CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Hydroxychloroquinedrug
Likely dose
Hydroxychloroquine 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01132118
NCT01132118Phase 3Completed

Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis

Brigham and Women's Hospital·interventional·Posted May 27, 2010·Updated Sep 3, 2014

In Brief

A Phase 3 clinical trial evaluating Hydroxychloroquine for Rheumatoid Arthritis and Insulin Resistance. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether hydroxychloroquine (HCQ) reduces insulin resistance in non-diabetic subjects with rheumatoid arthritis (RA). The investigators will conduct a double-blind randomized crossover trial in subjects with RA to test the hypothesis that HCQ improves insulin sensitivity. The investigators will also use data from the trial to identify determinants of insulin resistance in RA. The investigators hypothesize that RA will be associated with an increased risk of insulin resistance and that independent risk factors for increased insulin resistance in RA include higher BMI, elevated acute phase reactants, greater fat to muscle ratio, and less physical activity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 27, 2010
Enrollment StartJun 1, 2010
Primary CompletionApr 1, 2012
Study CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.1 years ago

Interventions

Hydroxychloroquinedrug

Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.