Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-04 @ 3:53 AM
Study NCT ID:
NCT01548768
Status:
COMPLETED
Last Update Posted:
2020-11-27
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RHYTHM (Formerly Escape II Myocardium)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'D000079424', 'term': 'Tumor Necrosis Factor Inhibitors'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}], 'ancestors': [{'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmb2311@cumc.columbia.edu', 'phone': '212-305-6327', 'title': 'Dr. Joan Bathon, MD', 'organization': 'Columbia University Irving Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'For those who underwent the baseline scans only (RA cross-sectional cohort, Healthy Controls), the gathering of adverse events were determined from the events from the visit alone (either acute, or patient-reported follow-up); For the group escalated in treatment therapy (n=12), adverse events were collected from baseline visit/randomization to the end-of-study safety visit conducted 6-8 weeks after the 6-month study visit.', 'description': 'An adverse event (AE) is any undesirable sign, symptom or medical condition occurring after starting study drug (or therapy). Medical conditions/diseases present before starting study treatment are only considered adverse events if they worsen after starting study therapy. In addition all adverse events regardless of whether they constitute unanticipated problems as well as AEs thought to be possibly related to study procedures will also be reported to IRB, safety officer, SMC, and NIH/NIAMS.', 'eventGroups': [{'id': 'EG000', 'title': 'RA Patients - Pharmacotherapy Escalation (TNFi)', 'description': 'Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.\n\nTNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'RA Patients - Pharmacotherapy Escalation (DMARD)', 'description': 'Participants were randomized to TNFi or DMARD therapy. Patients will receive their current treatment in an open label protocol in the context of standard of care.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Volunteers', 'description': 'Subjects without RA who will function as controls.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.', 'otherNumAtRisk': 121, 'deathsNumAtRisk': 121, 'otherNumAffected': 6, 'seriousNumAtRisk': 121, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Worsening Migraine', 'notes': 'Subject w/ h/o migraine; during study visit, mild migraine in morning worsened (BP 140/69, HR 100) - given acetaminophen 500mg x2 - decision made to admit to ED for observation. Same-day discharge from ED.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mobitz II Heart Block', 'notes': 'Could not tolerate adenosine - subject went into heart block (otherwise asymptomatic); IRB gave approval for regadenoson on re-try later.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina', 'notes': 'Angina during adenosine stress test w/ ischemic ECG changes during test. Resolved on completion of test.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Tachycardia', 'notes': 'Short run of atrial tachycardia which self-reverted to normal sinus rhythm after 100mg aminophyllin. No re-occurance.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic Attack', 'notes': 'Subject had panic attack during stress scan - test was aborted and not retried.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'notes': 'Subject had swelling from IV site; prescribed Keflex for 10 days, which resolved.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'notes': "Subject reported new pruritic skin rash (c/w eczema on exam) on start of study medication. Study medication d/c'ed 1mnth later and initiated medrol w/ good response. Later followed up with dermatology who confirmed eczema.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Shortness Of Breath', 'notes': 'Participant was admitted during overseas travel to hospital in Ecuador for an episode of acute dyspnea - she spent one night in a hospital in Panama before returning to the US.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 121, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Myocardial FDG Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive.'}], 'classes': [{'title': 'Diffuse FDG Uptake', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Focal FDG Uptake', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No FDG Uptake', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the cross sectional RA cohort to understand the correlation of disease activity measured by the Clinical Disease Activity Index (CDAI) with myocardial inflammation measured by fluorodeoxyglucose (FDG) uptake in positron emission tomography (PET) scan at the baseline visit. Myocardial FDG uptake is classified as "diffuse" or "focal."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 RA patients and 1 healthy volunteer (control subject) were not included in this analysis population because the subjects withdrew study participation prior to scan (no data were collected).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'RA Patients - Pharmacotherapy Escalation (TNFi)', 'description': 'Participants were randomized to TNFi or DMARD therapy.\n\nPatients will receive their current treatment in an open label protocol in the context of standard of care.\n\nTNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,'}, {'id': 'OG001', 'title': 'RA Patients - Pharmacotherapy Escalation (DMARD)', 'description': 'Participants were randomized to TNFi or DMARD therapy.\n\nPatients will receive their current treatment in an open label protocol in the context of standard of care.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.'}, {'id': 'OG002', 'title': 'Healthy Volunteers', 'description': 'A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive.'}], 'classes': [{'title': 'Focal Baseline FDG Uptake', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Focal Follow-up FDG Uptake', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Healthy Controls were not re-scanned 6-months later, and served as a comparison marker', 'groupId': 'OG002'}]}]}, {'title': 'Diffuse Baseline FDG Uptake', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diffuse Follow-up FDG Uptake', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Healthy Controls were not re-scanned 6-months later, and served as a comparison marker', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6-Month Follow-up', 'description': 'This is designed to measure the myocardial inflammation, and its association with change in CDAI, after ramp-up of RA therapy over 6 months. Measurements are taken at baseline and 6-months post treatment escalation. Myocardial FDG uptake is classified as "diffuse" or "focal."', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 TNFi, and 2 DMARDs and 1 healthy volunteer (control subject) were not included in this analysis population because the subjects withdrew participation prior to study completion or scan (no data were collected).'}, {'type': 'SECONDARY', 'title': 'LV Structure (Mean EDVI) in Association With Myocardial FDG Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive'}], 'classes': [{'categories': [{'measurements': [{'value': '53.8', 'spread': '11', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '12.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) structure measured by 2D/3D echocardiogram at the baseline visit.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 119 out of 121 subjects had data analyzed due to 2 subject withdrawals prior to scan.'}, {'type': 'SECONDARY', 'title': 'LV Function (Mean Stroke Volume Index) in Association With Myocardial FDG Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.'}, {'id': 'OG001', 'title': 'Healthy Volunteers', 'description': 'A cohort of healthy volunteers (those without an autoimmune or history of cardiac illness) was utilized. n=16 were recruited directly, while n=11 were recruited via the CUIMC Nuclear Cardiology archive'}], 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '31.3', 'spread': '7.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) function measured by 2D/3D echocardiogram at the baseline visit.', 'unitOfMeasure': 'ml/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 119 out of 121 subjects had data analyzed due to 2 subject withdrawals prior to scan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients - DMARDs + TNF Inhibitors', 'description': 'Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.\n\nTNF inhibitors: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.\n\nThe possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.'}, {'id': 'FG001', 'title': 'Patients - DMARDs Only', 'description': 'Patients will receive their current treatment in an open label protocol in the context of standard of care.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.'}, {'id': 'FG002', 'title': 'Healthy Volunteers', 'description': 'Subjects without RA who will function as controls.'}, {'id': 'FG003', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}, {'value': '149', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients - DMARDs + TNF Inhibitors', 'description': 'Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.\n\nTNF inhibitors: TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.\n\nThe possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.'}, {'id': 'BG001', 'title': 'Patients - DMARDs Only', 'description': 'Patients will receive their current treatment in an open label protocol in the context of standard of care.\n\nDMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.'}, {'id': 'BG002', 'title': 'Healthy Volunteers', 'description': 'Subjects without RA who will function as controls.'}, {'id': 'BG003', 'title': 'Patients - Cross Sectional (RA)', 'description': 'A cohort of patients with Rheumatoid Arthritis will undergo the baseline study visit only (no randomization to treatment). Note, that those who were randomized, their data will be utilized in the full cross sectional analysis.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.125', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '64'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '70'}, {'value': '52', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '68'}, {'value': '55.6', 'groupId': 'BG003', 'lowerLimit': '23', 'upperLimit': '80'}, {'value': '54.38', 'groupId': 'BG004', 'lowerLimit': '23', 'upperLimit': '80'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'RA participants=133, Healthy Volunteers=16'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-01-19', 'size': 898830, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-29T13:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2012-03-06', 'resultsFirstSubmitDate': '2020-09-21', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-04', 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Myocardial FDG Uptake', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the cross sectional RA cohort to understand the correlation of disease activity measured by the Clinical Disease Activity Index (CDAI) with myocardial inflammation measured by fluorodeoxyglucose (FDG) uptake in positron emission tomography (PET) scan at the baseline visit. Myocardial FDG uptake is classified as "diffuse" or "focal."'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy', 'timeFrame': 'Baseline, 6-Month Follow-up', 'description': 'This is designed to measure the myocardial inflammation, and its association with change in CDAI, after ramp-up of RA therapy over 6 months. Measurements are taken at baseline and 6-months post treatment escalation. Myocardial FDG uptake is classified as "diffuse" or "focal."'}, {'measure': 'LV Structure (Mean EDVI) in Association With Myocardial FDG Uptake', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) structure measured by 2D/3D echocardiogram at the baseline visit.'}, {'measure': 'LV Function (Mean Stroke Volume Index) in Association With Myocardial FDG Uptake', 'timeFrame': 'Baseline', 'description': 'This is designed to evaluate the baseline characteristics of the entire RA cohort to understand the association of myocardial inflammation measure by FDG uptake with measures of left ventricular (LV) function measured by 2D/3D echocardiogram at the baseline visit.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Cardiovascular disease', 'Myocardium', 'TNF-alpha inhibitors', 'ESCAPE', 'Co-morbidities', 'RHYTHM'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '30407745', 'type': 'RESULT', 'citation': 'Amigues I, Tugcu A, Russo C, Giles JT, Morgenstein R, Zartoshti A, Schulze C, Flores R, Bokhari S, Bathon JM. Myocardial Inflammation, Measured Using 18-Fluorodeoxyglucose Positron Emission Tomography With Computed Tomography, Is Associated With Disease Activity in Rheumatoid Arthritis. Arthritis Rheumatol. 2019 Apr;71(4):496-506. doi: 10.1002/art.40771. Epub 2019 Feb 28.'}], 'seeAlsoLinks': [{'url': 'http://www.rheumatologyatcolumbia.org/', 'label': 'Click here for information about this study'}]}, 'descriptionModule': {'briefSummary': 'For aim 1, the proposed studies will be performed in 150 patients with RA and 25 subjects without RA (healthy volunteers) who will function as controls.\n\nFor aim 2, 25 of the patients enrolled in aim 1 (who are in need for further treatment due to increased RA activity despite their current treatment) will be recruited to continue in the study for an additional 24 (+/- 2) weeks (or 6 months). These patient will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.\n\nThe investigators hypothesize that anti-TNF agents in RA patients without heart disease will not adversely affect the heart (will not cause a detrimental change in heart structure or its function).', 'detailedDescription': 'Patients with Rheumatoid Arthritis (RA) have a shortened life expectancy compared to the general population. Cardiovascular disease (CVD), including heart failure (HF), is the primary cause of the extra deaths in RA. HF, in general, results from failure of the heart muscle to pump adequately. In other words the heart muscle in HF becomes "weak". In patients without RA, the heart muscle gets larger before symptoms of HF appear. Contrary to that, patients with RA have reduced heart size and reduced heart strength. This may mean that in RA the pathway to heart failure may be different compared to what happens in patients without RA. It is possible - for example - that in RA the heart muscle becomes smaller before it becomes weak (while in non-RA patients the heart muscle becomes larger before it becomes weak). It is possible that cells that create inflammation in the joints may also do the same in the heart muscle making it smaller, thinner and eventually weaker.