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Trial record 3 of 8 for:    GSK3196165

Evaluation of Pharmacokinetics and Safety of GSK3196165 in Combination With Methotrexate in Japanese Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03028467
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : June 26, 2019
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: GSK3196165 Dose 1
Drug: GSK3196165 Dose 2
Drug: GSK3196165 Dose 3
Drug: Methotrexate
Drug: Placebo
Drug: Folic acid
Enrollment 15
Recruitment Details This study was conducted to assess pharmacokinetics (PK), safety, tolerability and efficacy of GSK3196165 for 12 weeks, in combination with Methotrexate (MTX), in Japanese participants with active moderate-severe rheumatoid arthritis (RA) despite treatment with MTX. Participants were enrolled at 15 centers in Japan from 24-Jan-2017 to 30-Jun-2017.
Pre-assignment Details A total of 35 participants were screened, and 20 participants failed screening because of not met eligibility criteria (18 participants) and withdrawal by participant (2 participants). Hence, a total of 15 participants were enrolled and randomized to study treatment.
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Period Title: Overall Study
Started 4 3 4 4
Completed 4 3 4 4
Not Completed 0 0 0 0
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg Total
Hide Arm/Group Description Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Total of all reporting groups
Overall Number of Baseline Participants 4 3 4 4 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 4 participants 4 participants 15 participants
52.0  (14.45) 58.0  (15.72) 66.5  (2.52) 52.0  (9.20) 57.1  (11.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 3 participants 4 participants 4 participants 15 participants
Female
3
  75.0%
2
  66.7%
1
  25.0%
3
  75.0%
9
  60.0%
Male
1
  25.0%
1
  33.3%
3
  75.0%
1
  25.0%
6
  40.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 4 participants 3 participants 4 participants 4 participants 15 participants
Japanese/East Asian Heritage (EAH)/South EAH
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
15
 100.0%
1.Primary Outcome
Title Maximum Observed Concentration (Cmax) of GSK3196165
Hide Description Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). Only those participants whose parameters could be determined were analyzed. PK Population included all GSK3196165-treated participants from whom PK samples were collected and analyzed.
Time Frame Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants with data available at the specified time points were analyzed.
Arm/Group Title GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 2 3 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: Nanogram per milliliter (ng/mL)
699.92
(48.18 to 10167.77)
1444.88
(148.02 to 14104.11)
3924.10
(3375.18 to 4562.30)
2.Primary Outcome
Title Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165
Hide Description Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient.
Time Frame Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants whose parameters could be determined were analyzed (represented by n=X in the category titles).
Arm/Group Title GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 3 4 4
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hour*Nanogram per milliliter (hr*ng/mL)
AUC (0-t), n=2, 3, 4 Number Analyzed 2 participants 3 participants 4 participants
189948.606
(508.091 to 71011815.710)
386497.495
(32248.035 to 4632229.918)
1186604.746
(589936.272 to 2386750.721)
AUC (0-inf), n=0, 1, 2 Number Analyzed 0 participants 1 participants 2 participants
732243.847 [1] 
(NA to NA)
1097422.958
(106189.728 to 11341371.436)
AUCtau, n=1, 3, 4 Number Analyzed 1 participants 3 participants 4 participants
196562.287 [1] 
(NA to NA)
303167.467
(38999.824 to 2356690.471)
787570.414
(570081.863 to 1088031.733)
[1]
NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient.
3.Primary Outcome
Title Time to Reach Cmax (Tmax) of GSK3196165
Hide Description Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71).
Time Frame Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants whose parameters could be determined were analyzed.
Arm/Group Title GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 2 3 4
Median (Full Range)
Unit of Measure: Hour
48.99167
(46.3500 to 51.6333)
70.61667
(47.2500 to 94.0667)
69.80000
(47.4000 to 70.8000)
4.Primary Outcome
Title Terminal Half-life (t1/2) of GSK3196165
Hide Description Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by standard non-compartmental analysis from the concentration data after last dosing (Day 71). NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient.
Time Frame Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155.
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population. Only those participants whose parameters could be determined were analyzed.
Arm/Group Title GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 0 1 2
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hour
282.85265 [1] 
(NA to NA)
245.12966
(66.51778 to 903.34570)
[1]
NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient.
5.Primary Outcome
Title Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI)
Hide Description 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. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. AESI included serious infections including serious respiratory infections and tuberculosis and opportunistic infections, neutropenia (grade 3 or 4), respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions including anaphylaxis and injection site reactions.
Time Frame Up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population. It included all participants who were randomized to treatment and who received at least one dose of study treatment.
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Any AE
3
  75.0%
2
  66.7%
3
  75.0%
2
  50.0%
Any SAE
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any AESI
2
  50.0%
0
   0.0%
1
  25.0%
0
   0.0%
6.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Hide Description Vital sign measurements including SBP and DBP were measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.
Time Frame Baseline and up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Mean (Standard Deviation)
Unit of Measure: Millimeter of mercury
SBP, Week 1 -0.3  (8.62) -7.7  (2.89) -15.0  (17.36) -1.0  (8.45)
SBP, Week 2 -1.8  (8.34) -6.7  (12.06) -4.5  (12.48) 1.5  (1.91)
SBP, Week 3 0.5  (4.80) -1.7  (12.01) -10.5  (20.47) -0.8  (6.02)
SBP, Week 4 -5.8  (10.14) -11.3  (17.10) -3.3  (17.88) 6.3  (7.63)
SBP, Week 6 -2.0  (5.66) -12.7  (11.59) -1.3  (15.50) -2.3  (11.62)
SBP, Week 8 -6.3  (7.41) -3.0  (13.00) -5.8  (18.55) 3.8  (2.22)
SBP, Week 10 2.3  (4.86) 6.7  (5.03) -11.8  (23.04) -1.5  (2.65)
SBP, Week 12 2.0  (11.49) -5.3  (9.45) -2.5  (14.29) 0.8  (6.60)
SBP, Follow up (Week 22) 4.0  (13.88) -4.7  (14.50) -2.5  (22.52) -4.3  (3.50)
DBP, Week 1 -1.0  (4.08) -3.3  (10.97) -6.8  (6.85) -0.5  (8.35)
DBP, Week 2 -1.5  (7.33) 0.3  (1.53) 2.0  (5.60) -0.3  (5.44)
DBP, Week 3 -4.3  (6.95) -1.0  (6.56) -5.3  (9.57) -4.3  (2.75)
DBP, Week 4 -1.0  (7.39) -1.3  (3.79) 1.3  (7.46) 1.3  (6.60)
DBP, Week 6 -1.0  (8.04) 7.7  (5.77) 5.3  (11.03) -5.5  (4.12)
DBP, Week 8 -2.5  (3.32) 11.3  (7.02) -1.5  (10.66) -2.0  (10.39)
DBP, Week 10 -2.3  (3.59) 2.7  (10.26) -3.0  (8.83) -4.5  (3.70)
DBP, Week 12 3.5  (6.24) -1.7  (4.73) -3.8  (10.53) -4.3  (6.40)
DBP, Follow up (Week 22) 2.8  (6.99) -1.0  (8.72) 3.0  (12.54) -3.5  (5.26)
7.Secondary Outcome
Title Change From Baseline in Heart Rate (HR)
Hide Description Vital sign measurements including HR was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.
