Trial Outcomes & Findings for Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) (NCT NCT02858492)
NCT ID: NCT02858492
Last Updated: 2021-06-15
Results Overview
An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with any nSAE or SAE are presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Up to Day 112
Results posted on
2021-06-15
Participant Flow
The study evaluated safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of GSK2982772 in participants with rheumatoid arthritis (RA). Participants were randomly assigned to receive either GSK2982772 60 milligram (mg) or placebo to be taken orally twice daily (BID) or three times daily (TID) for 84 days.
A total of 99 participants were screened, of them, 47 participants were screen failures and 52 participants were enrolled. Of them, 51 participants received study treatment. One participant was enrolled in the study but never received study treatment as eligibility criteria for dose was not met.
Participant milestones
| Measure |
Placebo BID
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
15
|
5
|
28
|
|
Overall Study
COMPLETED
|
3
|
14
|
5
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
6
|
Reasons for withdrawal
| Measure |
Placebo BID
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol defined stopping criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Efficacy of Repeat Doses of GSK2982772 in Subjects With Moderate to Severe Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.3 Years
STANDARD_DEVIATION 4.93 • n=5 Participants
|
53.1 Years
STANDARD_DEVIATION 7.80 • n=7 Participants
|
53.6 Years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
55.0 Years
STANDARD_DEVIATION 11.25 • n=4 Participants
|
54.2 Years
STANDARD_DEVIATION 9.60 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White-White/Caucasian/European Heritage
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 112Population: Safety Population comprised of all participants who received at least one dose of the study treatment.
An AE was any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment was categorized as SAE. Number of participants with any nSAE or SAE are presented.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Any nSAEs
|
3 Participants
|
10 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 112Population: Safety Population
Clinical chemistry parameters included alanine amino transferase (ALT), albumin, alkaline phosphatase, aspartate amino transferase (AST), calcium, creatinine, glucose, potassium, sodium and total bilirubin. PCI ranges were ALT(high): \>=2\*Upper limit of Normal(ULN) units per liter(U/L), albumin(low): 30 millimoles per liter(mmol/L), alkaline phosphatase(high): \>=2\*ULN U/L, AST(high): \>=2\*ULN U/L, calcium: \<2(low) or \>2.75 mmol/L(high), creatinine (high): increase from Baseline \>44.25 mmol/L, glucose: \<3(low) or \>9 mmol/L(high), potassium: \<3(low) or \>5.5 mmol/L(high), sodium: \<130(low) or \>150 mmol/L(high) and total bilirubin(high): \>=1.5\*ULN micromoles per liter(µmol/L). Participants were counted in the worst case category if their value changes (to low or to high), unless there is no change in their category. Only those clinical chemistry parameters with PCI values (to low and to high) have been presented.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
ALT; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
ALT; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Albumin; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Albumin; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Alkaline phosphatase; To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Alkaline phosphatase; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
AST; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
AST; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Calcium; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Calcium; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Creatinine; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Creatinine; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Glucose; To low
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Glucose; To high
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Potassium; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Potassium; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Sodium; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Sodium; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Total bilirubin; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Clinical Chemistry Parameters of Potential Clinical Importance (PCI)
Total bilirubin; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 112Population: Safety Population
Hematology parameters included hematocrit, hemoglobin, lymphocytes, platelet counts, total neutrophils and white blood cells (WBCs). PCI ranges were \< 0.075 (decrease from baseline) or \>0.54 proportion of red blood cells in blood (high) for hematocrit, \<25 (low) or \>180 grams per liter (g/L) (high) for hemoglobin, \<0.8 x10\^9 cells per liter (cells/L) for lymphocytes (low), \<100 (low) or \>550 x10\^9 cells/L(high) for platelets, \<1.5 x10\^9 cells/L (low) for total neutrophils and \< 3 (low) or \>20 x10\^9 cells/L (high) for WBCs. Participants were counted in the worst case category that their value changes (to low or to high), unless there is no change in their category. Only those hematology parameters with PCI values (to low and to high) have been presented.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Hematocrit; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Hematocrit; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Hemoglobin; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Hemoglobin; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Lymphocytes; To Low
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Lymphocytes; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Platelet count; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Platelet count; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Total neutrophils; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
Total neutrophils; To high
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
WBC; To low
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Case Hematology Parameters of PCI
WBC; To high
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 112Population: Safety Population
Urine samples were collected to assess glucose, ketones, occult blood and protein by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters glucose, ketones, occult blood and protein were categorized as 'any increase from Baseline', which imply any increase in their concentrations in the urine sample. Only participants with worst case any increase from Baseline values are presented.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Protein; Any increase
|
1 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Glucose; Any increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Ketones; Any increase
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
Occult blood; Any increase
|
0 Participants
|
6 Participants
|
1 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to Day 112Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Urine samples were collected to assess glucose, ketones, occult blood and protein by dipstick method. Microscopy was performed only on urine samples showing an abnormality on the dipstick. Microscopy was performed for hyaline casts, red blood cells and white blood cells. Results for microscopy parameters hyaline casts, red blood cells and white blood cells were categorized as 'any increase from Baseline', which imply any increase in their count in the urine sample. Only participants with worst case any increase from Baseline values are presented.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=7 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=1 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=11 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Microscopy Method
Hyaline casts;any increase;n=0,1,0,0
|
—
|
1 Participants
|
—
|
—
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Microscopy Method
Red blood cells;any increase;n=2,7,1,11
|
1 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Worst Case Any Increase in Urinalysis Results Post-Baseline Relative to Baseline by Microscopy Method
White blood cells;any increase;n=2,7,1,11
|
2 Participants
|
5 Participants
|
1 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
12- lead ECG was measured on each day using an ECG machine that automatically calculated the heart rate and measured PR interval, QRS duration, QT interval, QT interval corrected for heart rate according to either Bazett's formula (QTcB) and QT interval corrected for heart rate according to Fridericia's formula (QTcF). ECG was measured in semi-supine or supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 8; n=3,14,5,23
|
7.0 Beats per minute
Standard Deviation 5.57
|
1.1 Beats per minute
Standard Deviation 10.68
|
0.6 Beats per minute
Standard Deviation 7.09
|
0.6 Beats per minute
Standard Deviation 7.55
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 15; n=3,14,5,24
|
0.7 Beats per minute
Standard Deviation 2.08
|
-0.3 Beats per minute
Standard Deviation 11.64
|
-4.6 Beats per minute
Standard Deviation 4.16
|
1.0 Beats per minute
Standard Deviation 9.94
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 29; n=3,14,5,22
|
2.7 Beats per minute
Standard Deviation 4.93
|
-1.4 Beats per minute
Standard Deviation 8.27
|
-5.8 Beats per minute
Standard Deviation 13.66
|
1.3 Beats per minute
Standard Deviation 9.14
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 43; n=3,13,5,23
|
-0.7 Beats per minute
Standard Deviation 7.57
|
-3.5 Beats per minute
Standard Deviation 9.73
|
-6.0 Beats per minute
Standard Deviation 7.35
|
-0.2 Beats per minute
Standard Deviation 10.86
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 57; n=3,13,5,22
|
-3.7 Beats per minute
Standard Deviation 10.69
|
-2.4 Beats per minute
Standard Deviation 8.79
|
-4.2 Beats per minute
Standard Deviation 8.58
|
0.7 Beats per minute
Standard Deviation 9.75
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 71; n=3,13,5,22
|
0.3 Beats per minute
Standard Deviation 9.29
|
-3.0 Beats per minute
Standard Deviation 12.08
|
-7.6 Beats per minute
Standard Deviation 7.73
|
0.3 Beats per minute
Standard Deviation 9.32
|
|
Change From Baseline in Electrocardiogram (ECG) Heart Rate at Indicated Time Points
Day 85; n=3,13,5,21
|
-1.7 Beats per minute
Standard Deviation 5.69
|
-4.1 Beats per minute
Standard Deviation 11.51
|
-2.4 Beats per minute
Standard Deviation 4.72
|
-1.4 Beats per minute
Standard Deviation 9.12
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
12- lead ECG was measured on each day using an ECG machine that automatically calculated the heart rate and measured PR interval, QRS duration, QT interval QTcB and QTcF. ECG was measured in semi-supine or supine position after 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 8; n=3,14,5,23
|
-0.3 Millisecond
Standard Deviation 14.36
|
-1.9 Millisecond
Standard Deviation 26.35
|
-6.4 Millisecond
Standard Deviation 19.98
|
0.8 Millisecond
Standard Deviation 18.84
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 15; n=3,14,5,24
|
6.3 Millisecond
Standard Deviation 12.66
|
0.6 Millisecond
Standard Deviation 29.94
|
-2.0 Millisecond
Standard Deviation 23.10
|
3.0 Millisecond
Standard Deviation 15.71
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 29; n=3,14,5,22
|
5.3 Millisecond
Standard Deviation 24.01
|
-3.5 Millisecond
Standard Deviation 32.15
|
-0.2 Millisecond
Standard Deviation 22.66
|
-6.9 Millisecond
Standard Deviation 28.00
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 43; n=3,13,5,23
|
2.0 Millisecond
Standard Deviation 17.35
|
6.5 Millisecond
Standard Deviation 14.44
|
2.4 Millisecond
Standard Deviation 5.41
|
6.6 Millisecond
Standard Deviation 15.69
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 57; n=3,13,5,22
|
-12.0 Millisecond
Standard Deviation 5.29
|
5.8 Millisecond
Standard Deviation 21.75
|
5.0 Millisecond
Standard Deviation 6.36
|
4.1 Millisecond
Standard Deviation 17.51
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 71; n=3,13,5,22
|
1.0 Millisecond
Standard Deviation 17.78
|
1.2 Millisecond
Standard Deviation 18.65
|
2.2 Millisecond
Standard Deviation 23.92
|
0.8 Millisecond
Standard Deviation 15.06
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
PR interval; Day 85; n=3,13,5,21
|
1.3 Millisecond
Standard Deviation 10.02
|
6.2 Millisecond
Standard Deviation 15.38
|
-0.2 Millisecond
Standard Deviation 5.26
|
0.4 Millisecond
Standard Deviation 10.29
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 8; n=3,14,5,23
|
-4.7 Millisecond
Standard Deviation 5.03
|
-3.3 Millisecond
Standard Deviation 10.75
|
8.2 Millisecond
Standard Deviation 10.33
|
3.7 Millisecond
Standard Deviation 12.97
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 15; n=3,14,5,24
|
-3.3 Millisecond
Standard Deviation 4.16
|
-3.1 Millisecond
Standard Deviation 10.50
|
-1.2 Millisecond
Standard Deviation 7.26
|
1.1 Millisecond
Standard Deviation 6.89
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 29; n=3,14,5,22
|
-1.3 Millisecond
Standard Deviation 3.79
|
-2.1 Millisecond
Standard Deviation 10.89
|
0.4 Millisecond
Standard Deviation 5.03
|
-0.5 Millisecond
Standard Deviation 9.01
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 43; n=3,13,5,23
|
-3.3 Millisecond
Standard Deviation 5.51
|
-1.1 Millisecond
Standard Deviation 9.90
|
3.6 Millisecond
Standard Deviation 8.29
|
0.3 Millisecond
Standard Deviation 10.48
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 57; n=3,13,5,22
|
-6.0 Millisecond
Standard Deviation 6.00
|
-4.0 Millisecond
Standard Deviation 5.90
|
3.2 Millisecond
Standard Deviation 9.34
|
1.0 Millisecond
Standard Deviation 18.33
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 71; n=3,13,5,22
|
-10.0 Millisecond
Standard Deviation 7.55
|
-0.2 Millisecond
Standard Deviation 6.68
|
4.6 Millisecond
Standard Deviation 12.26
|
-0.5 Millisecond
Standard Deviation 8.31
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QRS duration; Day 85; n=3,13,5,21
|
-7.3 Millisecond
Standard Deviation 11.37
|
-1.0 Millisecond
Standard Deviation 9.07
|
3.4 Millisecond
Standard Deviation 8.68
|
1.5 Millisecond
Standard Deviation 10.68
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 8; n=3,14,5,23
|
-25.7 Millisecond
Standard Deviation 6.11
|
6.4 Millisecond
Standard Deviation 40.17
|
-14.2 Millisecond
Standard Deviation 22.49
|
-1.0 Millisecond
Standard Deviation 35.97
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 15; n=3,14,5,24
|
2.7 Millisecond
Standard Deviation 11.02
|
20.7 Millisecond
Standard Deviation 34.85
|
0.0 Millisecond
Standard Deviation 21.12
|
-4.5 Millisecond
