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

University of Indonesia (UI)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Hydroxychloroquine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03085940

HCQ-ED01

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Hydroxychloroquine

Experimental group

Treatment:

Drug: Hydroxychloroquine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo