Arthritis, Rheumatoid
Conditions
Keywords
DMARD-IR, GSK3196165, Rheumatoid Arthritis
Brief summary
This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram \[mg\]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for \>=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.
Interventions
DRUGGSK3196165
GSK3196165 is supplied as liquid and will be administered as SC injection.
DRUGMTX
MTX will be supplied as capsule, tablet or liquid and will be administered orally or as SC injection.
DRUGFolic acid
Folic acid will be supplied as capsule, tablet or liquid and will be administered orally.
DRUGPlacebo
Placebo is supplied as liquid as sterile 0.9% weight by volume (w/v) sodium chloride solution and will be administered as SC injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>=18 years at the time of signing informed consent. * Meets ACR/EULAR 2010 RA Classification Criteria, with disease duration of \>=12 weeks. * Swollen joint count of \>=4 (66-joint count) and tender joint count of \>=4 (68-joint count). * DAS28(CRP) \>=3.2. * CRP \>=5.0 milligram per litre (mg/L) at screening. * Must have previously received MTX (15-25 mg weekly) for at least 12 weeks before screening, with no change in route of administration, with a stable and tolerated dose for \>=4 weeks prior to Day 1. A stable dose of MTX \>=7.5 mg/week is acceptable, if the MTX dose has been reduced for reasons of documented intolerance to MTX, e.g. hepatic or hematologic toxicity, or per local requirement. * Weight \>=45 kilogram (kg). * Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria. * Diffusing capacity of the lung for carbon monoxide (DLCO) \>=60% predicted; forced expiratory volume in 1 second (FEV1) \>=70% predicted * No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
Exclusion criteria
* Pregnant or lactating women. * History of other inflammatory rheumatological or autoimmune disorders, other than Sjögren's syndrome secondary to RA. * History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis \[PAP\]). * Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained. * Significant unstable or uncontrolled acute or chronic disease which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. * A history of malignancy. * Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency. * Current/previous Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2 infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Week 24 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | 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). |
| Change From Baseline in DAS28(CRP) at All Assessment Time Points | Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24 | 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 to First DAS28(CRP) Remission | Up to Week 62 | 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). Median time, to remission has been presented. |
| Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | DAS28(CRP) scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as follows: Current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2=good response), (\>0.6 to \<=1.2 = moderate response) and (\<=0.6 =no response). Current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2 =moderate response), (\>0.6 to \<=1.2 = moderate response) and (\<=0.6 =no response). Current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2=moderate response), (\>0.6 to \<=1.2 = no response) and (\<=0.6 =no response). If the post-Baseline DAS28(CRP) score was missing, then the corresponding EULAR category was set to missing. |
| Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | The ACR definition for calculating improvement in rheumatoid arthritis is calculated as a 20% improvement (ACR20) in both tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: participant and physician global assessments, participant's assessment of arthritis pain, disability, and an acute-phase reactant (i.e. CRP value). Similarly, ACR50 and ACR70 were calculated with the respective percent improvement. The specific components of the ACR assessments are as follows: Tender/Painful Joint count 68 (TJC68), Swollen Joint Count 66 (SJC66), Participant's Assessment of Arthritis Pain, Participant's Global Assessment of Arthritis Disease Activity, Physician's Global Assessment of Arthritis, CRP (mg/L) and Health Assessment Questionnaire - Disability Index (HAQ-DI). For all visits, if any of the component scores were missing, then those scores were considered as not having met the criteria for improvement. |
| Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | Index-based remission was achieved if the following requirement was met: SDAI \<= 3.3. If the SDAI value was missing at an individual assessment point, Index-based remission for that assessment was set to missing. |
| Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | Boolean-based remission was achieved if all of the following requirements were met at the same time: TJC68 \<= 1,SJC66 \<= 1,CRP \<= 1mg/dL, PtGA \<= 10. If one of the components was missing at an individual assessment point, Boolean-based remission for that assessment was set to missing. |
| Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up) | CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI 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: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Remission was achieved for a non-missing CDAI value \<=2.8. |
| Change From Baseline in SDAI at All Assessment Time Points | Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24 | SDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician and acute phase reactants. The SDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal-phalangeal I-V, proximal interphalangeal I-V and knees. It is calculated using the following formula: SDAI = TJC28 + SJC28 + GH + GP + CRP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment, GP= physician assessment of disease activity using a 10 centimetre \[cm\] visual analogue scale \[VAS\] with 0 = best, 10 = worst), and CRP= C reactive Protein (in mg/L). It ranges between 0.1 and 86. High score indicates worse outcome, low score indicates 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. |
| Change From Baseline in CDAI at All Assessment Time Points | Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24 | CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI 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: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates 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. |
| Change From Baseline in DAS28(CRP) at Week 12 | Baseline and Week 12 | 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. |
| Change From Baseline in Pain Score at All Assessment Time Points | Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and Week 24 | Participants assessed the severity of their current arthritis pain using a 100 unit visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. 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. |
| Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Baseline and Weeks 4, 12, 24 | SF-36 is a generic health survey containing 36 questions covering 8 domains of health. SF-36 yields an 8-scale profile of functional health and well-being scores as well as PCS and MCS health summary scores. The version 2, 1-week recall questionnaire was used. Recoding, calculations and standardization were done as per the User's manual of SF-36. Domain scores were only calculated if less than half of the item scores were missing. All raw domain scores were transformed on a 0-100 scale (transformed domain scores) and then standardized into norm-based scores using Z-score. Following the transformation of the 8 domain scores into z-scores, the MCS and PCS were aggregated (AGG) using weights as PCS/MCS = 50 + (AGG\_PHYS \*10/AGG\_MENT \*10). High score (worse outcome) and low score (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. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Baseline and Weeks 4, 12, 24 | The FACIT-fatigue questionnaire is a participant reported measure developed to assess fatigue consisting of 13 statements regarding feeling fatigue using a numeric rating scale ranging from 0 to 4. For only two of the items (i.e. Answer 5 \[An5\] and An7) a higher value represents a lower fatigue; 11 of the item scores (i.e. HI7, HI12, An1, An2, An3, An4, An8, An12, An14, An15, An16) have to be reversed by subtracting the captured value from 4 (0 is turned to a 4; 1 into 3; 3 into 1; 4 into 0). After performing the reversals the sum of the non-missing individual items were multiplied by 13 and divided by the number of the non-missing individual items. The final score ranges from 0 to 52 with higher values representing a lower fatigue (i.e. a better quality of life). 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. |
| Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Baseline and Weeks 4, 12, 24 | BFI is a self-reported instrument consisting of nine questions which correlate well with quality-of-life measures. For this study, Question 3 only was used which asked about fatigue severity at its worst in the last 24 hours. A discrete 11 unit numeric reporting scale was used where 0 =No fatigue, and 10=As bad as you can imagine. 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. |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Up to 62 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situations as per Medical or Scientific judgment. Overall AEs and SAEs for the entire study duration until follow-up have been presented. |
| Number of Participants With Serious Infections | Up to 62 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious infections were categorized as AE of special interest. The number of participants with overall serious infections have been presented. |
| Number of Participants With Opportunistic Infections | Up to 62 weeks | An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Opportunistic infections were categorized as AE of special interest. The number of participants with overall opportunistic infections have been presented. |
| Number of Participants With Pulmonary Events | Up to 62 weeks | Pulmonary assessments were performed to determine the number of participants with pulmonary events including persistent cough, persistent dyspnea, and persistent Diffusing capacity of the lung for carbon monoxide (DLCO). Persistent is defined as any event with duration \>=15 days. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing pulmonary events have been reported. |
| Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | Up to 62 weeks | Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants with blood oxygen level \< 80%, 80% to \<90% and \>=90% have been reported. |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24 | HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas;dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each functional area contains at least two questions. For each question, there is a four level response set that is scored from 0 (without any difficulty) to 3 (unable to do). If aids or devices or physical assistance are used for a specific functional area and the maximum response of this functional area is 0 or 1 the according value is increased to a score of 2. HAQ-DI is only calculated if there are at least 6 functional area scores available. The average of these non-missing functional area scores defines the continuous HAQ-DI score ranging from 0 to 3. 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. |
Countries
Bulgaria, Canada, Czechia, Estonia, Germany, Hungary, Italy, Mexico, Poland, Russia, South Africa, Spain, Ukraine, United Kingdom
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Placebo 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. | 37 |
| GSK3196165 22.5 mg 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. | 37 |
| GSK3196165 45 mg 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. | 37 |
| GSK3196165 90 mg 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. | 37 |
| GSK3196165 135 mg 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. | 37 |
| GSK3196165 180 mg 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. | 37 |
| Total | 222 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 | 0 | 2 |
| Overall Study | Lack of Efficacy | 1 | 3 | 1 | 0 | 4 | 4 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 | 0 | 1 |
| Overall Study | Protocol defined stopping criteria | 7 | 4 | 3 | 5 | 3 | 3 |
| Overall Study | Protocol Violation | 2 | 1 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 5 | 4 | 4 | 5 | 3 |
Baseline characteristics
| Characteristic | Placebo | GSK3196165 22.5 mg | GSK3196165 45 mg | GSK3196165 90 mg | GSK3196165 135 mg | GSK3196165 180 mg | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.0 Years STANDARD_DEVIATION 11.33 | 48.4 Years STANDARD_DEVIATION 11.31 | 52.8 Years STANDARD_DEVIATION 12.22 | 52.7 Years STANDARD_DEVIATION 11.28 | 47.1 Years STANDARD_DEVIATION 10.04 | 52.3 Years STANDARD_DEVIATION 10.76 | 50.5 Years STANDARD_DEVIATION 11.27 |
| Race/Ethnicity, Customized American Indian/ Alaskan Native+White | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 11 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Black or African American+White | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 34 Participants | 30 Participants | 35 Participants | 35 Participants | 34 Participants | 35 Participants | 203 Participants |
| Sex: Female, Male Female | 28 Participants | 30 Participants | 33 Participants | 27 Participants | 33 Participants | 29 Participants | 180 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 4 Participants | 10 Participants | 4 Participants | 8 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 13 / 37 | 12 / 37 | 13 / 37 | 9 / 37 | 18 / 37 | 13 / 37 |
| serious Total, serious adverse events | 1 / 37 | 2 / 37 | 1 / 37 | 2 / 37 | 2 / 37 | 0 / 37 |
Outcome results
Primary
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
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
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 3 Percentage of participants |
| GSK3196165 22.5 mg | 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 | 5 Percentage of participants |
| GSK3196165 45 mg | 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 | 16 Percentage of participants |
| GSK3196165 90 mg | 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 | 19 Percentage of participants |
| GSK3196165 135 mg | 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 | 14 Percentage of participants |
| GSK3196165 180 mg | 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 | 14 Percentage of participants |
p-value: 0.54795% CI: [0.18, 24.52]Regression, Logistic
p-value: 0.07795% CI: [0.81, 62.44]Regression, Logistic
p-value: 0.05395% CI: [0.98, 72.14]Regression, Logistic
p-value: 0.12295% CI: [0.63, 51.4]Regression, Logistic
p-value: 0.13495% CI: [0.6, 48.83]Regression, Logistic
Secondary
Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points
BFI is a self-reported instrument consisting of nine questions which correlate well with quality-of-life measures. For this study, Question 3 only was used which asked about fatigue severity at its worst in the last 24 hours. A discrete 11 unit numeric reporting scale was used where 0 =No fatigue, and 10=As bad as you can imagine. 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 Weeks 4, 12, 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -0.63 Scores on a scale | Standard Error 0.346 |
| Placebo | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -1.83 Scores on a scale | Standard Error 0.635 |
| Placebo | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -0.60 Scores on a scale | Standard Error 0.348 |
| GSK3196165 22.5 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -1.26 Scores on a scale | Standard Error 0.342 |
