Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT04428502
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'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': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as adverse events were not collected for the study', 'description': 'Due to non-interventional nature of study, the minimum criteria for reporting an adverse event (i.e., identifiable participant, identifiable reporter, a suspect product, and event) was not met, hence adverse events were not collected and reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: ACCP Positive', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.'}, {'id': 'OG001', 'title': 'Etanercept: ACCP Negative', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.'}], 'timeFrame': 'Baseline, Month 1', 'description': "DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \\[mg/dL\\]), participant assessment of pain (0 to 10 centimeter \\[cm\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: ACCP Positive', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.'}, {'id': 'OG001', 'title': 'Etanercept: ACCP Negative', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.'}], 'timeFrame': 'Baseline, Month 12', 'description': "DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \\[mg/dL\\]), participant assessment of pain (0 to 10 centimeter \\[cm\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.", 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not evaluated and reported for this outcome measure since CRP variable to calculate DAPSA was not collected from the participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept: ACCP Positive', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had positive ACCP status.'}, {'id': 'OG001', 'title': 'Etanercept: ACCP Negative', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice and had negative ACCP status.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '4.06', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '3.35', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '3.34', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'At Month 1: P-value \\<0.05 was considered statistically significant, without multiplicity adjustment.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'At Month 6: P-value \\<0.05 was considered statistically significant, without multiplicity adjustment.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'At Month 12: P-value \\<0.05 was considered statistically significant, without multiplicity adjustment.', 'statisticalMethod': "Student's t-test", 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Hypothesis tested was to evaluate that there is no difference in response between ACCP positive and ACCP negative PsA participants who were treated with etanercept.'}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 6 and 12', 'description': "DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \\[mm/hour\\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\\*sqrt (PJC28) + 0.28\\*sqrt (SJC28) + 0.70\\*In (ESR) + 0.014\\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (\\<=) 3.2 = low disease activity, DAS28 ESR greater than (\\>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on all participants who were included in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}], 'preAssignmentDetails': "Data of Iraq's participants, 1) who aged greater than or equal to (\\>=) 18 years, 2) who met American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010 criteria for psoriatic arthritis (PsA), and 3) who received etanercept for at least for 1 year from May 2012 until August 2019 in the Baghdad teaching hospital (rheumatology center) were collected. Data collected were assessed in approximately 1.8 months of this retrospective observational study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants received etanercept to treat PsA at least for 1 year from May 2012 until August 2019 under standard clinical practice. Data of these participants was studied for approximately 1.8 months.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '43.0', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis was performed on all participants who were included in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-27', 'size': 1476236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-17T10:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2020-06-10', 'resultsFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-17', 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease Activity Score 28 Erythrocyte Sedimentation Rate (DAS28 ESR) at Month 1, 6 and 12', 'timeFrame': 'Month 1, 6 and 12', 'description': "DAS28 ESR was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, ESR (millimeters per hour \\[mm/hour\\]) and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated high disease activity). DAS 28 ESR =0.56\\*sqrt (PJC28) + 0.28\\*sqrt (SJC28) + 0.70\\*In (ESR) + 0.014\\*PtGA; ln = natural logarithm, sqrt = square root of. DAS28 ESR less than equal to (\\<=) 3.2 = low disease activity, DAS28 ESR greater than (\\>) 3.2 to 5.1 = moderate to high disease activity. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants."}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 1', 'timeFrame': 'Baseline, Month 1', 'description': "DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \\[mg/dL\\]), participant assessment of pain (0 to 10 centimeter \\[cm\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants."}, {'measure': 'Change From Baseline in Disease Activity in Psoriatic Arthritis (DAPSA) Score at Month 12', 'timeFrame': 'Baseline, Month 12', 'description': "DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), C-reactive protein (CRP) level (milligram per deciliter \\[mg/dL\\]), participant assessment of pain (0 to 10 centimeter \\[cm\\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and participant's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0= excellent and 10= poor). A higher DAPSA score indicated more active disease activity. The assessment did not have a score range with an upper or lower bound. The outcome measure compared response between anti-cyclic citrullinated peptide positive and negative participants."}]}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1801418', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the local data in Iraqi patients with psoriatic arthritis on Enbrel treatment with positive Anti-Cyclic Citrullinated Peptide using data from the Rheumatologist in Baghdad Teaching Hospital registry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients data from the local Rheumatology Center of Baghdad Teaching Hospital registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed PsA patients.\n* ≥18 years of age\n* Have not received previous biological treatment\n\nExclusion Criteria:\n\n* Previous use of other biological treatments.\n* Etanercept use for less than 1 year duration.'}, 'identificationModule': {'nctId': 'NCT04428502', 'briefTitle': 'Study To Evaluate The Impact Of Anti-Cyclic Citrullinated Peptide(Anti-CCP) For Management With Enbrel In Patients With Psoriatic Arthritis(PsA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Correlation of Anti-CCP With Disease Activity and Its Impact on Biological Response in PsA in Iraqi Patients', 'orgStudyIdInfo': {'id': 'B1801418'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with psoriatic arthritis', 'description': 'Iraqi patients diagnosed with psoriatic arthritis that receive Enbrel as treatment for disease', 'interventionNames': ['Drug: Enbrel']}], 'interventions': [{'name': 'Enbrel', 'type': 'DRUG', 'description': 'As provided in real world practice', 'armGroupLabels': ['Patients with psoriatic arthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Pfizer', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}