Ignite Creation Date:
2025-12-24 @ 3:34 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02874092
Status:
COMPLETED
Last Update Posted:
2021-10-25
First Post:
2016-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'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': 'D000077486', 'term': 'Ticagrelor'}], 'ancestors': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jeffrey.Berger@nyulangone.org', 'phone': '212-263-0855', 'title': 'Dr. Jeffrey Berger', 'organization': 'NYU Langone'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Osteoarthritis', 'description': '-Diagnosis of osteoarthritis made by physician.\n\nMTX therapy', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Activity Score for 28-joint Counts (DAS28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.7', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': '30 days', 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': "The DAS28 is a composite score derived from 4 of these measures. This '28' version is a simplification of the original DAS score, which requires 44 joints to be counted. Other versions of the DAS28 allow the CRP to be used instead of the ESR, or the omission of either. To calculate the DAS28 your rheumatologist or specialist nurse will:-\n\ncount the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask you (the patient) to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad).\n\nThese results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.\n\nThe total scale range is from 2 to 10, with higher scores indicating more disease activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '47', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': '30 days', 'categories': [{'measurements': [{'value': '23', 'spread': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 Days', 'description': 'The VAS is a psychometric response scale that ranges from "no pain" (0) to "worst pain" (100); patients mark a line on a continuum to indicate how they are feeling. Provides global assessment of RA severity.', 'unitOfMeasure': 'Units on VAS scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment'}, {'type': 'SECONDARY', 'title': 'Change in Brachial Artery Diameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': '30 days', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 30 Days', 'description': 'Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest the diameter after increased forearm blood flow (reactive hyperemia). Brachial artery reactivity testing (BART) is a noninvasive technique for evaluating endothelial function', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy'}, {'id': 'FG001', 'title': 'Osteoarthritis', 'description': '-Diagnosis of osteoarthritis made by physician.\n\nMTX therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks\n\nTicagrelor\n\nMTX therapy'}, {'id': 'BG001', 'title': 'Osteoarthritis', 'description': '-Diagnosis of osteoarthritis made by physician.\n\nMTX therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'spread': '16', 'groupId': 'BG000'}, {'value': '48', 'spread': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline age was only collected for the 7 RA participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-27', 'size': 335628, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-27T15:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2016-08-17', 'resultsFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2016-08-17', 'lastUpdatePostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-27', 'studyFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Activity Score for 28-joint Counts (DAS28)', 'timeFrame': '30 Days', 'description': "The DAS28 is a composite score derived from 4 of these measures. This '28' version is a simplification of the original DAS score, which requires 44 joints to be counted. Other versions of the DAS28 allow the CRP to be used instead of the ESR, or the omission of either. To calculate the DAS28 your rheumatologist or specialist nurse will:-\n\ncount the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask you (the patient) to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad).\n\nThese results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.\n\nThe total scale range is from 2 to 10, with higher scores indicating more disease activity."}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale Disease Activity', 'timeFrame': '30 Days', 'description': 'The VAS is a psychometric response scale that ranges from "no pain" (0) to "worst pain" (100); patients mark a line on a continuum to indicate how they are feeling. Provides global assessment of RA severity.'}, {'measure': 'Change in Brachial Artery Diameter', 'timeFrame': 'Baseline, 30 Days', 'description': 'Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest the diameter after increased forearm blood flow (reactive hyperemia). Brachial artery reactivity testing (BART) is a noninvasive technique for evaluating endothelial function'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methotrexate (MTX)', 'Ticagrelor'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is an open label study to assess the improvement in the Disease Activity Score for 28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria). There will also be a cross sectional analysis of baseline platelet activity in subjects with rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any study medication, and will only have one study visit.\n\nPatients will receive 90 mg ticagrelor orally bid. The patients will receive drug for 30-days. Methotrexate dose will remain stable throughout the study duration.', 'detailedDescription': 'The two main goals of this study are to demonstrate the heightened cardiovascular risk in RA by comparing platelet activity, inflammation and endothelial function in baseline rheumatoid arthritis versus age- and sex-matched patients with osteoarthritis; and 2) to demonstrate the effect of ticagrelor in rheumatoid arthritis by the pre- and post- measures of clinical RA severity, platelet activity, inflammation and endothelial function in rheumatoid arthritis before and after ticagrelor therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\nRA cohort\n\n* Receiving MTX at stable doses of 10 to 25 mg weekly for at least 12 weeks\n* Have a DAS28 of 3.2 or higher (The level of disease activity is considered to be low if the DAS28 is 3.2 or less) (Prevoo et al., 1995)\n\nOA cohort\n\n* Diagnosis of osteoarthritis made by physician.\n\nExclusion Criteria:\n\nRA cohort\n\n* History of sensitivity to study medications or any of their excipients\n* Previous intolerance to MTX\n* Current treatment with antiplatelet therapy\n* Absolute indication for anti-platelet therapy\n* Need for chronic oral anticoagulant therapy\n* Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)\n* Renal failure (eGFR \\<30 or requiring dialysis)\n* A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding\n* Prior stroke\n* Active pathological bleeding\n* History of intracranial haemorrhage\n* Life expectancy \\<12 months based on investigator's judgement\n* Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular \\[AV)\\] block) unless already treated with a permanent pacemaker\n* Anemia (hematocrit \\< 27%)\n* Platelet count \\< 100,000/ml\n* Concomitant use of strong CYP 3A inhibitors or inducers\n* History of thrombocytopenia or neutropenia\n* Pregnant or nursing women, or females with a positive pregnancy test at screening\n* Females of child bearing potential not using acceptable method of birth control prior to or during study\n* Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)\n\nOA cohort:\n\n* History of sensitivity to study medications or any of their excipients\n* Current treatment with antiplatelet therapy\n* Absolute indication for anti-platelet therapy\n* Need for chronic oral anticoagulant therapy\n* Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)\n* Renal failure (eGFR \\<30 or requiring dialysis)\n* A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding\n* Prior stroke\n* Active pathological bleeding\n* History of intracranial haemorrhage\n* Life expectancy \\<12 months based on investigator's judgement\n* Anemia (hematocrit \\< 27%)\n* Platelet count \\< 100,000/ml\n* History of thrombocytopenia or neutropenia\n* Pregnant or nursing women, or females with a positive pregnancy test at screening\n* Females of child bearing potential not using acceptable method of birth control prior to or during study\n* Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)"}, 'identificationModule': {'nctId': 'NCT02874092', 'acronym': 'TIMERA', 'briefTitle': 'Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '15-01003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Rheumatoid Arthritis', 'description': '-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks', 'interventionNames': ['Drug: Ticagrelor', 'Drug: MTX therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Osteoarthritis', 'description': '-Diagnosis of osteoarthritis made by physician.', 'interventionNames': ['Drug: MTX therapy']}], 'interventions': [{'name': 'Ticagrelor', 'type': 'DRUG', 'armGroupLabels': ['Rheumatoid Arthritis']}, {'name': 'MTX therapy', 'type': 'DRUG', 'armGroupLabels': ['Osteoarthritis', 'Rheumatoid Arthritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeffrey Berger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}