Time Frame Baseline and up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Mean (Standard Deviation)
Unit of Measure: Beats per minute
Week 1 0.3  (5.12) -8.0  (3.61) 11.5  (13.30) -0.8  (4.27)
Week 2 3.0  (11.34) -5.3  (2.31) 9.5  (15.15) -5.0  (1.41)
Week 3 1.3  (3.59) -5.3  (3.79) 10.8  (18.10) -7.0  (5.94)
Week 4 2.5  (5.45) -5.7  (14.01) 12.0  (15.12) -7.8  (2.06)
Week 6 7.3  (10.11) -7.3  (6.43) 11.0  (15.92) -0.5  (11.50)
Week 8 5.8  (8.26) -2.7  (10.12) 1.8  (11.30) -11.5  (6.66)
Week 10 8.3  (9.07) 1.3  (8.02) 0.8  (11.41) -8.8  (10.94)
Week 12 -2.0  (8.68) -10.0  (7.00) 12.5  (11.03) -7.8  (5.56)
Follow up (Week 22) -2.3  (7.14) -6.0  (11.53) 6.3  (20.34) -1.3  (8.22)
8.Secondary Outcome
Title Change From Baseline in Body Temperature
Hide Description Vital sign measurements including body temperature was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.
Time Frame Baseline and up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Mean (Standard Deviation)
Unit of Measure: Celsius
Week 1 0.00  (0.469) -0.20  (0.346) 0.18  (0.287) 0.05  (0.265)
Week 2 0.07  (0.330) 0.03  (0.153) -0.13  (0.250) 0.22  (0.718)
Week 3 -0.10  (0.476) -0.30  (0.265) 0.18  (0.359) 0.15  (0.843)
Week 4 -0.20  (0.327) -0.47  (0.379) 0.20  (0.316) -0.15  (0.387)
Week 6 -0.03  (0.377) 0.07  (0.404) -0.10  (0.200) -0.02  (0.457)
Week 8 -0.20  (0.424) 0.03  (0.503) -0.07  (0.377) 0.05  (0.332)
Week 10 0.00  (0.337) 0.13  (0.252) -0.02  (0.386) 0.17  (0.499)
Week 12 -0.07  (0.427) 0.00  (0.458) -0.25  (0.370) 0.02  (0.670)
Follow up (Week 22) -0.47  (0.862) -0.13  (0.208) 0.25  (0.311) -0.18  (0.171)
9.Secondary Outcome
Title Change From Baseline in Respiratory Rate
Hide Description Vital sign measurements including respiratory rate was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value.
Time Frame Baseline and up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Mean (Standard Deviation)
Unit of Measure: Breaths per minute
Week 1 -2.0  (1.63) 0.7  (1.15) -1.0  (1.41) 0.8  (2.22)
Week 2 -0.5  (3.42) 0.0  (0.00) -1.0  (2.00) 0.3  (1.26)
Week 3 0.3  (3.10) 1.3  (2.31) 0.8  (0.96) 1.5  (3.11)
Week 4 -2.5  (3.42) -1.7  (2.89) -0.5  (2.38) 0.3  (1.71)
Week 6 1.5  (5.45) -1.0  (1.73) -0.3  (0.96) 2.3  (5.19)
Week 8 -0.3  (2.63) 1.3  (2.31) -1.3  (0.96) 0.3  (1.71)
Week 10 0.0  (1.63) -0.7  (1.15) -2.3  (1.50) 1.0  (3.46)
Week 12 1.0  (1.41) -0.3  (2.52) -2.5  (3.11) 0.8  (3.59)
Follow up (Week 22) 0.0  (0.82) 0.3  (3.51) -1.5  (2.08) 0.5  (1.00)
10.Secondary Outcome
Title Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Hide Description 12-Lead ECGs were taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. Number of participants with any abnormal findings in ECG recordings were summarized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time Frame At Week 12
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Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal - Not clinically significant
1
  25.0%
1
  33.3%
1
  25.0%
0
   0.0%
Abnormal - Clinically significant
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Emergent Hematology Results Relative to Normal Range
Hide Description Blood samples were collected to evaluate hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocytes, reticulocytes, white blood cells (WBC), total neutrophils, eosinophils, basophils, monocytes, lymphocytes, platelet count, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, erythrocyte sedimentation rate (ESR). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances.
Time Frame Up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
APTT, To Low
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
APTT, To Normal or No change
3
  75.0%
3
 100.0%
3
  75.0%
4
 100.0%
APTT, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Basophils, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Basophils, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Basophils, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Eosinophils, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Eosinophils, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ESR, To low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ESR, To Normal or No change
2
  50.0%
3
 100.0%
4
 100.0%
4
 100.0%
ESR, To High
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fibrinogen, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fibrinogen, To Normal or No change
3
  75.0%
3
 100.0%
4
 100.0%
4
 100.0%
Fibrinogen, To High
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hemoglobin, To Low
1
  25.0%
1
  33.3%
2
  50.0%
0
   0.0%
Hemoglobin, To Normal or No change
3
  75.0%
2
  66.7%
2
  50.0%
4
 100.0%
Hemoglobin, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hematocrit, To Low
1
  25.0%
2
  66.7%
1
  25.0%
0
   0.0%
Hematocrit, To Normal or No change
3
  75.0%
1
  33.3%
3
  75.0%
4
 100.0%
Hematocrit, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lymphocytes, To Low
2
  50.0%
1
  33.3%
3
  75.0%
0
   0.0%
Lymphocytes, To Normal or No change
2
  50.0%
2
  66.7%
1
  25.0%
4
 100.0%
Lymphocytes, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCHC, To Low
1
  25.0%
1
  33.3%
0
   0.0%
0
   0.0%
MCHC, To Normal or No change
3
  75.0%
2
  66.7%
4
 100.0%
4
 100.0%
MCHC, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCH, To Low
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCH, To Normal or No change
3
  75.0%
3
 100.0%
4
 100.0%
4
 100.0%
MCH, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCV, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
MCV, To Normal or No change
3
  75.0%
3
 100.0%
4
 100.0%
4
 100.0%
MCV, To High
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes, To Low
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
Monocytes, To Normal or No change
2
  50.0%
3
 100.0%
4
 100.0%
4
 100.0%
Monocytes, To High
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total neutrophils, To Low
0
   0.0%
1
  33.3%
0
   0.0%
1
  25.0%
Total neutrophils, To Normal or No change
4
 100.0%
2
  66.7%
3
  75.0%
3
  75.0%
Total neutrophils, To High
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Platelet count, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelet count, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Platelet count, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PT, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
PT, To Normal or No change
4
 100.0%
2
  66.7%
4
 100.0%
4
 100.0%
PT, To High
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
RBC, To Low
0
   0.0%
0
   0.0%
3
  75.0%
0
   0.0%
RBC, To Normal or No change
4
 100.0%
3
 100.0%
1
  25.0%
4
 100.0%
RBC, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Reticulocytes, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Reticulocytes, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
WBC, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
WBC, To High
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
12.Secondary Outcome
Title Number of Participants With Emergent Clinical Chemistry Results Relative to Normal Range
Hide Description Blood samples were collected to evaluate Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin, Calcium, Cholesterol, Creatine Kinase, C-Reactive protein (CRP), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, High Density Lipids (HDL), Potassium, Lactate Dehydrogenase, Low Density Lipids (LDL), Sodium, Phosphorus inorganic, Triglycerides, Total Protein and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances.
