Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    GSK3196165 AND MTX
Previous Study | Return to List | Next Study

Mechanistic Study of GSK3196165 Plus Methotrexate (MTX) in Subjects With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02799472
Recruitment Status : Completed
First Posted : June 14, 2016
Results First Posted : November 16, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: GSK3196165
Drug: Placebo
Drug: MTX
Drug: Folic (or folinic) acid
Enrollment 39
Recruitment Details A total of 39 participants with active early/established Rheumatoid arthritis were randomized across 9 centers in 3 countries from 15 June 2016 to 30 October 2017.
Pre-assignment Details Out of the 88 participants screened for this study, 49 participants were screen failures and 39 participants were randomized and received treatment in the study.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description Eligible participants received matching placebo subcutaneously (SC) into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received methotrexate (MTX) 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. Eligible participants received GSK3196165 180 milligrams (mg) SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Period Title: Overall Study
Started 11 28
Completed 7 23
Not Completed 4 5
Reason Not Completed
Withdrawal by Subject             2             4
Lack of Efficacy             2             0
Lost to Follow-up             0             1
Arm/Group Title Placebo GSK3196165 180 mg Total
Hide Arm/Group Description Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period. Total of all reporting groups
Overall Number of Baseline Participants 11 28 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 28 participants 39 participants
50.3  (11.57) 59.1  (9.47) 56.6  (10.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 28 participants 39 participants
Female
10
  90.9%
24
  85.7%
34
  87.2%
Male
1
   9.1%
4
  14.3%
5
  12.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 11 participants 28 participants 39 participants
Black or African American
2
  18.2%
4
  14.3%
6
  15.4%
White
9
  81.8%
24
  85.7%
33
  84.6%
1.Primary Outcome
Title Change From Baseline in Target Engagement Biomarkers- Soluble Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Complexed to GSK3196165
Hide Description Blood samples were collected for markers which may influence rheumatoid arthritis. Target engagement biomarkers included soluble GM-CSF complexed to GSK3196165. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for GM-CSF - Complex log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Analysis was performed on Intent-to-Treat (ITT) Population which consisted of all participants who were randomized to treatment and who received at least one dose of study treatment. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week follow-up (FU) (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of GM-CSF complex
GM-CSF - Complex, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.972
(35.98%)
13.799
(20.65%)
GM-CSF - Complex, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.960
(31.23%)
31.056
(17.58%)
GM-CSF - Complex, Week 4, n=8, 27 Number Analyzed 8 participants 27 participants
0.959
(34.51%)
53.496
(18.55%)
GM-CSF - Complex, Week 6, n=7, 26 Number Analyzed 7 participants 26 participants
0.964
(40.96%)
46.620
(22.37%)
GM-CSF - Complex, Week 8, n=7, 24 Number Analyzed 7 participants 24 participants
0.964
(41.80%)
33.404
(22.47%)
GM-CSF - Complex, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.970
(44.95%)
22.556
(24.38%)
GM-CSF - Complex, 12-Week FU, n=8, 21 Number Analyzed 8 participants 21 participants
0.954
(20.80%)
1.176
(12.88%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 14.201
Confidence Interval (2-Sided) 95%
6.251 to 32.262
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 32.360
Confidence Interval (2-Sided) 95%
15.828 to 66.156
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 55.772
Confidence Interval (2-Sided) 95%
25.646 to 121.287
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 48.336
Confidence Interval (2-Sided) 95%
19.341 to 120.798
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 34.635
Confidence Interval (2-Sided) 95%
13.690 to 87.629
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 23.249
Confidence Interval (2-Sided) 95%
8.579 to 63.005
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments GM-CSF - Complex, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.233
Confidence Interval (2-Sided) 95%
0.742 to 2.048
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Predictive Biomarkers: 14-3-3 ETA Protein, S100 Calcium Binding Protein (CBP) A8 and A9
Hide Description Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of 14-3-3 ETA Protein, S100 CBP A8 and A9. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for 14-3-3 ETA Protein (mg/L) and S100 CBP A8 and A9 log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of predictive biomarker
14-3-3 ETA Protein, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.046
(3.88%)
0.986
(2.16%)
14-3-3 ETA Protein, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.959
