Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-29 @ 1:14 AM
Study NCT ID:
NCT00705367
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2008-06-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'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': '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': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Abatacept 30 mg/kg', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'OROPHARYNGEAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Discontinued due to AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Acute infusional AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Peri-infusional AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of double-blind period to 1st dose of long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuations due to AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 infusion of abatacept during the open-label long-term extension period of the study.'}, {'type': 'SECONDARY', 'title': 'Minimum (Cmin) Plasma Concentration of Abatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'title': 'Day 15 (n=6)', 'categories': [{'measurements': [{'value': '55.47', 'spread': '29.356', 'groupId': 'OG000'}]}]}, {'title': 'Day 29 (N=9)', 'categories': [{'measurements': [{'value': '42.69', 'spread': '12.534', 'groupId': 'OG000'}]}]}, {'title': 'Day 85 (n=8)', 'categories': [{'measurements': [{'value': '18.54', 'spread': '11.492', 'groupId': 'OG000'}]}]}, {'title': 'Day 169 (n=7)', 'categories': [{'measurements': [{'value': '22.66', 'spread': '10.312', 'groupId': 'OG000'}]}]}, {'title': 'Day 253 (n=7)', 'categories': [{'measurements': [{'value': '28.24', 'spread': '13.883', 'groupId': 'OG000'}]}]}, {'title': 'Day 337 (n=4)', 'categories': [{'measurements': [{'value': '25.98', 'spread': '6.833', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 15, 29, 85, 169, 253 and 337', 'description': 'Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: Number of Adverse Events (AEs) Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Dizziness (mild)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Oropharyngeal pain (mild)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea (mild)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 of double-blind period to 1st dose of long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: MeanSystolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Systolic blood pressure: Day 1 predose', 'categories': [{'measurements': [{'value': '129.0', 'spread': '20.47', 'groupId': 'OG000'}, {'value': '133.0', 'spread': '8.89', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure: Day 1 postdose', 'categories': [{'measurements': [{'value': '125.8', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '131.7', 'spread': '9.29', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure: Day 1 predose', 'categories': [{'measurements': [{'value': '84.2', 'spread': '8.86', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '12.06', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure: Day 1 postdose', 'categories': [{'measurements': [{'value': '82.7', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '82.7', 'spread': '14.22', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure: Day 2', 'categories': [{'measurements': [{'value': '127.5', 'spread': '13.69', 'groupId': 'OG000'}, {'value': '126.7', 'spread': '11.55', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure: Day 2', 'categories': [{'measurements': [{'value': '79.5', 'spread': '8.69', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '10.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Day 1 predose', 'categories': [{'measurements': [{'value': '77.0', 'spread': '8.49', 'groupId': 'OG000'}, {'value': '81.0', 'spread': '10.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 postdose', 'categories': [{'measurements': [{'value': '81.2', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '87.7', 'spread': '19.60', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '83.5', 'spread': '4.46', 'groupId': 'OG000'}, {'value': '84.0', 'spread': '5.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital signs measurements are summarized without regard to position (sitting, standing, supine).', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: Mean Respirations Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Day 1 predose', 'categories': [{'measurements': [{'value': '17.7', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 postdose', 'categories': [{'measurements': [{'value': '18.7', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '2.52', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '14.0', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).', 'unitOfMeasure': 'Respirations per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Maximum (Cmax) Plasma Concentration of Abatacept', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '463.10', 'spread': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdosing Day 1', 'description': "Cmax is a drug's maximum, or peak, concentration observed after its administration.", 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug and had a serum concentration measurement relative to dosing time. n=number of evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: Mean Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Day 1 predose', 'categories': [{'measurements': [{'value': '36.7', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '36.7', 'spread': '0.15', 'groupId': 'OG001'}]}]}, {'title': 'Day 1 postdose', 'categories': [{'measurements': [{'value': '36.8', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '36.9', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '36.9', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).', 'unitOfMeasure': 'Degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}], 'classes': [{'title': 'Laboratory Abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ECG Abnormalities', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and Days 1 and 2', 'description': 'Laboratory tests consisted of complete blood count, chemistry, and urinalysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study drug'}, {'type': 'SECONDARY', 'title': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept, 30/10 mg/kg', 'description': 'Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'title': 'Hemoglobin (low)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin (high)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (low)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (high)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes (high)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Platelet count (low or high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes (low)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils +bands (absolute) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils +bands (absolute) (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute lymphocytes (low)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute lymphocytes (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute monocytes (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Absolute monocytes (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute basophils (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Absolute basophils (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute eosinophils (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Absolute eosinophils (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): \\>3g/dL drop from preRX; hematocrit (%): \\<0.75\\*preRX; erythrocytes (\\*10\\^6 c/uL): \\<0.75\\*preRX; platelet count (\\*10\\^9 c/L): \\<0.67\\*LLN or \\>1.5\\*ULN, or \\<100,000/mm\\^3 or if preRX\\<LLN, use \\<0.5\\*preRX and \\<100,000/mm\\^3; leukocytes (\\*10\\^3 c/uL): \\<0.75\\*LLN, \\>1.25\\*ULN, \\<0.8\\*preRX if preRX \\<LLN or \\>1.2\\*preRX if preRX \\>ULN; \\>ULN if preRX \\<LLN, \\<LLN if \\>ULN preRX; neutrophils+bands (\\*10\\^3 c/uL): if value \\<1.00\\*10\\^3 c/uL; lymphocytes (\\*10\\^3 c/uL): if value \\<0.750\\*10\\^3 c/uL or if value \\>7.50\\*10\\^3 c/uL; monocytes (\\*10\\^3 c/uL): if value \\>2000/mm\\^3; basophils (\\*10\\^3 c/uL): if value \\>400/mm\\^3; eosinophils (\\*10\\^3 c/uL): if value\\> 0.750\\*10\\^3 c/uL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept, 30/10 mg/kg', 'description': 'Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'title': 'Glucose, serum (low)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, serum (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, fasting serum (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, fasting serum (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Protein, total (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Protein, total (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Albumin (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Albumin (high)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Uric acid (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluable', 'groupId': 'OG000'}]}]}, {'title': 'Uric acid (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Protein, urine (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Protein, urine (high)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, urine (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Glucose, urine (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood, urine (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Blood, urine (high)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'WBC, urine (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'White blood cell (WBC) count, urine (high)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): \\<65 or \\>220. Glucose, fasting(mg/dL): \\<0.8\\*LLN or \\>1.5\\* ULN; if preRX\\<LLN, use \\<0.8\\*preRX or \\>ULN; if preRX\\>ULN, use \\>2.0\\*preRX or \\<LLN. Protein, total (g/dL): \\<0.9\\*LLN or \\>1.1\\*ULN; if preRX\\<LLN, use 0.9\\*preRX or \\>ULN if preRX \\>ULN, use 1.1\\*preRX or \\<LLN. Albumin (g/dL): \\<0.9\\*LLN, or if preRX\\<LLN use \\<0.75\\*preRX. Uric acid (mg/dL): \\>1.5\\*ULN; if preRX\\>ULN use \\>2\\*preRX. Protein, urine: if missing preRX, use\\>=2; if \\>=4; if preRX=0 or 0.5, use \\>=2; if preRX=1, use \\>=3, or if preRX=2 or 3, use \\>= 4. Glucose, urine: if preRX missing, use \\>=2; if \\>=4, or if preRX=0 or 0.5 use \\>=2,or if preRX=1, use \\>=3, or if preRX=2 or 3 use \\>=4. Blood, urine: if preRX missing, use\\>= 2, or if \\>=4, or if preRX=0 or 0.5, use \\>=2, or if preRX=1, use \\>=3; if preRX=2 or 3 use \\>=4. WBC, urine (hpf): if missing preRX, use\\>= 2, or if \\>= 4, or if preRX =0 or 0.5 use \\>=2, or if preRX=1 use \\>=3, or if preRX=2 or 3 use \\>=4.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept, 30/10 mg/kg', 'description': 'Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'title': 'Alkaline phosphatase (ALP) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'ALP (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate aminotransferase (AST) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'AST (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Alanine aminotransferase (ALT) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'ALT (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'G-glutamyl transferase (GGT) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'GGT (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, total (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin, total (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Blood urea nitrogen (BUN) (low)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not evaluated', 'groupId': 'OG000'}]}]}, {'title': 'BUN (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, serum (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sodium, serum (high)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, serum (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Potassium, serum (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, serum (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chloride, serum (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, total (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Calcium, total (high)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus, inorganic (low)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phosphorus, inorganic (high)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): \\>2\\*ULN, or if preRX\\>ULN, use \\>3\\*preRX; AST (U/L): \\>3\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; ALT (U/L): \\>3X\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; GGT (/L): \\>\\*ULN, or if preRX\\>ULN, use \\>3\\*preRX; bilirubin (mg/dL): \\>2\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; BUN (mg/dL):\\>2\\*preRX; sodium: \\<.95\\*LLN, \\>1.05\\*ULN, \\<.95\\* preRX if \\<LLN preRX, \\>1.05\\*preRX if \\>ULN preRX; \\>ULN if \\<LLN preRX, \\<LLN if \\>ULN preRX; potassium: chloride: calcium: phosphorous:', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Long-term Period: Number of Participants With Abatacept-specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Abatacept (10 mg/kg)', 'description': 'Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day15 to 56 days post last dose of the long-term period', 'description': 'Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of abatacept and had an immunogenicity test result.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Abatacept, 30/10 mg/kg', 'description': 'Short-term period: Participants received a single dose of 30-mg/kg dose of abatacept intravenously (IV) Long-term period: All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}, {'id': 'FG001', 'title': 'Placebo/Abatacept,10 mg/kg', 'description': 'Short-term period: Participants received a single dose of placebo intravenously Long-term period: Placebo arm discontinued. All participants received 10-mg/kg dose of abatacept IV on days 15 and 29 followed by doses every 4 weeks until the end of the study'}], 'periods': [{'title': 'Short-term Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Long-term Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'No longer met study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative reason by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Thirteen (13) participants were enrolled in the short-term period of the study. Four (4/13, 30.8%) of these participants were not randomized: 3 (23.1%) no longer met study criteria after screening, and 1 (7.7%) withdrew consent. All 9 participants who completed the short-term period entered the long-term period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Abatacept (30 mg/kg)', 'description': 'Infusion, Intravenous, 30 mg/kg, single dose, 24 hours'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Infusion, Intravenous, single dose, 24 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.50', 'spread': '8.76', 'groupId': 'BG000'}, {'value': '41.33', 'spread': '8.33', 'groupId': 'BG001'}, {'value': '35.44', 'spread': '9.21', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Lupus Nephritis', 'classes': [{'categories': [{'measurements': [{'value': '41.23', 'spread': '32.90', 'groupId': 'BG000'}, {'value': '85.26', 'spread': '65.03', 'groupId': 'BG001'}, {'value': '55.90', 'spread': '47.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Systemic Lupus Erythematosus (SLE)', 'classes': [{'categories': [{'measurements': [{'value': '7.20', 'spread': '5.06', 'groupId': 'BG000'}, {'value': '11.11', 'spread': '3.18', 'groupId': 'BG001'}, {'value': '8.50', 'spread': '4.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '58.83', 'spread': '10.38', 'groupId': 'BG000'}, {'value': '63.67', 'spread': '4.04', 'groupId': 'BG001'}, {'value': '60.44', 'spread': '8.79', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2008-06-24', 'resultsFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2008-06-24', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-04', 'studyFirstPostDateStruct': {'date': '2008-06-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term Period: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths, Discontinuations and Infusional AEs', 'timeFrame': 'From Day 1 of double-blind period to 1st dose of long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Short-term Period: Number of Adverse Events (AEs) Related to Study Drug', 'timeFrame': 'From Day 1 of double-blind period to 1st dose of long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. Intensity = mild (grade 1), moderate (grade 2), severe (grade 3), life-threatening/disabling (grade 4).'}, {'measure': 'Short-term Period: MeanSystolic and Diastolic Blood Pressure', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).'}, {'measure': 'Short-term Period: Mean Heart Rate', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital signs measurements are summarized without regard to position (sitting, standing, supine).'}, {'measure': 'Short-term Period: Mean Respirations Rate', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).'}, {'measure': 'Short-term Period: Mean Temperature', 'timeFrame': 'Day 1 predose and postdose and Day 2', 'description': 'Vital sign measurements are summarized without regard to position (sitting, standing, supine).'}, {'measure': 'Short-term Period: Number of Participants With Clinical Laboratory and Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Screening and Days 1 and 2', 'description': 'Laboratory tests consisted of complete blood count, chemistry, and urinalysis.'}], 'secondaryOutcomes': [{'measure': 'Long-term Period: Number of Participants With Death as Outcome, Serious AEs (SAEs), Discontinuations Due to AEs, and Treatment-related AEs', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. Related AE=relationship of certain, probable, possible, or missing. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.'}, {'measure': 'Minimum (Cmin) Plasma Concentration of Abatacept', 'timeFrame': 'Days 15, 29, 85, 169, 253 and 337', 'description': 'Cmin is the minimum, or trough, concentration of a drug observed after its administration and just prior to the administration of a subsequent dose.'}, {'measure': 'Maximum (Cmax) Plasma Concentration of Abatacept', 'timeFrame': 'Postdosing Day 1', 'description': "Cmax is a drug's maximum, or peak, concentration observed after its administration."}, {'measure': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. hemoglobin (g/dL): \\>3g/dL drop from preRX; hematocrit (%): \\<0.75\\*preRX; erythrocytes (\\*10\\^6 c/uL): \\<0.75\\*preRX; platelet count (\\*10\\^9 c/L): \\<0.67\\*LLN or \\>1.5\\*ULN, or \\<100,000/mm\\^3 or if preRX\\<LLN, use \\<0.5\\*preRX and \\<100,000/mm\\^3; leukocytes (\\*10\\^3 c/uL): \\<0.75\\*LLN, \\>1.25\\*ULN, \\<0.8\\*preRX if preRX \\<LLN or \\>1.2\\*preRX if preRX \\>ULN; \\>ULN if preRX \\<LLN, \\<LLN if \\>ULN preRX; neutrophils+bands (\\*10\\^3 c/uL): if value \\<1.00\\*10\\^3 c/uL; lymphocytes (\\*10\\^3 c/uL): if value \\<0.750\\*10\\^3 c/uL or if value \\>7.50\\*10\\^3 c/uL; monocytes (\\*10\\^3 c/uL): if value \\>2000/mm\\^3; basophils (\\*10\\^3 c/uL): if value \\>400/mm\\^3; eosinophils (\\*10\\^3 c/uL): if value\\> 0.750\\*10\\^3 c/uL'}, {'measure': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'preRX=pretreatment; LLN=lower limit of normal; ULN=upper limit of normal. Glucose (mg/dL): \\<65 or \\>220. Glucose, fasting(mg/dL): \\<0.8\\*LLN or \\>1.5\\* ULN; if preRX\\<LLN, use \\<0.8\\*preRX or \\>ULN; if preRX\\>ULN, use \\>2.0\\*preRX or \\<LLN. Protein, total (g/dL): \\<0.9\\*LLN or \\>1.1\\*ULN; if preRX\\<LLN, use 0.9\\*preRX or \\>ULN if preRX \\>ULN, use 1.1\\*preRX or \\<LLN. Albumin (g/dL): \\<0.9\\*LLN, or if preRX\\<LLN use \\<0.75\\*preRX. Uric acid (mg/dL): \\>1.5\\*ULN; if preRX\\>ULN use \\>2\\*preRX. Protein, urine: if missing preRX, use\\>=2; if \\>=4; if preRX=0 or 0.5, use \\>=2; if preRX=1, use \\>=3, or if preRX=2 or 3, use \\>= 4. Glucose, urine: if preRX missing, use \\>=2; if \\>=4, or if preRX=0 or 0.5 use \\>=2,or if preRX=1, use \\>=3, or if preRX=2 or 3 use \\>=4. Blood, urine: if preRX missing, use\\>= 2, or if \\>=4, or if preRX=0 or 0.5, use \\>=2, or if preRX=1, use \\>=3; if preRX=2 or 3 use \\>=4. WBC, urine (hpf): if missing preRX, use\\>= 2, or if \\>= 4, or if preRX =0 or 0.5 use \\>=2, or if preRX=1 use \\>=3, or if preRX=2 or 3 use \\>=4.'}, {'measure': 'Long-term Period: Number of Participants With Marked Abnormalities in Results of Clinical Laboratory Tests (Continued)', 'timeFrame': 'Days 15 to 56 days post last dose of the long-term period', 'description': 'ULN=upper limit of normal; preRX=pretreatment: ALP (U/L): \\>2\\*ULN, or if preRX\\>ULN, use \\>3\\*preRX; AST (U/L): \\>3\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; ALT (U/L): \\>3X\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; GGT (/L): \\>\\*ULN, or if preRX\\>ULN, use \\>3\\*preRX; bilirubin (mg/dL): \\>2\\*ULN, or if preRX\\>ULN, use \\>4\\*preRX; BUN (mg/dL):\\>2\\*preRX; sodium: \\<.95\\*LLN, \\>1.05\\*ULN, \\<.95\\* preRX if \\<LLN preRX, \\>1.05\\*preRX if \\>ULN preRX; \\>ULN if \\<LLN preRX, \\<LLN if \\>ULN preRX; potassium: chloride: calcium: phosphorous:'}, {'measure': 'Long-term Period: Number of Participants With Abatacept-specific Antibodies', 'timeFrame': 'Day15 to 56 days post last dose of the long-term period', 'description': 'Antiabatacept antibodies in human serum were assayed using a validated electrochemiluminescent immunoassay during the period of known analyte stability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis']}, 'referencesModule': {'references': [{'pmid': '11678454', 'type': 'BACKGROUND', 'citation': 'Liu MF, Wang CR, Lin LC, Wu CR. CTLA-4 gene polymorphism in promoter and exon-1 regions in Chinese patients with systemic lupus erythematosus. Lupus. 2001;10(9):647-9. doi: 10.1191/096120301682430249.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether abatacept at a dose 30 mg/kg via intravenous infusion is safe and well tolerated in the treatment of lupus nephritis in mainland Chinese subjects with systemic lupus erythematosus (SLE)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, at least 18 years of age, with a diagnosis of systemic lupus erythematosus (SLE) and with lupus nephritis currently stable for the last 3 months without change in treatment for lupus nephritis\n* Stable renal disease\n* No flaring of other organ systems in a minimum of the last 3 months\n\nExclusion Criteria:\n\n* Unstable lupus nephritis and serum creatinine \\>3 mg/dL\n* Progressive renal failure, end stage renal disease, or renal transplant requiring continuous dialysis\n* Severe unstable, refractory, or progressive SLE\n* History of cancer\n* Participants at risk for tuberculosis\n* Autoimmune disease other than SLE as main diagnosis\n* Human immunodeficiency virus or herpes zoster infection\n* Hepatitis-B surface antigen-positive or hepatitis C antibody-positive participants'}, 'identificationModule': {'nctId': 'NCT00705367', 'briefTitle': 'Phase I Study in China - Tolerability of a Single Dose of Abatacept 30 mg/kg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Single Center, Randomized, Placebo-Controlled, Double Blind, Parallel Group Study to Evaluate the Tolerability of a Single Dose of Abatacept 30 mg/kg Via Intravenous Infusion in Chinese SLE Subjects With Lupus Nephritis', 'orgStudyIdInfo': {'id': 'IM101-217'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept, 30 mg/kg', 'interventionNames': ['Drug: Abatacept']}, {'type': 'OTHER', 'label': 'Abatacept, 10 mg/kg', 'description': 'Open-label long-term extension phase', 'interventionNames': ['Drug: Abatacept']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Infusion, Intravenous, single dose, Day 1', 'armGroupLabels': ['Placebo']}, {'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia', 'BMS-188667'], 'description': 'Infusion, Intravenous, 30mg/kg, single dose, Day 1', 'armGroupLabels': ['Abatacept, 30 mg/kg']}, {'name': 'Abatacept', 'type': 'DRUG', 'otherNames': ['Orencia', 'BMS-188667'], 'description': 'Infusion, intravenous, 10 mg/kg, administered on Days 15 and 29 followed by doses every 4 weeks until the end of the study', 'armGroupLabels': ['Abatacept, 10 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200001', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Local Institution', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}