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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL086553 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks and other complications of their blood vessels. New therapies are needed to prevent this complication. The purpose of this study is to establish the role of the medication pioglitazone in improving the function of the blood vessels and heart and decreasing the risk of future atherosclerosis development in individuals with rheumatoid arthritis. As a secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation.
This study will establish the role of pioglitazone in improvement of endothelial function, arterial compliance and disease activity in patients with rheumatoid arthritis. This will be a placebo-controlled, double blind, cross-over trial.
Two of the measures which were initially listed as separate outcome measures: (Decrease in inflammation) and Efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation are now shown as a combined score (DAS-28-CRP). The Risks or Side Effects as an outcome measure would be duplicative of the tables in the adverse event section and therefore were deleted as an outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone then placebo | Other | Oral daily pioglitazone 30 mg tablets daily for 2 weeks, followed by 45 mg daily tablets until end of study for 3 months compared to placebo in tablets of equal presentation for 3 months, then crossover after a 2 month washout. |
|
| placebo then study drug (pioglitazone) | Other | Oral daily placebo for 3 months compared to pioglitazone for 3 months, then crossover after a 2 month washout. Similar doses as mentioned above. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | daily dose, 30 mg daily for 2 weeks followed by 45 mg daily until completing 3 months unless higher dose not tolerated in which case patient remained at 30 mg daily |
| Measure | Description | Time Frame |
|---|---|---|
| Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia | This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rheumatoid Arthritis Disease Activity | Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)). Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariana J Kaplan, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21727237 | Background | Marder W, Khalatbari S, Myles JD, Hench R, Yalavarthi S, Lustig S, Brook R, Kaplan MJ. Interleukin 17 as a novel predictor of vascular function in rheumatoid arthritis. Ann Rheum Dis. 2011 Sep;70(9):1550-5. doi: 10.1136/ard.2010.148031. Epub 2011 Jul 4. | |
| 23962407 | Background | Zhao W, Berthier CC, Lewis EE, McCune WJ, Kretzler M, Kaplan MJ. The peroxisome-proliferator activated receptor-gamma agonist pioglitazone modulates aberrant T cell responses in systemic lupus erythematosus. Clin Immunol. 2013 Oct;149(1):119-32. doi: 10.1016/j.clim.2013.07.002. Epub 2013 Jul 20. |
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Out of the 144 individuals screened, one was not randomized to either arm.
Participant came into University of Michigan Rheumatology clinic learned about the study and then came in for baseline to sign consent or signed consent at screening visit and then came in for baseline visit at a latter date.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Drug (Pioglitazone) Then Placebo | Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months. |
| FG001 | Placebo Then Study Drug (Pioglitazone) | Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Arm of Study |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Crossover Arm (3 Months) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Drug (Pioglitazone) Then Placebo | Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout. |
| BG001 | Placebo Then Study Drug (Pioglitazone) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia | This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study. | Vascular function parameters were performed in patients with rheumatoid arthritis at baseline and at completion of each arm , as well as at the beginning of crossover following washout period. | Posted | Mean | Inter-Quartile Range | % changes in diameter of artery | 8 months |
|
8 months, but no more than 10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Drug (Pioglitazone) Then Placebo, While on Drug | Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trauma - Car Crash | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PPAR-gamma agonist, rheumatoid arthritis and cardiovascular disease | UMichigan | 734-936-7905 | makaplan@umich.edu |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Sublingual nitroglycerine | Drug | Used during nitroglycerin-mediated dilatation vascular function measures in both arms of the study if patient's blood pressure permitted. One single tablet was used per vascular test performed. |
|
| 8 mo |
| 24252844 | Derived | Marder W, Khalatbari S, Myles JD, Hench R, Lustig S, Yalavarthi S, Parameswaran A, Brook RD, Kaplan MJ. The peroxisome proliferator activated receptor-gamma pioglitazone improves vascular function and decreases disease activity in patients with rheumatoid arthritis. J Am Heart Assoc. 2013 Nov 19;2(6):e000441. doi: 10.1161/JAHA.113.000441. |
| NOT COMPLETED |
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| NOT COMPLETED |
|
Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout. |
|
|
| Secondary | Rheumatoid Arthritis Disease Activity | Quantification of disease activity using validated assessments (disease activity score on 28 joints (DAS28) and and C-reactive protein ( CRP) (Inflammatory marker) as a combined score (DAS-28CRP)). Mean decrease in DAS-28-CRP score when compared to baseline was measured. The range of DAS-28-CRP is 0-10, with 0 meaning no active disease detected and 10 being the most severe active disease detected by joint count and C-reactive protein levels in blood. | Posted | Mean | Standard Deviation | mean decrease in DAS28-CRP score | 8 mo |
|
|
|
|
| 5 |
| 72 |
| 22 |
| 72 |
| EG001 | Study Drug (Pioglitazone) Then Placebo, During Washout | Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months. | 1 | 72 | 2 | 72 |
| EG002 | Study Drug (Pioglitazone) Then Placebo, While on Placebo | Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months. | 0 | 72 | 8 | 72 |
| EG003 | Placebo Then Study Drug (Pioglitazone) While on Placebo | Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months. | 1 | 71 | 12 | 71 |
| EG004 | Placebo Then Study Drug (Pioglitazone) During Washout | Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months. | 3 | 71 | 0 | 71 |
| EG005 | Placebo Then Study Drug (Piolglitazone) While on Study Drug | Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months. | 5 | 71 | 9 | 71 |
| Edema, Chest Pain | General disorders | Non-systematic Assessment |
|
| Dyspnea, Asthma, Chest Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cellulitis - Left Ear | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Right Hip Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Tachycardia, Elevated BP | Cardiac disorders | Non-systematic Assessment |
|
| Infection - Left 1st Toe | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Revision MCP Arthroplasty with Removal of Implant and Rheumatoid Nodule | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| C Diff Colitis | Infections and infestations | Non-systematic Assessment |
|
| Breast Cancer | General disorders | Non-systematic Assessment |
|
| Intracranial Bleed | Nervous system disorders | Non-systematic Assessment |
|
| Breast Cancer - Stage 1 | General disorders | Non-systematic Assessment |
|
| Low Potassium and Low Sodium Levels | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Death 7 mo post study termination from pneumonia complications of end stage pulmonary fibrosis | Infections and infestations | Non-systematic Assessment |
|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Metastic Merkel Cell Cancer | General disorders | Non-systematic Assessment |
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| Weight Gain | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Swollen, Painful Ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Flushed and Nauseated due to Reaction to Nitroglycerin | General disorders | Non-systematic Assessment |
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| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Itchy Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Elevated Blood Pressure | Cardiac disorders | Non-systematic Assessment |
|
| Lightheaded | General disorders | Non-systematic Assessment |
|
| Decrease Blood Pressure due to Nitroglycerin | Cardiac disorders | Non-systematic Assessment |
|
| URI progressed to Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Eczema due to use of Humira | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Left Lower Leg Wound Infection (Cellulitis) | Infections and infestations | Non-systematic Assessment |
|
| Low Blood Pressure | Cardiac disorders | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | Non-systematic Assessment |
|
| Sprain - Left Knee | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Infection to Salivary Gland | Infections and infestations | Non-systematic Assessment |
|
| RA Flare - Pain in L Wrist and Hand | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Possible Allergic Reaction to Study Drug | General disorders | Non-systematic Assessment |
|
| Neck Pain, Cervicalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervicalgia due to Car Accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Infection on the Skin | Infections and infestations | Non-systematic Assessment |
|
| Edema / Swelling | Cardiac disorders | Non-systematic Assessment |
|
| Elevated Liver Enzymes | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Infection of Ulcer on Left 1st Toe | Infections and infestations | Non-systematic Assessment |
|
| Edema in the Ankles | Cardiac disorders | Non-systematic Assessment |
|
| Swelling to hands, feet, knees, or legs | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Bladder Infection | Infections and infestations | Non-systematic Assessment |
|
| Drug Reaction | General disorders | Non-systematic Assessment |
|
| Hives after Dose Escalation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Root Canal | Infections and infestations | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Tightness in Upper Chest | Cardiac disorders | Non-systematic Assessment |
|
| Shortness of breath | Cardiac disorders | Non-systematic Assessment |
|
| Small Avulsion Right Distal Fibula Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Diaphoretic, Low BP (Dehydration), Fainted | Cardiac disorders | Non-systematic Assessment |
|
| Wheezing (history of Asthma) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |