Abatacept plus for Myocarditis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Brigham and Women's Hospital, Boston, MA
Myocarditis+2 More
Abatacept plus - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.

Eligible Conditions

  • Myocarditis
  • Malignancies

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 6 months

6 months
Clinical status at 6 months after first infusion of study drug
Clinical status at 90 days after first infusion of study drug
Fatal and non-fatal DVT and PE
Major adverse cardiac events
Myocarditis illness severity using a 7-point ordinal severity scale containing each of the individual endpoints in a hierarchical ranking order.
Other immune-related adverse events between the two groups
The combination of the rates of the plus the proportion of patients with a troponin increase.
The increase in serum troponin levels
The individual components of the primary endpoint.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Abatacept plus standard of care
1 of 2
Placebo plus standard of care
1 of 2
Experimental Treatment
Non-Treatment Group

390 Total Participants · 2 Treatment Groups

Primary Treatment: Abatacept plus · Has Placebo Group · Phase 3

Abatacept plus standard of care
Drug
Experimental Group · 1 Intervention: Abatacept plus · Intervention Types: Drug
Placebo plus standard of care
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Brigham and Women's Hospital · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2008First Recorded Clinical Trial
1 TrialsResearching Myocarditis
1043 CompletedClinical Trials

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,462 Previous Clinical Trials
3,907,625 Total Patients Enrolled
1 Trials studying Myocarditis
20 Patients Enrolled for Myocarditis
Massachusetts General HospitalLead Sponsor
2,660 Previous Clinical Trials
30,828,407 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of myocarditis.\n
You have a high white blood cell count.
You are aged at least 18 years.
You have ALT or AST levels that are less than 20 times the upper limit of the institutional normal ranges.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.