NCT03085940

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2017

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

8 months

First QC Date

February 7, 2017

Last Update Submit

September 29, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Endothelial dysfunction marker

    VCAM

    3 months

  • Endothelial dysfunction marker

    E-Selektine

    3 months

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL
Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HydroxychloroquineDRUG

Hydroxychloroquine 400mg once daily initially

Also known as: HCQ
Hydroxychloroquine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid Arthritis patients (2010 ACR/EULAR criteria)
  • Being or will be treated with methotrexate (monotherapy)
  • Agree to join the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ciptomangunkusumo Hospital

Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2017

First Posted

March 21, 2017

Study Start

January 20, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

ID(1)