(12.14%)
0.986
(6.70%)
14-3-3 ETA Protein, Week 4, n=9, 26 Number Analyzed 9 participants 26 participants
1.128
(16.59%)
0.838
(9.55%)
14-3-3 ETA Protein, Week 6, n=7, 26 Number Analyzed 7 participants 26 participants
1.093
(15.55%)
0.833
(8.88%)
14-3-3 ETA Protein, Week 8, n=7, 23 Number Analyzed 7 participants 23 participants
0.950
(15.19%)
0.842
(8.48%)
14-3-3 ETA Protein, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.131
(20.90%)
0.897
(11.89%)
14-3-3 ETA Protein, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
1.040
(24.06%)
0.893
(13.45%)
S100 CBP A8 and A9, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.940
(15.20%)
0.939
(8.92%)
S100 CBP A8 and A9, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.871
(15.28%)
0.823
(8.65%)
S100 CBP A8 and A9, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.874
(19.20%)
0.889
(11.26%)
S100 CBP A8 and A9, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
0.828
(21.92%)
0.812
(11.81%)
S100 CBP A8 and A9, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.804
(21.04%)
0.857
(11.46%)
S100 CBP A8 and A9, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.694
(21.61%)
0.879
(12.05%)
S100 CBP A8 and A9, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.582
(20.60%)
1.018
(11.83%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.193
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.943
Confidence Interval (2-Sided) 95%
0.861 to 1.032
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.842
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.028
Confidence Interval (2-Sided) 95%
0.776 to 1.362
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.743
Confidence Interval (2-Sided) 95%
0.505 to 1.093
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.137
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.762
Confidence Interval (2-Sided) 95%
0.531 to 1.095
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.488
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.886
Confidence Interval (2-Sided) 95%
0.623 to 1.259
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.793
Confidence Interval (2-Sided) 95%
0.488 to 1.290
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments 14-3-3 ETA Protein, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.582
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.859
Confidence Interval (2-Sided) 95%
0.491 to 1.502
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.996
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.999
Confidence Interval (2-Sided) 95%
0.699 to 1.427
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.944
Confidence Interval (2-Sided) 95%
0.662 to 1.346
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.939
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.017
Confidence Interval (2-Sided) 95%
0.649 to 1.593
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.937
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.981
Confidence Interval (2-Sided) 95%
0.595 to 1.617
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.787
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.067
Confidence Interval (2-Sided) 95%
0.659 to 1.727
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.267
Confidence Interval (2-Sided) 95%
0.769 to 2.086
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments S100 CBP A8 and A9, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.748
Confidence Interval (2-Sided) 95%
1.076 to 2.838
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in Predictive Biomarkers: Amyloid A
Hide Description Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Amyloid A. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Amyloid A log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data has been presented for only those time points at which the samples were collected.
Time Frame Baseline and Week 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of predictive biomarker
Amyloid A, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.845
(49.31%)
0.653
(25.45%)
Amyloid A, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.529
(35.12%)
0.623
(19.68%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Amyloid A, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.632
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.774
Confidence Interval (2-Sided) 95%
0.261 to 2.290
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Amyloid A, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.176
Confidence Interval (2-Sided) 95%
0.519 to 2.663
Estimation Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in Predictive Biomarkers: Amyloid A, Chemokine (C-C Motif) Ligand 17, Chemokine (C-X-C Motif) Ligand 13, Interleukin 6, Macrophage-Derived Chemokine
Hide Description Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chemokine (C-C Motif) Ligand 17 (CL17), Chemokine (C-X-C Motif) Ligand 13 (CL13), Interleukin 6, Macrophage-Derived Chemokine (MDC). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for CL17, CL13, Interleukin 6, MDC log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data has been presented for only those time points at which the samples were collected.
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of predictive biomarker
CL17, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.117
(18.81%)
0.773
(10.94%)
CL17, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.912
(24.37%)
0.651
(13.60%)
CL17, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
1.117
(21.91%)
0.679
(12.51%)
CL17, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.032
(24.38%)
0.779
(12.48%)
CL17, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
1.211
(20.63%)
0.675
(11.21%)
CL17, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.711
(24.96%)
0.890
(13.90%)
CL17, 12-Week FU, n=7, 20 Number Analyzed 7 participants 20 participants
1.434
(23.26%)
1.357
(13.59%)
CL13, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.198
(15.63%)
0.915
(8.87%)
CL13, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.090
(13.98%)
1.095
(7.78%)
CL13, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.947
(15.58%)
1.170
(8.90%)
CL13, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
0.839
(17.20%)
1.038
(8.91%)
CL13, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.913
(23.70%)
1.021
(12.38%)
CL13, Week 12, n=7,24 Number Analyzed 7 participants 24 participants
0.924
(31.17%)
1.077
(16.31%)
CL13, 12-Week FU, n=7,21 Number Analyzed 7 participants 21 participants
0.774
(27.82%)
1.224
(15.04%)
Interleukin 6, Week 1, n=9, 26 Number Analyzed 9 participants 26 participants
1.179
(27.92%)
1.064
(16.38%)
Interleukin 6, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.153
(29.33%)
0.830
(16.63%)
Interleukin 6, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.986
(26.22%)
0.811
(15.10%)
Interleukin 6, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.136
(24.95%)
0.748
(13.51%)
Interleukin 6, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
1.275
(23.65%)
0.872
(13.35%)
Interleukin 6, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.770
(21.89%)
0.939
(12.35%)
Interleukin 6, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.817
(33.13%)
1.308
(18.63%)
MDC, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.987
(5.02%)
0.914
(2.89%)
MDC, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.925
(7.33%)
0.911
(4.15%)
MDC, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.936
(8.13%)
0.895
(4.67%)
MDC, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
0.984
(8.38%)
0.994
(4.48%)
MDC, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
1.049
(9.36%)
0.899
(5.09%)
MDC, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.245
(9.51%)
1.058
(5.23%)
MDC, 12-Week FU, n=7, 20 Number Analyzed 7 participants 20 participants
1.303
(12.66%)
1.321
(7.53%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.692
Confidence Interval (2-Sided) 95%
0.445 to 1.074
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.713
Confidence Interval (2-Sided) 95%
0.407 to 1.249
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.608
Confidence Interval (2-Sided) 95%
0.365 to 1.012
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.307
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.755
Confidence Interval (2-Sided) 95%
0.435 to 1.309
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.557
Confidence Interval (2-Sided) 95%
0.348 to 0.894
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.520
Confidence Interval (2-Sided) 95%
0.294 to 0.922
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL17, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.839
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.947
Confidence Interval (2-Sided) 95%
0.548 to 1.636
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.764
Confidence Interval (2-Sided) 95%
0.530 to 1.100
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.976
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.005
Confidence Interval (2-Sided) 95%
0.726 to 1.390
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.236
Confidence Interval (2-Sided) 95%
0.859 to 1.778
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.278
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.237
Confidence Interval (2-Sided) 95%
0.836 to 1.830
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.677
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.118
Confidence Interval (2-Sided) 95%
0.651 to 1.920
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.165
Confidence Interval (2-Sided) 95%
0.573 to 2.369
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CL13, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.581
Confidence Interval (2-Sided) 95%
0.832 to 3.007
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.751
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.903
Confidence Interval (2-Sided) 95%
0.471 to 1.729
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.330
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.720
Confidence Interval (2-Sided) 95%
0.367 to 1.413
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.519
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.822
Confidence Interval (2-Sided) 95%
0.447 to 1.512
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.659
Confidence Interval (2-Sided) 95%
0.372 to 1.167
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.166
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.684
Confidence Interval (2-Sided) 95%
0.396 to 1.180
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.432
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.221
Confidence Interval (2-Sided) 95%
0.734 to 2.031
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Interleukin 6, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.602
Confidence Interval (2-Sided) 95%
0.750 to 3.423
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.195
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.926
Confidence Interval (2-Sided) 95%
0.823 to 1.042
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.851
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.984
Confidence Interval (2-Sided) 95%
0.829 to 1.168
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.637
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.956
Confidence Interval (2-Sided) 95%
0.790 to 1.158
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.915
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.010
Confidence Interval (2-Sided) 95%
0.833 to 1.225
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.857
Confidence Interval (2-Sided) 95%
0.690 to 1.064
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.849
Confidence Interval (2-Sided) 95%
0.681 to 1.059
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MDC, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.929
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.013
Confidence Interval (2-Sided) 95%
0.745 to 1.378
Estimation Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in Predictive Biomarkers: Chitinase 3 Like 1, Matrix Metalloproteinase 3 (MMP-3)
Hide Description Blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Predictive biomarkers included analysis of Chitinase 3 Like 1 and MMP-3. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Chitinase 3 Like 1 and MMP-3 log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of predictive biomarker
Chitinase 3 Like 1, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.033
(13.97%)
0.917
(8.13%)
Chitinase 3 Like 1, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.013
(15.05%)
0.966
(8.55%)
Chitinase 3 Like 1, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.961
(17.14%)
1.088
(9.96%)
Chitinase 3 Like 1, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
0.897
(17.08%)
1.031
(8.80%)
Chitinase 3 Like 1, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.851
(18.24%)
0.947
(9.70%)
Chitinase 3 Like 1, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.066
(21.53%)
1.071
(11.64%)
Chitinase 3 Like 1, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.735
(16.87%)
1.019
(9.75%)
MMP 3, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.076
(6.72%)
0.984
(3.88%)
MMP-3, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.067
(7.26%)
1.024
(4.09%)
MMP-3, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
1.112
(8.30%)
1.016
(4.73%)
MMP-3, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.005
(26.26%)
0.804
(13.44%)
MMP-3, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.939
(15.43%)
1.088
(8.21%)
MMP-3, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.000
(13.57%)
0.951
(7.35%)
MMP-3, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.803
(16.05%)
0.984
(9.00%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.463
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.887
Confidence Interval (2-Sided) 95%
0.640 to 1.231
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.782
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.953
Confidence Interval (2-Sided) 95%
0.672 to 1.352
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.533
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.132
Confidence Interval (2-Sided) 95%
0.759 to 1.690
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.149
Confidence Interval (2-Sided) 95%
0.779 to 1.694
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.608
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.112
Confidence Interval (2-Sided) 95%
0.733 to 1.687
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.005
Confidence Interval (2-Sided) 95%
0.613 to 1.645
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Chitinase 3 Like 1, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.386
Confidence Interval (2-Sided) 95%
0.934 to 2.057
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.259
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.915
Confidence Interval (2-Sided) 95%
0.781 to 1.071
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.959
Confidence Interval (2-Sided) 95%
0.809 to 1.137
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.354
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.914
Confidence Interval (2-Sided) 95%
0.752 to 1.110
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.800
Confidence Interval (2-Sided) 95%
0.443 to 1.444
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.160
Confidence Interval (2-Sided) 95%
0.813 to 1.653
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.951
Confidence Interval (2-Sided) 95%
0.695 to 1.301
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-3, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.279
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.226
Confidence Interval (2-Sided) 95%
0.837 to 1.796
Estimation Comments [Not Specified]
6.Primary Outcome
Title Change From Baseline in Cartilage Biomarkers
Hide Description Blood samples were collected and analyzed for markers that may be predictive of rheumatoid arthritis disease activity. Cartilage biomarkers included analysis of ARGS Neo-Epitope, Citrullinated MMP-Degraded Vimentin (CMDV), MMP-Degraded C Reactive Protein (CRP), MMP-Degraded Type I Collagen (MD1C), MMP-Degraded Type II Collagen (MD2C), MMP-Degraded Type III Collagen (MD3C). Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for ARGS Neo-Epitope, Citrullinated MMP-Degraded Vimentin, MMP-Degraded CRP, MMP-Degraded Type I Collagen, MMP-Degraded Type II Collagen and MMP-Degraded Type III Collagen log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 2, 4, 6, 8, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of cartilage biomarker
ARGS Neo-Epitope, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.979
(16.10%)
1.075
(9.67%)
ARGS Neo-Epitope, Week 2, n=8, 25 Number Analyzed 8 participants 25 participants
0.790
(17.38%)
1.249
(9.87%)
ARGS Neo-Epitope, Week 4, n=8, 26 Number Analyzed 8 participants 26 participants
0.904
(17.02%)
1.104
(10.05%)
ARGS Neo-Epitope, Week 6, n=6, 26 Number Analyzed 6 participants 26 participants
0.894
(14.28%)
1.164
(7.82%)
ARGS Neo-Epitope, Week 8, n=7, 24 Number Analyzed 7 participants 24 participants
0.854
(26.42%)
1.238
(14.20%)
ARGS Neo-Epitope, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.913
(13.97%)
1.156
(7.78%)
ARGS Neo-Epitope, 12-Week FU, n=8, 21 Number Analyzed 8 participants 21 participants
1.129
(17.44%)
1.124
(9.86%)
CMDV, Week 1,n=9,27 Number Analyzed 9 participants 27 participants
0.981
(24.12%)
0.876
(13.80%)
