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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2017

Interventions

  • Drug: Hydroxychloroquine
    • Hydroxychloroquine 400mg once daily initially
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Experimental: Hydroxychloroquine
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Endothelial dysfunction marker
    • Time Frame: 3 months
    • VCAM
  • Endothelial dysfunction marker
    • Time Frame: 3 months
    • E-Selektine

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indonesia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rudy Hidayat, MD – Indonesia University

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