Time Frame Up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Albumin, To Low
0
   0.0%
0
   0.0%
2
  50.0%
0
   0.0%
Albumin, To Normal or No change
4
 100.0%
3
 100.0%
2
  50.0%
4
 100.0%
Albumin, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALP, To Normal or No change
2
  50.0%
3
 100.0%
4
 100.0%
4
 100.0%
ALP, To High
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
ALT, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
ALT, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
AST, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
AST, To High
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Total Bilirubin, To Low
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Bilirubin, To Normal or No change
2
  50.0%
3
 100.0%
4
 100.0%
4
 100.0%
Total Bilirubin, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Calcium, To Low
1
  25.0%
0
   0.0%
1
  25.0%
1
  25.0%
Calcium, To Normal or No change
3
  75.0%
3
 100.0%
3
  75.0%
3
  75.0%
Calcium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cholesterol, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Cholesterol, To Normal or No change
2
  50.0%
2
  66.7%
4
 100.0%
4
 100.0%
Cholesterol, To High
2
  50.0%
1
  33.3%
0
   0.0%
0
   0.0%
Creatine Kinase, To Low
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
Creatine Kinase, To Normal or No change
3
  75.0%
2
  66.7%
4
 100.0%
3
  75.0%
Creatine Kinase, To High
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
CRP, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CRP, To Normal or No change
2
  50.0%
3
 100.0%
4
 100.0%
4
 100.0%
CRP, To High
2
  50.0%
0
   0.0%
0
   0.0%
0
   0.0%
Creatinine, To Low
0
   0.0%
1
  33.3%
1
  25.0%
0
   0.0%
Creatinine, To Normal or No change
4
 100.0%
2
  66.7%
3
  75.0%
4
 100.0%
Creatinine, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
GGT, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
GGT, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
GGT, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glucose, To Low
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Glucose, To Normal or No change
1
  25.0%
2
  66.7%
3
  75.0%
2
  50.0%
Glucose, To High
3
  75.0%
1
  33.3%
1
  25.0%
1
  25.0%
HDL, To Low
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
HDL, To Normal or No change
4
 100.0%
2
  66.7%
4
 100.0%
4
 100.0%
HDL, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Potassium To Low
2
  50.0%
1
  33.3%
1
  25.0%
0
   0.0%
Potassium, To Normal or No change
2
  50.0%
2
  66.7%
3
  75.0%
4
 100.0%
Potassium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lactate Dehydrogenase, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Lactate Dehydrogenase, To Normal or No change
3
  75.0%
3
 100.0%
3
  75.0%
3
  75.0%
Lactate Dehydrogenase, To High
1
  25.0%
0
   0.0%
1
  25.0%
1
  25.0%
LDL, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
LDL, To Normal or No change
2
  50.0%
2
  66.7%
4
 100.0%
4
 100.0%
LDL, To High
2
  50.0%
1
  33.3%
0
   0.0%
0
   0.0%
Sodium, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sodium, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Sodium, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phosphorus inorganic, To Low
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Phosphorus inorganic, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Phosphorus inorganic, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Triglycerides, To Low
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Triglycerides, To Normal or No change
4
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
Triglycerides, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total Protein, To Low
1
  25.0%
1
  33.3%
1
  25.0%
0
   0.0%
Total Protein, To Normal or No change
3
  75.0%
2
  66.7%
3
  75.0%
4
 100.0%
Total Protein, To High
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urea, To Low
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
Urea, To Normal or No change
3
  75.0%
3
 100.0%
3
  75.0%
3
  75.0%
Urea, To High
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Urinalysis Dipstick Findings
Hide Description Urine samples were collected for analysis of presence of glucose and protein in urine by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and glucose can be read as negative, Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample
Time Frame Up to 22 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4, Glucose, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Glucose, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Glucose, 3+
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Week 4, Glucose, Negative
4
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
Week 4, Glucose, Trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Protein, 1+
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
Week 4, Protein, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Protein, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Protein, Negative
1
  25.0%
3
 100.0%
2
  50.0%
4
 100.0%
Week 4, Protein, Trace
2
  50.0%
0
   0.0%
1
  25.0%
0
   0.0%
Week 8, Glucose, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Week 8, Glucose, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, Glucose, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, Glucose, Negative
4
 100.0%
3
 100.0%
4
 100.0%
3
  75.0%
Week 8, Glucose, Trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, Protein, 1+
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
Week 8, Protein, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, Protein, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 8, Protein, Negative
1
  25.0%
3
 100.0%
3
  75.0%
2
  50.0%
Week 8, Protein, Trace
3
  75.0%
0
   0.0%
0
   0.0%
2
  50.0%
Week 12, Glucose, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Glucose, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Glucose, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Glucose, Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Week 12, Glucose, Trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Protein, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
Week 12, Protein, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Protein, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Protein, Negative
3
  75.0%
3
 100.0%
3
  75.0%
3
  75.0%
Week 12, Protein, Trace
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
Follow up (Week 22), Glucose, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Glucose, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Glucose, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Glucose, Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Follow up (Week 22), Glucose, Trace
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Protein, 1+
1
  25.0%
0
   0.0%
1
  25.0%
0
   0.0%
Follow up (Week 22), Protein, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Protein, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Follow up (Week 22), Protein, Negative
2
  50.0%
3
 100.0%
3
  75.0%
3
  75.0%
Follow up (Week 22), Protein, Trace
1
  25.0%
0
   0.0%
0
   0.0%
1
  25.0%
14.Secondary Outcome
Title Number of Participants With Anti-GSK3196165 Antibody Test Results
Hide Description Serum samples were collected and tested for presence of antibodies that bind to GSK3196165. The presence of treatment emergent anti-drug antibodies (ADA) were determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. These ADA positive samples were further evaluated in a confirmatory assay, and confirmed positive samples were further characterized by assessment of titer. Baseline was considered as the latest pre-dose assessment. Number of participants with post-Baseline negative or positive anti-GSK3196165 antibody test results were presented.
Time Frame Weeks 2, 4, 12 and 22
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity Population. The immunogenicity Population included all participants in the ITT Population, who had at least one immunogenicity assessment.
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Week 2, Positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 2, Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Week 4, Positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4, Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Week 12, Positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 12, Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
Week 22 (Follow up), Positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 22 (Follow up), Negative
4
 100.0%
3
 100.0%
4
 100.0%
4
 100.0%
15.Secondary Outcome
Title Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints
Hide Description DAS28 (CRP) is a measure of disease activity in rheumatoid arthritis obtained by examination of 28 joints for swelling and tenderness using CRP as a blood biomarker for inflammation. Its components include: Tender/Painful Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), CRP and Patient’s Global Assessment of Arthritis. DAS28 (CRP) was calculated by 0.56 (square root of TJC28)+ 0.28 (square root of SJC28)+ 0.36 (natural logarithm [CRP+1])+ (0.014*patients global assessment)+0.96. Scores ranges from 0 to infinity, where higher scores indicates high disease activity. Scores higher than 5.1 indicates high disease activity and scores lower than 2.6 indicates remission. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. Adjusted mean and standard error of adjusted mean are presented using Mixed Model for Repeated Measures.
Time Frame Baseline, up to Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
Overall Number of Participants Analyzed 4 3 4 4
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 -0.2179  (0.44925) -1.3289  (0.51977) -0.7356  (0.42589) -0.7511  (0.42569)
Week 2 0.1643  (0.48797) -0.9744  (0.56457) -0.7262  (0.46260) -0.6404  (0.46238)
Week 4 -0.0887  (0.59912) -1.5462  (0.69316) -0.9781  (0.56796) -1.2502  (0.56769)
Week 6 -0.5455  (0.55367) -0.8664  (0.64058) -0.7330  (0.52487) -1.0048  (0.52463)
Week 8 -0.2710  (0.69364) -0.9231  (0.80253) -0.8209  (0.65757) -1.2375  (0.65726)
Week 12 -0.8234  (0.76338) -1.1810  (0.88321) -0.6383  (0.72368) -0.9415  (0.72335)
Week 22 (Follow-up) -0.3044  (0.62302) -1.7320  (0.72082) 0.2371  (0.59062) -1.0976  (0.59035)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1110
Confidence Interval (2-Sided) 95%
-2.7186 to 0.4965
Estimation Comments Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5177
Confidence Interval (2-Sided) 95%
-1.9040 to 0.8685
Estimation Comments Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5332
Confidence Interval (2-Sided) 95%
-1.9140 to 0.8475
Estimation Comments Week 1. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1387
Confidence Interval (2-Sided) 95%
-2.8848 to 0.6075
Estimation Comments Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8905
Confidence Interval (2-Sided) 95%
-2.3962 to 0.6153
Estimation Comments Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8047
Confidence Interval (2-Sided) 95%
-2.3045 to 0.6951
Estimation Comments Week 2. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4575
Confidence Interval (2-Sided) 95%
-3.6013 to 0.6863
Estimation Comments Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.8894
Confidence Interval (2-Sided) 95%
-2.7381 to 0.9593
Estimation Comments Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.1615
Confidence Interval (2-Sided) 95%
-3.0028 to 0.6799
Estimation Comments Week 4. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3209
Confidence Interval (2-Sided) 95%
-2.3021 to 1.6603
Estimation Comments Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1876
Confidence Interval (2-Sided) 95%
-1.8960 to 1.5209
Estimation Comments Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4593
Confidence Interval (2-Sided) 95%
-2.1610 to 1.2424
Estimation Comments Week 6. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.6521
Confidence Interval (2-Sided) 95%
-3.1342 to 1.8300
Estimation Comments Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.5499
Confidence Interval (2-Sided) 95%
-2.6903 to 1.5904
Estimation Comments Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9665
Confidence Interval (2-Sided) 95%
-3.0984 to 1.1654
Estimation Comments Week 8. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3576
Confidence Interval (2-Sided) 95%
-3.0892 to 2.3740
Estimation Comments Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1851
Confidence Interval (2-Sided) 95%
-2.1704 to 2.5407
Estimation Comments Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1181
Confidence Interval (2-Sided) 95%
-2.4643 to 2.2281
Estimation Comments Week 12. The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4276
Confidence Interval (2-Sided) 95%
-3.6569 to 0.8018
Estimation Comments Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.5415
Confidence Interval (2-Sided) 95%
-1.3810 to 2.4639
Estimation Comments Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.7932
Confidence Interval (2-Sided) 95%
-2.7080 to 1.1217
Estimation Comments Week 22 (Follow up). The analysis method was mixed-model for repeated measures with Visit,Treatment group,Visit by Treatment interaction,Baseline DAS28(CRP),and Visit by Baseline DAS28(CRP) interaction as fixed effects.
Time Frame Serious adverse events (SAEs) and non-serious adverse events (non-serious AEs) were collected from the start of the study treatment up to Week 22.
Adverse Event Reporting Description SAEs and non-serious AEs were reported for the ITT Population.
 
Arm/Group Title Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Hide Arm/Group Description Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
All-Cause Mortality
Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/3 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      0/3 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Respiratory, thoracic and mediastinal disorders         
Pleurisy  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo GSK3196165 45 mg GSK3196165 90 mg GSK3196165 180 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      2/3 (66.67%)      3/4 (75.00%)      2/4 (50.00%)    
Eye disorders         
Cataract  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Conjunctival haemorrhage  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Conjunctivitis allergic  1  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Gastrointestinal disorders         
Dental caries  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%)  0
Large intestine polyp  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Lip oedema  1  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Periodontal disease  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Stomatitis  1  0/4 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
General disorders         
Feeling hot  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Infections and infestations         
Nasopharyngitis  1  0/4 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/4 (25.00%) 
Oral candidiasis  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Upper respiratory tract infection  1  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Rib fracture  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Investigations         
Carbon monoxide diffusing capacity decreased  1  1/4 (25.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Blood creatine phosphokinase increased  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Blood lactate dehydrogenase increased  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Nervous system disorders         
Hypoaesthesia  1  0/4 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Oropharyngeal discomfort  1  1/4 (25.00%)  0/3 (0.00%)  0/4 (0.00%)  0/4 (0.00%) 
Upper respiratory tract inflammation  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Erythema  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
Haemorrhage subcutaneous  1  0/4 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/4 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03028467     History of Changes
Other Study ID Numbers: 201789
First Submitted: January 10, 2017
First Posted: January 23, 2017
Results First Submitted: December 12, 2018
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019