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CTLA4-Ig fusion protein

Non- Tumor necrosis factor (TNF) inhibitor arm for Rheumatoid Arthritis (AMiRA Trial)

Phase 4

Waitlist Available

Led By Laura Geraldino-Pardilla, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 16 weeks

Awards & highlights

AMiRA Trial Summary

This trial will study the effects of abatacept on subclinical myocarditis in rheumatoid arthritis patients. Myocarditis is an inflammation of the heart muscle and a possible contributor to heart failure. The objective is to compare the change in myocardial FDG uptake in RA patients treated with abatacept vs adalimumab, and identify T cell subpopulations associated with myocardial FDG uptake in each treatment arm.

Eligible Conditions

Rheumatoid Arthritis
Myocarditis

AMiRA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Myocardial FDG Uptake in Rheumatoid Arthritis (RA) Patients Treated With Abatacept vs Adalimumab.

Secondary outcome measures

Prevalence of T Cell Subpopulations Associated With Myocardial FDG Uptake in RA Patients Treated With Abatacept vs Adalimumab.

AMiRA Trial Design

2Treatment groups

Active Control

Group I: Non- Tumor necrosis factor (TNF) inhibitor armActive Control1 Intervention

Treatment with abatacept will consist of weekly subcutaneous (SQ) injections at a dose of 125mg.

Group II: TNF inhibitor armActive Control1 Intervention

Treatment with a adalimumab, as the TNF-inhibitor arm, will consist of every 2 weeks SQ injections at a dose of 40mg.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,447,248 Total Patients Enrolled

1 Trials studying Rheumatoid Arthritis

149 Patients Enrolled for Rheumatoid Arthritis

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,053 Total Patients Enrolled

108 Trials studying Rheumatoid Arthritis

371,529 Patients Enrolled for Rheumatoid Arthritis

Laura Geraldino-Pardilla, MD3.08 ReviewsPrincipal Investigator - CUMC

Columbia University

1Patient Review

My video chat consultation — which I was charged an exorbitant $400 for — resulted in a recommendation for the most expensive and invasive treatment option. I was also discouraged from pursuing any holistic or natural treatments, which is understandable given her training. However, I became concerned when I attempted to schedule the CT scan she referred me for and was met with delays and roadblocks at every turn. After months of trying, I finally realized that her office was intentionally preventing me from getting the scan. I would not recommend her to anyone.