Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-02-24 @ 3:15 PM
Study NCT ID:
NCT01240694
Status:
TERMINATED
Last Update Posted:
2022-12-30
First Post:
2010-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C535176', 'term': 'spliceosomal peptide P140'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to business decision; there were no safety issues.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 72', 'description': 'Safety analysis set included all enrolled participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 89, 'seriousNumAtRisk': 136, 'deathsNumAffected': 0, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 17, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 26, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Systemic lupus erythematosus rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myelitis transverse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 72', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': 'An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI 2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \\>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \\>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Change at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '3.10', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '3.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '3.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '3.34', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '3.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '3.94', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '4.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '5.52', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '6.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.62', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': "The BILAG-2004 is a validated objective and subjective global measure of the SLE disease activity, based on the physician's intention to treat, and refers to disease activity within the last 4 weeks before completion of the index. It includes 97 clinical and laboratory components to evaluate SLE disease activity in 9 different body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each body system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stab1e or mild disease; D=previous system involvement but no current disease activity; and E=no current disease activity and the body system has never been involved. BILAG 2004 response was defined as no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': "Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Week 68', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': 'The PhGA was completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicates worsening. The number of participants showing no worsening are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': "Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 12', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 72', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12, 24, 36, 48, 60, and 72', 'description': 'The PtGA was completed by the participant, using a 3-inch VAS labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicated worsening. The number of participants showing no worsening are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short-Form 36 (SF-36) Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Bodily pain: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '16.43', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain: Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '20.68', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain: Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '23.09', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain: Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '16.18', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain: Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '28.59', 'groupId': 'OG000'}]}]}, {'title': 'Bodily pain: Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '20.26', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '12.28', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '15.57', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '17.20', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '14.36', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '15.45', 'groupId': 'OG000'}]}]}, {'title': 'Physical functioning: Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '17.04', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '15.18', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '19.43', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '21.87', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '22.75', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '21.06', 'groupId': 'OG000'}]}]}, {'title': 'Social functioning: Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '20.56', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '15.28', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '18.04', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '19.03', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '17.78', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '23.25', 'groupId': 'OG000'}]}]}, {'title': 'Vitality: Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '15.94', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])', 'description': 'The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) physical role functioning, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) emotional role functioning, and 8) mental health. All domains are scored on a scale from 0 (worst) to 100 (best), with higher scores representing the best possible health state. Change from baseline scores in the following individual standardized domains: Bodily pain, physical functioning, social functioning and vitality were presented.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for specified category."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193.0', 'spread': '505.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '313.6', 'spread': '642.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '199.2', 'spread': '497.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '327.7', 'spread': '643.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '480.1', 'spread': '723.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '154.7', 'spread': '470.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])', 'description': 'Anti-UI RNP Ab was measured from blood serum collected at specified time points.', 'unitOfMeasure': 'units (U)/milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Biomarker: C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])', 'description': 'CRP was measured from blood serum samples at specified time points.', 'unitOfMeasure': 'milligrams (mg)/deciliter (dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-nuclear Antibodies (ANA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'title': 'None detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '<1:40', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '1:40', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': '1:80', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': '1:160', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': '1:320', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': '1:640', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': '1:1280', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '>=1:1280', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Anti-nuclear antibodies (ANA) were measured from blood serum samples at specified time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '114', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Mild/moderate flare', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Severe flare', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No flare', 'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SELENA Flare Index divides flares into 2 categories: mild/moderate and severe. A severe flare would lead to early withdrawal. The number of participants with mild to moderate flare, severe flare, and no flare at each visit during the treatment period were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Change at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SLICC/ACR damage index assesses specific comorbidities associated with SLE. It consists of 41 items and covers 12 body systems. Total damage scores were calculated using the 41 items. The total damage score ranges from 0 (no damage) to 47 (maximum disease damage severity) with higher scores indicating increasing disease damage severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants Achieving Remission of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 44', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Remission of disease was defined as a reduction of SLEDAI-2K score to 0. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Steroid Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': '<7.5 mg at Baseline to <7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': '<7.5 mg at Baseline to >=7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '<7.5 mg at Baseline to None at Final Assessment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '>=7.5 mg at Baseline to <7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '>=7.5 mg at Baseline to >=7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': '>=7.5 mg at Baseline to None at Final Assessment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'None at Baseline to <7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'None at Baseline to >=7.5 mg at Final Assessment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'None at Baseline to None at Final Assessment', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline up to Final Assessment (or Early Termination [up to Week 72])', 'description': 'Number of participants with change in steroid dose (prednisone equivalent/day) were reported. The change in steroid dose was evaluated to determine the number of participants taking a dose less than 7.5 mg of prednisone equivalent/day, a dose of 7.5 mg prednisone equivalent/day or more, and none per day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Final Assessment (or Early Termination [up to Week 72])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Reactive', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Non-reactive', 'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Immunogenicity was assessed by detection of the presence of specific anti-CEP-33457 antibodies in blood serum samples collected at the specified time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable at specified timepoint."}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Received Concomitant Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 72', 'description': 'Any concomitant therapy or medication taken while the participant received study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all enrolled participants who took at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CEP-33457', 'description': 'Participants received 200 micrograms (mcg) of CEP-33457 subcutaneously (SC) every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawn due to early study termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '107'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CEP-33457', 'description': 'Participants received 200 mcg of CEP-33457 SC every 4 weeks for a maximum of 17 doses (64 weeks).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '11.44', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'Black', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Enrolled analysis set included all participants who were enrolled in the study, regardless of whether or not a participant took any study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'whyStopped': 'Business Decision; there were no safety issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2013-09-09', 'completionDateStruct': {'date': '2012-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2010-10-15', 'dispFirstSubmitQcDate': '2013-09-09', 'resultsFirstSubmitDate': '2022-12-05', 'studyFirstSubmitQcDate': '2010-11-12', 'dispFirstPostDateStruct': {'date': '2013-09-17', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-05', 'studyFirstPostDateStruct': {'date': '2010-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to Week 72', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs included clinically significant vitals, labs, and physical examination findings. Serious adverse events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.'}, {'measure': 'Number of Participants Who Received Concomitant Medications', 'timeFrame': 'Baseline up to Week 72', 'description': 'Any concomitant therapy or medication taken while the participant received study drug.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Achieving a Clinical Response Using the Systemic Lupus Erythematosus (SLE) Responder Index (SRI)', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': 'An SRI response was defined as a reduction from baseline in SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 points, no worsening in Physician Global Assessment (PhGA), no new British Isles Lupus Assessment Group (BILAG) A body system score, and ≤1 new BILAG B body system score from baseline. SLEDAI 2K includes 24 weighted clinical and laboratory variables. Total score = 0 to 105. A score of 6 to 10 = moderate disease activity, and a reduction of \\>3 points = improvement. PhGA was completed by physician using a visual analog scale (VAS) from 0=none to 3=severe. A change of \\>0.3 points = worsening. BILAG includes 97 clinical and laboratory items. Each organ system is assigned a score displayed as a grade from A to E: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stable or mild disease; D=previous organ involvement but no current disease activity; and E=no current disease activity and organ system has never been involved.'}, {'measure': 'Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Total Score', 'timeFrame': 'Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.'}, {'measure': 'Number of Participants With British Isles Lupus Assessment Group 2004 (BILAG-2004) Response', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': "The BILAG-2004 is a validated objective and subjective global measure of the SLE disease activity, based on the physician's intention to treat, and refers to disease activity within the last 4 weeks before completion of the index. It includes 97 clinical and laboratory components to evaluate SLE disease activity in 9 different body systems (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each body system is assigned a score displayed as a grade from A to E, as follows: A=very active disease; B=participant needs increase in treatment for moderately active disease; C=stab1e or mild disease; D=previous system involvement but no current disease activity; and E=no current disease activity and the body system has never been involved. BILAG 2004 response was defined as no new BILAG A body system score and no more than 1 new BILAG B body system score from baseline."}, {'measure': "Number of Participants Showing No Worsening on Physician's Global Assessment (PhGA) Scale", 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72', 'description': 'The PhGA was completed by the physician using a 3-inch visual analog scale (VAS) labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicates worsening. The number of participants showing no worsening are presented.'}, {'measure': "Number of Participants Showing No Worsening on Patient's Global Assessment (PtGA) Scale", 'timeFrame': 'Week 12, 24, 36, 48, 60, and 72', 'description': 'The PtGA was completed by the participant, using a 3-inch VAS labeled from 0=none to 3=severe. A change of greater than 0.3 point on the VAS indicated worsening. The number of participants showing no worsening are presented.'}, {'measure': 'Change From Baseline in Short-Form 36 (SF-36) Domain Scores', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])', 'description': 'The SF-36 questionnaire has 36 questions composing the scale that represent 8 domains: 1) physical functioning, 2) physical role functioning, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) emotional role functioning, and 8) mental health. All domains are scored on a scale from 0 (worst) to 100 (best), with higher scores representing the best possible health state. Change from baseline scores in the following individual standardized domains: Bodily pain, physical functioning, social functioning and vitality were presented.'}, {'measure': 'Change From Baseline in the Biomarker: Anti-U1 Ribonucleoprotein Antibody (Anti-UI RNP Ab)', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60 and final assessment (or early termination [up to Week 72])', 'description': 'Anti-UI RNP Ab was measured from blood serum collected at specified time points.'}, {'measure': 'Change From Baseline in the Biomarker: C-Reactive Protein (CRP)', 'timeFrame': 'Baseline, Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])', 'description': 'CRP was measured from blood serum samples at specified time points.'}, {'measure': 'Number of Participants With Anti-nuclear Antibodies (ANA)', 'timeFrame': 'Week 12, 24, 36, 48, 60, and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Anti-nuclear antibodies (ANA) were measured from blood serum samples at specified time points.'}, {'measure': 'Number of Participants With Mild to Moderate Flare, Severe Flare, and No Flare, Based on the Safety of Estrogens in Lupus Erythematosus: National Assessment (SELENA) Flare Index', 'timeFrame': 'Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SELENA Flare Index divides flares into 2 categories: mild/moderate and severe. A severe flare would lead to early withdrawal. The number of participants with mild to moderate flare, severe flare, and no flare at each visit during the treatment period were reported.'}, {'measure': 'Change From Baseline in Total Damage Score as Assessed by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) Damage Index', 'timeFrame': 'Baseline, Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'The SLICC/ACR damage index assesses specific comorbidities associated with SLE. It consists of 41 items and covers 12 body systems. Total damage scores were calculated using the 41 items. The total damage score ranges from 0 (no damage) to 47 (maximum disease damage severity) with higher scores indicating increasing disease damage severity.'}, {'measure': 'Number of Participants Achieving Remission of Disease', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Remission of disease was defined as a reduction of SLEDAI-2K score to 0. The SLEDAI-2K is a validated objective measure that assesses disease activity within the last 28 days before completion of the index. It is a global index and includes 24 weighted clinical and laboratory variables. The total score (sum of all 24 scores) ranges from 0 to 105, with higher scores representing increased disease activity.'}, {'measure': 'Number of Participants With Change in Steroid Dose', 'timeFrame': 'From Baseline up to Final Assessment (or Early Termination [up to Week 72])', 'description': 'Number of participants with change in steroid dose (prednisone equivalent/day) were reported. The change in steroid dose was evaluated to determine the number of participants taking a dose less than 7.5 mg of prednisone equivalent/day, a dose of 7.5 mg prednisone equivalent/day or more, and none per day.'}, {'measure': 'Number of Participants With Reactive and Non-Reactive Anti-CEP-33457 Antibodies', 'timeFrame': 'Week 24, 48 and Final Assessment (or Early Termination [up to Week 72])', 'description': 'Immunogenicity was assessed by detection of the presence of specific anti-CEP-33457 antibodies in blood serum samples collected at the specified time points.'}]}, 'conditionsModule': {'keywords': ['Lupus', 'SLE'], 'conditions': ['Systemic Lupus Erythematosus']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The participant has an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.\n* The participant previously participated in and completed at least Visit 8 (Week 24) the Cephalon sponsored clinical study with CEP-33457 (study C33457/2047) and, in the investigator's opinion, would benefit from continued participation in a clinical study.\n* Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment.\n\nExclusion Criteria:\n\n* The participant has New York Heart Association (NYHA) Class III or IV congestive heart failure.\n* The participant has an estimated glomerular filtration rate (eGFR) of less than 30 milliliters (mL)/minute (min)/1.73 square meter (m\\^2) (via Modification of Diet in Renal Disease \\[MDRD\\] equation).\n* The participant has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of normal (ULN) or a total bilirubin level greater than 1.5 times ULN.\n* The participant has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the first dose of study drug and for 3 months after administration of the last dose of study drug.\n* The participant has any clinically significant abnormalities on electrocardiogram (ECG) that are not related to SLE, as determined by the investigator. Participants with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.\n* The participant has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the first dose of study drug. Less severe infections in the 3 months prior to administration of the first dose of study drug are permitted at the discretion of the investigator and medical monitor.\n* The participant has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.\n* The participant has a history of a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).\n* The participant has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease.\n* The participant has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit for study C33457/2047, or has current substance abuse.\n* The participant has a history of severe allergic reactions to or hypersensitivity to any component of the study drug.\n* The participant is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)\n* The participant has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 30 days prior to the 1st dose of study drug, except for treatment with CEP-33457 or placebo in study C33457/2047.\n* The participant has a known history of antibodies to CEP-33457.\n* The participant is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor."}, 'identificationModule': {'nctId': 'NCT01240694', 'briefTitle': 'A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Patients With Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'C33457/3075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CEP-33457', 'description': 'Participants will receive 200 micrograms (mcg) of CEP-33457', 'interventionNames': ['Drug: CEP-33457']}], 'interventions': [{'name': 'CEP-33457', 'type': 'DRUG', 'otherNames': ['Lupuzor'], 'description': 'CEP-33457 will be administered subcutaneously per dose specified in the arm description.', 'armGroupLabels': ['CEP-33457']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 27', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85715', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 20', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 16', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1769', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 5', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 7', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94578', 'city': 'San Leandro', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14', 'geoPoint': {'lat': 37.72493, 'lon': -122.15608}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 17', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 30', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 4', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 32', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 35', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 1', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 11', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 8', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 31', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30281', 'city': 'Stockbridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 38', 'geoPoint': {'lat': 33.54428, 'lon': -84.23381}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'Teva Investigational Site 23', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '40504', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 37', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 36', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 10', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 22', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 9', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27599-7600', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 3', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 28', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 18', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 2', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '73103', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Teva Investigational Site 21', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 25', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 26', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 15', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 29', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77034', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 40', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77074', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 6', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75150', 'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 39', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 34', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 24', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 19', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 12', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Teva Investigational Site 33', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Teva Investigational Site 102', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Teva Investigational Site 101', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '5530', 'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Teva Investigational Site 100', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': '638 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Teva Investigational Site 201', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '775 20', 'city': 'Olomouc', 'country': 'Czechia', 'facility': 'Teva Investigational Site 200', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 202', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Teva Investigational Site 203', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Teva Investigational Site 301', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Teva Investigational Site 302', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Teva Investigational Site 300', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75674', 'city': 'Paris', 'country': 'France', 'facility': 'Teva Investigational Site 303', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Teva Investigational Site 304', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Teva Investigational Site 402', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Teva Investigational Site 403', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Teva Investigational Site 401', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Teva Investigational Site 404', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Teva Investigational Site 406', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Teva Investigational Site 405', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'Teva Investigational Site 400', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '1023', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Teva Investigational Site 501', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Teva Investigational Site 502', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '8900', 'city': 'Zalaegerszeg', 'country': 'Hungary', 'facility': 'Teva Investigational Site 500', 'geoPoint': {'lat': 46.83695, 'lon': 16.84401}}, {'zip': '62-069', 'city': 'Dąbrówka', 'country': 'Poland', 'facility': 'Teva Investigational Site 603', 'geoPoint': {'lat': 52.48388, 'lon': 21.29794}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'Teva Investigational Site 600', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '26-200', 'city': 'Gmina Końskie', 'country': 'Poland', 'facility': 'Teva Investigational Site 602', 'geoPoint': {'lat': 51.19166, 'lon': 20.40607}}, {'zip': '20-090', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Teva Investigational Site 604', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '20-607', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Teva Investigational Site 601', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '00-235', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Teva Investigational Site 606', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '50-556', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Teva Investigational Site 605', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '2720-276', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'Teva Investigational Site 701', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '3000-075', 'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Teva Investigational Site 702', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'zip': '4099-001', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Teva Investigational Site 703', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4200-319', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Teva Investigational Site 700', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Spain', 'facility': 'Teva Investigational Site 751'}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Teva Investigational Site 752', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Teva Investigational Site 750', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '83059', 'city': 'Donetsk', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 901', 'geoPoint': {'lat': 48.023, 'lon': 37.80224}}, {'zip': '76018', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 905', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '01601', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 900', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '03151', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 902', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '04107', 'city': 'Kyiv', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 903', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '79035', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Teva Investigational Site 904', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': 'BA1 1RL', 'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 803', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'LS7 4SA', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 801', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 800', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE7 7DN', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Teva Investigational Site 802', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Teva Medical Expert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cephalon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}