Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT01181050
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2010-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624132', 'term': 'NNC0142-0002 monoclonal antibody'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RA-RNDUS-ClinTriDisc@ITS.JNJ.com', 'title': 'Public Access to Clinical Trials', 'organization': 'Novo Nordisk A/S'}, 'certainAgreement': {'otherDetails': 'Novo Nordisk reserves the right to defer data release until specified milestones, e.g. availability of a clinical trial report. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property. Novo Nordisk reserves the right to prior review of site-specific publications and to ask for deferment of publication of individual site results until after the primary manuscript is accepted for publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'As per protocol, this clinical proof-of-principle trial investigated a limited number of participants and doses (single-dose regimen).'}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected from dosing until end of trial (a total of 24 weeks)', 'description': 'Safety analysis set includes all subjects who received one dose of the investigational product or its comparator', 'eventGroups': [{'id': 'EG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002', 'otherNumAtRisk': 41, 'otherNumAffected': 5, 'seriousNumAtRisk': 41, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo', 'otherNumAtRisk': 22, 'otherNumAffected': 5, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}], 'seriousEvents': [{'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Portal hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'medDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in DAS28-CRP After 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9334', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.50', 'statisticalMethod': 'Mixed effect model repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 12', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.", 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in DAS28-CRP was calculated by using last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Change in DAS28-CRP After 6 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.58', 'statisticalMethod': 'Mixed effect model repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 6', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.", 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in DAS28-CRP was calculated by using last observation carried forward method.'}, {'type': 'SECONDARY', 'title': 'Change in DAS28-CRP After 24 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8867', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.56', 'statisticalMethod': 'Mixed effect model repeated measures', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 24', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.", 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in DAS28-CRP was calculated by using last observation carried forward method.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted at 8 trial sites in 3 different countries (Germany, the Russian Federation and Ukraine) as follows: Germany: 1 site, the Russian Federation: 6 sites and Ukraine: 1 site. All sites enrolled, randomised and dosed at least 1 subject.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects received a single dose of placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.6', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '52.0', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'DAS28-CRP (Disease Activity Score based on count of 28 joints and the C-reactive protein)', 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '1.0', 'groupId': 'BG001'}, {'value': '5.4', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease", 'unitOfMeasure': 'scores', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'dispFirstSubmitDate': '2012-05-10', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2010-08-12', 'dispFirstSubmitQcDate': '2012-05-10', 'resultsFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2010-08-12', 'dispFirstPostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-26', 'studyFirstPostDateStruct': {'date': '2010-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in DAS28-CRP After 12 Weeks of Treatment', 'timeFrame': 'Week 0, Week 12', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment."}], 'secondaryOutcomes': [{'measure': 'Change in DAS28-CRP After 6 Weeks of Treatment.', 'timeFrame': 'Week 0, Week 6', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment."}, {'measure': 'Change in DAS28-CRP After 24 Weeks of Treatment.', 'timeFrame': 'Week 0, Week 24', 'description': "DAS28-CRP=0.56×sqrt(tender joints \\[count:1-28\\])+0.28×sqrt(swollen joints \\[count:1-28\\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \\[100=most severe\\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product\n* Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)\n* Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing\n* Ability to be examined by Magnetic Resonance Imaging (MRI)\n* Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs\n\nExclusion Criteria:\n\n* Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)\n* Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start\n* Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m\\^2'}, 'identificationModule': {'nctId': 'NCT01181050', 'briefTitle': 'Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'NN8555-3796'}, 'secondaryIdInfos': [{'id': 'U1111-1114-9194', 'type': 'OTHER', 'domain': 'WHO'}, {'id': '2010-019261-28', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4.0 mg/kg', 'description': 'Subjects received a single dose of 4 mg/kg NNC0142-0002', 'interventionNames': ['Drug: NNC0142-0002']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects received a single dose of placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'NNC0142-0002', 'type': 'DRUG', 'description': 'A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['4.0 mg/kg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '109240', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '03680', 'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}