An interventional study of Pioglitazone and Placebo in Rheumatoid Arthritis, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-13.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Basic science
Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness, and loss of function in the joints. Over time, joint deformity, joint destruction, and loss of function can occur. Current treatment aims to improve symptoms, but there is no cure for the disease. Pioglitazone is drug that is effective in treating people with diabetes. This study will determine whether pioglitazone can also be used to effectively treat people with RA.
RA is an autoimmune disease that causes long-term inflammation of the joints and sometimes other body tissues, too. Recent studies have found that there is an increased prevalence of coronary artery atherosclerosis, metabolic syndrome, and insulin resistance among people with RA. Furthermore, insulin resistance, which can lead to hyperinsulinemia-too much insulin in the blood-has been associated with RA disease activity and the severity of coronary artery atherosclerosis. These correlations suggest that inflammation and hyperinsulinemia somehow interact and facilitate one another.
Pioglitazone is a prescription drug that reduces insulin resistance and is currently used to treat people with diabetes. This study will determine whether pioglitazone can also be used to effectively treat people with RA. Specifically, the study will evaluate the effect of pioglitazone on inflammation, insulin resistance, and atherosclerosis.
Participation in this study will last about 20 weeks. At an initial 1-hour screening, participants will undergo a physical examination, medical history review, blood sampling, and, if female, a urine pregnancy test. Eligible participants will then return for the first of six monthly study visits. At this first visit, participants will be randomly assigned to receive either pioglitazone or placebo, both of which will be taken daily for 8 weeks. This will be followed by a 4-week wash-out period, during which no study treatments will be taken. Then, at Week 12, participants will begin daily treatments of whatever they were not assigned to originally. This second treatment phase will also last for 8 weeks.
All of the study visits will involve the same tests and procedures. The morning before each study visit, participants will collect their urine in a jug, which they will bring to the clinic. Participants will then undergo blood sampling, blood pressure measurements, and artery stiffness measurements. During the study visits at Weeks 4, 8, 16, and 20, participants will be asked to report on their symptoms, pain, and any adverse effects.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 34 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo for first 8 weeks, then washout period for 4 weeks, and finally pioglitazone for 8 weeks.
Drug: Pioglitazone · Drug: Placebo
Pioglitazone for first 8 weeks, then washout period for 4 weeks, and finally placebo for 8 weeks.
Drug: Pioglitazone · Drug: Placebo
45 mg by mouth once a day for 8 weeks
Also known as: Actos
By mouth once a day for 8 weeks
Disease Activity Score Based on 28-joint Disease Activity Score (DAS28)
A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56\*sqrt(t28) + 0.28\*sqrt(sw28) + 0.70\*Ln(ESR) + 0.014\*GH
Time frame: Measured after 8 weeks of treatment
Homeostasis Model Assessment (HOMA) for Insulin Sensitivity
Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose \* Insulin/22/5
Time frame: Measured after 8 weeks of treatment
C-reactive Protein (CRP)
Time frame: Measured after 8 weeks of treatment
ESR
sed rate
Time frame: baseline and after 8 weeks on either placebo or pioglitazone
| Milestone | Placebo 1st, Pioglitazone 2nd | Pioglitazone 1st, Placebo 2nd |
|---|---|---|
| Started | 17 | 17 |
| Completed | 12 | 14 |
| Not completed | 5 | 3 |
| Withdrew: Adverse event | 4 | 2 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Med change not allowed by protocol | 1 | 0 |
A measure of disease activity based upon tender joint count of 28 joints, swollen joint count of 28 joints, erythrocyte sedimentation rate, and global disease activity (GH) as reported by participant. Calculation is as follows: DAS28=0.56\*sqrt(t28) + 0.28\*sqrt(sw28) + 0.70\*Ln(ESR) + 0.014\*GH
| units on a scale | Pioglitazone Phase Baseline | Pioglitazone Phase After 8 Weeks | Placebo Phase Baseline | Placebo Phase wk 8/20 |
|---|---|---|---|---|
| Disease Activity Score Based on 28-joint Disease Activity Score (DAS28) | 4.40 ± 1 | 4.03 ± 1.15 | 4.57 ± 1.28 | 4.48 ± 1.20 |
Homa is a measure of insulin sensitivity, using glucose measured in mmol/L and insulin measured in milliUnits per liter (mU/L) Calculated using the formula Glucose \* Insulin/22/5
| units on a scale | Pioglitazone Phase Baseline | Pioglitazone Phase After 8 Weeks | Placebo Phase Baseline | Placebo Phase wk 8/20 |
|---|---|---|---|---|
| Homeostasis Model Assessment (HOMA) for Insulin Sensitivity | 2.83 ± 2.5 | 2.44 ± 2.08 | 2.38 ± 1.75 | 3.11 ± 3.47 |
| mg/dl | Pioglitazone Phase Baseline | Pioglitazone Phase After 8 Weeks | Placebo Phase Baseline | Placebo Phase wk After 8 Weeks |
|---|---|---|---|---|
| C-reactive Protein (CRP) | 8.1 ± 11.41 | 5.02 ± 7.64 | 7.7 ± 13.6 | 8.25 ± 10.32 |
sed rate
| mm/hr | Pioglitazone Phase Baseline | Pioglitazone Phase After 8 Weeks | Placebo Phase Baseline | Placebo Phase After 8 Weeks |
|---|---|---|---|---|
| ESR | 18.5 ± 18.2 | 17 ± 17.06 | 19.5 ± 20 | 18.88 ± 20.8 |
Collected over Adverse Event data were collected over the course of the 20 week study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pioglitazone | — | 0/34 (0%) | 6/34 (17.6%) |
| Placebo | — | 2/34 (5.9%) | 6/34 (17.6%) |
| Event | Pioglitazone | Placebo |
|---|---|---|
| PregnancyPregnancy, puerperium and perinatal conditions | 0/34 | 2/34 |
| Event | Pioglitazone | Placebo |
|---|---|---|
| ankle edemaGeneral disorders | 3/34 | 2/34 |
| upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 2/34 | 3/34 |
| liver function tests elevatedHepatobiliary disorders | 2/34 | 1/34 |
| Age, Continuous(years) | Baseline Characteristics of Participants |
|---|---|
| Mean | 51.0 ± 14.2 |
| Sex: Female, Male(Participants) | Baseline Characteristics of Participants |
|---|---|
| Female | 28 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Baseline Characteristics of Participants |
|---|---|
| American Indian or Alaska Native | 2 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 29 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Baseline Characteristics of Participants |
|---|---|
| United States | 34 |
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University