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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:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT04350216
Date of registration:	08/04/2020
Prospective Registration:	Yes
Primary sponsor:	Instituto de Investigación Marqués de Valdecilla
Public title:	Effect of Sarilumab on Atherosclerotic Disease Assessed by PET/CET in Patients With RA (SARIPET) SARIPET
Scientific title:	Effect of Sarilumab Therapy on Atherosclerotic Disease Assessed by Positron Emission Tomography/Computed Tomography (PET/CT) in Patients With Rheumatoid Arthritis
Date of first enrolment:	April 30, 2020
Target sample size:	20
Recruitment status:	Not yet recruiting
URL:	https://clinicaltrials.gov/show/NCT04350216
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment

Contacts

Contact type:
Name:	Miguel Ángel González-Gay Mantecón, MDPhD
Address:
Telephone:
Email:
Affiliation:	hospital universitario marques Valdecilla

Contact type:
Name:	Miguel Ángel González-Gay Mantecón, MDPhD
Address:
Telephone:	+34 942-202510
Email:	miguelaggay@hotmail.com
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =18 years with active RA: DAS28>3.2 and PCR levels =1 mg/dL

2. Naïve to biological DMARDs or refractory to a single biological other than anti-IL-6
drugs.

3. Only patients with plaques detected by carotid ultrasound (at least 1.5 mm) should
have a PET/CT scan.

4. Patients who are candidates for Sarilumab according to the summary of product
characteristics

5. Patients who sign the informed consent form.

Exclusion Criteria:

1. Previous history of CV events.

2. History of diabetes or chronic renal failure.

3. Absolute neutrophil count <2 x109/L.

4. Platelet count <150 x 103/µL.

5. Elevated transaminases (ALT or AST > 1.5 x LSN).

6. Active infection, including localized infection.

7. That have contraindicated the administration of Sarilumab.

8. Patients who are participating in another clinical trial or research project.

9. Refusal to participate in the study and to sign the consent form.

10. Pregnant or nursing women, or women of childbearing age who are not using an effective
method of contraception.

Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atherosclerosis

Rheumatoid Arthritis

Intervention(s)

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]

Primary Outcome(s)

Effect of Sarilumab on carotid atheroma plaque (effect on the inflammatory component) using ultrasound in patients with RA [Time Frame: 6 months]

Effect of Sarilumab on carotid atheroma plaque (effect on the mineralization) using ultrasound in patients with RA [Time Frame: 6 months]

Secondary Outcome(s)

Change in PET/CT 18F-FDG uptake in the aortic wall [Time Frame: 6 months]

Modulation of the lipid profile using blood test [Time Frame: 6 months]

Determine disease activity with DAS 28 index (Rheumatoid arthritis disease activity index) with 4 items corresponding to low (DAS28 = 2.43), medium (DAS28 = 4.05), high (DAS28 = 6.32) or very high (DAS28 = 8.40) activity. [Time Frame: 6 months]

Changes in mRNA expression by gene expression studies [Time Frame: 6 months]

Routine inflammatory parameters [Time Frame: 6 months]

Change in PET/CT 18F-FNa uptake in the aortic wall [Time Frame: 6 months]

Change in the index of insulin sensitivity. [Time Frame: 6 months]

Changes in serum adipocine levels by ELISA/multiplex Serological studies [Time Frame: 6 months]

Change in the index of insulin resistance. [Time Frame: 6 months]

Determine disease activity [Time Frame: 6 months]

Change in levels biomarker levels biomarkers associated with MS by ELISA/multiplex Serological studies [Time Frame: 6 months]

Determine disease activity with CDAI index ( number of painful and swollen joints with 28 joints, the activity assessment by the patient and the physician on a scale from 0 to 10 and the PCR in mg/dl) [Time Frame: 6 months]

Change in levels biomarkers of endothelial cell activation and inflammation. [Time Frame: 6 months]

Secondary ID(s)

SARIPET_2019.099

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
URL:
URL of the protocol:
Date Posted:
Date of completion:
Date of first publication:
Results summary:
Baseline characteristics:
Adverse events:
Outcome measures:
IPD sharing plan:	No
IPD sharing description:

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