Standard Deviation 25.27
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 29; n=3,14,5,22
|
-9.3 Millisecond
Standard Deviation 17.67
|
7.6 Millisecond
Standard Deviation 25.03
|
-5.6 Millisecond
Standard Deviation 22.37
|
5.5 Millisecond
Standard Deviation 31.49
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 43; n=3,13,5,23
|
-12.7 Millisecond
Standard Deviation 28.10
|
18.5 Millisecond
Standard Deviation 38.73
|
1.0 Millisecond
Standard Deviation 20.74
|
0.6 Millisecond
Standard Deviation 29.36
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 57; n=3,13,5,22
|
12.3 Millisecond
Standard Deviation 30.04
|
13.6 Millisecond
Standard Deviation 41.48
|
2.4 Millisecond
Standard Deviation 22.78
|
-1.8 Millisecond
Standard Deviation 36.44
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 71; n=3,13,5,22
|
-9.3 Millisecond
Standard Deviation 33.98
|
13.8 Millisecond
Standard Deviation 32.50
|
10.2 Millisecond
Standard Deviation 28.71
|
-2.1 Millisecond
Standard Deviation 22.06
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QT interval; Day 85; n=3,13,5,21
|
-0.3 Millisecond
Standard Deviation 14.50
|
17.2 Millisecond
Standard Deviation 32.16
|
-3.2 Millisecond
Standard Deviation 14.60
|
3.0 Millisecond
Standard Deviation 17.28
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 8; n=2,14,5,22
|
-12.1 Millisecond
Standard Deviation 8.34
|
10.5 Millisecond
Standard Deviation 46.28
|
-10.3 Millisecond
Standard Deviation 14.09
|
0.7 Millisecond
Standard Deviation 33.20
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 15; n=2,14,5,23
|
7.2 Millisecond
Standard Deviation 7.18
|
22.9 Millisecond
Standard Deviation 46.10
|
-12.9 Millisecond
Standard Deviation 17.59
|
-0.9 Millisecond
Standard Deviation 19.63
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 29; n=2,14,5,21
|
-2.4 Millisecond
Standard Deviation 7.96
|
4.4 Millisecond
Standard Deviation 25.73
|
-21.2 Millisecond
Standard Deviation 29.58
|
10.3 Millisecond
Standard Deviation 29.02
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 43; n=2,13,5,22
|
-13.0 Millisecond
Standard Deviation 14.51
|
9.1 Millisecond
Standard Deviation 37.18
|
-14.2 Millisecond
Standard Deviation 14.64
|
0.6 Millisecond
Standard Deviation 27.77
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 57; n=2,13,5,21
|
-1.5 Millisecond
Standard Deviation 1.83
|
7.5 Millisecond
Standard Deviation 38.73
|
-7.0 Millisecond
Standard Deviation 11.67
|
1.1 Millisecond
Standard Deviation 47.85
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 71; n=2,13,5,21
|
-9.3 Millisecond
Standard Deviation 16.59
|
4.6 Millisecond
Standard Deviation 34.77
|
-11.0 Millisecond
Standard Deviation 16.47
|
-1.1 Millisecond
Standard Deviation 20.55
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcB; Day 85; n=2,13,5,20
|
4.2 Millisecond
Standard Deviation 15.78
|
7.0 Millisecond
Standard Deviation 32.09
|
-9.1 Millisecond
Standard Deviation 12.42
|
-0.7 Millisecond
Standard Deviation 17.51
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 8; n=2,14,5,22
|
-16.0 Millisecond
Standard Deviation 3.35
|
9.0 Millisecond
Standard Deviation 42.58
|
-11.4 Millisecond
Standard Deviation 14.05
|
0.3 Millisecond
Standard Deviation 33.04
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 15; n=2,14,5,23
|
7.5 Millisecond
Standard Deviation 7.65
|
22.2 Millisecond
Standard Deviation 39.68
|
-8.4 Millisecond
Standard Deviation 18.00
|
-2.3 Millisecond
Standard Deviation 17.61
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 29; n=2,14,5,21
|
-3.3 Millisecond
Standard Deviation 13.16
|
5.6 Millisecond
Standard Deviation 22.87
|
-15.6 Millisecond
Standard Deviation 18.24
|
8.7 Millisecond
Standard Deviation 27.77
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 43; n=2,13,5,22
|
-13.5 Millisecond
Standard Deviation 23.40
|
12.4 Millisecond
Standard Deviation 35.37
|
-8.7 Millisecond
Standard Deviation 13.81
|
0.7 Millisecond
Standard Deviation 25.16
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 57; n=2,13,5,21
|
5.9 Millisecond
Standard Deviation 11.57
|
9.6 Millisecond
Standard Deviation 38.25
|
-3.5 Millisecond
Standard Deviation 11.35
|
-0.1 Millisecond
Standard Deviation 42.41
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 71; n=2,13,5,21
|
-11.1 Millisecond
Standard Deviation 27.30
|
7.6 Millisecond
Standard Deviation 30.12
|
-3.5 Millisecond
Standard Deviation 18.48
|
-1.2 Millisecond
Standard Deviation 17.15
|
|
Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time Points
QTcF; Day 85; n=2,13,5,20
|
2.5 Millisecond
Standard Deviation 17.46
|
10.6 Millisecond
Standard Deviation 28.46
|
-7.0 Millisecond
Standard Deviation 11.36
|
0.6 Millisecond
Standard Deviation 12.45
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
SBP and DBP were measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=25 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 8; n=3,15,5,25
|
-9.7 Millimeters of Mercury (mmHg)
Standard Deviation 5.69
|
0.5 Millimeters of Mercury (mmHg)
Standard Deviation 12.61
|
-4.6 Millimeters of Mercury (mmHg)
Standard Deviation 14.33
|
2.7 Millimeters of Mercury (mmHg)
Standard Deviation 11.0
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 15; n=3,15,5,25
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 7.55
|
-2.7 Millimeters of Mercury (mmHg)
Standard Deviation 11.21
|
-13.0 Millimeters of Mercury (mmHg)
Standard Deviation 12.79
|
4.6 Millimeters of Mercury (mmHg)
Standard Deviation 9.43
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 29; n=3,15,5,24
|
-9.3 Millimeters of Mercury (mmHg)
Standard Deviation 15.70
|
-0.8 Millimeters of Mercury (mmHg)
Standard Deviation 10.82
|
-8.2 Millimeters of Mercury (mmHg)
Standard Deviation 19.12
|
1.9 Millimeters of Mercury (mmHg)
Standard Deviation 11.94
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 43; n=3,14,5,24
|
-7.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.54
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 15.11
|
-11.4 Millimeters of Mercury (mmHg)
Standard Deviation 19.72
|
-1.6 Millimeters of Mercury (mmHg)
Standard Deviation 10.01
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 57; n=3,14,5,23
|
-14.7 Millimeters of Mercury (mmHg)
Standard Deviation 17.21
|
0.5 Millimeters of Mercury (mmHg)
Standard Deviation 16.19
|
-9.6 Millimeters of Mercury (mmHg)
Standard Deviation 18.49
|
-0.3 Millimeters of Mercury (mmHg)
Standard Deviation 12.84
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 71; n=3,14,5,23
|
-7.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.85
|
1.1 Millimeters of Mercury (mmHg)
Standard Deviation 14.35
|
-8.2 Millimeters of Mercury (mmHg)
Standard Deviation 12.19
|
1.2 Millimeters of Mercury (mmHg)
Standard Deviation 14.40
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
SBP; Day 85; n=3,14,5,22
|
-4.3 Millimeters of Mercury (mmHg)
Standard Deviation 12.70
|
-0.1 Millimeters of Mercury (mmHg)
Standard Deviation 14.68
|
-4.8 Millimeters of Mercury (mmHg)
Standard Deviation 11.23
|
1.9 Millimeters of Mercury (mmHg)
Standard Deviation 12.97
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 8; n=3,15,5,25
|
2.00 Millimeters of Mercury (mmHg)
Standard Deviation 5.00
|
2.0 Millimeters of Mercury (mmHg)
Standard Deviation 11.32
|
1.0 Millimeters of Mercury (mmHg)
Standard Deviation 8.69
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.12
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 15; n=3,15,5,25
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 6.11
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 7.85
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 4.39
|
1.1 Millimeters of Mercury (mmHg)
Standard Deviation 7.61
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 29; n=3,15,5,24
|
-4.0 Millimeters of Mercury (mmHg)
Standard Deviation 8.89
|
0.2 Millimeters of Mercury (mmHg)
Standard Deviation 8.28
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 6.04
|
0.7 Millimeters of Mercury (mmHg)
Standard Deviation 7.65
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 43; n=3,14,5,24
|
0.3 Millimeters of Mercury (mmHg)
Standard Deviation 14.36
|
-0.3 Millimeters of Mercury (mmHg)
Standard Deviation 8.96
|
-1.4 Millimeters of Mercury (mmHg)
Standard Deviation 8.76
|
-0.8 Millimeters of Mercury (mmHg)
Standard Deviation 6.68
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 57; n=3,14,5,23
|
-3.7 Millimeters of Mercury (mmHg)
Standard Deviation 8.33
|
0.8 Millimeters of Mercury (mmHg)
Standard Deviation 9.90
|
1.4 Millimeters of Mercury (mmHg)
Standard Deviation 6.43
|
-0.9 Millimeters of Mercury (mmHg)
Standard Deviation 7.78
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 71; n=3,14,5,23
|
-7.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.17
|
1.4 Millimeters of Mercury (mmHg)
Standard Deviation 8.36
|
-7.2 Millimeters of Mercury (mmHg)
Standard Deviation 9.76
|
-1.5 Millimeters of Mercury (mmHg)
Standard Deviation 6.90
|
|
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points
DBP; Day 85; n=3,14,5,22
|
1.0 Millimeters of Mercury (mmHg)
Standard Deviation 6.24
|
2.1 Millimeters of Mercury (mmHg)
Standard Deviation 10.79
|
-1.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.67
|
-0.4 Millimeters of Mercury (mmHg)
Standard Deviation 7.50
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Respiratory rate was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=25 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 15; n=3,15,5,25
|
1.0 Breaths per minute
Standard Deviation 1.73
|
0.2 Breaths per minute
Standard Deviation 1.08
|
-1.2 Breaths per minute
Standard Deviation 1.79
|
0.2 Breaths per minute
Standard Deviation 1.91
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 8; n=3,15,5,25
|
0.7 Breaths per minute
Standard Deviation 1.53
|
0.1 Breaths per minute
Standard Deviation 1.13
|
-0.4 Breaths per minute
Standard Deviation 2.61
|
0.0 Breaths per minute
Standard Deviation 1.14
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 29; n=3,15,5,24
|
1.0 Breaths per minute
Standard Deviation 1.00
|
-0.2 Breaths per minute
Standard Deviation 1.47
|
-1.6 Breaths per minute
Standard Deviation 1.67
|
0.1 Breaths per minute
Standard Deviation 1.28
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 43; n=3,14,5,24
|
1.7 Breaths per minute
Standard Deviation 0.58
|
0.3 Breaths per minute
Standard Deviation 1.33
|
-0.8 Breaths per minute
Standard Deviation 1.10
|
0.5 Breaths per minute
Standard Deviation 2.70
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 57; n=3,14,5,23
|
1.7 Breaths per minute
Standard Deviation 2.08
|
0.2 Breaths per minute
Standard Deviation 0.70
|
0.4 Breaths per minute
Standard Deviation 3.29
|
0.6 Breaths per minute
Standard Deviation 2.00
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 71; n=3,14,5,23
|
1.7 Breaths per minute
Standard Deviation 0.58
|
0.5 Breaths per minute
Standard Deviation 0.65
|
0.0 Breaths per minute
Standard Deviation 2.45
|
0.7 Breaths per minute
Standard Deviation 2.07
|
|
Change From Baseline in Respiratory Rate at Indicated Time Points
Day 85; n=3,14,5,22
|
0.7 Breaths per minute
Standard Deviation 0.58
|
0.4 Breaths per minute
Standard Deviation 0.84
|
-0.4 Breaths per minute
Standard Deviation 2.61
|
0.5 Breaths per minute
Standard Deviation 1.60
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Body temperature was measured in a supine or semi-supine position after approximately 5 minutes rest. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=25 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 8; n=3,15,5,25
|
0.60 Degrees Celsius
Standard Deviation 0.529
|
-0.03 Degrees Celsius
Standard Deviation 0.209
|
-0.06 Degrees Celsius
Standard Deviation 0.261
|
0.06 Degrees Celsius
Standard Deviation 0.222
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 15; n=3,15,5,25
|
0.80 Degrees Celsius
Standard Deviation 0.500
|
-0.07 Degrees Celsius
Standard Deviation 0.171
|
-0.04 Degrees Celsius
Standard Deviation 0.219
|
0.06 Degrees Celsius
Standard Deviation 0.251
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 29; n=3,15,5,24
|
0.60 Degrees Celsius
Standard Deviation 0.656
|
-0.02 Degrees Celsius
Standard Deviation 0.204
|
0.10 Degrees Celsius
Standard Deviation 0.187
|
0.11 Degrees Celsius
Standard Deviation 0.249
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 43; n=3,14,5,24
|
0.53 Degrees Celsius
Standard Deviation 0.513
|
-0.01 Degrees Celsius
Standard Deviation 0.251
|
0.04 Degrees Celsius
Standard Deviation 0.270
|
0.06 Degrees Celsius
Standard Deviation 0.286
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 57; n=3,14,5,23
|
0.53 Degrees Celsius
Standard Deviation 0.462
|
-0.02 Degrees Celsius
Standard Deviation 0.226
|
-0.02 Degrees Celsius
Standard Deviation 0.239
|
0.16 Degrees Celsius
Standard Deviation 0.310
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 71; n=3,14,5,23
|
0.27 Degrees Celsius
Standard Deviation 0.404
|
-0.06 Degrees Celsius
Standard Deviation 0.210
|
-0.00 Degrees Celsius
Standard Deviation 0.141
|
0.17 Degrees Celsius
Standard Deviation 0.255
|
|
Change From Baseline in Body Temperature at Indicated Time Points
Day 85; n=3,14,5,22
|
0.53 Degrees Celsius
Standard Deviation 0.379
|
-0.10 Degrees Celsius
Standard Deviation 0.162
|
-0.12 Degrees Celsius
Standard Deviation 0.356
|
0.14 Degrees Celsius
Standard Deviation 0.353
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 8, 15, 29, 43, 57, 71 and 85Population: The data for assessment of vital sign-heart rate was not collected.
Vital sign-heart rate was planned to be assessed as a measure of safety and tolerability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Day 8 and Day 43Population: Pharmacokinetic GSK298772 Population comprised of participants in the safety population who received an active dose and for whom a GSK2982772 pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected on Day 8 and Day 43 for determining pre-dose plasma concentrations of GSK2982772. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Placebo BID
n=5 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=24 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Pre-dose Plasma Concentrations of GSK2982772 on Days 8 and 43
Day 8;n=5,24
|
88.332 Nanogram per milliliter
Standard Deviation 96.5705
|
181.774 Nanogram per milliliter
Standard Deviation 322.8428
|
—
|
—
|
|
Pre-dose Plasma Concentrations of GSK2982772 on Days 8 and 43
Day 43;n=5,23
|
33.994 Nanogram per milliliter
Standard Deviation 51.1033
|
142.792 Nanogram per milliliter
Standard Deviation 176.2630
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 8 and 43: 1, 2, 4 and 6 hours post-dosePopulation: Pharmacokinetic GSK298772 Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected on Day 1, Day 8 and Day 43 for determining post-dose plasma concentrations of GSK2982772. Pharmacokinetic parameters were determined using standard non-compartmental methods.
