Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
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ClinicalTrials.gov Identifier: NCT02338999 |
Recruitment Status :
Completed
First Posted : January 15, 2015
Results First Posted : September 14, 2021
Last Update Posted : September 14, 2021
|
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention |
Condition |
Systemic Lupus Erythematosus |
Interventions |
Radiation: PET/CT Drug: Pioglitazone Drug: Placebo |
Enrollment | 88 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | 88 subjects were consented; 5 subjects declined participation after consent and 3 subjects did not meet eligibility criteria. |
Arm/Group Title | Pioglitazone, Then Placebo | Placebo, Then Pioglitazone |
---|---|---|
Arm/Group Description | Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months. | Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months. |
Period Title: First Intervention | ||
Started | 39 | 41 |
Completed | 36 | 40 |
Not Completed | 3 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 1 |
Period Title: Washout Period | ||
Started | 36 | 40 |
Completed | 36 | 38 |
Not Completed | 0 | 2 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 2 |
Period Title: Second Intervention | ||
Started | 36 | 38 |
Completed | 36 | 36 |
Not Completed | 0 | 2 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 2 |
Baseline Characteristics
Arm/Group Title | Pioglitazone, Then Placebo | Placebo, Then Pioglitazone | Total | |
---|---|---|---|---|
Arm/Group Description | Treatment with pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for three months. Followed by a two-month washout period before cross over to placebo treatment for 3 months. | Treatment with placebo for 3 months. Followed by a 2-month washout period before cross over to pioglitazone 45 mg daily (may be titrated down to 30 mg if subject experiences weight gain or other side effects) for an additional 3 months. | Total of all reporting groups | |
Overall Number of Baseline Participants | 39 | 41 | 80 | |
Baseline Analysis Population Description |
[Not Specified]
|
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 39 participants | 41 participants | 80 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
33 84.6%
|
39 95.1%
|
72 90.0%
|
|
>=65 years |
6 15.4%
|
2 4.9%
|
8 10.0%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 39 participants | 41 participants | 80 participants | |
Female |
33 84.6%
|
37 90.2%
|
70 87.5%
|
|
Male |
6 15.4%
|
4 9.8%
|
10 12.5%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 39 participants | 41 participants | 80 participants | |
Hispanic or Latino |
16 41.0%
|
17 41.5%
|
33 41.3%
|
|
Not Hispanic or Latino |
22 56.4%
|
24 58.5%
|
46 57.5%
|
|
Unknown or Not Reported |
1 2.6%
|
0 0.0%
|
1 1.3%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 39 participants | 41 participants | 80 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
4 10.3%
|
5 12.2%
|
9 11.3%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
9 23.1%
|
10 24.4%
|
19 23.8%
|
|
White |
17 43.6%
|
17 41.5%
|
34 42.5%
|
|
More than one race |
1 2.6%
|
1 2.4%
|
2 2.5%
|
|
Unknown or Not Reported |
8 20.5%
|
8 19.5%
|
16 20.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Kaplan, Mariana |
Organization: | National Inst of Arthritis and Musculoskeletal and Skin Diseases |
Phone: | +1 301 496 0517 |
EMail: | mariana.kaplan@nih.gov |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) ) |
ClinicalTrials.gov Identifier: | NCT02338999 |
Other Study ID Numbers: |
150060 15-AR-0060 |
First Submitted: | January 14, 2015 |
First Posted: | January 15, 2015 |
Results First Submitted: | July 12, 2021 |
Results First Posted: | September 14, 2021 |
Last Update Posted: | September 14, 2021 |