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

NCT ID: NCT03085940

Last Updated: 2017-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-20

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Hydroxychloroquine

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine 400mg once daily initially

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Hydroxychloroquine

Hydroxychloroquine 400mg once daily initially

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Other Intervention Names

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HCQ

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Rudy Hidayat

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ciptomangunkusumo Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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HCQ-ED01

Identifier Type: -

Identifier Source: org_study_id