Outcome measures
| Measure |
Placebo BID
n=5 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=27 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 1;1 hour;n=5,27
|
851.000 Nanogram per milliliter
Standard Deviation 375.5110
|
953.037 Nanogram per milliliter
Standard Deviation 556.4630
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 1;2 hour;n=5,27
|
656.000 Nanogram per milliliter
Standard Deviation 386.5741
|
911.630 Nanogram per milliliter
Standard Deviation 376.7128
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 1;4 hour;n=5,27
|
269.600 Nanogram per milliliter
Standard Deviation 156.3052
|
421.215 Nanogram per milliliter
Standard Deviation 211.7969
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 1;6 hour;n=5,27
|
120.240 Nanogram per milliliter
Standard Deviation 54.6881
|
382.419 Nanogram per milliliter
Standard Deviation 485.6076
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 8;1 hour;n=5,23
|
796.600 Nanogram per milliliter
Standard Deviation 397.7120
|
881.783 Nanogram per milliliter
Standard Deviation 550.4666
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 8;2 hour;n=5,24
|
689.000 Nanogram per milliliter
Standard Deviation 317.5602
|
930.958 Nanogram per milliliter
Standard Deviation 446.0379
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 8;4 hour;n=5,24
|
265.000 Nanogram per milliliter
Standard Deviation 129.6360
|
520.958 Nanogram per milliliter
Standard Deviation 324.4127
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 8;6 hour;n=5,23
|
112.280 Nanogram per milliliter
Standard Deviation 78.0491
|
444.470 Nanogram per milliliter
Standard Deviation 358.1685
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 43;1 hour;n=5,23
|
672.200 Nanogram per milliliter
Standard Deviation 165.4470
|
862.487 Nanogram per milliliter
Standard Deviation 501.4882
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 43;2 hour;n=5,23
|
598.600 Nanogram per milliliter
Standard Deviation 253.0036
|
872.652 Nanogram per milliliter
Standard Deviation 354.1155
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 43;4 hour;n=5,23
|
313.200 Nanogram per milliliter
Standard Deviation 226.0845
|
553.783 Nanogram per milliliter
Standard Deviation 430.5811
|
—
|
—
|
|
Post-dose Plasma Concentrations of GSK2982772 on Days 1, 8, and 43 at 1, 2, 4 and 6 Hours
Day 43;6 hour;n=5,23
|
177.980 Nanogram per milliliter
Standard Deviation 192.6731
|
332.522 Nanogram per milliliter
Standard Deviation 240.9716
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 85Population: Pharmacokinetic GSK298772 Population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected to evaluate plasma concentration of GSK2982772. Pharmacokinetic parameters including trough plasma concentration was determined using standard non-compartmental methods.
Outcome measures
| Measure |
Placebo BID
n=5 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=17 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Trough Plasma Concentration of GSK2982772 on Day 85
|
54.64 Nanogram per milliliter
Standard Deviation 50.714
|
391.11 Nanogram per milliliter
Standard Deviation 694.270
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Days 1, 8 and 43Population: Pharmacokinetic Methotrexate Population comprised of participants in the safety population who received an active dose and for whom a methotrexate pharmacokinetic sample was obtained and analyzed. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Blood samples were collected on Day 1, Day 8 and Day 43 for determining pre-dose plasma concentrations of methotrexate. Pharmacokinetic parameters were determined using standard non-compartmental methods. Only participants who received methotrexate during the study were included.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=22 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Pre-dose Plasma Concentrations of Methotrexate on Days 1, 8 and 43
Day 1;n=3,13,5,22
|
0.450 Nanogram per milliliter
Standard Deviation 0.7794
|
16.236 Nanogram per milliliter
Standard Deviation 56.4280
|
0.546 Nanogram per milliliter
Standard Deviation 0.7909
|
6.309 Nanogram per milliliter
Standard Deviation 15.4993
|
|
Pre-dose Plasma Concentrations of Methotrexate on Days 1, 8 and 43
Day 8;n=3,12,5,17
|
1.117 Nanogram per milliliter
Standard Deviation 1.9341
|
0.509 Nanogram per milliliter
Standard Deviation 0.9879
|
4.640 Nanogram per milliliter
Standard Deviation 10.3754
|
11.939 Nanogram per milliliter
Standard Deviation 47.4493
|
|
Pre-dose Plasma Concentrations of Methotrexate on Days 1, 8 and 43
Day 43;n=3,11,5,19
|
36.000 Nanogram per milliliter
Standard Deviation 62.3538
|
0.909 Nanogram per milliliter
Standard Deviation 2.0658
|
1.512 Nanogram per milliliter
Standard Deviation 3.3809
|
1.445 Nanogram per milliliter
Standard Deviation 3.1606
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
CRP is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of CRP. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
Day 43;n=3,14,5,24
|
-24.02 Percent change
Standard Deviation 53.259
|
63.02 Percent change
Standard Deviation 331.286
|
-10.37 Percent change
Standard Deviation 94.318
|
12.68 Percent change
Standard Deviation 107.207
|
|
Percent Change From Baseline in C-Reactive Protein (CRP)
Day 85;n=3,14,5,22
|
-43.62 Percent change
Standard Deviation 49.968
|
220.05 Percent change
Standard Deviation 828.334
|
-16.42 Percent change
Standard Deviation 70.096
|
274.25 Percent change
Standard Deviation 879.900
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
IL6 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of IL6. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Interleukin 6 (IL6)
Day 43;n=3,14,5,24
|
89.12 Percent change
Standard Deviation 96.649
|
55.00 Percent change
Standard Deviation 257.661
|
-3.95 Percent change
Standard Deviation 66.008
|
74.49 Percent change
Standard Deviation 358.187
|
|
Percent Change From Baseline in Interleukin 6 (IL6)
Day 85;n=3,14,5,22
|
5.21 Percent change
Standard Deviation 16.978
|
27.52 Percent change
Standard Deviation 97.215
|
-24.44 Percent change
Standard Deviation 67.817
|
0.52 Percent change
Standard Deviation 106.029
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
MMP-1, MMP-3, and MMP-13 are an inflammatory biomarkers present in blood. Blood samples were collected at indicated time points for the assessment of MMP-1, MMP-3, and MMP-13. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-1;Day 43;n=3,14,5,24
|
-11.25 Percent change
Standard Deviation 6.591
|
-4.04 Percent change
Standard Deviation 23.016
|
-15.36 Percent change
Standard Deviation 13.399
|
-4.07 Percent change
Standard Deviation 27.244
|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-1;Day 85;n=3,14,5,22
|
-19.77 Percent change
Standard Deviation 28.013
|
9.75 Percent change
Standard Deviation 41.645
|
-20.21 Percent change
Standard Deviation 19.417
|
-1.61 Percent change
Standard Deviation 28.420
|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-3;Day 43;n=3,14,5,24
|
8.86 Percent change
Standard Deviation 27.501
|
6.07 Percent change
Standard Deviation 27.883
|
-26.82 Percent change
Standard Deviation 20.757
|
-4.07 Percent change
Standard Deviation 36.176
|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-3;Day 85;n=3,14,5,22
|
32.61 Percent change
Standard Deviation 32.849
|
11.98 Percent change
Standard Deviation 42.337
|
-38.26 Percent change
Standard Deviation 19.306
|
-2.14 Percent change
Standard Deviation 34.751
|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-13;Day 43;n=3,12,5,22
|
-6.45 Percent change
Standard Deviation 7.000
|
32.94 Percent change
Standard Deviation 139.157
|
-7.27 Percent change
Standard Deviation 34.373
|
-3.55 Percent change
Standard Deviation 29.506
|
|
Percent Change From Baseline in Matrix Metalloproteinase-1 (MMP-1), MMP-3, and MMP-13
MMP-13;Day 85;n=3,11,5,17
|
-34.65 Percent change
Standard Deviation 35.926
|
114.18 Percent change
Standard Deviation 223.386
|
-21.16 Percent change
Standard Deviation 31.372
|
67.91 Percent change
Standard Deviation 157.027
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
TIMP-1 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of TIMP-1. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Tissue Inhibitor of Metalloproteinases-1 (TIMP-1)
Day 43;n=3,14,5,24
|
-1.82 Percent change
Standard Deviation 6.578
|
-9.89 Percent change
Standard Deviation 37.032
|
-7.39 Percent change
Standard Deviation 11.298
|
-5.59 Percent change
Standard Deviation 23.922
|
|
Percent Change From Baseline in Tissue Inhibitor of Metalloproteinases-1 (TIMP-1)
Day 85;n=3,14,5,22
|
35.61 Percent change
Standard Deviation 73.383
|
-2.63 Percent change
Standard Deviation 57.144
|
49.38 Percent change
Standard Deviation 114.161
|
-1.75 Percent change
Standard Deviation 33.789
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
MCP-1 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=23 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Monocyte Chemo Attractant Protein-1 (MCP-1)
Day 43;n=3,14,5,23
|
-4.57 Percent change
Standard Deviation 19.262
|
388.23 Percent change
Standard Deviation 565.617
|
-4.37 Percent change
Standard Deviation 11.309
|
156.79 Percent change
Standard Deviation 297.549
|
|
Percent Change From Baseline in Monocyte Chemo Attractant Protein-1 (MCP-1)
Day 85;n=3,14,5,21
|
-33.39 Percent change
Standard Deviation 49.411
|
422.45 Percent change
Standard Deviation 514.842
|
-30.35 Percent change
Standard Deviation 36.118
|
199.94 Percent change
Standard Deviation 392.590
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
MIF is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MIF. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Migration Inhibitory Factor (MIF)
Day 43;n=3,14,5,24
|
8.98 Percent change
Standard Deviation 29.041
|
4.69 Percent change
Standard Deviation 46.772
|
120.23 Percent change
Standard Deviation 362.931
|
34.46 Percent change
Standard Deviation 160.400
|
|
Percent Change From Baseline in Migration Inhibitory Factor (MIF)
Day 85;n=3,14,5,22
|
15.39 Percent change
Standard Deviation 26.888
|
-15.72 Percent change
Standard Deviation 49.080
|
-11.80 Percent change
Standard Deviation 47.351
|
-5.76 Percent change
Standard Deviation 49.377
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
MRP8/14 is an inflammatory biomarker present in blood. Blood samples were collected at indicated time points for the assessment of MRP8/14. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Percent change from Baseline was calculated by 100\*\[(post-dose value minus Baseline value)/ Baseline value\].
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=14 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Myeloid-related Protein 8/14 (MRP8/14)
Day 85;n=3,14,5,22
|
13.84 Percent change
Standard Deviation 66.492
|
70.37 Percent change
Standard Deviation 199.467
|
-28.27 Percent change
Standard Deviation 17.112
|
-11.35 Percent change
Standard Deviation 77.927
|
|
Percent Change From Baseline in Myeloid-related Protein 8/14 (MRP8/14)
Day 43;n=3,14,5,24
|
3.15 Percent change
Standard Deviation 47.472
|
25.14 Percent change
Standard Deviation 75.189
|
-49.21 Percent change
Standard Deviation 19.168
|
-22.95 Percent change
Standard Deviation 38.992
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
A total of 25 locations in the hand and wrist were evaluated for RAMRIS bone erosions. Individual location scores range from 0 (no erosions) to 10 (91 to 100 percent of bone eroded) based on the proportion of eroded bone compared to the "assessed bone volume" on all available images. The final bone erosion score was the sum of the individual location scores. The total score from the 25 locations ranges from 0 to 250, with 0 implying no bone erosion and 250 implying 91 to 100 percent bone eroded. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Bone Erosion Total Score by "Outcome Measures in Rheumatology, Rheumatoid Arthritis Magnetic Resonance Image Scoring System (OMERACT-RAMRIS)" Scoring System
Day 43;n=3,13,5,24
|
0.7 Scores on a scale
Standard Deviation 1.15
|
0.6 Scores on a scale
Standard Deviation 1.04
|
0.4 Scores on a scale
Standard Deviation 1.52
|
-0.2 Scores on a scale
Standard Deviation 1.83
|
|
Change From Baseline in Bone Erosion Total Score by "Outcome Measures in Rheumatology, Rheumatoid Arthritis Magnetic Resonance Image Scoring System (OMERACT-RAMRIS)" Scoring System
Day 85;n=3,13,5,22
|
1.7 Scores on a scale
Standard Deviation 2.89
|
1.3 Scores on a scale
Standard Deviation 2.43
|
0.4 Scores on a scale
Standard Deviation 1.52
|
-0.1 Scores on a scale
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
RAMRIQ bone erosions (normalized) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the volume of bone erosions divided by sum of the individual measurements of the bone volume. The total score ranged from 0 to 1, with 0 implying no erosive damage. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=23 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Bone Erosions by the Rheumatoid Arthritis MRI Quantitative (RAMRIQ) Scoring System
Day 43;n=2,13,5,23
|
-0.00160 Scores on a scale
Standard Deviation 0.002550
|
-0.00110 Scores on a scale
Standard Deviation 0.002265
|
-0.00072 Scores on a scale
Standard Deviation 0.001662
|
-0.00069 Scores on a scale
Standard Deviation 0.004145
|
|
Change From Baseline in Bone Erosions by the Rheumatoid Arthritis MRI Quantitative (RAMRIQ) Scoring System
Day 85;n=2,13,5,21
|
-0.00069 Scores on a scale
Standard Deviation 0.001134
|
-0.00075 Scores on a scale
Standard Deviation 0.001301
|
-0.00273 Scores on a scale
Standard Deviation 0.003505
|
0.00059 Scores on a scale
Standard Deviation 0.003946
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Data was not collected for this outcome measure, as bone erosion is not a part of modified CARLOS. Bone erosion was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 23 and 24, respectively.
Change from Baseline in bone erosions was planned to be assessed by modified CARLOS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
A total of 8 joints in the hand and wrist were evaluated for RAMRIS synovitis. Individual joint scores were assessed on a scale of 0 (no synovitis) to 3 (67 to 100 percent volume enhancement). The final synovitis score was the sum of the individual joint scores. The total score from 8 joints ranges from 0 to 24, with 0 implying normal (no synovitis) and 24 implying 67 to 100 percent volume enhancement. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Synovitis by OMERACT-RAMRIS Scoring System
Day 43;n=3,13,5,24
|
0.0 Scores on a scale
Standard Deviation 1.73
|
0.3 Scores on a scale
Standard Deviation 1.55
|
-0.4 Scores on a scale
Standard Deviation 1.52
|
-0.3 Scores on a scale
Standard Deviation 1.90
|
|
Change From Baseline in Synovitis by OMERACT-RAMRIS Scoring System
Day 85;n=3,13,5,22
|
0.3 Scores on a scale
Standard Deviation 1.15
|
0.5 Scores on a scale
Standard Deviation 2.67
|
-0.4 Scores on a scale
Standard Deviation 1.52
|
-0.5 Scores on a scale
Standard Deviation 2.20
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
RAMRIQ synovitis (normalised) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the volume of enhancing pannus (VEP) divided by sum of the individual measurements of the joint volume. The total score ranged from 0 to 1, with 0 implying no synovitis. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=23 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Synovitis by RAMRIQ Scoring System
Day 43;n=2,13,5,23
|
-0.0570 Scores on a scale
Standard Deviation 0.02302
|
-0.0165 Scores on a scale
Standard Deviation 0.04302
|
-0.0592 Scores on a scale
Standard Deviation 0.06931
|
-0.0084 Scores on a scale
Standard Deviation 0.10490
|
|
Change From Baseline in Synovitis by RAMRIQ Scoring System
Day 85;n=2,13,5,21
|
-0.0659 Scores on a scale
Standard Deviation 0.01625
|
0.0251 Scores on a scale
Standard Deviation 0.12286
|
-0.0270 Scores on a scale
Standard Deviation 0.07061
|
-0.0107 Scores on a scale
Standard Deviation 0.11472
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Data was not collected for this outcome measure, as synovitis is not a part of modified CARLOS. Synovitis was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 26 and 27, respectively.