\n\nPatients with RA nowadays can be treated with a variety of medications for their joint inflammation. These medications are powerful and have reduced the risk of permanent joint damage and disability. However it is unknown what is the effect of these medications on the heart size and strength and whether they increase or decrease the risk for cardiovascular disease and heart failure.\n\nAmong the medications used for RA are medications called TNF inhibitors. They are usually prescribed to patients who have joint inflammation that has not responded to treatment with the first line medication Methotrexate. Data in non-RA patients with advanced heart failure suggest that anti-TNF agents may not help heart failure and may even be harmful. However, the effect of these agents on the hearts of RA patients has never been directly studied. Some observational studies suggest that RA patients treated with TNF inhibitors have a lower risk of developing heart disease. Overall the knowledge regarding the effect of TNF inhibitors on RA patients heart function is limited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For RA patients (150 patients):\n\nINCLUSION CRITERIA\n\n* Diagnosis of Rheumatoid Arthritis by 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) diagnostic criteria\n* Age\\>18 years old\n* Moderate to high RA disease activity defined by a Clinical Disease Activity Index (CDAI) of \\>10\n* Stable dose of Methotrexate for 6 weeks prior to enrollment\n* Stable doses of Nonsteroidal anti-inflammatory drug (NSAID) and prednisone (if already taking these medications) for 2 weeks prior to study\n\nEXCLUSION CRITERIA\n\n* Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)\n* Contraindications to having a PET-CT scan or receive adenosine or Fludeoxyglucose (FDG)\n* Active treatment for Cancer\n* Uncontrolled hypertension\n* Diabetes\n* Smoking\n* Treatment with a TNF inhibitor or other biologic currently or within the last 6 months\n* Current treatment with "Triple Therapy" or within the last 2 months\n* Untreated positive purified protein derivative (PPD) tuberculosis skin test or active tuberculosis\n* History of Lymphoma and Melanoma\n* Ejection Fraction (EF) \\< 40% (if not known in advance then the Study Visit I Echocardiogram results will be used to exclude the patient from randomization and follow up)\n* Change in NSAID/Prednisone dosage in last 2 weeks\n* Participation in other research studies involving imaging/radiation exposure\n\nFor non-RA subjects (25 controls):\n\nINCLUSION CRITERIA\n\n* Age\\>18 years old\n* Absence of diagnosis of RA\n\nEXCLUSION CRITERIA\n\n* Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)\n* Contraindications to having a PET-CT scan or receive adenosine or FDG\n* Uncontrolled hypertension\n* Participation in other research studies involving imaging/radiation exposure'}, 'identificationModule': {'nctId': 'NCT01548768', 'acronym': 'RHYTHM', 'briefTitle': 'RHYTHM (Formerly Escape II Myocardium)', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'RHYTHM (RHeumatoid Arthritis studY of THe Myocardium): How Rheumatoid Arthritis (RA) and Tumor Necrosis Factor (TNF) Inhibitors Affect the Myocardial Structure and Function.', 'orgStudyIdInfo': {'id': 'AAAI1026'}, 'secondaryIdInfos': [{'id': '7R01AR050026-07', 'link': 'https://reporter.nih.gov/quickSearch/7R01AR050026-07', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients - DMARDs + TNF Inhibitors', 'description': 'Patients will receive a TNF inhibitor in addition to their current treatment in an open label protocol for increased disease activity and in the context of standard of care.', 'interventionNames': ['Drug: TNF inhibitors', 'Drug: DMARDs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients - DMARDs only', 'description': 'Patients will receive their current treatment in an open label protocol in the context of standard of care.', 'interventionNames': ['Drug: DMARDs']}, {'type': 'NO_INTERVENTION', 'label': 'Healthy Volunteers', 'description': 'Subjects without RA who will function as controls.'}], 'interventions': [{'name': 'TNF inhibitors', 'type': 'DRUG', 'otherNames': ['Anti-TNF drugs'], 'description': 'TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.\n\nThe possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.', 'armGroupLabels': ['Patients - DMARDs + TNF Inhibitors']}, {'name': 'DMARDs', 'type': 'DRUG', 'otherNames': ['Disease-modifying antirheumatic drugs'], 'description': 'Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.', 'armGroupLabels': ['Patients - DMARDs + TNF Inhibitors', 'Patients - DMARDs only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joan M Bathon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Medicine, Rheumatology', 'investigatorFullName': 'Joan M. Bathon', 'investigatorAffiliation': 'Columbia University'}}}}