CMDV,Week 2,n=8,26 Number Analyzed 8 participants 26 participants
0.820
(28.46%)
0.714
(15.89%)
CMDV, Week 4,n=9,27 Number Analyzed 9 participants 27 participants
0.715
(27.30%)
0.801
(15.52%)
CMDV, Week 6,n=7,27 Number Analyzed 7 participants 27 participants
1.099
(30.47%)
0.726
(15.94%)
CMDV, Week 8,n=7,25 Number Analyzed 7 participants 25 participants
0.929
(24.72%)
0.759
(13.39%)
CMDV, Week12,n=7,24 Number Analyzed 7 participants 24 participants
1.123
(29.34%)
0.917
(16.00%)
CMDV, 12-Week FU,n=7,21 Number Analyzed 7 participants 21 participants
0.936
(28.05%)
0.769
(15.81%)
MMP-Degraded CRP, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.971
(6.83%)
1.021
(3.99%)
MMP-Degraded CRP, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.970
(5.55%)
1.000
(3.07%)
MMP-Degraded CRP, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.992
(6.01%)
1.004
(3.49%)
MMP-Degraded CRP, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.122
(6.55%)
1.099
(3.50%)
MMP-Degraded CRP, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.977
(7.37%)
1.087
(4.05%)
MMP-Degraded CRP, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.006
(7.13%)
1.108
(3.95%)
MMP-Degraded CRP, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
1.075
(8.01%)
1.129
(4.48%)
MD1C, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.079
(9.60%)
0.858
(5.63%)
MD1C, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.028
(11.98%)
0.907
(6.63%)
MD1C, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
1.142
(14.57%)
0.896
(8.35%)
MD1C, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.392
(12.64%)
0.889
(6.98%)
MD1C, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
1.131
(13.05%)
0.904
(7.23%)
MD1C, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.148
(13.74%)
1.023
(7.81%)
MD1C, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
1.095
(14.21%)
0.952
(8.31%)
MD2C, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
1.059
(11.83%)
1.038
(6.88%)
MD2C, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
1.046
(11.27%)
1.015
(6.28%)
MD2C, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
1.035
(10.18%)
1.003
(5.86%)
MD2C, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.158
(12.07%)
1.064
(6.30%)
MD2C, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
1.091
(11.42%)
1.023
(6.12%)
MD2C, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
1.174
(10.73%)
1.072
(5.87%)
MD2C, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
1.338
(13.10%)
1.041
(7.50%)
MD3C, Week 1, n=9, 27 Number Analyzed 9 participants 27 participants
0.950
(6.44%)
0.959
(3.74%)
MD3C, Week 2, n=8, 26 Number Analyzed 8 participants 26 participants
0.920
(6.82%)
0.954
(3.91%)
MD3C, Week 4, n=9, 27 Number Analyzed 9 participants 27 participants
0.940
(8.06%)
0.886
(4.68%)
MD3C, Week 6, n=7, 27 Number Analyzed 7 participants 27 participants
1.013
(8.09%)
0.894
(4.34%)
MD3C, Week 8, n=7, 25 Number Analyzed 7 participants 25 participants
0.918
(9.04%)
0.881
(4.84%)
MD3C, Week 12, n=7, 24 Number Analyzed 7 participants 24 participants
0.929
(9.28%)
0.910
(5.08%)
MD3C, 12-Week FU, n=7, 21 Number Analyzed 7 participants 21 participants
0.847
(9.75%)
0.910
(5.46%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.098
Confidence Interval (2-Sided) 95%
0.750 to 1.606
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.581
Confidence Interval (2-Sided) 95%
1.046 to 2.388
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.317
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.222
Confidence Interval (2-Sided) 95%
0.817 to 1.827
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.302
Confidence Interval (2-Sided) 95%
0.936 to 1.810
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.217
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.450
Confidence Interval (2-Sided) 95%
0.795 to 2.645
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.266
Confidence Interval (2-Sided) 95%
0.916 to 1.750
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments ARGS Neo-Epitope, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.985
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.996
Confidence Interval (2-Sided) 95%
0.662 to 1.499
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.892
Confidence Interval (2-Sided) 95%
0.511 to 1.560
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.870
Confidence Interval (2-Sided) 95%
0.454 to 1.669
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.120
Confidence Interval (2-Sided) 95%
0.597 to 2.101
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.661
Confidence Interval (2-Sided) 95%
0.333 to 1.310
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.817
Confidence Interval (2-Sided) 95%
0.464 to 1.437
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.541
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.816
Confidence Interval (2-Sided) 95%
0.417 to 1.597
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CMDV, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.822
Confidence Interval (2-Sided) 95%
0.422 to 1.602
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.051
Confidence Interval (2-Sided) 95%
0.895 to 1.233
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.635
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.031
Confidence Interval (2-Sided) 95%
0.906 to 1.173
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.866
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.012
Confidence Interval (2-Sided) 95%
0.879 to 1.165
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.979
Confidence Interval (2-Sided) 95%
0.842 to 1.139
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.113
Confidence Interval (2-Sided) 95%
0.938 to 1.320
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.242
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.102
Confidence Interval (2-Sided) 95%
0.934 to 1.300
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MMP-Degraded CRP, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.597
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.050
Confidence Interval (2-Sided) 95%
0.870 to 1.267
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.047
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.795
Confidence Interval (2-Sided) 95%
0.634 to 0.997
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.367
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.883
Confidence Interval (2-Sided) 95%
0.668 to 1.165
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.155
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.784
Confidence Interval (2-Sided) 95%
0.558 to 1.102
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.638
Confidence Interval (2-Sided) 95%
0.477 to 0.855
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.140
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.799
Confidence Interval (2-Sided) 95%
0.591 to 1.080
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.470
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.891
Confidence Interval (2-Sided) 95%
0.647 to 1.228
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD1C, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.401
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.869
Confidence Interval (2-Sided) 95%
0.621 to 1.217
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.887
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.981
Confidence Interval (2-Sided) 95%
0.742 to 1.296
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.814
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.970
Confidence Interval (2-Sided) 95%
0.744 to 1.263
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.794
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.969
Confidence Interval (2-Sided) 95%
0.762 to 1.233
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.539
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.919
Confidence Interval (2-Sided) 95%
0.696 to 1.213
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.623
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.937
Confidence Interval (2-Sided) 95%
0.719 to 1.221
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.467
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.913
Confidence Interval (2-Sided) 95%
0.711 to 1.173
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD2C, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.108
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.778
Confidence Interval (2-Sided) 95%
0.570 to 1.061
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.010
Confidence Interval (2-Sided) 95%
0.868 to 1.175
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 2
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.644
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.037
Confidence Interval (2-Sided) 95%
0.884 to 1.218
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.530
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.943
Confidence Interval (2-Sided) 95%
0.780 to 1.139
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 6
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.182
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.882
Confidence Interval (2-Sided) 95%
0.733 to 1.063
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 8
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.960
Confidence Interval (2-Sided) 10%
0.779 to 1.182
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.979
Confidence Interval (2-Sided) 95%
0.790 to 1.214
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments MD3C, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.524
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.075
Confidence Interval (2-Sided) 95%
0.855 to 1.351
Estimation Comments [Not Specified]
7.Primary Outcome
Title Change From Baseline in Flow Cytometry: Helper/Suppressor Cells
Hide Description Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of Helper/Suppressor. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Analysis was performed using repeated measures analysis adjusted for Helper/Suppressor log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of Helper/Suppressor cells
Helper/Suppressor, Week 1, n=8, 25 Number Analyzed 8 participants 25 participants
1.024
(6.98%)
0.976
(4.00%)
Helper/Suppressor, Week 4, n=8, 25 Number Analyzed 8 participants 25 participants
1.053
(7.18%)
0.998
(4.11%)
Helper/Suppressor, Week 12, n=6, 25 Number Analyzed 6 participants 25 participants
1.040
(6.83%)
1.088
(3.49%)
Helper/Suppressor, 12-Week FU, n=6, 21 Number Analyzed 6 participants 21 participants
1.051
(8.99%)
1.065
(4.88%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Helper/Suppressor, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.953
Confidence Interval (2-Sided) 95%
0.809 to 1.123
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Helper/Suppressor, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.515
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.947
Confidence Interval (2-Sided) 95%
0.801 to 1.120
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Helper/Suppressor, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.046
Confidence Interval (2-Sided) 95%
0.895 to 1.222
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments Helper/Suppressor, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.897
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.013
Confidence Interval (2-Sided) 95%
0.822 to 1.249
Estimation Comments [Not Specified]
8.Primary Outcome
Title Change From Baseline in Flow Cytometry: 6 Colour TB Natural Killer (NK) Panel- CD16+CD56+, CD19, CD3, CD3+CD4+
Hide Description Whole blood samples were collected and analyzed for markers which may be predictive of rheumatoid arthritis disease activity. Flow cytometry assessment included assessment of cluster of differentiation (CD)16+CD56+, CD19, CD3, CD3+CD4+. Baseline was defined at Day 1. Change from Baseline was calculated as ratio of Baseline value to post-dose value. Repeated measures analysis adjusted for CD16+CD56+, CD19, CD3, CD3+CD4+, CD3+CD8+ and T Cell B Cell NKL log(Baseline value), treatment group, disease duration (<=2 or >2 years), visit and treatment group by visit interaction. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and Weeks 1, 4, 12, 12-Week FU (Week 22)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population.
Arm/Group Title Placebo GSK3196165 180 mg
Hide Arm/Group Description:
Eligible participants received matching placebo SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to placebo, participants also received MTX 7.5–25 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Eligible participants received GSK3196165 180 mg SC into thigh or abdomen once weekly for 5 weeks, and then every other week until Week 10. In addition to GSK3196165, participants also received MTX 7.5–5 mg/week and folic (or folinic) acid >=5 mg/week during the combination treatment period.
Overall Number of Participants Analyzed 11 28
Geometric Least Squares Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio of biomarker
CD16+CD56+, Week 1, n=8, 25 Number Analyzed 8 participants 25 participants
0.989
(11.39%)
1.025
(6.30%)
CD16+CD56+, Week 4, n=8, 25 Number Analyzed 8 participants 25 participants
1.163
(12.97%)
0.951
(7.25%)
CD16+CD56+, Week 12, n=6, 25 Number Analyzed 6 participants 25 participants
1.193
(15.49%)
0.911
(7.81%)
CD16+CD56+, 12-Week FU, n=6, 21 Number Analyzed 6 participants 21 participants
1.298
(15.10%)
0.920
(7.98%)
CD19, Week 1, n=8, 25 Number Analyzed 8 participants 25 participants
0.880
(11.05%)
0.984
(6.23%)
CD19, Week 4, n=8, 25 Number Analyzed 8 participants 25 participants
1.090
(15.31%)
0.971
(8.60%)
CD19, Week 12, n=6, 25 Number Analyzed 6 participants 25 participants
1.054
(12.26%)
1.003
(6.51%)
CD19, Week 22, n=6, 21 Number Analyzed 6 participants 21 participants
0.980
(17.75%)
0.938
(9.75%)
CD3, Week 1, n=8, 25 Number Analyzed 8 participants 25 participants
0.918
(8.73%)
0.994
(4.95%)
CD3, Week 4, n=8, 25 Number Analyzed 8 participants 25 participants
0.997
(11.79%)
0.934
(6.66%)
CD3, Week 12, n=6, 25 Number Analyzed 6 participants 25 participants
0.912
(9.01%)
0.992
(4.60%)
CD3, 12-Week FU, n=6, 21 Number Analyzed 6 participants 21 participants
0.931
(9.17%)
0.989
(4.98%)
CD3+CD4+, Week 1, n=8, 25 Number Analyzed 8 participants 25 participants
0.926
(9.56%)
0.991
(5.42%)
CD3+CD4+, Week 4, n=8, 25 Number Analyzed 8 participants 25 participants
1.028
(12.80%)
0.933
(7.23%)
CD3+CD4+, Week 12, n=6, 25 Number Analyzed 6 participants 25 participants
0.952
(9.69%)
1.013
(4.94%)
CD3+CD4+, 12-Week FU, n=6, 21 Number Analyzed 6 participants 21 participants
0.970
(9.92%)
1.000
(5.37%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CD16+CD56+, Week 1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.786
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.037
Confidence Interval (2-Sided) 95%
0.794 to 1.354
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CD16+CD56+, Week 4
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.188
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.818
Confidence Interval (2-Sided) 95%
0.603 to 1.109
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CD16+CD56+, Week 12
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.129
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.763
Confidence Interval (2-Sided) 95%
0.536 to 1.087
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GSK3196165 180 mg
Comments CD16+CD56+, 12-Week FU
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Repeated measures analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.709
Confidence Interval (2-Sided) 95%
0.499 to 1.006
Estimation Comments [Not Specified]