Change from Baseline in synovitis was planned to be assessed by modified CARLOS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
A total of 25 locations in the hand and wrist were evaluated for RAMRIS bone edema or osteitis. Individual location scores range from 0 (no edema) to 3 (67 to 100 percent involvement of original articular bone) based on the proportion of estimated originally non-eroded bone involved. The final bone edema or osteitis score is the sum of the individual location scores. The total score from the 25 locations ranges from 0 to 75, with 0 implying no bone edema or osteitis and 75 implying 67 to 100 percent involvement of original articular bone. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Bone Edema by OMERACT-RAMRIS Scoring System
Day 43;n=3,13,5,24
|
-1.0 Scores on a scale
Standard Deviation 1.73
|
-0.2 Scores on a scale
Standard Deviation 1.52
|
-0.8 Scores on a scale
Standard Deviation 3.27
|
-0.9 Scores on a scale
Standard Deviation 2.47
|
|
Change From Baseline in Bone Edema by OMERACT-RAMRIS Scoring System
Day 85;n=3,13,5,22
|
0.3 Scores on a scale
Standard Deviation 0.58
|
0.3 Scores on a scale
Standard Deviation 1.38
|
-4.4 Scores on a scale
Standard Deviation 6.80
|
-1.1 Scores on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
RAMRIQ bone edema (normalised) was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements of the Volume of bone edema divided by sum of the individual measurements of the bone volume. The total score ranged from 0 to 1, with 0 implying no bone marrow lesions. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=22 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Bone Edema by RAMRIQ Scoring System
Day 43;n=2,13,5,22
|
-0.00396 Scores on a scale
Standard Deviation 0.000647
|
-0.00463 Scores on a scale
Standard Deviation 0.007465
|
-0.01963 Scores on a scale
Standard Deviation 0.031481
|
-0.00095 Scores on a scale
Standard Deviation 0.018745
|
|
Change From Baseline in Bone Edema by RAMRIQ Scoring System
Day 85;n=2,13,5,21
|
0.00116 Scores on a scale
Standard Deviation 0.010166
|
-0.00229 Scores on a scale
Standard Deviation 0.010143
|
-0.03921 Scores on a scale
Standard Deviation 0.055431
|
-0.00384 Scores on a scale
Standard Deviation 0.016126
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Data was not collected for this outcome measure, as bone edema is not a part of modified CARLOS. Bone edema was measured by OMERACT-RAMRIS and RAMRIQ scoring system and is presented in outcome measures 29 and 30, respectively.
Change from Baseline in bone edema was planned to be assessed by modified CARLOS.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Data was not collected for this outcome measure, as joint space narrowing is not a part of OMERACT-RAMRIS scoring system. Joint space narrowing was measured by RAMRIQ scoring system and modified CARLOS and is presented in outcome measures 33 and 34, respectively.
Change from Baseline in joint space narrowing was planned to be assessed by OMERACT-RAMRIS scoring system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
RAMRIQ joint space narrowing was a quantitative measurement from the bones and synovial capsules of the joints from the most affected (or dominant hand if equally affected). It was calculated as the sum of the individual measurements (in millimeter) for the joints measured. The minimum possible total score is 0 implying complete loss of the joint space. The maximum possible total score will be largest possible joint space. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=23 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Joint Space Narrowing by RAMRIQ Scoring System
Day 43;n=2,13,5,23
|
1.121 Scores on a scale
Standard Deviation 1.4793
|
0.378 Scores on a scale
Standard Deviation 1.3394
|
0.484 Scores on a scale
Standard Deviation 2.8980
|
-0.335 Scores on a scale
Standard Deviation 1.4365
|
|
Change From Baseline in Joint Space Narrowing by RAMRIQ Scoring System
Day 85;n=2,13,5,21
|
0.534 Scores on a scale
Standard Deviation 0.8910
|
0.216 Scores on a scale
Standard Deviation 0.6974
|
0.235 Scores on a scale
Standard Deviation 2.2525
|
-0.433 Scores on a scale
Standard Deviation 1.1205
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
A total of 20 locations in the hand and wrist were evaluated for CARLOS joint space narrowing/cartilage loss. Individual location scores range from 0 (no cartilage loss or Joint Space Narrowing) to 4 (complete ankylosis) in increments of 0.5 based on the amount of narrowing present in a given joint. The final cartilage loss score was the sum of the individual location scores. The total score from 20 location ranged from 0 to 80, with 0 implying no cartilage loss at any location and 80 implying complete ankylosis. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=13 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=24 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Joint Space Narrowing by Modified CARLOS
Day 43;n=3,13,5,24
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.08 Scores on a scale
Standard Deviation 0.408
|
|
Change From Baseline in Joint Space Narrowing by Modified CARLOS
Day 85;n=3,13,5,22
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.00 Scores on a scale
Standard Deviation 0.00
|
0.09 Scores on a scale
Standard Deviation 0.426
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Contrast agent volume transfer constant (Ktrans) relates to the exchange of contrast agent between the blood plasma and the tissue extravascular extracellular spaces and reflects blood flow and capillary permeability. Ktrans was measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) tracer kinetic modeling in the most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=9 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=19 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Exchange Rate (Ktrans)
Day 43;n=2,9,5,19
|
0.0012 Per minute
Standard Deviation 0.00076
|
0.0022 Per minute
Standard Deviation 0.01214
|
-0.0095 Per minute
Standard Deviation 0.01716
|
-0.0018 Per minute
Standard Deviation 0.01443
|
|
Change From Baseline in Exchange Rate (Ktrans)
Day 85;n=2,9,5,17
|
0.0002 Per minute
Standard Deviation 0.01726
|
-0.0021 Per minute
Standard Deviation 0.01385
|
-0.0073 Per minute
Standard Deviation 0.00618
|
-0.0043 Per minute
Standard Deviation 0.01747
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Interstitial volume (Ve) is the fractional volume of the extravascular extracellular (EC) space per unit volume tissue within which contrast agent can accumulate. Ve was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=9 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=18 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Interstitial Volume (Ve)
Day 43;n=2,9,5,18
|
-0.305 Ratio of EC space to tissue volume
Standard Deviation 0.3128
|
-0.066 Ratio of EC space to tissue volume
Standard Deviation 0.3615
|
-0.140 Ratio of EC space to tissue volume
Standard Deviation 0.4825
|
0.073 Ratio of EC space to tissue volume
Standard Deviation 0.4044
|
|
Change From Baseline in Interstitial Volume (Ve)
Day 85;n=2,9,5,15
|
0.009 Ratio of EC space to tissue volume
Standard Deviation 0.7840
|
-0.024 Ratio of EC space to tissue volume
Standard Deviation 0.2450
|
-0.278 Ratio of EC space to tissue volume
Standard Deviation 0.5170
|
0.113 Ratio of EC space to tissue volume
Standard Deviation 0.4664
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Fractional volume of blood plasma (Vp) is the fractional volume of blood plasma per unit volume of tissue. Vp was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=9 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=19 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Fractional Volume of Blood Plasma (Vp)
Day 43;n=2,9,5,19
|
0.0018 Ratio of plasma volume to tissue volume
Standard Deviation 0.00166
|
0.0007 Ratio of plasma volume to tissue volume
Standard Deviation 0.00678
|
-0.0023 Ratio of plasma volume to tissue volume
Standard Deviation 0.00786
|
-0.0007 Ratio of plasma volume to tissue volume
Standard Deviation 0.00358
|
|
Change From Baseline in Fractional Volume of Blood Plasma (Vp)
Day 85;n=2,9,5,17
|
0.0000 Ratio of plasma volume to tissue volume
Standard Deviation 0.00019
|
-0.0022 Ratio of plasma volume to tissue volume
Standard Deviation 0.00407
|
-0.0001 Ratio of plasma volume to tissue volume
Standard Deviation 0.00272
|
-0.0007 Ratio of plasma volume to tissue volume
Standard Deviation 0.00282
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Initial Rate of Enhancement (IRE) is a measure of how quickly tissue enhances over 60 seconds following administration of contrast agent. IRE was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=9 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=19 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Initial Rate of Enhancement (IRE)
Day 43;n=2,9,5,19
|
-0.00002 Millimole per second
Standard Deviation 0.000044
|
0.00008 Millimole per second
Standard Deviation 0.000538
|
-0.00043 Millimole per second
