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Trial record 2 of 4 for:    GSK3196165 AND MTX

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02504671
Recruitment Status : Completed
First Posted : July 22, 2015
Results First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: GSK3196165
Drug: MTX
Drug: Folic acid
Drug: Placebo
Enrollment 222
Recruitment Details This study was conducted at a total of 60 sites in 12 countries: Ukraine (11), Poland (10), Russian Federation (10), Mexico (6), Czech Republic (5), Bulgaria (4), South Africa (3), Hungary (3), Estonia (2), Canada (2), United Kingdom (2), and Germany (2) from 23-July-2015 until 29-December-2017.
Pre-assignment Details A total of 526 participants were screened of which 304 were screen failures and 222 participants were enrolled in the study.
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg
Hide Arm/Group Description Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 milliliter (mL) drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with methotrexate (MTX) tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 milligram (mg)/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/ divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Period Title: Overall Study
Started 37 37 37 37 37 37
Completed 25 23 27 27 25 23
Not Completed 12 14 10 10 12 14
Reason Not Completed
Withdrawal by Subject             1             5             4             4             5             3
Lack of Efficacy             1             3             1             0             4             4
Adverse Event             1             1             0             1             0             2
Protocol Violation             2             1             0             0             0             1
Lost to Follow-up             0             0             2             0             0             1
Protocol defined stopping criteria             7             4             3             5             3             3
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg Total
Hide Arm/Group Description Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneous in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter. Total of all reporting groups
Overall Number of Baseline Participants 37 37 37 37 37 37 222
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 37 participants 37 participants 37 participants 37 participants 37 participants 222 participants
50.0  (11.33) 48.4  (11.31) 52.8  (12.22) 52.7  (11.28) 47.1  (10.04) 52.3  (10.76) 50.5  (11.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 37 participants 37 participants 37 participants 37 participants 222 participants
Female
28
  75.7%
30
  81.1%
33
  89.2%
27
  73.0%
33
  89.2%
29
  78.4%
180
  81.1%
Male
9
  24.3%
7
  18.9%
4
  10.8%
10
  27.0%
4
  10.8%
8
  21.6%
42
  18.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 37 participants 37 participants 37 participants 37 participants 37 participants 222 participants
American Indian or Alaskan Native
2
   5.4%
3
   8.1%
1
   2.7%
2
   5.4%
2
   5.4%
1
   2.7%
11
   5.0%
Black or African American
0
   0.0%
3
   8.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   1.4%
White
34
  91.9%
30
  81.1%
35
  94.6%
35
  94.6%
34
  91.9%
35
  94.6%
203
  91.4%
American Indian/ Alaskan Native+White
1
   2.7%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.9%
Black or African American+White
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
1
   2.7%
1
   2.7%
3
   1.4%
1.Primary Outcome
Title Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Week 24
Hide Description DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant’s response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC – Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter [mm] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in [milligrams/liter] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). ITT population comprised of all participants who were randomized to treatment and who received at least one dose of study treatment (GSK3196165 or placebo).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Overall Number of Participants Analyzed 37 37 37 37 37 37
Measure Type: Number
Unit of Measure: Percentage of participants
3 5 16 19 14 14
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.547
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.12
Confidence Interval (2-Sided) 95%
0.18 to 24.52
Estimation Comments 95% Confidence Intervals (CI) were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.11
Confidence Interval (2-Sided) 95%
0.81 to 62.44
Estimation Comments 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 8.39
Confidence Interval (2-Sided) 95%
0.98 to 72.14
Estimation Comments 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.122
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.69
Confidence Interval (2-Sided) 95%
0.63 to 51.40
Estimation Comments 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.40
Confidence Interval (2-Sided) 95%
0.60 to 48.83
Estimation Comments 95% CI were constructed using asymptotic Wald confidence limits without correction.
2.Secondary Outcome
Title Change From Baseline in DAS28(CRP) at Week 12
Hide Description DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant’s response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC – Tender joint Count, SJC= Swollen Joint Count, (GH=participant global assessment of disease activity (PtGA) using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post dose visit value from the Baseline value.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the indicated time point were analyzed.
