': '7.05', 'groupId': 'OG000'}, {'value': '16.00', 'spread': '4.83', 'groupId': 'OG001'}]}]}, {'title': '16 week GSUS', 'categories': [{'measurements': [{'value': '12.75', 'spread': '2.22', 'groupId': 'OG000'}, {'value': '17.75', 'spread': '5.19', 'groupId': 'OG001'}]}]}, {'title': 'baseline PDUS', 'categories': [{'measurements': [{'value': '5.25', 'spread': '5.12', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': '16 week PDUS', 'categories': [{'measurements': [{'value': '2.00', 'spread': '1.83', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'completers of 16 weeks of treatment/placebo at one study center (UCLA)'}, {'type': 'SECONDARY', 'title': 'Number of AEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'title': 'AEs grade II or less', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'AEs not related', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'AEs possibly related', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'AEs probably related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'AEs grade III or higher', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects dosed with either abatacept or placebo at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Tender and Swollen Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.73', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '5.00', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '1.54', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.82', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 4, 8, 12 and 16 weeks', 'description': 'Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each timepoint reports the number of participants who attended each visit for physician assessment'}, {'type': 'SECONDARY', 'title': 'Change in the Total Sum of Tender and Swollen Joints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.1818', 'spread': '4.2619', 'groupId': 'OG000'}, {'value': '-4.2000', 'spread': '1.3116', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients Who Tapered Prednisone to <10mg/Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo injected subcutaneously weekly for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day. Among all the subjects entered, 6 in each group were taking 10 mg of prednisone daily or higher at baseline'}, {'type': 'SECONDARY', 'title': 'Mean Prednisone Dose (mg/Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.73', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '4.77', 'spread': '6.64', 'groupId': 'OG001'}]}]}, {'title': '8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.46', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '5.64', 'spread': '6.89', 'groupId': 'OG001'}]}]}, {'title': '16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.45', 'spread': '10.04', 'groupId': 'OG000'}, {'value': '5.70', 'spread': '7.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 and 16 weeks', 'description': 'prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results are reported for the number of participants who completed the study visit/assessment at each time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept', 'description': 'abatacept: 125mg injected subcutaneously weekly for 16 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo subcutaneous injection weekly for 16 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '40.8', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'education', 'classes': [{'categories': [{'title': 'high school', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '2 year college', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': '4 year college', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'trade school', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': "master's degree", 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'professional', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'insurance', 'classes': [{'categories': [{'title': 'PPO', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'HMO', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Medicare', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Medicaid', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'smoking history', 'classes': [{'categories': [{'title': 'never smoked', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'past smoker', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'current smoker', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-11', 'size': 1160998, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-15T18:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Response rate in placebo group for primary outcome was 100% on interim analysis.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2015-04-24', 'resultsFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-05-11', 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count', 'timeFrame': 'Baseline, 8 Weeks, 16 Weeks', 'description': 'Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.'}], 'secondaryOutcomes': [{'measure': 'Change in SLEDAI 2K', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement.'}, {'measure': 'Change in the PGA Score', 'timeFrame': 'Baseline, 16 weeks', 'description': "Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome"}, {'measure': 'Clinical Disease Activity Index (CDAI) Index Score', 'timeFrame': '16 weeks', 'description': "CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (\\<=) 2.8 indicates disease remission, greater than (\\>) 2.8 to 10 = low disease activity, greater than (\\>) 10 to 22 = moderate disease activity, and \\>22 = high disease activity."}, {'measure': 'Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS)', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level.'