Status:
UNKNOWN
Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET)
Lead Sponsor:
Instituto de Investigación Marqués de Valdecilla
Conditions:
Rheumatoid Arthritis
Atherosclerosis
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is a condition associated with a high incidence of cardiovascular disease (CV), primarily as a result of accelerated atherosclerosis . Patients with RA also have a high preva...
Detailed Description
RA is a chronic inflammatory disease characterized by chronic and erosive arthritis that mainly involves peripheral joints. RA affects activities of daily living, significantly decreasing the quality ...
Eligibility Criteria
Inclusion
- Age ≥18 years with active RA: DAS28\>3.2 and PCR levels ≥1 mg/dL
- Naïve to biological DMARDs or refractory to a single biological other than anti-IL-6 drugs.
- Only patients with plaques detected by carotid ultrasound (at least 1.5 mm) should have a PET/CT scan.
- Patients who are candidates for Sarilumab according to the summary of product characteristics
- Patients who sign the informed consent form.
Exclusion
- Previous history of CV events.
- History of diabetes or chronic renal failure.
- Absolute neutrophil count \<2 x109/L.
- Platelet count \<150 x 103/μL.
- Elevated transaminases (ALT or AST \> 1.5 x LSN).
- Active infection, including localized infection.
- That have contraindicated the administration of Sarilumab.
- Patients who are participating in another clinical trial or research project.
- Refusal to participate in the study and to sign the consent form.
- Pregnant or nursing women, or women of childbearing age who are not using an effective method of contraception.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04350216
Start Date
April 30 2020
End Date
April 30 2021
Last Update
April 27 2020
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