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Overall Number of Participants Analyzed 34 35 33 37 34 36
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
CRP -5.21  (2.730) -4.75  (2.701) -8.57  (2.749) -7.79  (2.624) -7.71  (2.722) -7.21  (2.659)
PtGA -6.72  (3.660) -14.40  (3.653) -20.40  (3.611) -24.11  (3.544) -19.35  (3.614) -23.90  (3.606)
SJC28 -2.35  (1.093) -4.77  (1.085) -5.52  (1.080) -6.91  (1.056) -5.33  (1.080) -8.39  (1.070)
TJC28 -2.81  (1.191) -5.11  (1.181) -6.73  (1.173) -8.53  (1.151) -6.43  (1.175) -9.13  (1.167)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-7.13 to 8.05
Estimation Comments CRP, Week 12
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.387
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.36
Confidence Interval (2-Sided) 95%
-11.00 to 4.28
Estimation Comments CRP, Week 12
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.58
Confidence Interval (2-Sided) 95%
-10.04 to 4.87
Estimation Comments CRP, Week 12
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.68
Confidence Interval (2-Sided) 95%
-17.92 to 2.55
Estimation Comments PtGA, Week 12
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -13.68
Confidence Interval (2-Sided) 95%
-23.85 to -3.52
Estimation Comments PtGA, Week 12
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.40
Confidence Interval (2-Sided) 95%
-27.44 to -7.35
Estimation Comments PtGA, Week 12
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.42
Confidence Interval (2-Sided) 95%
-5.45 to 0.62
Estimation Comments SJC28, Week 12
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.17
Confidence Interval (2-Sided) 95%
-6.20 to -0.14
Estimation Comments SJC28, Week 12
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.56
Confidence Interval (2-Sided) 95%
-6.00 to 0.05
Estimation Comments SJC28, Week 12
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.30
Confidence Interval (2-Sided) 95%
-5.61 to 1.01
Estimation Comments TC28, Week 12
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.92
Confidence Interval (2-Sided) 95%
-7.22 to -0.62
Estimation Comments TJC28, Week 12
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -5.72
Confidence Interval (2-Sided) 95%
-8.98 to -2.45
Estimation Comments TJC28, Week 12
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.518
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.51
Confidence Interval (2-Sided) 95%
-10.13 to 5.12
Estimation Comments CRP, Week 12
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.00
Confidence Interval (2-Sided) 95%
-9.50 to 5.49
Estimation Comments CRP, Week 12
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -12.63
Confidence Interval (2-Sided) 95%
-22.78 to -2.48
Estimation Comments PtGA, Week 12
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -17.18
Confidence Interval (2-Sided) 95%
-27.27 to -7.10
Estimation Comments PtGA, Week 12
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.98
Confidence Interval (2-Sided) 95%
-6.00 to 0.05
Estimation Comments SJC28, Week 12
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]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.04
Confidence Interval (2-Sided) 95%
-9.05 to -3.02
Estimation Comments SJC28, Week 12
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.63
Confidence Interval (2-Sided) 95%
-6.92 to -0.33
Estimation Comments TJC28, Week 12
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -6.32
Confidence Interval (2-Sided) 95%
-9.61 to -3.02
Estimation Comments TJC28, Week 12
3.Secondary Outcome
Title Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points
Hide Description DAS28(CRP) remission is defined as a DAS28 score of <2.6 points. The DAS index combines information relating to the number of swollen and tender joints. The DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant’s response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC – Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome).