}, {'measure': 'Number of AEs and SAEs', 'timeFrame': '16 weeks', 'description': 'Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug'}, {'measure': 'Number of Tender and Swollen Joints', 'timeFrame': 'baseline, 4, 8, 12 and 16 weeks', 'description': 'Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit'}, {'measure': 'Change in the Total Sum of Tender and Swollen Joints', 'timeFrame': 'Baseline, 16 weeks', 'description': 'Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit'}, {'measure': 'Number of Patients Who Tapered Prednisone to <10mg/Day', 'timeFrame': '16 weeks', 'description': 'This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day.'}, {'measure': 'Mean Prednisone Dose (mg/Day)', 'timeFrame': 'Baseline, 8 and 16 weeks', 'description': 'prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Systemic Lupus Erythematosus (SLE)', 'Abatacept (Orencia)', 'Arthritis'], 'conditions': ['Systemic Lupus Erythematosus Arthritis']}, 'descriptionModule': {'briefSummary': 'This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.\n\nThe purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits.\n\nStudy Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet.\n\nIn this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Meet at least 4 of the 11 American College of Rheumatology (ACR) 1997 criteria for classification of SLE (see Appendix 1).OR meet the recent classification recommended by SLICC (Appendix 2) 6\n2. ≥3 swollen and tender joints on 2 examinations at least 2 weeks apart and no more than 8 weeks apart.\n3. SLEDAI2K score ≥4 indicating active disease.\n4. Documented positive ANA (≥1:80) and/or anti-dsDNA during course of SLE.\n5. Men and women, at least 18 years of age. Women of childbearing potential must use adequate method(s) of contraception to avoid pregnancy throughout the study and for up to 2 months after last study drug dose. They must have a negative serum or urine pregnancy test prior to the start of study medication.\n6. Background therapies allowed: antimalarials (dose constant for ≥ one month before study entry and during 16 weeks of trial), methotrexate (same criteria as for antimalarials), azathioprine (same criteria), mycophenolate (same criteria), leflunomide (same criteria).\n\nDuring the screening period and for up to 6 weeks after randomization, a daily prednisone (or equivalent) regimen of up to 20 mg daily may be initiated to treat the moderate to severe disease activity present at screening. The initial steroid regimen is not required if investigators or patients believe that the risks would outweigh the potential benefits. Patients who do not take any glucocorticoids during the study will be included in the treatment groups and analysis.\n\n\\*Steroids should be tapered to a target dose of no more than 10 mg/day of prednisone (or equivalent) by the end of Week 8 (Day 56). The steroid regimen should be tapered as quickly as safely possible. Prednisone dose requirements higher than 10 mg daily at the 8 week visit will cause the patient to be ruled a non-responder for the abatacept treatment arm.\n\nExclusion Criteria:\n\n1. Subjects with active infection requiring oral or IV antibiotics within one month of first dose of study medication.\n2. Subjects with BILAG A in any system outside the musculoskeletal system.\n3. Subjects with positive quantiferon Gold test in the absence of treatment for tuberculosis.\n4. Subjects with positive tests for active infection with hepatitis B or C during the past 6 months. Any confirmed positive test for HIV at any time prior to entry into this study.\n5. Subjects with active glomerulonephritis (\\>3 g protein/24h and/or active urine sediment).\n6. Subjects with active CNS disease.\n7. Subjects with any other serious disease that would require immunosuppressive or parenteral anti-microbial therapy outside the study protocol.\n8. Inability to self-administer subcutaneous injections, to comply with instructions, or to keep appointments for study visits.\n9. Treatment with rituximab within the past 6 months (B cells must be detectable in peripheral blood at onset of treatment with study biologic), belimumab within the past 5 months, cyclophosphamide within the past 3 months.\n10. Treatment with any other immunomodulatory biologic or cyclophosphamide during treatment with abatacept is not allowed.\n11. Patients requiring \\>20 mg of prednisone daily.\n12. Women who are pregnant or breast feeding.\n13. Women of child bearing potential unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 2 months after last study drug.\n14. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection).\n15. Any laboratory test results that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study.'}, 'identificationModule': {'nctId': 'NCT02429934', 'briefTitle': 'Abatacept for SLE Arthritis (IM101-330)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'IM101-330 SLE Arthritis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept also known as Orencia also known as CTLA4Ig', 'description': '32 SLE patients to be treated with subcutaneous abatacept 125mg sq once a week for 16 weeks.', 'interventionNames': ['Biological: abatacept also known as Orencia also known as CTLA4-Ig']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '32 SLE patients to be treated with subcutaneous placebo once a week for 16 weeks. Injection will be vehicle injected subcutaneously once a week for 16 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'abatacept also known as Orencia also known as CTLA4-Ig', 'type': 'BIOLOGICAL', 'otherNames': ['Orencia'], 'description': '125mg injected subcutaneously weekly for 16 weeks', 'armGroupLabels': ['Abatacept also known as Orencia also known as CTLA4Ig']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA David Geffen School of Medicine, Division of Rheumatology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Bevra Hahn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}