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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03085940
Recruitment Status : Completed
First Posted : March 21, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Rudy Hidayat, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Hydroxychloroquine Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Actual Study Start Date : January 20, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hydroxychloroquine Drug: Hydroxychloroquine
Hydroxychloroquine 400mg once daily initially
Other Name: HCQ

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Endothelial dysfunction marker [ Time Frame: 3 months ]
    VCAM

  2. Endothelial dysfunction marker [ Time Frame: 3 months ]
    E-Selektine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03085940


Locations
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Indonesia
Ciptomangunkusumo Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

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Responsible Party: Rudy Hidayat, MD, Indonesia University
ClinicalTrials.gov Identifier: NCT03085940     History of Changes
Other Study ID Numbers: HCQ-ED01
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

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

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents