Trial Outcomes & Findings for Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE) (NCT NCT02338999)
NCT ID: NCT02338999
Last Updated: 2021-09-14
Results Overview
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)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
88 participants
Primary outcome timeframe
3 months after start of first intervention (Baseline to 3 months)
Results posted on
2021-09-14
Participant Flow
88 subjects were consented; 5 subjects declined participation after consent and 3 subjects did not meet eligibility criteria.
Participant milestones
| Measure |
Pioglitazone, Then Placebo
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.
|
Placebo, Then Pioglitazone
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.
|
|---|---|---|
|
First Intervention
STARTED
|
39
|
41
|
|
First Intervention
COMPLETED
|
36
|
40
|
|
First Intervention
NOT COMPLETED
|
3
|
1
|
|
Washout Period
STARTED
|
36
|
40
|
|
Washout Period
COMPLETED
|
36
|
38
|
|
Washout Period
NOT COMPLETED
|
0
|
2
|
|
Second Intervention
STARTED
|
36
|
38
|
|
Second Intervention
COMPLETED
|
36
|
36
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Pioglitazone, Then Placebo
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.
|
Placebo, Then Pioglitazone
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.
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
3
|
1
|
|
Washout Period
Withdrawal by Subject
|
0
|
2
|
|
Second Intervention
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Role of PPAR-y Agonists in Immunomodulation and Vascular Prevention in SLE (PPAR-SLE)
Baseline characteristics by cohort
| Measure |
Pioglitazone, Then Placebo
n=39 Participants
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.
|
Placebo, Then Pioglitazone
n=41 Participants
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
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after start of first intervention (Baseline to 3 months)Population: The analyses included only subjects who completed all visits
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)
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=39 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=41 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by Left CAVI at Month 3
|
-0.32 unitless
Standard Deviation 0.96
|
0.09 unitless
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 3 months after start of second intervention (5 months to 8 months)Population: The analyses included only subjects who completed all visits
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)
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=38 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=36 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by Left CAVI at Month 8
|
-0.29 unitless
Standard Deviation 0.55
|
-0.07 unitless
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: 3 months after start of first intervention (Baseline to 3 months)Population: The analyses included only subjects who completed all visits
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)
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=39 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=41 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by Right CAVI at Month 3
|
-0.42 unitless
Standard Deviation 0.88
|
0.12 unitless
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: 3 months after start of second intervention (5 months to 8 months)Population: The analyses included only subjects who completed all visits
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)
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=38 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=36 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by Right CAVI at Month 8
|
-0.26 unitless
Standard Deviation 0.61
|
-0.08 unitless
Standard Deviation 0.71
|
PRIMARY outcome
Timeframe: 3 months after start of first intervention (Baseline to 3 months)Population: The analyses included only subjects who completed all visits
Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Pulse, wave, velocity (PWV). The central aortic pressure PWV was determined by using the pressure tonometer and an EKG signal was used simultaneously to visualize ventricular-vascular interactions. It increases with atherosclerosis progression. Central aortic BP and stiffness were quantified using SphygmoCor CP system (AtCor Medical Pty Ltd.; New South Wales, Australia).
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=39 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=41 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by PWV at Month 3
|
-0.31 m/s
Standard Deviation 2.06
|
0.03 m/s
Standard Deviation 2.03
|
PRIMARY outcome
Timeframe: 3 months after start of second intervention (5 months to 8 months)Population: The analyses included only subjects who completed all visits
Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Pulse, wave, velocity (PWV). The central aortic pressure PWV was determined by using the pressure tonometer and an EKG signal was used simultaneously to visualize ventricular-vascular interactions. It increases with atherosclerosis progression. Central aortic BP and stiffness were quantified using SphygmoCor CP system (AtCor Medical Pty Ltd.; New South Wales, Australia).
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=38 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=36 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by PWV at Month 8
|
-0.31 m/s
Standard Deviation 1.86
|
-0.25 m/s
Standard Deviation 0.94
|
PRIMARY outcome
Timeframe: 3 months after start of first intervention (Baseline to 3 months)Population: The analyses included only subjects who completed all visits
Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Reactive hyperemia index (RHI). RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=39 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=41 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by RHI at Month 3
|
0.07 ratio
Standard Deviation 0.35
|
0.02 ratio
Standard Deviation 0.48
|
PRIMARY outcome
Timeframe: 3 months after start of second intervention (5 months to 8 months)Population: The analyses included only subjects who completed all visits
Change in vascular function using non-invasive vascular tests, measuring vascular compliance -Reactive hyperemia index (RHI). RHI is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. The possible range of scores is 1 to 3. Increasing score indicates the improvement of coronary endothelial function
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=38 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=36 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Change in Vascular Function and Cardiometabolic Risk as Measured by RHI at Month 8
|
-0.05 ratio
Standard Deviation 0.35
|
0.02 ratio
Standard Deviation 0.36
|
PRIMARY outcome
Timeframe: 3 months after start of first intervention (Baseline to 3 months)Population: The analyses included only subjects who completed all visits
Change in vascular inflammation using non-invasive vascular test, measuring changes in target to blood pool ratio (TBR) value by positron emission tomography (PET) computerized tomography (CT). The higher the value, the higher the degree of vascular inflammation.
Outcome measures
| Measure |
Pioglitazone, Then Placebo
n=15 Participants
Treatment with pioglitazone up to 45 mg orally daily for three months. Followed by a two-month washout period before cross over to placebo orally daily for three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
Placebo, Then Pioglitazone
n=15 Participants
Treatment with placebo orally daily for three months. Followed by a two-month washout period before cross over to pioglitazone up to 45 mg daily orally for an additional three months. A randomly selected subset of subjects underwent optional FDG-PET/CT for measurement of inflammatory activity in the blood vessels.
|
|---|---|---|
|
Effect of Pioglitazone on Vascular Inflammation and Cardiometabolic Risk as Measured by TBR Value at Month 3
|
0.0337 ratio
Standard Deviation 0.1991
|
0.0351 ratio
Standard Deviation 0.2954
|
Adverse Events
Pioglitazone
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone
n=77 participants at risk
Treatment with pioglitazone up to 45 mg orally daily for three months.
|
Placebo
n=77 participants at risk
Treatment with placebo orally daily for 3 months.
|
|---|---|---|
|
Endocrine disorders
Thyroid mass
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/77 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
Other adverse events
| Measure |
Pioglitazone
n=77 participants at risk
Treatment with pioglitazone up to 45 mg orally daily for three months.
|
Placebo
n=77 participants at risk
Treatment with placebo orally daily for 3 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
3/77 • Number of events 3 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Cardiac disorders
Osler's nodes
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Eye disorders
Dry eye
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Eye disorders
Episcleritis
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Eye disorders
Lacrimation increased
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
3/77 • Number of events 3 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
2/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Gastrointestinal disorders
Gastritis
|
2.6%
2/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
1/77 • Number of events 1 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Gastrointestinal disorders
Nausea
|
5.2%
4/77 • Number of events 4 • 8 months
|
5.2%
4/77 • Number of events 4 • 8 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
General disorders
Administration site pain
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Fatigue
|
6.5%
5/77 • Number of events 5 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Feeling cold
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Influenza like illness
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
General disorders
Localised oedema
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/77 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
General disorders
Oedema peripheral
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Pain
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Infections and infestations
Gastritis viral
|
1.3%
1/77 • Number of events 1 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Infections and infestations
Herpes zoster
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Infections and infestations
Influenza
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Infections and infestations
Sinusitis
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 2 • 8 months
|
|
Infections and infestations
Upper respiratory tract infection
|
9.1%
7/77 • Number of events 8 • 8 months
|
13.0%
10/77 • Number of events 11 • 8 months
|
|
Infections and infestations
Urinary tract infection
|
1.3%
1/77 • Number of events 1 • 8 months
|
11.7%
9/77 • Number of events 10 • 8 months
|
|
Infections and infestations
Vaginal infection
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.9%
3/77 • Number of events 3 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Injury, poisoning and procedural complications
Exposure to allergen
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
5/77 • Number of events 5 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
2/77 • Number of events 3 • 8 months
|
3.9%
3/77 • Number of events 3 • 8 months
|
|
Investigations
Biopsy lymph gland
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Blood bicarbonate decreased
|
1.3%
1/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Blood creatinine increased
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Investigations
Blood urea increased
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Investigations
Cardiac murmur
|
3.9%
3/77 • Number of events 3 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Computerised tomogram abnormal
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Computerised tomogram coronary artery abnormal
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Helicobacter test positive
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
International normalised ratio increased
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Investigations
Lymphocyte count decreased
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Investigations
Neutrophil count decreased
|
1.3%
1/77 • Number of events 2 • 8 months
|
1.3%
1/77 • Number of events 2 • 8 months
|
|
Investigations
Platelet count decreased
|
2.6%
2/77 • Number of events 2 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Investigations
Weight decreased
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
Weight increased
|
3.9%
3/77 • Number of events 3 • 8 months
|
0.00%
0/77 • 8 months
|
|
Investigations
White blood cell count decreased
|
9.1%
7/77 • Number of events 8 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Metabolism and nutrition disorders
Anorexia nervosa
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Chills
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
4/77 • Number of events 4 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Nervous system disorders
Disturbance in attention
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Nervous system disorders
Dizziness
|
5.2%
4/77 • Number of events 5 • 8 months
|
9.1%
7/77 • Number of events 7 • 8 months
|
|
Nervous system disorders
Headache
|
2.6%
2/77 • Number of events 2 • 8 months
|
9.1%
7/77 • Number of events 8 • 8 months
|
|
Nervous system disorders
Memory impairment
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Nervous system disorders
Numbness
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Nervous system disorders
Paraesthesia
|
2.6%
2/77 • Number of events 3 • 8 months
|
0.00%
0/77 • 8 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Nervous system disorders
Somnolence
|
2.6%
2/77 • Number of events 2 • 8 months
|
3.9%
3/77 • Number of events 3 • 8 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Psychiatric disorders
Insomnia
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Psychiatric disorders
Panic attack
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Renal and urinary disorders
Dysuria
|
3.9%
3/77 • Number of events 3 • 8 months
|
0.00%
0/77 • 8 months
|
|
Renal and urinary disorders
Fluid retention
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Renal and urinary disorders
Micturition disorder
|
2.6%
2/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Reproductive system and breast disorders
Galactorrhoea
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/77 • Number of events 2 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
2/77 • Number of events 2 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
1.3%
1/77 • Number of events 1 • 8 months
|
2.6%
2/77 • Number of events 2 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.6%
2/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
2/77 • Number of events 2 • 8 months
|
0.00%
0/77 • 8 months
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.3%
1/77 • Number of events 1 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/77 • 8 months
|
1.3%
1/77 • Number of events 1 • 8 months
|
|
Vascular disorders
Hot flush
|
1.3%
1/77 • Number of events 1 • 8 months
|
0.00%
0/77 • 8 months
|
Additional Information
Kaplan, Mariana
National Inst of Arthritis and Musculoskeletal and Skin Diseases
Phone: +1 301 496 0517
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place