Trial Outcomes & Findings for RHYTHM (Formerly Escape II Myocardium) (NCT NCT01548768)

Last Updated: 2020-11-27

Results Overview

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."

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

149 participants

Primary outcome timeframe

Baseline

Results posted on

2020-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Patients - DMARDs + TNF Inhibitors 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. TNF 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. The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Patients - DMARDs Only Patients will receive their current treatment in an open label protocol in the context of standard of care. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Healthy Volunteers Subjects without RA who will function as controls.	Patients - Cross Sectional (RA) 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.
Overall Study STARTED	8	4	16	121
Overall Study COMPLETED	7	2	15	117
Overall Study NOT COMPLETED	1	2	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients - DMARDs + TNF Inhibitors 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. TNF 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. The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Patients - DMARDs Only Patients will receive their current treatment in an open label protocol in the context of standard of care. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Healthy Volunteers Subjects without RA who will function as controls.	Patients - Cross Sectional (RA) 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.
Overall Study Withdrawal by Subject	0	2	1	0
Overall Study Physician Decision	1	0	0	0
Overall Study Adverse Event	0	0	0	1
Overall Study Non-Compliance	0	0	0	3

Baseline Characteristics

RHYTHM (Formerly Escape II Myocardium)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients - DMARDs + TNF Inhibitors n=8 Participants 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. TNF 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. The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Patients - DMARDs Only n=4 Participants Patients will receive their current treatment in an open label protocol in the context of standard of care. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Healthy Volunteers n=16 Participants Subjects without RA who will function as controls.	Patients - Cross Sectional (RA) n=121 Participants 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.	Total n=149 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants	105 Participants n=4 Participants	130 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	16 Participants n=4 Participants	19 Participants n=21 Participants
Age, Continuous	55.125 years n=5 Participants	56 years n=7 Participants	52 years n=5 Participants	55.6 years n=4 Participants	54.38 years n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants	105 Participants n=4 Participants	127 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	16 Participants n=4 Participants	22 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	52 Participants n=4 Participants	60 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants	69 Participants n=4 Participants	89 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	28 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants	53 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	36 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 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).

Outcome measures

Outcome measures
Measure	Patients - Cross Sectional (RA) n=119 Participants A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.	Healthy Volunteers n=15 Participants 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.	Healthy Volunteers 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.
Number of Participants With Myocardial FDG Uptake Diffuse FDG Uptake	21 Participants	4 Participants	—
Number of Participants With Myocardial FDG Uptake Focal FDG Uptake	25 Participants	1 Participants	—
Number of Participants With Myocardial FDG Uptake No FDG Uptake	73 Participants	10 Participants	—

SECONDARY outcome

Timeframe: Baseline, 6-Month Follow-up

Population: 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).

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."

Outcome measures

Outcome measures
Measure	Patients - Cross Sectional (RA) n=6 Participants A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.	Healthy Volunteers n=2 Participants 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.	Healthy Volunteers n=15 Participants 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.
Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy Focal Baseline FDG Uptake	1 participants	1 participants	1 participants
Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy Focal Follow-up FDG Uptake	1 participants	0 participants	NA participants Healthy Controls were not re-scanned 6-months later, and served as a comparison marker
Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy Diffuse Baseline FDG Uptake	4 participants	1 participants	4 participants
Number of Participants With Myocardial FDG Uptake After Escalation of RA Pharmacotherapy Diffuse Follow-up FDG Uptake	2 participants	0 participants	NA participants Healthy Controls were not re-scanned 6-months later, and served as a comparison marker

SECONDARY outcome

Timeframe: Baseline

Population: Only 119 out of 121 subjects had data analyzed due to 2 subject withdrawals prior to scan.

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.

Outcome measures

Outcome measures
Measure	Patients - Cross Sectional (RA) n=119 Participants A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.	Healthy Volunteers n=16 Participants 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.	Healthy Volunteers 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.
LV Structure (Mean EDVI) in Association With Myocardial FDG Uptake	53.8 ml/m^2 Standard Deviation 11	49.1 ml/m^2 Standard Deviation 12.9	—

SECONDARY outcome

Timeframe: Baseline

Population: Only 119 out of 121 subjects had data analyzed due to 2 subject withdrawals prior to scan.

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.

Outcome measures

Outcome measures
Measure	Patients - Cross Sectional (RA) n=119 Participants A cohort of patients with Rheumatoid Arthritis who underwent the baseline visit analysis and completed the visit in the full cross sectional analysis.	Healthy Volunteers n=16 Participants 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.	Healthy Volunteers 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.
LV Function (Mean Stroke Volume Index) in Association With Myocardial FDG Uptake	58.6 ml/m^2 Standard Deviation 13.9	31.3 ml/m^2 Standard Deviation 7.5	—

Adverse Events

RA Patients - Pharmacotherapy Escalation (TNFi)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

RA Patients - Pharmacotherapy Escalation (DMARD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients - Cross Sectional (RA)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RA Patients - Pharmacotherapy Escalation (TNFi) n=8 participants at risk 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. TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,	RA Patients - Pharmacotherapy Escalation (DMARD) n=4 participants at risk 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. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Healthy Volunteers n=16 participants at risk Subjects without RA who will function as controls.	Patients - Cross Sectional (RA) n=121 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Shortness Of Breath	12.5% 1/8 • Number of events 1 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.00% 0/121 • 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. 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.

Other adverse events

Other adverse events
Measure	RA Patients - Pharmacotherapy Escalation (TNFi) n=8 participants at risk 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. TNFi: biologic treatment for RA, such as Humira, Enbrel, Remicade,	RA Patients - Pharmacotherapy Escalation (DMARD) n=4 participants at risk 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. DMARDs: Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.	Healthy Volunteers n=16 participants at risk Subjects without RA who will function as controls.	Patients - Cross Sectional (RA) n=121 participants at risk 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.
General disorders Worsening Migraine	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
Cardiac disorders Mobitz II Heart Block	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
General disorders Angina	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
Cardiac disorders Atrial Tachycardia	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
Psychiatric disorders Panic Attack	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Thrombophlebitis	0.00% 0/8 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.83% 1/121 • Number of events 1 • 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. 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.
Skin and subcutaneous tissue disorders Eczema	12.5% 1/8 • Number of events 1 • 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. 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.	0.00% 0/4 • 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. 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.	0.00% 0/16 • 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. 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.	0.00% 0/121 • 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. 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.

Additional Information

Dr. Joan Bathon, MD

Columbia University Irving Medical Center

Phone: 212-305-6327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place