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NCT01132118 · ClinicalTrials.gov registry record · Phase 3
Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis
A Phase 3 study of Rheumatoid Arthritis and Insulin Resistance, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01132118: Completed Phase 3 study of Rheumatoid Arthritis and Insulin Resistance, sponsored by Brigham and Women's Hospital.
NCT01132118 is a Phase 3 study of Rheumatoid Arthritis and Insulin Resistance that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 30 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132118, a Phase 3 study of Rheumatoid Arthritis and Insulin Resistance, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We will examine the effect of HCQ on the Matsuda Insulin Sensitivity Index (ISI) during the active treatment phase compared with placebo phase. ISI is based on insulin and glucose levels in a fasting state during an oral glucose tolerance test (OGTT) and is calculated as follows: ISI (Matsuda) = 10000/√ G0 X I0 X Gmean X Imean G0 - fasting plasma glucose (mg/dL) I0 - fasting plasma insulin (mIU/L) Gmean - mean plasma glucose during OGTT (mg/dL) Imean - mean plasma insulin during OGTT (mIU/L)
Conditions Studied
Interventions
- DRUG Hydroxychloroquine
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01132118 record still lists
NCT01132118 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Hydroxychloroquine is the first listed.
NCT01132118 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01132118 about?
NCT01132118 is a clinical study titled "Hydroxychloroquine to Improve Insulin Sensitivity in Rheumatoid Arthritis". 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...
What is the current status of trial NCT01132118?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2010-06. Estimated completion is 2012-06.
What conditions does trial NCT01132118 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Insulin Resistance.
What interventions are being tested in trial NCT01132118?
The interventions under investigation include: Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT01132118?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01132118 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01132118's enrollment target sits among peer trials
30 162nd of 197 higher than 34 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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