Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 11:19 PM
Study NCT ID:
NCT01248793
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2010-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '610-500-3369', 'title': 'Associate Director, Clinical Research', 'organization': 'Janssen Research & Development'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo -> Golimumab 50 mg', 'description': 'Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48', 'otherNumAtRisk': 103, 'otherNumAffected': 37, 'seriousNumAtRisk': 103, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48', 'otherNumAtRisk': 108, 'otherNumAffected': 33, 'seriousNumAtRisk': 108, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Liver Function Test Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'seriousEvents': [{'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Tuberculous Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Tibia Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Ovarian Epithelial Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Placebo', 'description': 'Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape'}, {'id': 'OG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 14', 'description': 'Number of patients who achieved a \\>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment'}, {'type': 'SECONDARY', 'title': 'Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Placebo', 'description': 'Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape'}, {'id': 'OG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Number of patients who achieved a \\>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Placebo', 'description': 'Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape'}, {'id': 'OG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '0.113', 'spread': '2.0967', 'groupId': 'OG000'}, {'value': '-1.262', 'spread': '2.5698', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 14', 'description': "BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale \\[Score\\]; 0 cm \\[easy\\] to 10 cm \\[impossible\\]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I: Placebo', 'description': 'Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape'}, {'id': 'OG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.718', 'groupId': 'OG000'}, {'value': '-0.42', 'spread': '0.906', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 14', 'description': 'BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population according to their assigned treatment group regardless of whether or not they receive the assigned treatment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I: Placebo', 'description': 'Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape'}, {'id': 'FG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I: Placebo', 'description': 'Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape'}, {'id': 'BG001', 'title': 'Group II: Golimumab 50 mg', 'description': 'Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'spread': '8.60', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '10.27', 'groupId': 'BG001'}, {'value': '30.5', 'spread': '9.46', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-14', 'studyFirstSubmitDate': '2010-11-24', 'resultsFirstSubmitDate': '2012-05-25', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-25', 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14', 'timeFrame': 'Week 14', 'description': 'Number of patients who achieved a \\>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation'}], 'secondaryOutcomes': [{'measure': 'Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24', 'timeFrame': 'Week 24', 'description': 'Number of patients who achieved a \\>= 20% improvement in ankylosing spondylitis symptoms, including back pain, function, and inflammation'}, {'measure': 'Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14', 'timeFrame': 'Baseline and Week 14', 'description': "BASFI is a participant's self-assessment, represented as a mean (Visual Analogue Scale \\[Score\\]; 0 cm \\[easy\\] to 10 cm \\[impossible\\]) of 10 questions, 8 of which relate to the participant's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. A negative change from baseline indicates improvement."}, {'measure': 'Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14', 'timeFrame': 'Baseline and Week 14', 'description': 'BASMI is a combined score of 5 components of spine flexibility, ranging from 0 (least impairment) to 10 (most impairment). A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ankylosing Sponylitis, injection, golimumab, simponi'], 'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '24729398', 'type': 'DERIVED', 'citation': 'Bao C, Huang F, Khan MA, Fei K, Wu Z, Han C, Hsia EC. Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial. Rheumatology (Oxford). 2014 Sep;53(9):1654-63. doi: 10.1093/rheumatology/keu132. Epub 2014 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis', 'detailedDescription': 'Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Have a diagnosis of definite akylosing spondylitis for at least 3 months\n\n* Have symptoms of active disease at screening and at baseline\n* no active infections\n\nExclusion Criteria:\n\n* Have other inflammatory diseases that might confound the evaluations of benefit from the golimumab therapy\n* Have complete ankylosis of the spine\n* Have a history of latent or active granulomatous infection\n* Have had a serious infection, or have been hospitalized for an infection, or have been treated with intravenous (IV) antibiotics for an infection within 2 months prior to first administration of study agent.'}, 'identificationModule': {'nctId': 'NCT01248793', 'briefTitle': 'Study of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis', 'orgStudyIdInfo': {'id': 'CR015916'}, 'secondaryIdInfos': [{'id': 'C0524T29', 'type': 'OTHER', 'domain': 'Centocor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo', 'Drug: Golimumab (placebo group)']}, {'type': 'EXPERIMENTAL', 'label': 'Golimumab', 'interventionNames': ['Drug: Golimumab']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20', 'armGroupLabels': ['Placebo']}, {'name': 'Golimumab', 'type': 'DRUG', 'description': 'Golimumab 50 mg SC injection every 4 weeks for 48 weeks', 'armGroupLabels': ['Golimumab']}, {'name': 'Golimumab (placebo group)', 'type': 'DRUG', 'description': 'Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chengdu', 'country': 'China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hefei', 'country': 'China', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Jinan', 'country': 'China', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': "Xi'an", 'country': 'China', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Centocor, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centocor, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}