Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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17 August 2021 |
Main ID: |
NCT03619876 |
Date of registration:
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03/08/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effects of Abatacept on Myocarditis in Rheumatoid Arthritis
AMiRA |
Scientific title:
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Effects of Abatacept on Myocarditis in Rheumatoid Arthritis |
Date of first enrolment:
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July 10, 2019 |
Target sample size:
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20 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03619876 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Laura Geraldino-Pardilla, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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CUMC |
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Name:
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Laura Geraldino-Pardilla, MD |
Address:
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Telephone:
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212-305-4308 |
Email:
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lbg2124@columbia.edu |
Affiliation:
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Name:
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Laura Geraldino-Pardilla, MD |
Address:
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Telephone:
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Email:
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lbg2124@columbia.edu |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Written informed consent signed by the subject.
- Patients age > 18 years.
- Fulfilling the American College of Rheumatology 2010 classification criteria for RA.
- MTX for = 8 weeks at = 15mg weekly or on at least 7.5mg of methotrexate weekly for =8
weeks with a documented intolerance of higher MTX doses, and on a stable dose for the
previous 4 weeks;
- Naïve to biologic treatment.
- If the subject is a woman with childbearing potential, a urine sample will be taken
for a pregnancy test. The results of the pregnancy test must be negative.
Exclusion Criteria:
- Prior biologic use.
- Any prior self-reported physician diagnosed CV event (myocardial infarction; angina;
stroke or Transient Ischemic Attack (TIA); heart failure; prior CV procedure (i.e.,
coronary artery bypass graft, angioplasty, valve replacement, pacemaker).
- Active history of cancer.
- Prior use of immune checkpoint inhibitors.
- Known pregnancy, HIV, hepatitis B, hepatitis C, active (or untreated latent)
tuberculosis.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Inflammation
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Adalimumab
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Drug: Abatacept
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Primary Outcome(s)
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Change in myocardial FDG uptake in RA patients treated with abatacept vs adalimumab.
[Time Frame: Baseline, 16 weeks from BL-randomization]
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Secondary Outcome(s)
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Prevalence of T cell subpopulations associated with myocardial FDG uptake in RA patients treated with abatacept vs adalimumab.
[Time Frame: Baseline, 16 weeks from BL-randomization]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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