Standard Deviation 0.000750
|
-0.00008 Millimole per second
Standard Deviation 0.000575
|
|
Change From Baseline in Initial Rate of Enhancement (IRE)
Day 85;n=2,9,5,17
|
-0.00011 Millimole per second
Standard Deviation 0.000566
|
-0.00010 Millimole per second
Standard Deviation 0.000542
|
-0.00037 Millimole per second
Standard Deviation 0.000271
|
-0.00014 Millimole per second
Standard Deviation 0.000735
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Maximum enhancement (ME) is a measure of the maximum concentration of contrast agent in the tissue over the duration of the DCE-MRI time series. ME was measured by DCE-MRI in most affected hand/wrist at indicated time points. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=2 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=9 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=19 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Maximal Signal Intensity Enhancement (ME)
Day 43;n=2,9,5,19
|
-0.0300 Millimole
Standard Deviation 0.00994
|
0.0029 Millimole
Standard Deviation 0.05405
|
-0.0531 Millimole
Standard Deviation 0.06876
|
0.0007 Millimole
Standard Deviation 0.06159
|
|
Change From Baseline in Maximal Signal Intensity Enhancement (ME)
Day 85;n=2,9,5,17
|
-0.0533 Millimole
Standard Deviation 0.00473
|
-0.0138 Millimole
Standard Deviation 0.05168
|
-0.0584 Millimole
Standard Deviation 0.06009
|
-0.0074 Millimole
Standard Deviation 0.07180
|
SECONDARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
The DAS28-CRP is a composite measure of inflammation in rheumatoid arthritis calculated from the sum of tender joint count 28 (TJC28), swollen joint count (SJC28), CRP and patient global assessment of disease activity (PtGA). The formula used to calculate DAS28 score was 0.56 multiplied by square root of TJC28 plus 0.28 multiplied by square root of SJC28 plus 0.36 log of (CRP plus 1) plus 0.014 multiplied by PtGA plus 0.96. Scores of DAS28-CRP ranged from 0.96 to 9.4 with higher scores indicating greater disease burden. A DAS28-CRP score of \<=2.6 suggested remission, \<3.2 suggested a low level of disease activity, while a score of \>5.1 suggested a high level of disease activity. Baseline was defined as the latest pre-dose assessment (Day 1 pre-dose). Change from Baseline was calculated by subtracting post-dose value from Baseline value.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=12 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=22 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) Scores
|
-1.00 Scores on a scale
Interval -2.45 to 0.46
|
-0.87 Scores on a scale
Interval -1.57 to -0.17
|
-1.47 Scores on a scale
Interval -2.6 to 0.35
|
-1.23 Scores on a scale
Interval -1.75 to 0.71
|
SECONDARY outcome
Timeframe: Day 85Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
DAS28-CRP scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as; if current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2: good response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response); if current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: moderate response) and (\<=0.6: no response) and if current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2: moderate response), (\>0.6 to \<=1.2: no response) and (\<=0.6: no response). If the post-Baseline DAS28-CRP score was missing, then the corresponding EULAR category was set to missing.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=12 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=22 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants Achieving Categorical DAS28-CRP Response Using European League Against Rheumatism [EULAR] Response
No response
|
2 Participants
|
6 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants Achieving Categorical DAS28-CRP Response Using European League Against Rheumatism [EULAR] Response
Moderate response
|
0 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
|
Number of Participants Achieving Categorical DAS28-CRP Response Using European League Against Rheumatism [EULAR] Response
Good response
|
1 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 85Population: Safety Population
The ACR score was based on improvement from Baseline in tender joint counts and swollen joint counts. A participant had achieved ACR20 if he experienced \>=20 percent improvement from Baseline in Tender Joint count 28 (TJC28) and Swollen Joint Count 28 (SJC28) and a \>=20 percent improvement from Baseline in 3 out of 5 of the following assessments: participant pain assessment on a 100 millimeter (mm) visual analog scale (VAS), participant global assessment on a 100 mm VAS scale, physician global assessment on a 100 mm VAS scale, C-reactive protein and Health Assessment Questionnaire - Disability Index (HAQ-DI). Similarly, ACR50 and ACR70 are calculated using 50 or 70 percent improvement from baseline respectively. For all visits, if any of the component scores were missing; then those scores were considered as not having met the criteria for improvement.
Outcome measures
| Measure |
Placebo BID
n=3 Participants
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 Participants
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg BID
n=5 Participants
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60 mg TID
n=28 Participants
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Number of Participants Achieving Categorical American College of rheumatology20/50/70 (ACR20/50/70) Response
ACR20
|
1 Participants
|
6 Participants
|
3 Participants
|
12 Participants
|
|
Number of Participants Achieving Categorical American College of rheumatology20/50/70 (ACR20/50/70) Response
ACR50
|
1 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants Achieving Categorical American College of rheumatology20/50/70 (ACR20/50/70) Response
ACR70
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
Joint volume was planned to be measured by DCE-MRI in most affected hand/wrist at indicated time points.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1 pre-dose), Days 43 and 85Population: Safety Population. This was an other pre-specified outcome measure. Data will not be analyzed and reported.
Enhancing volume was planned to be measured by DCE-MRI in most affected hand/wrist at indicated time points.
Outcome measures
Outcome data not reported
Adverse Events
Placebo BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo TID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
GSK2982772 60mg BID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
GSK2982772 60mg TID
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo BID
n=3 participants at risk
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 participants at risk
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60mg BID
n=5 participants at risk
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60mg TID
n=28 participants at risk
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
Other adverse events
| Measure |
Placebo BID
n=3 participants at risk
Participants received placebo orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
Placebo TID
n=15 participants at risk
Participants received placebo orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60mg BID
n=5 participants at risk
Participants received GSK2982772 orally twice daily (BID) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
GSK2982772 60mg TID
n=28 participants at risk
Participants received GSK2982772 orally three times daily (TID) (approximately 8 hours apart) for 84 days (12 weeks). Participants received methotrexate for the treatment of RA during conduct of the study, if required.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
7.1%
2/28 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
7.1%
2/28 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
13.3%
2/15 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
7.1%
2/28 • Number of events 3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
13.3%
2/15 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Investigations
Transaminases increased
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
General disorders
Influenza like illness
|
33.3%
1/3 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Pertussis
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Respiratory tract infection
|
33.3%
1/3 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Nervous system disorders
Vascular headache
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
20.0%
1/5 • Number of events 2 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/15 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
3.6%
1/28 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
6.7%
1/15 • Number of events 1 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/5 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
0.00%
0/28 • On-therapy non-SAEs and SAEs were reported from start of study treatment and up to 112 days
Non-SAE and SAEs were reported for Safety Population. Adverse events were presented treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER