Trial Outcomes & Findings for Effects of Abatacept on Myocarditis in Rheumatoid Arthritis (NCT NCT03619876)

Results Overview

Using FDG PET cardiac imaging to identify myocardial inflammation at baseline and post-treatment, the study will quantitatively compare the change in myocardial FDG uptake in biologic naïve RA patients without clinical CVD and with inadequate methotrexate response, following randomization to 16-week treatment with abatacept vs the TNF-inhibitor adalimumab. Conventional cardiovascular disease (CVD) risk factors and measures of RA disease activity and severity will be ascertained.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Baseline, 16 weeks

Results posted on

2023-05-08

Participant Flow

Eleven participants enrolled and 10 randomized. One participant withdrew prior to randomization.

Participant milestones

Participant milestones
Measure	Non-TNF Inhibitor Arm Treatment with abatacept will consist of weekly subcutaneous (SQ) injections at a dose of 125mg. Abatacept: 125 MG/ML subcutaneous injections	TNF Inhibitor Arm Treatment with a adalimumab, as the TNF-inhibitor arm, will consist of every 2 weeks SQ injections at a dose of 40mg. Adalimumab: 40 Mg/0.8 mL Subcutaneous Kit
Overall Study STARTED	4	6
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-TNF Inhibitor Arm Treatment with abatacept will consist of weekly subcutaneous (SQ) injections at a dose of 125mg. Abatacept: 125 MG/ML subcutaneous injections	TNF Inhibitor Arm Treatment with a adalimumab, as the TNF-inhibitor arm, will consist of every 2 weeks SQ injections at a dose of 40mg. Adalimumab: 40 Mg/0.8 mL Subcutaneous Kit
Overall Study Withdrawal by Subject	1	2
Overall Study Withdrawal due to incidental finding	0	2

Baseline Characteristics

Effects of Abatacept on Myocarditis in Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-TNF Inhibitor Arm n=3 Participants Treatment with abatacept will consist of weekly subcutaneous (SQ) injections at a dose of 125mg. Abatacept: 125 MG/ML subcutaneous injections	TNF Inhibitor Arm n=4 Participants Treatment with a adalimumab, as the TNF-inhibitor arm, will consist of every 2 weeks SQ injections at a dose of 40mg. Adalimumab: 40 Mg/0.8 mL Subcutaneous Kit	Total n=7 Participants Total of all reporting groups
Age, Continuous	59 years STANDARD_DEVIATION 13.45362 • n=5 Participants	44.75 years STANDARD_DEVIATION 12.60622 • n=7 Participants	50.86 years STANDARD_DEVIATION 14.06448 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 16 weeks

Population: Zero participants analyzed as none of the participants treated had FDG uptake at any timepoint.

Using FDG PET cardiac imaging to identify myocardial inflammation at baseline and post-treatment, the study will quantitatively compare the change in myocardial FDG uptake in biologic naïve RA patients without clinical CVD and with inadequate methotrexate response, following randomization to 16-week treatment with abatacept vs the TNF-inhibitor adalimumab. Conventional cardiovascular disease (CVD) risk factors and measures of RA disease activity and severity will be ascertained.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: Zero participants analyzed as none of the participants treated had FDG uptake at any timepoint.

This is to test whether elevations in different T cell subsets are associated with myocardial FDG uptake in RA patients treated with abatacept vs adalimumab. Subsequently, the transcriptional phenotype of candidate subpopulations.

Outcome measures

Outcome data not reported

Adverse Events

Non-TNF Inhibitor Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TNF Inhibitor Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Non-TNF Inhibitor Arm n=3 participants at risk Treatment with abatacept will consist of weekly subcutaneous (SQ) injections at a dose of 125mg. Abatacept: 125 MG/ML subcutaneous injections	TNF Inhibitor Arm n=2 participants at risk Treatment with a adalimumab, as the TNF-inhibitor arm, will consist of every 2 weeks SQ injections at a dose of 40mg. Adalimumab: 40 Mg/0.8 mL Subcutaneous Kit
General disorders Cough	33.3% 1/3 • 20 weeks	0.00% 0/2 • 20 weeks
Renal and urinary disorders Urinary Tract Infection	0.00% 0/3 • 20 weeks	50.0% 1/2 • 20 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/3 • 20 weeks	50.0% 1/2 • 20 weeks

Additional Information

Laura Geraldino-Pardilla, MD

Columbia University

Phone: 212-305-4308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place