Trial Outcomes & Findings for PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease (NCT NCT00554853)
NCT ID: NCT00554853
Last Updated: 2017-02-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
143 participants
Primary outcome timeframe
8 months
Results posted on
2017-02-02
Participant Flow
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.
Out of the 144 individuals screened, one was not randomized to either arm.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Arm of Study
STARTED
|
72
|
71
|
|
First Arm of Study
COMPLETED
|
56
|
64
|
|
First Arm of Study
NOT COMPLETED
|
16
|
7
|
|
Washout Period (2 Weeks)
STARTED
|
56
|
64
|
|
Washout Period (2 Weeks)
COMPLETED
|
56
|
57
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
7
|
|
Crossover Arm (3 Months)
STARTED
|
56
|
57
|
|
Crossover Arm (3 Months)
COMPLETED
|
53
|
55
|
|
Crossover Arm (3 Months)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PPAR-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
Study Drug (Pioglitazone) Then Placebo
n=72 Participants
Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
|
Placebo Then Study Drug (Pioglitazone)
n=71 Participants
Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
59 Participants
n=39 Participants
|
57 Participants
n=41 Participants
|
116 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 12.3 • n=39 Participants
|
56.0 years
STANDARD_DEVIATION 12.0 • n=41 Participants
|
55.2 years
STANDARD_DEVIATION 12.1 • n=35 Participants
|
|
Gender
Female
|
56 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
109 Participants
n=35 Participants
|
|
Gender
Male
|
16 Participants
n=39 Participants
|
18 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=39 Participants
|
71 participants
n=41 Participants
|
143 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 8 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Study Drug (Pioglitazone) Then Placebo
n=72 Participants
Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
|
Placebo Then Study Drug (Pioglitazone)
n=71 Participants
Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
|
|---|---|---|
|
Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia
|
8.3 % changes in diameter of artery
Interval 4.4 to 17.5
|
9.43 % changes in diameter of artery
Interval 4.3 to 20.0
|
SECONDARY outcome
Timeframe: 8 moQuantification 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.
Outcome measures
| Measure |
Study Drug (Pioglitazone) Then Placebo
n=116 Participants
Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
|
Placebo Then Study Drug (Pioglitazone)
n=110 Participants
Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
|
|---|---|---|
|
Rheumatoid Arthritis Disease Activity
|
0.15 mean decrease in DAS28-CRP score
Standard Deviation 1.2
|
.31 mean decrease in DAS28-CRP score
Standard Deviation 1.2
|
Adverse Events
Study Drug (Pioglitazone) Then Placebo, While on Drug
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Study Drug (Pioglitazone) Then Placebo, During Washout
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Study Drug (Pioglitazone) Then Placebo, While on Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Then Study Drug (Pioglitazone) While on Placebo
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Then Study Drug (Pioglitazone) During Washout
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Then Study Drug (Piolglitazone) While on Study Drug
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study Drug (Pioglitazone) Then Placebo, While on Drug
n=72 participants at risk
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.
|
Study Drug (Pioglitazone) Then Placebo, During Washout
n=72 participants at risk
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.
|
Study Drug (Pioglitazone) Then Placebo, While on Placebo
n=72 participants at risk
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.
|
Placebo Then Study Drug (Pioglitazone) While on Placebo
n=71 participants at risk
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.
|
Placebo Then Study Drug (Pioglitazone) During Washout
n=71 participants at risk
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.
|
Placebo Then Study Drug (Piolglitazone) While on Study Drug
n=71 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
C Diff Colitis
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
General disorders
Breast Cancer
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Nervous system disorders
Intracranial Bleed
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
General disorders
Breast Cancer - Stage 1
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
General disorders
Trauma - Car Crash
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
General disorders
Edema, Chest Pain
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea, Asthma, Chest Pain
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Cellulitis - Left Ear
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Right Hip Fracture
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Tachycardia, Elevated BP
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Infection - Left 1st Toe
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Revision MCP Arthroplasty with Removal of Implant and Rheumatoid Nodule
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Metabolism and nutrition disorders
Low Potassium and Low Sodium Levels
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Death 7 mo post study termination from pneumonia complications of end stage pulmonary fibrosis
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolus
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
General disorders
Metastic Merkel Cell Cancer
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
Other adverse events
| Measure |
Study Drug (Pioglitazone) Then Placebo, While on Drug
n=72 participants at risk
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.
|
Study Drug (Pioglitazone) Then Placebo, During Washout
n=72 participants at risk
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.
|
Study Drug (Pioglitazone) Then Placebo, While on Placebo
n=72 participants at risk
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.
|
Placebo Then Study Drug (Pioglitazone) While on Placebo
n=71 participants at risk
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.
|
Placebo Then Study Drug (Pioglitazone) During Washout
n=71 participants at risk
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.
|
Placebo Then Study Drug (Piolglitazone) While on Study Drug
n=71 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Metabolism and nutrition disorders
Weight Gain
|
5.6%
4/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Swollen, Painful Ankle
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
General disorders
Flushed and Nauseated due to Reaction to Nitroglycerin
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Itchy Rash
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
General disorders
Lightheaded
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Decrease Blood Pressure due to Nitroglycerin
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Respiratory, thoracic and mediastinal disorders
URI progressed to Bronchitis
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Eczema due to use of Humira
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Left Lower Leg Wound Infection (Cellulitis)
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Low Blood Pressure
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Nervous system disorders
Headaches
|
4.2%
3/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
4.2%
3/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Sprain - Left Knee
|
1.4%
1/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Infection to Salivary Gland
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
RA Flare - Pain in L Wrist and Hand
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
General disorders
Possible Allergic Reaction to Study Drug
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Neck Pain, Cervicalgia
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Cervicalgia due to Car Accident
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Infection on the Skin
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Edema / Swelling
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
Metabolism and nutrition disorders
Elevated Liver Enzymes
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
2.8%
2/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Infection of Ulcer on Left 1st Toe
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Edema in the Ankles
|
4.2%
3/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
4.2%
3/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Swelling to hands, feet, knees, or legs
|
5.6%
4/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Bladder Infection
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
General disorders
Drug Reaction
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Skin and subcutaneous tissue disorders
Hives after Dose Escalation
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Infections and infestations
Root Canal
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
|
General disorders
Fatigue
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Tightness in Upper Chest
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Shortness of breath
|
2.8%
2/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Musculoskeletal and connective tissue disorders
Small Avulsion Right Distal Fibula Fracture
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Cardiac disorders
Diaphoretic, Low BP (Dehydration), Fainted
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
1.4%
1/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing (history of Asthma)
|
1.4%
1/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/72 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
0.00%
0/71 • 8 months, but no more than 10 months
|
Additional Information
PPAR-gamma agonist, rheumatoid arthritis and cardiovascular disease
UMichigan
Phone: 734-936-7905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60