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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085940
• Other study ID #: HCQ-ED01
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: September 29, 2017
• Start date: January 20, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Indonesia	Ciptomangunkusumo Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial dysfunction marker	VCAM	3 months
Primary	Endothelial dysfunction marker	E-Selektine	3 months