Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-03-30 @ 9:58 PM
Study NCT ID:
NCT01439204
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2011-09-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb
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': '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': 'Bristol-Myers Squibb 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': {'timeFrame': 'Day 1 to Day 71', 'eventGroups': [{'id': 'EG000', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.', 'otherNumAtRisk': 36, 'otherNumAffected': 11, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.', 'otherNumAtRisk': 36, 'otherNumAffected': 12, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '262', 'spread': '27', 'groupId': 'OG000'}, {'value': '255', 'spread': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 to 71', 'description': 'Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles. All completers had evaluable PK.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.55', 'upperLimit': '2.12'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '33195', 'spread': '26', 'groupId': 'OG000'}, {'value': '35255', 'spread': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams\\*hours per milliliter (µg\\*h/mL).', 'unitOfMeasure': 'µg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '39295', 'spread': '23', 'groupId': 'OG000'}, {'value': '41916', 'spread': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams\\*hour per milliliter (µg\\*h/mL).', 'unitOfMeasure': 'µg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '40385', 'spread': '23', 'groupId': 'OG000'}, {'value': '43229', 'spread': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg\\*h/mL.', 'unitOfMeasure': 'µg*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '344', 'spread': '87.6', 'groupId': 'OG000'}, {'value': '364', 'spread': '106', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).', 'unitOfMeasure': 'h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.237', 'spread': '24', 'groupId': 'OG000'}, {'value': '0.219', 'spread': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).', 'unitOfMeasure': 'mL/h/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.088', 'spread': '33', 'groupId': 'OG000'}, {'value': '0.083', 'spread': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).', 'unitOfMeasure': 'L/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) population: all participants who received study drug and had adequate PK profiles.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Positive Abatacept-induced Immunogenicity Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 29, 57, 71', 'description': 'Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Data Set: All participants with at least 1 postdose visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'title': 'Creatine Kinase (high) Day 2 (N=36)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (high) Day 15 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (high) Day 29 (N=34,33)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (high) Day 57 (N=31,33)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lactate Dehydrogenase (high) Day 2 (N=36)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood urea nitrogen (high) Day 15 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blood urea nitrogen (high) Day 29 (N=34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Blood urea nitrogen (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Direct (high) Day 29 (N=34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Direct (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fasting Glucose (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 to Day 71', 'description': 'Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'title': 'Any marked abnormalities Day 2 (N=36)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any marked abnormalities Day 15 (n=36,34)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (high) Day 29 (N=34,33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (high) Day 57 (N=31,33)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (absolute) (high) Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 2 to Day 72', 'description': 'Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11\\*10\\^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2\\*10\\^3/µL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received study drug (safety population) and had a laboratory assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (Lonza arm N=34; Devens arm N=33); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'title': 'Day 1 (1 hour post dose) (N=36)', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '9.06', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 (N=36)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '10.35', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 (N=36,34)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '12.09', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '8.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (N=33)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '10.94', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '9.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (N=31,33)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.96', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '9.48', 'groupId': 'OG001'}]}]}, {'title': 'Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '12.09', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '9.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received study drug (safety population) and had systolic assessment were included in the analysis. Days 1 and 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'title': 'Day 1 (1 hour post dose) N=36', 'categories': [{'measurements': [{'value': '-4.9', 'spread': '5.91', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '5.78', 'groupId': 'OG001'}]}]}, {'title': 'Day 2 (N=36)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Day 15 (N=36,34)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '7.45', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '7.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 29 (N=33)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '7.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 57 (N=31,33)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '7.48', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '7.56', 'groupId': 'OG001'}]}]}, {'title': 'Day 71 (N=36,34)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '8.59', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '5.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to Day 71', 'description': 'Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received study drug (safety population) and had diastolic assessment were included in the analysis. Day 2 N=36 both arms; Day 15 (Lonza arm N=36; Devens arm N=34; Day 29 (N=33 in both arms); Day 57 (Lonza arm N=31; Devens arm N=33); Day 71 (Lonza arm N=36; Devens arm N=34).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'OG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'classes': [{'title': 'Change from baseline in QT >60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in QT >30 msec < 60 msec', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in QTc >60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline in QTc >30 msec < 60 msec', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'QT > 500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QT > 450 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcF >450 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 71', 'description': '12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (\\>) 30 msec or less than (\\<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received study drug and had at least one ECG value.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'FG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'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': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'No longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'poor/non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '10 October 2011 to 11 Feb 2012. Participants who were randomized to an arm were admitted to a clinical facility the day prior to dosing (Day -1) and confined until 24 hours post the single dose; participants followed to Day 71.', 'preAssignmentDetails': 'Healthy participants who weighed between 60 and 100 kilograms, inclusive. 223 enrolled; 72 randomized to an arm. Reasons for not being randomized: 24 withdrew consent, 5 poor/non-compliance, 111 no longer met study criteria, 11 other. Participants were age and sex matched between treatment arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '750 mg Abatacept From Lonza, NH', 'description': 'A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'BG001', 'title': '750 mg Abatacept From Devens, MA', 'description': 'A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.6', 'spread': '10.02', 'groupId': 'BG000'}, {'value': '31.2', 'spread': '8.90', 'groupId': 'BG001'}, {'value': '31.4', 'spread': '9.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '62', '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': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.93', 'spread': '11.472', 'groupId': 'BG000'}, {'value': '79.39', 'spread': '11.057', 'groupId': 'BG001'}, {'value': '79.16', 'spread': '11.189', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'An inclusion criterion was that participants would weigh between 60 and 100 kilograms (kg), inclusive.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-21', 'studyFirstSubmitDate': '2011-09-21', 'resultsFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2011-09-22', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-30', 'studyFirstPostDateStruct': {'date': '2011-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Days 1 to 71', 'description': 'Cmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Cmax was measured in micro grams per milliliter (µg/mL).'}, {'measure': 'Time to Reach Maximum Concentration (Tmax) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'Tmax was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Tmax was measured in hours (h).'}, {'measure': 'Area Under the Concentration-time Curve (AUC) From Time Zero to 28 Days [AUC(0-28 Days)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - 28) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - 28) was measured in micro grams\\*hours per milliliter (µg\\*h/mL).'}, {'measure': 'Area Under the Concentration-time Curve From Zero to the Last Time of the Last Quantifiable Concentration [AUC(0-T)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - T) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - T) was measured in micro grams\\*hour per milliliter (µg\\*h/mL).'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity [AUC(0 - INF)] of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'AUC (0 - INF) was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). AUC (0 - INF) was measured in µg\\*h/mL.'}, {'measure': 'Terminal Phase Elimination Half-life (T-HALF) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'T-HALF was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). T-HALF was measured in hours (h).'}, {'measure': 'Total Body Clearance (CLT) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'CLT was the volume of abatacept cleared by the system, normalized by baseline body weight. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). CLT was measured in milliliters per hours per kilogram of body weight (mL/h/kg).'}, {'measure': 'Volume of Distribution at Steady-state (Vss) of Single Dose Abatacept - Pharmacokinetic Evaluable Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'Vss was derived from serum concentration versus time data. Serum samples were analyzed for abatacept by a validated enzyme-linked immunosorbent assay (ELISA) and were obtained at: predose (0 hours), 0.25 hours (h), 0.5, 1, 2, 6, 12, 24, 72, 168, 336, 504, 672, 1008, 1344, and 1688 h post dose (Days 1 to 71). The results were summarized. The lower limit of assay quantitation (LLOQ) was 1.00 nanograms per milliliter (ng/mL). Vss was measured in liters per kg body weight (L/kg).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Positive Abatacept-induced Immunogenicity Response', 'timeFrame': 'Days 29, 57, 71', 'description': 'Immunogenicity determination was based on titers of anti-abatacept and anti- cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4-T) antibodies in serum over time. A participant had a positive abatacept-induced immunogenicity if 1 of the following criteria were met: missing baseline measurement and a positive response after baseline; negative baseline response and positive response after baseline; a baseline response and a positive response after baseline that has a titer value strictly greater than the baseline titer value. A validated, sensitive, electrochemiluminescence assay (ECL) method was used to analyze the antibodies in serum. Samples confirmed positive with ECL and with abatacept serum concentrations of less than equal to 1 µg/mL were further analyzed with a validated, in vitro, cell-based bioassay to analyze the sera containing the abatacept neutralizing activity. Samples obtained on Days 29, 57 and 71 post dose of abatacept on Day 1 (baseline).'}, {'measure': 'Number of Participants With Marked Serum Chemistry Abnormalities on Days 2, 15, 29, 57 and 71 - Safety Population', 'timeFrame': 'Day 2 to Day 71', 'description': 'Blood samples obtained: Days 1, 2, 4, 8, 15, 22, 29, 43, 57 and 71. International Units per liter (U/L); milligram per deciliter (mg/dL); Male(M); Female (F). Reference ranges (low/high) for laboratories for which participants were identified with marked abnormalities during the study: Blood Urea Nitrogen (M/F) 10-20mg/dL ; Creatine Kinase (F) 21-21 U/L,(M) 32-294 U/L; Direct Bilirubin (M/F) 0.1-0.4 mg/dL ; Fasting Glucose (M/F) 70-110 mg/dL; Lactate Dehydrogenase (M/F) 110-209 U/L.'}, {'measure': 'Number of Participants With Marked Hematology Abnormalities on Days 2, 15, 29, 57, and 71 - Safety Population', 'timeFrame': 'Day 2 to Day 72', 'description': 'Blood samples obtained: Days 2, 4, 8, 15, 22, 29, 43, 57 and 71. Male(M); Female (F). Reference ranges (low/high) for laboratory parameters for which participants were identified with marked abnormalities during the study: Leukocytes (quantitative White blood cells) (M/F) 4-11\\*10\\^3/microliters (µL); Neutrophils (absolute)(M/F) 1.4- 8.2\\*10\\^3/µL.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure - Safety Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.'}, {'measure': 'Change From Baseline in Diastolic Blood Pressure on Days 1, 2, 15, 29, 57, and 71 - Safety Population', 'timeFrame': 'Day 1 to Day 71', 'description': 'Blood pressure was obtained while the participant had been quietly seated for at least 5 minutes. Baseline was the 0 hour measurement on Day 1 (day of dosing) or if this value was missing, the last measurement before dosing. Blood pressure was measured in millimeters of mercury (mmHg) on Days 1, 2, 15, 29, 57, and 71.'}, {'measure': 'Number of Participants With a Change From Baseline in QT Interval and Corrected (Fridericia) QT Interval (QTcF) - Safety Population', 'timeFrame': 'Day 1 to Day 71', 'description': '12-lead electrocardiograms were performed on a supine participant (5 minutes supine) at baseline (baseline = screening; Days -21 to -2) and at Day 71. QT interval and QTc were measured in mille seconds (msec). A change from baseline QT and QTc (corrected for heart rate by Fridericia formula) greater than (\\>) 30 msec or less than (\\<) 60 msec were presented, as well as values over 450 and 500 msec. QT interval on ECG image defined as: time from the beginning of the QRS (complex consisting of Q, R and S waves) to the end of the T wave.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects', 'detailedDescription': 'Primary Purpose of this study is to compare the pharmacokinetic (PK) of Abatacept (BMS-188667) manufactured at Lonza relative to Abatacept (BMS-188667) manufactured at Devens, MA facility following a single intravenous infusion of 750 mg in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations\n* Body weight will be between 60 and 100 kg, inclusive\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* Any major surgery within 4 weeks of study drug administration\n* Smoking more than 10 cigarettes per day\n* Recent (within 6 months of study drug administration) drug or alcohol abuse.\n* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus-1, Human Immunodeficiency Virus-2 antibody\n* History of any significant drug allergy or asthma\n* Women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period'}, 'identificationModule': {'nctId': 'NCT01439204', 'briefTitle': 'Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, Massachusetts (MA) Facility of Bristol-Myers Squibb', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Open-label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of Abatacept (BMS-188667) Drug Products Using Active Pharmaceutical Ingredient Manufactured at Devens, MA Site Relative to Active Pharmaceutical Ingredient Manufactured at Lonza, New Hampshire (NH) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM101-292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Abatacept (BMS-188667) manufactured at Lonza, NH facility', 'interventionNames': ['Biological: Abatacept (BMS-188667)']}, {'type': 'EXPERIMENTAL', 'label': 'Abatacept (BMS-188667) manufactured at Devens, MA facility', 'interventionNames': ['Biological: Abatacept (BMS-188667)']}], 'interventions': [{'name': 'Abatacept (BMS-188667)', 'type': 'BIOLOGICAL', 'otherNames': ['BMS-188667'], 'description': 'Solution for injection, Intravenous, 750 mg, Single dose, 1 day,', 'armGroupLabels': ['Abatacept (BMS-188667) manufactured at Devens, MA facility', 'Abatacept (BMS-188667) manufactured at Lonza, NH facility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Icon Clinical Pharmacology Unit, Llc', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}