Time Frame Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Overall Number of Participants Analyzed 37 37 37 37 37 37
Measure Type: Number
Unit of Measure: Percentage of participants
Week 1 0 0 0 0 0 0
Week 2 0 0 0 0 0 1
Week 4 0 0 0 5 3 4
Week 6 5 5 0 5 3 8
Week 8 3 0 5 14 5 8
Week 12 3 8 5 24 3 16
Week 16 0 3 14 27 5 19
Week 20 3 0 16 19 14 16
Week 24 3 5 16 19 14 14
Week 28 3 3 16 16 14 22
Week 32 3 5 22 14 11 19
Week 36 3 5 19 8 16 19
Week 40 0 5 14 14 11 24
Week 44 3 5 14 16 14 16
Week 48 0 5 14 14 14 19
Week 52 3 5 14 11 14 14
Week 62 (follow-up) 3 0 8 3 11 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
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 Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-1.9 to 12.7
Estimation Comments Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-10.3 to 10.3
Estimation Comments Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 3 Hide Statistical Analysis 3
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 Difference
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-12.7 to 1.9
Estimation Comments Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 4 Hide Statistical Analysis 4
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 Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-10.3 to 10.3
Estimation Comments Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-7.9 to 2.5
Estimation Comments Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 6 Hide Statistical Analysis 6
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 Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 7 Hide Statistical Analysis 7
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-4.8 to 15.6
Estimation Comments Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 9 Hide Statistical Analysis 9
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 Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 10 Hide Statistical Analysis 10
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 Difference
Estimated Value 21.6
Confidence Interval (2-Sided) 95%
6.8 to 36.4
Estimation Comments Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-2.5 to 7.9
Estimation Comments Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 12 Hide Statistical Analysis 12
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 13 Hide Statistical Analysis 13
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 Difference
Estimated Value 27.0
Confidence Interval (2-Sided) 95%
12.7 to 41.3
Estimation Comments Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-7.9 to 2.5
Estimation Comments Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 15 Hide Statistical Analysis 15
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 16 Hide Statistical Analysis 16
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 18 Hide Statistical Analysis 18
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 19 Hide Statistical Analysis 19
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-7.4 to 7.4
Estimation Comments Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 21 Hide Statistical Analysis 21
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 22 Hide Statistical Analysis 22
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 24 Hide Statistical Analysis 24
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 Difference
Estimated Value 18.9
Confidence Interval (2-Sided) 95%
4.7 to 33.2
Estimation Comments Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 25 Hide Statistical Analysis 25
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 27 Hide Statistical Analysis 27
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 28 Hide Statistical Analysis 28
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 Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-4.8 to 15.6
Estimation Comments Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-1.9 to 12.7
Estimation Comments Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 30 Hide Statistical Analysis 30
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 31 Hide Statistical Analysis 31
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 33 Hide Statistical Analysis 33
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 34 Hide Statistical Analysis 34
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-1.9 to 12.7
Estimation Comments Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 36 Hide Statistical Analysis 36
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 37 Hide Statistical Analysis 37
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 39 Hide Statistical Analysis 39
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 40 Hide Statistical Analysis 40
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 Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-3.2 to 19.4
Estimation Comments Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-7.9 to 2.5
Estimation Comments Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 42 Hide Statistical Analysis 42
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 Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-4.8 to 15.6
Estimation Comments Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 43 Hide Statistical Analysis 43
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 Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-7.4 to 7.4
Estimation Comments Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-2.5 to 7.9
Estimation Comments Week 2. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-2.5 to 7.9
Estimation Comments Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 46 Hide Statistical Analysis 46
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
0.8 to 20.8
Estimation Comments Week 4. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-11.7 to 6.3
Estimation Comments 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 48 Hide Statistical Analysis 48
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 Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-8.7 to 14.1
Estimation Comments Week 6. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.7
Confidence Interval (2-Sided) 95%
-6.3 to 11.7
Estimation Comments Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 50 Hide Statistical Analysis 50
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 Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-4.8 to 15.6
Estimation Comments Week 8. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-7.4 to 7.4
Estimation Comments Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 52 Hide Statistical Analysis 52
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 12. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
-1.9 to 12.7
Estimation Comments Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 54 Hide Statistical Analysis 54
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 Difference
Estimated Value 18.9
Confidence Interval (2-Sided) 95%
6.3 to 31.5
Estimation Comments Week 16. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 56 Hide Statistical Analysis 56
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 20. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 58 Hide Statistical Analysis 58
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 24. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 60 Hide Statistical Analysis 60
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 Difference
Estimated Value 18.9
Confidence Interval (2-Sided) 95%
4.7 to 33.2
Estimation Comments Week 28. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 61 Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-3.2 to 19.4
Estimation Comments Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 62 Hide Statistical Analysis 62
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 32. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 63 Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 36. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 64 Hide Statistical Analysis 64
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 36, 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 65 Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
0.8 to 20.8
Estimation Comments Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 66 Hide Statistical Analysis 66
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 Difference
Estimated Value 24.3
Confidence Interval (2-Sided) 95%
10.5 to 38.1
Estimation Comments Week 40. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 67 Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 68 Hide Statistical Analysis 68
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 Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
0.5 to 26.5
Estimation Comments Week 44. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 69 Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
2.5 to 24.5
Estimation Comments Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 70 Hide Statistical Analysis 70
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 Difference
Estimated Value 18.9
Confidence Interval (2-Sided) 95%
6.3 to 31.5
Estimation Comments Week 48. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 71 Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 72 Hide Statistical Analysis 72
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 Difference
Estimated Value 10.8
Confidence Interval (2-Sided) 95%
-1.4 to 23.0
Estimation Comments Week 52. 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 73 Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 8.1
Confidence Interval (2-Sided) 95%
-3.2 to 19.4
Estimation Comments Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.
Show Statistical Analysis 74 Hide Statistical Analysis 74
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 Difference
Estimated Value 16.2
Confidence Interval (2-Sided) 95%
2.6 to 29.9
Estimation Comments Week 62 (follow-up). 95% CI were constructed using asymptotic Wald confidence limits without correction.
4.Secondary Outcome
Title Change From Baseline in DAS28(CRP) at All Assessment Time Points
Hide Description DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant’s response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96. Where TJC – Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 mm visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). Baseline was defined as the last available assessment prior to the start of study treatment. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline.
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
Arm/Group Title Placebo GSK3196165 22.5 mg GSK3196165 45 mg GSK3196165 90 mg GSK3196165 135 mg GSK3196165 180 mg
Hide Arm/Group Description:
Participants received placebo liquid (sterile 0.9% weight/volume) sodium chloride solution) 0.6 mL drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 22.5 mg (0.15 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 45 mg (0.3 mL) liquid drawn into a small (03 mL/0.5 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 90 mg (0.6 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 135 mg (0.9 mL) liquid drawn into a small (1 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Participants received GSK3196165 180 mg (1.2 mL) liquid drawn into a small (2 mL/3 mL syringe) administered subcutaneously in the thigh/abdomen up to 52 weeks in combination with MTX tablets (orally)/liquid (subcutaneous injection) at a dose of 7.5 to 25 mg/week and folic acid tablet/capsule (orally) at a dose of >=5 mg/week. MTX was taken as a single weekly dose/divided weekly dose, folic acid was taken the day after and at least 12 hours following MTX administration. Safety was monitored for 1 hour after the injection, for the first 3 injections, then for 30 minutes thereafter.
Overall Number of Participants Analyzed 37 37 37 37 37 37
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1; n=35, 36, 33, 35, 34, 37 Number Analyzed 35 participants 36 participants 33 participants 35 participants 34 participants 37 participants
-0.14  (0.114) -0.47  (0.114) -0.44  (0.117) -0.52  (0.114) -0.55  (0.116) -0.63  (0.112)
Week 2; n=36, 35, 34, 36, 36, 36 Number Analyzed 36 participants 35 participants 34 participants 36 participants 36 participants 36 participants
-0.37  (0.138) -0.64  (0.141) -0.69  (0.142) -0.78  (0.138) -0.84  (0.139) -0.88  (0.139)
Week 4; n=32, 33, 34, 36, 36, 36 Number Analyzed 32 participants 33 participants 34 participants 36 participants 36 participants 36 participants
-0.45  (0.169) -0.85  (0.169) -1.01  (0.167) -1.21  (0.163) -1.12  (0.164) -1.46  (0.164)
Week 6; n=35, 34, 34, 36, 33, 36 Number Analyzed 35 participants 34 participants 34 participants 36 participants 33 participants 36 participants
-0.65  (0.184) -1.07  (0.186) -1.12  (0.185) -1.26  (0.181) -1.12  (0.185) -1.51  (0.182)
Week 8; n=34, 33, 34, 37, 35, 32 Number Analyzed 34 participants 33 participants 34 participants 37 participants 35 participants 32 participants
-0.61  (0.195) -1.04  (0.197) -1.40  (0.196) -1.44  (0.190) -1.51  (0.194) -1.72  (0.196)
Week 12; n=34, 35, 33, 37, 34, 36 Number Analyzed 34 participants 35 participants 33 participants 37 participants 34 participants 36 participants
-0.60  (0.232) -1.13  (0.231) -1.48  (0.233) -1.84  (0.225) -1.28  (0.230) -1.87  (0.228)
Week 16; n=8, 16, 20, 24, 18, 36 Number Analyzed 8 participants 16 participants 20 participants 24 participants 18 participants 36 participants
-0.87  (0.335) -1.16  (0.274) -1.86  (0.261) -1.88  (0.247) -1.64  (0.265) -1.98  (0.232)
Week 20; n=8, 15, 20, 25, 19, 36 Number Analyzed 8 participants 15 participants 20 participants 25 participants 19 participants 36 participants
-1.23  (0.359) -1.30  (0.284) -1.81  (0.260) -1.89  (0.241) -2.00  (0.263) -2.03  (0.221)
Week 24; n=8, 14, 20, 24, 19, 33 Number Analyzed 8 participants 14 participants 20 participants 24 participants 19 participants 33 participants
-0.23  (0.402) -1.45  (0.322) -1.76  (0.288) -1.62  (0.269) -1.71  (0.291) -2.05  (0.246)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.64 to -0.01
Estimation Comments Week 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.30
Confidence Interval (2-Sided) 95%
-0.62 to 0.03
Estimation Comments Week 1
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.37
Confidence Interval (2-Sided) 95%
-0.69 to -0.05
Estimation Comments Week 1
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.160
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.67 to 0.11
Estimation Comments Week 2
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.71 to 0.07
Estimation Comments Week 2
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.80 to -0.03
Estimation Comments Week 2
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.096
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.87 to 0.07
Estimation Comments Week 4
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.56
Confidence Interval (2-Sided) 95%
-1.02 to -0.09
Estimation Comments Week 4
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.76
Confidence Interval (2-Sided) 95%
-1.22 to -0.29
Estimation Comments Week 4
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.93 to 0.10
Estimation Comments Week 6
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.98 to 0.05
Estimation Comments Week 6
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-1.11 to -0.10
Estimation Comments Week 6
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.97 to 0.12
Estimation Comments Week 8
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.33 to -0.24
Estimation Comments Week 8
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.82
Confidence Interval (2-Sided) 95%
-1.36 to -0.29
Estimation Comments Week 8
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.110
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.53
Confidence Interval (2-Sided) 95%
-1.17 to 0.12
Estimation Comments Week 12
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.53 to -0.23
Estimation Comments Week 12
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.24
Confidence Interval (2-Sided) 95%
-1.88 to -0.60
Estimation Comments Week 12
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.500
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-1.15 to 0.56
Estimation Comments Week 16
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.99
Confidence Interval (2-Sided) 95%
-1.83 to -0.15
Estimation Comments Week 16
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.00
Confidence Interval (2-Sided) 95%
-1.83 to -0.18
Estimation Comments Week 16
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-0.98 to 0.83
Estimation Comments Week 20
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.190
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-1.46 to 0.29
Estimation Comments Week 20
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.66
Confidence Interval (2-Sided) 95%
-1.51 to 0.20
Estimation Comments Week 20
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 22.5 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-2.24 to -0.20
Estimation Comments Week 24
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 45 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.53
Confidence Interval (2-Sided) 95%
-2.51 to -0.55
Estimation Comments Week 24
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 90 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.39
Confidence Interval (2-Sided) 95%
-2.34 to -0.43
Estimation Comments Week 24
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.41
Confidence Interval (2-Sided) 95%
-0.73 to -0.09
Estimation Comments Week 1
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.80 to -0.17
Estimation Comments Week 1
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.86 to -0.09
Estimation Comments Week 2
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.52
Confidence Interval (2-Sided) 95%
-0.90 to -0.13
Estimation Comments Week 2
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.13 to -0.20
Estimation Comments Week 4
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.01
Confidence Interval (2-Sided) 95%
-1.48 to -0.55
Estimation Comments Week 4
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.99 to 0.04
Estimation Comments Week 6
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.85
Confidence Interval (2-Sided) 95%
-1.36 to -0.34
Estimation Comments Week 6
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.89
Confidence Interval (2-Sided) 95%
-1.43 to -0.35
Estimation Comments Week 8
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-1.65 to -0.56
Estimation Comments Week 8
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 135 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments MMRM analysis adjusted for DAS28(CRP) Baseline score, treatment group, visit and treatment group by visit and Baseline by visit interactions.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-1.32 to -0.03
Estimation Comments Week 12
Show Statistical Analysis 39 Hide Statistical Analysis 39
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Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]