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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Approved for 5 Other Conditions

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

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

1,486 Previous Clinical Trials

2,663,169 Total Patients Enrolled

1 Trials studying Rheumatoid Arthritis

149 Patients Enrolled for Rheumatoid Arthritis

Bristol-Myers SquibbIndustry Sponsor

2,682 Previous Clinical Trials

4,129,536 Total Patients Enrolled

108 Trials studying Rheumatoid Arthritis

371,540 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.