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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ciptomangunkusumo Hospital

Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroxychloroquine

Drug

Hydroxychloroquine 400mg once daily initially

Other names: HCQ

Placebo

Drug

Placebo

Primary outcomes

Endothelial dysfunction marker

Time frame: 3 months

VCAM
Endothelial dysfunction marker

Time frame: 3 months

E-Selektine

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Mar 21, 2017
Registry last updated: Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed