World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03085940
Date of registration: 07/02/2017
Prospective Registration: No
Primary sponsor: Indonesia University
Public title: Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Scientific title: Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
Date of first enrolment: January 20, 2017
Target sample size: 37
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03085940
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  N/A
Countries of recruitment
Indonesia
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Placebo
Drug: Hydroxychloroquine
Primary Outcome(s)
Endothelial dysfunction marker [Time Frame: 3 months]
Secondary Outcome(s)
Secondary ID(s)
HCQ-ED01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history