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
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
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
NCT ID
NCT03085940
First Posted
February 7, 2017
Last Updated
September 29, 2017
Sponsor
Indonesia University
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
Learn more about this trial
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs