Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis

Indonesia University37 enrolled

Overview

Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction. Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some metabolic effects. The investigators intend to find the role of HCQ to improve endothelial dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL (oxidized-LDL) level change, with endothelial dysfunction improvement.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 400mg once daily initially

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Rheumatoid Arthritis patients (2010 ACR/EULAR criteria) * Being or will be treated with methotrexate (monotherapy) * Agree to join the study Exclusion Criteria: * Autoimmune diseases other than RA * Acute severe infection, acute coronary syndrome, heart failure, stroke * Malignancy or chronic inflammatory diseases * Eye disease involving the retina and visual field defects * G6PD (glucose 6-phosphate dehydrogenase) deficiency * History of smoking within last 5 years * Lipid lowering, insulin resistance lowering, antidiabetic, insulin, ACE(angiotensin converting enzyme)-inhibitor or ARB(angiotensin receptor blocker) drugs

Locations (1)

Ciptomangunkusumo Hospital

Jakarta, Indonesia

Outcomes

Primary Outcomes

Endothelial dysfunction marker

VCAM

Time frame: 3 months

Endothelial dysfunction marker

E-Selektine

Time frame: 3 months

Data from ClinicalTrials.gov

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