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NCT02338999 · ClinicalTrials.gov registry record · Phase 1
Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
A Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
NCT02338999: Completed Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT02338999 is a Phase 1 study that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 88 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338999, a Phase 1 study, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
Study Summary
Background: \- Lupus causes a person s immune system to attack the body. It can cause blood vessel problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may help. Objectives: \- To see how well pioglitazone improves blood vessel function and decreases blood vessel inflammation. To study its effect on lupus symptoms. Eligibility: \- Adults at least 18 years old with lupus. Design: * Participants will be screened with medical history, heart test, and blood and urine tests. They may have a bone density test. * Visit 1: * Participants will have: * Physical exam and blood drawn. * Peripheral Arterial Tonometry (Endopat). A cup will be placed on the finger and a pressure cuff on the arm. * Cardio-ankle vascular index (CAVI) and/or Sphygmocor. Electrodes will be placed on both wrists, a microphone on the chest, and a blood pressure cuff on each arm and leg. Another test will involve placing a small device on a fingertip. * 18-Fluorodeoxyglucose (FDG) positron emission tomography/computerized tomography (PET/CT) (some participants). A radioactive sugar will be injected into a small plastic tube in an arm vein. Participants will lie on a bed that moves in and out of a scanner that takes pictures. * Participants will get a 3-month-supply of the study drug or placebo. After 1 week, their dose may increase. * After those 3 months, they will not take either drug for 8 weeks. Then they will switch and take the other drug for 3 months. * Participants will have 6 more visits over 8 months after Visit 1. Tests from Visit 1 may be repeated. They may have a urine test.
Primary Outcome
Change in vascular function using non-invasive vascular tests, measuring vascular compliance - Cardio ankle vascular index (CAVI). CAVI is an index reflecting the stiffness of the artery from the heart to ankles; it increases with atherosclerosis progression. CAVI was measured using VaSera-1500A (Fukuda Denshi Co. Redmond, WA)
Interventions
- DRUG Placebo
- DRUG Pioglitazone
- RADIATION PET/CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2015-06-18 |
| Est. Completion | 2020-07-14 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT02338999 record still lists
NCT02338999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02338999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02338999 about?
NCT02338999 is a clinical study titled "Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)". Background: \- Lupus causes a person s immune system to attack the body. It can cause blood vessel problems, heart attack, or stroke. Researchers want to see if the drug pioglitazone may help. Objectives: \- To see how well pioglitazone improves blood vessel function and decreases blood vessel in...
What is the current status of trial NCT02338999?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2015-06-18. Estimated completion is 2020-07-14.
What interventions are being tested in trial NCT02338999?
The interventions under investigation include: Placebo (DRUG), Pioglitazone (DRUG), PET/CT (RADIATION).
Who is sponsoring clinical trial NCT02338999?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02338999's enrollment target sits among peer trials
88 650th of 2000 higher than 1,350 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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