Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 9:39 PM
Study NCT ID:
NCT01008995
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2009-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1 215-793-7646', 'title': 'Director, Clinical Research', 'organization': 'Janssen R&D US'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': "One patient from the 'Placebo (CP)' group was randomized, but never received any treatment. Therefore, he was not included in any safety analysis.", 'eventGroups': [{'id': 'EG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group', 'otherNumAtRisk': 161, 'otherNumAffected': 21, 'seriousNumAtRisk': 161, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group', 'otherNumAtRisk': 160, 'otherNumAffected': 28, 'seriousNumAtRisk': 160, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo -> Ustekinumab 45 mg (After CP)', 'description': 'After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg at Week 12 and Week 16', 'otherNumAtRisk': 158, 'otherNumAffected': 27, 'seriousNumAtRisk': 158, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Ustekinumab 45 mg (After CP)', 'description': 'After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16', 'otherNumAtRisk': 159, 'otherNumAffected': 14, 'seriousNumAtRisk': 159, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Psoriatic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 161, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 160, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 159, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The study was designed to maintain a Type I error of 0.05 or less for the primary analysis.', 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 45 mg and placebo for the primary endpoint at a significance level of 0.05. Power calculations were based on two sample size assumptions: 220 (1:1 ratio) and 320 participants (1:1 ratio). Simulation studies evaluated the power to detect a treatment difference between ustekinumab 45 mg group and placebo using a CMH test stratified by baseline weight \\[\\<=65 kg vs \\> 65 kg). The power was \\>99% for both sample size assumptions.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 65kg vs \\> 65 kg)\\].', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to Week 12', 'description': 'Scores could range from 0 (mild) to 72 (severe).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were analyzed according to the treatment group to which they were randomized, regardless of the treatment they actually received.'}, {'type': 'SECONDARY', 'title': "The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiplicity adjustment was made and nominal p-value was reported.', 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Stratified by baseline weight \\[≤ 65kg vs \\> 65 kg)\\].', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants were included and analyzed according to their randomized treatment group.'}, {'type': 'SECONDARY', 'title': 'The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group'}, {'id': 'OG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '-9.3', 'spread': '7.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiplicity adjustment was made and nominal p-value was reported.', 'groupDescription': 'Null Hypothesis: No difference between ustekinumab 45 mg and placebo at a significance level of 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Analysis of variance on van der Waerden normal scores (Conover, 1980) with treatment and baseline weight (≤ 65kg vs \\> 65 kg) as factors in the model.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) to Week 12', 'description': 'Scores could range from 0 to 30. A lower DLQI score represents better quality of life.', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was based on the subset of participants with evaluable measurements according to their randomized treatment group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group'}, {'id': 'FG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group'}, {'id': 'FG002', 'title': 'Placebo -> Ustekinumab 45 mg (After CP)', 'description': 'After controlled period (Week 12-36) - receiving Placebo at Weeks 0 and 4 -\\> receiving ustekinumab 45 mg at Week 12 and Week 16'}, {'id': 'FG003', 'title': 'Ustekinumab 45 mg (After CP)', 'description': 'After controlled period (Week 12-36) - receiving ustekinumab 45 mg at Weeks 0 and 4 -\\> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16'}], 'periods': [{'title': 'Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '160'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to Control Period.', 'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'After Controlled Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '"0" in column indicates this reporting group is not relevant to after Control Period.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '"0" in column indicates this reporting group is not relevant to after Control Period.', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': '1 placebo participant discontinued after completing the CP and did not receive ustekinumab 45 mg.', 'groupId': 'FG002', 'numSubjects': '158'}, {'comment': '2 participants discontinued in CP, had follow-up, and are among frequent and serious adverse events.', 'groupId': 'FG003', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '156'}, {'groupId': 'FG003', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo (CP)', 'description': 'Controlled period (Week 0-12) - Placebo Group'}, {'id': 'BG001', 'title': 'Ustekinumab 45 mg (CP)', 'description': 'Controlled period (Week 0-12) - Ustekinumab 45 mg Group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '12.21', 'groupId': 'BG000'}, {'value': '40.1', 'spread': '12.36', 'groupId': 'BG001'}, {'value': '39.7', 'spread': '12.28', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '322', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-17', 'studyFirstSubmitDate': '2009-11-05', 'resultsFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2013-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-08-15', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Patients Who Achieved at Least a 75% Improvement in PASI (Psoriasis Area and Severity Index) From Baseline at Week 12.', 'timeFrame': 'Baseline (Week 0) to Week 12', 'description': 'Scores could range from 0 (mild) to 72 (severe).'}], 'secondaryOutcomes': [{'measure': "The Number of Patients With a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12", 'timeFrame': 'Week 12'}, {'measure': 'The Change in Dermatology Life Quality Index (DLQI) From Baseline at Week 12.', 'timeFrame': 'Baseline (Week 0) to Week 12', 'description': 'Scores could range from 0 to 30. A lower DLQI score represents better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['psoriasis', 'asian patients', 'Chinese', 'ustekinumab', 'CNTO 1275', 'Stelara'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of ustekinumab in the treatment of patients with moderate to severe psoriasis in China.', 'detailedDescription': "In this study, 220 patients will be divided into two groups randomly (by chance), like flipping a coin. Each group will receive a different treatment. The results for each group are compared to each other. There are 2 treatment groups in this study, Group 1 and Group 2. Group 1 will receive placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. Group 2 will receive ustekinumab 45 mg at Weeks 0, 4, and 16 and placebo at Week 12. All patients in the study will eventually receive ustekinumab after Week 12. The patients will be in the study for about 36 weeks, with study visit approximately 10 times. Effectiveness evaluations will be conducted throughout the study and include the Psoriasis Area and Severity Index (PASI), Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI). Safety assessments will also be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure) and the occurrence and severity of adverse events. GROUP 1: Placebo at Weeks 0 and 4, ustekinumab 45 mg at Weeks 12 and 16. GROUP 2: Ustekinumab 45 mg at Weeks 0, 4, and 16. Placebo at Week 12"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be of Chinese ancestry\n* Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start\n* Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the time of study start\n* Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start\n* Must be candidates for phototherapy or systemic treatment of psoriasis (either naive or history of previous treatment)\n\nExclusion Criteria:\n\n* Currently have nonplaque forms of psoriasis\n* Have current drug-induced psoriasis\n* Have used any investigational drug within the previous 4 weeks\n* Have used any biologic within the previous 3 months\n* Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis'}, 'identificationModule': {'nctId': 'NCT01008995', 'briefTitle': 'A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Chinese Subjects With Moderate to Severe Plaque-type Psoriasis', 'orgStudyIdInfo': {'id': 'CR016318'}, 'secondaryIdInfos': [{'id': 'C0743T23', 'type': 'OTHER', 'domain': 'Centocor'}, {'id': 'CR016318', 'type': 'OTHER', 'domain': 'Centocor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'placebo Subcutaneous injection at Week 0 and 4,ustekinumab 45 mg subcutaneous injection at Week 12 and 16', 'interventionNames': ['Drug: placebo', 'Drug: ustekinumab']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'placebo Subcutaneous injection at Week 12,ustekinumab 45 mg subcutaneous injection at Week 0 4 and 16', 'interventionNames': ['Drug: placebo', 'Drug: ustekinumab']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection at Week 0 and 4', 'armGroupLabels': ['001']}, {'name': 'ustekinumab', 'type': 'DRUG', 'description': '45 mg subcutaneous injection at Week 12 and 16', 'armGroupLabels': ['001']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection at Week 12', 'armGroupLabels': ['002']}, {'name': 'ustekinumab', 'type': 'DRUG', 'description': '45 mg subcutaneous injection at Week 0, 4 and 16', 'armGroupLabels': ['002']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Dalian', 'country': 'China', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'country': 'China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Nanjing', 'country': 'China', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shenyang', 'country': 'China', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'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'}}}}