Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01320293
Status:
COMPLETED
Last Update Posted:
2016-12-26
First Post:
2011-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
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': 'D000068879', 'term': 'Adalimumab'}], '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': {'email': 'alugosom@med.unc.edu', 'phone': '919-843-9447', 'title': 'Aida Lugo-Somolinos MD', 'organization': 'University of North Carolina'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Smaller number of subjects analyzed due to low enrollment. Technical problems with Elisa measurement leading to unreliable or uninterpretable data.'}}, 'adverseEventsModule': {'timeFrame': 'Duration of study- 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months', 'otherNumAtRisk': 18, 'otherNumAffected': 5, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'elbow strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'allergic drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Endothelial Function Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.414', 'groupId': 'OG000', 'lowerLimit': '-1.86', 'upperLimit': '-0.97'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: Percent change in endothelial function from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.'}, {'type': 'SECONDARY', 'title': 'Changes in IL-6 Profile Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.92', 'groupId': 'OG000', 'lowerLimit': '-0.93', 'upperLimit': '-0.91'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: change in IL-6 levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.'}, {'type': 'SECONDARY', 'title': 'Changes in Adiponectin Profile Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '6.125', 'groupId': 'OG000', 'lowerLimit': '-9.24', 'upperLimit': '21.49'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'groupDescription': 'Null hypothesis: change in adiponectin levels from baseline visit to end of treatment/month 6 will be zero change. (percent change=0)', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '17 of 18 participants completed these assessments at both time points due to one of them having an adverse event that required treatment and therefore end of treatment assessments could not be performed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Adalimumab', 'description': 'active\n\nAdalimumab: 40mg subcutaneously, every other week for 6 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2011-03-18', 'resultsFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-27', 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Endothelial Function Compared to Baseline.', 'timeFrame': '6 months', 'description': 'Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).'}], 'secondaryOutcomes': [{'measure': 'Changes in IL-6 Profile Compared to Baseline', 'timeFrame': '6 months', 'description': 'IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.'}, {'measure': 'Changes in Adiponectin Profile Compared to Baseline', 'timeFrame': '24 weeks', 'description': 'Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Moderate to Severe Chronic plaque type psoriasis'], 'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.\n\nIn this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must understand and voluntarily sign an informed consent form.\n* Must be male or female and age 18-55 years at time of consent.\n* Must be able to adhere to the study visit schedule and other protocol requirements\n* Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.\n* Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).\n* Negative PPD at Screening or 3 months earlier.\n* Have not used any biologic treatment for psoriasis in the past 12 months.\n\nExclusion Criteria:\n\n* Inability to provide voluntary consent\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study\n* Pregnant, trying to become pregnant or breastfeeding\n* Prior diagnosis of coronary artery disease (CAD) or heart disease.\n* Systemic fungal infection\n* History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative \\[PPD\\] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.\n* History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)\n* Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.\n* Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)\n* History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C\n* Positive Hepatitis B Surface antigen at screening\n* Malignancy or history of malignancy (except for treated \\[ie, cured\\] basal-cell skin carcinomas \\> 3 years prior to screening)\n* History of any demyelinating disorder such as multiple sclerosis.'}, 'identificationModule': {'nctId': 'NCT01320293', 'briefTitle': 'Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': 'ABBO-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adalimumab 40mg', 'description': 'Adalimumab 40 MG/0.8 ML Subcutaneous Solution \\[HUMIRA\\] Dose administered every other week for 6 months', 'interventionNames': ['Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]']}], 'interventions': [{'name': 'Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]', 'type': 'DRUG', 'otherNames': ['Humira'], 'description': '40mg subcutaneously, every other week for 6 months', 'armGroupLabels': ['Adalimumab 40mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27516', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Dermatology Clinical Trials Unit', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Aida Lugo-Somolinos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan to share data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'AbbVie', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Aida Lugo-Somolinos, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}