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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Hydroxychloroquine
Placebo
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ciptomangunkusumo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hydroxychloroquine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Endothelial dysfunction marker
VCAM
Endothelial dysfunction marker
E-Selektine

Secondary Outcome Measures

Full Information

First Posted
February 7, 2017
Last Updated
September 29, 2017
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03085940
Brief Title
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Official Title
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
HCQ
Intervention Description
Hydroxychloroquine 400mg once daily initially
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Endothelial dysfunction marker
Description
VCAM
Time Frame
3 months
Title
Endothelial dysfunction marker
Description
E-Selektine
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ciptomangunkusumo Hospital
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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

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