Effect of Sarilumab on atherosclerotic disease in Rheumatoid Arthritis

Phase 1

• Conditions: RHEUMATOID ARTHRITIS; MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2019-004078-24-ES
• Lead Sponsor: IDIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-21
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Patients = 18 years diagnosed with active RA: DAS28>3.2 and levels of CRP of at least 1 mg/dl.
- Naïve to biologic DMARDs (bDMARDs) or refractory to a single bDMARD different from anti-
IL-6 agents.
- Only patients with plaques assessed by carotid US will be included in the PET/CT study. Plaques will be detected by US (for this purpose of at least 1.5 mm).
- Patients who are candidates for sarilumab according to summary of product characteristics (SmPC).
- Patients must sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients with previous history of CV events.
- Patients with history of diabetes or chronic renal failure.
- Patients with an absolute neutrophil count (ANC) less than 2 x 109/L.
- Patients with platelet count below 150 x 103/µL.
- Patients with elevated transaminases, ALT or AST greater than 1.5 x ULN.
- Patients with an active infection, including localized infections.
- Patients who are not candidates for sarilumab according to SmPC.
- Patients enrolled in other clinical trial or research project.
- Patients who do not sign the informed consent.
-Women who are pregnant or breastfeeding, or those of child-bearing who are not using an effective method of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified