Trial Outcomes & Findings for Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis (NCT NCT02965599)

Last Updated: 2020-10-30

Results Overview

The DAS28 score is a derived measurement with differential weighing given to each component as: Tender/Painful Joint Count (TJC28) and swollen joint count (SJC28) both scored 0-28 (higher scores indicate higher disease activity), CRP measured in milligrams per liter and Patient's Global Assessment of Arthritis (PtGA) (visual analogue scale with values from 0 \[best\] to 100 \[worst\]). 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. DAS28 scores ranged from 0 (best) to 10 (worst). A negative change from Baseline value indicated improvement. Baseline was defined at Day 1 (pre-dose). Change from Baseline was post-baseline value minus the value at Baseline. Safety Population consisted of all participants who received at least one dose of study medication. Individual participant data at Day 28 has been presented.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Baseline (pre-dose, Day 1) and Day 28

Results posted on

2020-10-30

Participant Flow

This study was conducted in participants with severe, active rheumatoid arthritis receiving GSK3117391, 40 milligrams (mg) or placebo at one center in Poland and one in Romania.

This study was terminated early by the sponsor following internal review. A total number of 26 participants were screened, of which three participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Placebo Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Overall Study STARTED	2	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Overall Study Protocol-defined stop criteria reached	1	0

Baseline Characteristics

Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3117391 in Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.	Total n=3 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 14.85 • n=5 Participants	46 Years STANDARD_DEVIATION NA • n=7 Participants	54.3 Years STANDARD_DEVIATION 12.74 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-dose, Day 1) and Day 28

Population: Safety Population. Only those participants with data available at specified time point were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=1 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Change From Baseline in Disease Activity Score for 28 Different Joints With (DAS28) C-reactive Protein (CRP) at Day 28	-0.38 Units on a scale	-1.73 Units on a scale

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population.

An AE is 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. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect and other situations which involve medical or scientific judgment, and is associated with liver injury and impaired liver function.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Any non-SAE	2 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs Any SAE	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature and heart rate were measured in semi-supine position after 5 minutes rest. The PCI ranges for vitals were as follows; for SBP \<85 or \>160 millimeters of mercury (mmHg), for DBP \<45 or \>100 mmHg, for heart rate \<40 or \>110 beats per minute and for temperature \<36 or \>38 Celsius. The number of participants with vital signs of PCI have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Vital Signs Values of Potential Clinical Importance (PCI) SBP	0 Participants	0 Participants
Number of Participants With Vital Signs Values of Potential Clinical Importance (PCI) DBP	0 Participants	0 Participants
Number of Participants With Vital Signs Values of Potential Clinical Importance (PCI) Heart rate	0 Participants	0 Participants
Number of Participants With Vital Signs Values of Potential Clinical Importance (PCI) Temperature	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population

Twelve-lead ECGs were performed during the study using an automated ECG machine, after 5 minutes of rest. The number of participants with abnormal ECG findings were reported and categorized as clinically significant and not clinically significant. Any value for ECG parameters out of the following normal range was considered as clinically significant abnormality; for PR interval \<110 or \>220 milliseconds, for QRS interval \<75 or \>110 milliseconds and for QT corrected interval \<450 milliseconds.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-clinically significant	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Abnormal-Not clinically significant	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population

Blood samples were collected for analysis of clinical chemistry parameters. The PCI ranges were for Albumin \<30 millimoles/Liter (mmol/L), Calcium (\<2 or \>2.75 mmol/L), Creatinine (\>44.2 mmol/L), Glucose (\<3 or \>9 mmol/L), Magnesium (\<0.5 or \>1.23 mmol/L), Phosphorus (\<0.8 or \> 1.6 mmol/L), Potassium (\<3 or \> 5.5 mmol/L), Sodium (\<130 or 150 mmol/L), Total carbon-dioxide (\<18 or \> 32 mmol/L), Alanine aminotransferase (\>= 2x Upper Limit of Normal \[ULN\]), Aspartate aminotransferase (\>=2x ULN), alkaline phosphatase (\>=2x ULN), and total bilirubin (\>=1.5xULN). The number of participants with values for clinical chemistry parameters of PCI have been presented

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Values for Clinical Chemistry Parameters of PCI	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population

Blood samples were collected for analysis of hematology parameters. PCI ranges were for platelets (\< 50 or \>550 × 10\^9 cells/L), white blood cell count (\<3 or \>14 × 10\^9 cells/L), hemoglobin (\<90 or \>180 g/L), hematocrit (if proportion of red blood cells in blood was \<0.3 or \>0.54), lymphocytes (\<0.5 × 10\^9 cells/L), neutrophils (\<1.0 × 10\^9 cells/L) and monocytes (\<0.2 or 1.5 × 10\^9 cells/L). The number of participants with values for hematology parameters of PCI have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Values for Hematology Parameters of PCI	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population

Urine samples were collected for the analysis of specific gravity, potential of hydrogen (pH), glucose, protein, blood and ketones at specified time points. The number of participants with abnormal urinalysis findings have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Participants With Abnormal Findings for Urinalysis Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

A participant was considered to be a responder according to the ACR20 criteria if the participant had at least 20% improvement in both the tender joint count and swollen joint count measures, and 20% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

A participant was considered to be a responder according to the ACR50 criteria if the participant had at least 50% improvement in both the tender joint count and swollen joint count measures, and 50% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Day 44

Population: Safety Population. Data was not collected, as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

A participant was considered to be a responder according to the ACR70 criteria if the participant had at least 70% improvement in both the tender joint count and swollen joint count measures, and 70% improvement in at least 3 of the following 5 measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. This analysis was planned but data was not collected , as the sample size was too small and study was terminated pre-maturely, by the sponsor following internal review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 7, 14, 21, 28 and Follow-up (Day 44)

Population: Safety Population. Only those participants with data available at specified time point has been analyzed (represented by n=x in category titles). Data has been presented for participants as per the actual treatment received.

The total number of joints ranging from 0 to 28 joints with a present swelling were assessed. The following 28 joints were taken into account for SJC28: Shoulder (2 joints), Knee (2), Elbow (2), Wrist (2), Fingers (Joints for proximal interphalangeal \[PIP\] and metacarpophalangeal \[MCP\]: 20). No missing observations were considered. Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Swollen Joints Assessed Using 28-joint Counts Participant 1; Day 1; n=1,0	7 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 1; Day 7; n=1,0	2 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 1; Follow-up (Day 44); n=1,0	1 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Day 1; n=1,0	8 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Day 7; n=1,0	7 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Day 14; n=1,0	4 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Day 21; n=1,0	1 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Day 28; n=1,0	1 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 2; Follow-up (Day 44); n=1,0	1 Swollen joints	—
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Day 1;n=0,1	—	28 Swollen joints
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Day 7;n=0,1	—	18 Swollen joints
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Day 14;n=0,1	—	12 Swollen joints
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Day 21;n=0,1	—	7 Swollen joints
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Day 28;n=0,1	—	11 Swollen joints
Number of Swollen Joints Assessed Using 28-joint Counts Participant 3; Follow-up (Day 44);n=0,1	—	5 Swollen joints

SECONDARY outcome

Timeframe: Days 1, 7, 14, 21, 28 and Follow-up (Day 44)

The total number of joints ranging from 0 to 28 joints with a present tenderness were assessed. The following 28 joints were taken into account for TJC28: Shoulder (2 joints), Knee (2), Elbow (2), Wrist (2), Fingers (PIP and MCP: 20). No missing observations were considered. Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 1; Day 1; n=1, 0	12 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 1; Day 7; n=1, 0	8 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 1; Follow-up (Day 44); n=1, 0	1 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Day 1; n=1, 0	9 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Day 7; n=1, 0	7 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Day 14; n=1, 0	5 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Day 21; n=1, 0	7 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Day 28; n=1, 0	4 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 2; Follow-up (Day 44); n=1, 0	1 Tender/painful joints	—
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Day 1; n=0,1	—	28 Tender/painful joints
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Day 7; n=0,1	—	26 Tender/painful joints
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Day 14; n=0,1	—	19 Tender/painful joints
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Day 21; n=0,1	—	18 Tender/painful joints
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Day 28; n=0,1	—	19 Tender/painful joints
Number of Tender/Painful Joints Assessed Using 28-joint Counts Participant 3; Follow-up (Day 44); n=0,1	—	8 Tender/painful joints

SECONDARY outcome

Timeframe: Baseline (pre-dose, Day 1) and Days 7, 14, 21, 28, Follow-up (Day 44)

The DAS28 score is a derived measurement with differential weighing given to each component as: TJC28 and SJC28 both scored 0-28 (higher scores indicate higher disease activity), CRP measured in milligrams per liter and PtGA (visual analogue scale with values from 0 \[best\] to 100 \[worst\]). 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. DAS28 scores ranged from 0 (best) to 10 (worst). A negative change from Baseline value indicated improvement. Baseline was defined at Day 1 (pre-dose). Change from Baseline was post-baseline value minus the value at Baseline. Only data available at specified visit with respect to the participant has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Change From Baseline in DAS28-CRP Over Time Participant 1; Day 7 ;n=1, 0	-0.48 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 1; Follow-up (Day 44) ;n=1, 0	-2.84 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 2; Day 7 ;n=1, 0	-0.24 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 2; Day 14 ;n=1, 0	-0.96 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 2; Day 21 ;n=1, 0	-0.77 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 2; Day 28 ;n=1, 0	-0.38 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 2; Follow-up (Day 44) ;n=1, 0	-2.30 Scores on a Scale	—
Change From Baseline in DAS28-CRP Over Time Participant 3; Day 7 ;n=0, 1	—	-0.79 Scores on a Scale
Change From Baseline in DAS28-CRP Over Time Participant 3; Day 14 ;n=0, 1	—	-1.35 Scores on a Scale
Change From Baseline in DAS28-CRP Over Time Participant 3; Day 21 ;n=0, 1	—	-1.54 Scores on a Scale
Change From Baseline in DAS28-CRP Over Time Participant 3; Day 28 ;n=0, 1	—	-1.73 Scores on a Scale
Change From Baseline in DAS28-CRP Over Time Participant 3; Follow-up (Day 44) ;n=0, 1	—	-2.59 Scores on a Scale

SECONDARY outcome

Timeframe: Days 1, 7, 14, 21, 28 and Follow-up (Day 44)

Participants completed the global assessment of disease activity using the PtGA item using visual analogue scale (VAS) ranging from "0" (none) to "100" (extremely active), respectively. Individual participant score has been presented. Only data available at specified visit with respect to the participant has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 1; Day 1; n=1, 0	58 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 1; Day 7; n=1, 0	73 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 1; Follow-up (Day 44); n=1, 0	25 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Day 1; n=1, 0	87 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Day 7; n=1, 0	86 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Day 14; n=1, 0	71 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Day 21; n=1, 0	78 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Day 28; n=1, 0	96 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 2; Follow-up (Day 44); n=1, 0	33 Scores on a Scale	—
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Day 1; n=0,1	—	100 Scores on a Scale
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Day 7; n=0,1	—	82 Scores on a Scale
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Day 14; n=0,1	—	79 Scores on a Scale
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Day 21; n=0,1	—	74 Scores on a Scale
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Day 28; n=0,1	—	72 Scores on a Scale
Assessment of Disease Activity Using Patient's Global Assessment of Arthritis (PtGA) Participant 3; Follow-up (Day 44); n=0,1	—	62 Scores on a Scale

SECONDARY outcome

Timeframe: Baseline (pre-dose, Day 1) and Days 7, 14, 21, 28, Follow-up (Day 44)

Blood samples were collected at indicated time points for the analysis of CRP. Change from Baseline, was defined as the post-baseline value minus the value at Baseline. Baseline was defined as the value from the Day 1 (pre-dose). Individual participant data has been presented. Only data available at specified visit with respect to the participant has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=2 Participants Eligible participants in this arm, received a matching placebo to the study drug GSK3117391, administered orally once a day as 2 capsules in the morning, following every other day, for 28-days.	GSK3117391, 40 mg n=1 Participants Eligible participants in this arm, received a dose of 40 mg of GSK3117391, administered orally once a day as 2 capsules of 20 mg each in the morning, following every other day, for 28-days.
Change From Baseline in CRP Participant 1; Day 7; n=1, 0	0.50 Milligrams per liter	—
Change From Baseline in CRP Participant 1; Follow-up (Day 44); n=1, 0	-11.20 Milligrams per liter	—
Change From Baseline in CRP Participant 2; Day 7; n=1, 0	0.50 Milligrams per liter	—
Change From Baseline in CRP Participant 2; Day 14; n=1, 0	-1.60 Milligrams per liter	—
Change From Baseline in CRP Participant 2; Day 21; n=1, 0	1.60 Milligrams per liter	—
Change From Baseline in CRP Participant 2; Day 28; n=1, 0	30.20 Milligrams per liter	—
Change From Baseline in CRP Participant 2; Follow-up (Day 44); n=1, 0	2.20 Milligrams per liter	—
Change From Baseline in CRP Participant 3; Day 7; n=0,1	—	-14.00 Milligrams per liter
Change From Baseline in CRP Participant 3; Day 14; n=0,1	—	-3.10 Milligrams per liter
Change From Baseline in CRP Participant 3; Day 21; n=0,1	—	23.40 Milligrams per liter
Change From Baseline in CRP Participant 3; Day 28; n=0,1	—	-22.40 Milligrams per liter
Change From Baseline in CRP Participant 3; Follow-up (Day 44); n=0,1	—	26.70 Milligrams per liter

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 1) and 24 hours (Day 2) post-dose; pre-dose, 0.25, 0.5, 1, 4, and 8 hours (Day 3) post-dose; pre-dose (Day 7); pre-dose (Day 21); pre-dose, 0.25, 0.5, 1, 2, 4, 6, 10 hours (Day 27) and 24 hours post-dose