| GSK3196165 22.5 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -2.19 Scores on a scale | Standard Error 0.496 |
| GSK3196165 22.5 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -0.67 Scores on a scale | Standard Error 0.348 |
| GSK3196165 45 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -1.76 Scores on a scale | Standard Error 0.418 |
| GSK3196165 45 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -1.10 Scores on a scale | Standard Error 0.339 |
| GSK3196165 45 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -1.83 Scores on a scale | Standard Error 0.341 |
| GSK3196165 90 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -1.60 Scores on a scale | Standard Error 0.335 |
| GSK3196165 90 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -2.03 Scores on a scale | Standard Error 0.395 |
| GSK3196165 90 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -2.02 Scores on a scale | Standard Error 0.333 |
| GSK3196165 135 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -2.07 Scores on a scale | Standard Error 0.341 |
| GSK3196165 135 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -1.86 Scores on a scale | Standard Error 0.339 |
| GSK3196165 135 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -2.59 Scores on a scale | Standard Error 0.435 |
| GSK3196165 180 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | -1.53 Scores on a scale | Standard Error 0.341 |
| GSK3196165 180 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -2.41 Scores on a scale | Standard Error 0.353 |
| GSK3196165 180 mg | Change From Baseline in Brief Fatigue Inventory (BFI) Question 3 at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | -2.20 Scores on a scale | Standard Error 0.339 |
p-value: 0.88895% CI: [-1.04, 0.9]MMRM
p-value: 0.30795% CI: [-1.46, 0.46]MMRM
p-value: 0.04195% CI: [-1.95, -0.04]MMRM
p-value: 0.19195% CI: [-1.6, 0.32]MMRM
p-value: 0.01495% CI: [-2.16, -0.24]MMRM
p-value: 0.00495% CI: [-2.34, -0.45]MMRM
p-value: 0.65695% CI: [-1.94, 1.23]MMRM
p-value: 0.92895% CI: [-1.43, 1.57]MMRM
p-value: 0.78895% CI: [-1.68, 1.28]MMRM
p-value: 0.0195% CI: [-2.22, -0.3]MMRM
p-value: 0.05995% CI: [-1.89, 0.03]MMRM
p-value: 0.00395% CI: [-2.4, -0.48]MMRM
p-value: 0.00195% CI: [-2.53, -0.62]MMRM
p-value: 0.32495% CI: [-2.28, 0.76]MMRM
p-value: 0.43295% CI: [-2.02, 0.87]MMRM
Secondary
Change From Baseline in CDAI at All Assessment Time Points
CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI 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: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates 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 Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -4.25 Scores on a scale | Standard Error 1.782 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -16.91 Scores on a scale | Standard Error 3.419 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -15.61 Scores on a scale | Standard Error 3.077 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -1.34 Scores on a scale | Standard Error 1.449 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -6.59 Scores on a scale | Standard Error 2.658 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -7.57 Scores on a scale | Standard Error 2.298 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -8.20 Scores on a scale | Standard Error 2.089 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -4.95 Scores on a scale | Standard Error 2.013 |
| Placebo | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -5.77 Scores on a scale | Standard Error 4.267 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -13.40 Scores on a scale | Standard Error 2.64 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -17.30 Scores on a scale | Standard Error 2.586 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -5.18 Scores on a scale | Standard Error 1.455 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -8.42 Scores on a scale | Standard Error 1.807 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -12.15 Scores on a scale | Standard Error 2.024 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -13.68 Scores on a scale | Standard Error 2.094 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -13.98 Scores on a scale | Standard Error 2.315 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -15.87 Scores on a scale | Standard Error 2.73 |
| GSK3196165 22.5 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -15.14 Scores on a scale | Standard Error 3.389 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -14.05 Scores on a scale | Standard Error 2.101 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -11.68 Scores on a scale | Standard Error 1.978 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -16.17 Scores on a scale | Standard Error 2.27 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -5.18 Scores on a scale | Standard Error 1.497 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -7.72 Scores on a scale | Standard Error 1.771 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -21.94 Scores on a scale | Standard Error 2.445 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -22.31 Scores on a scale | Standard Error 2.47 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -16.39 Scores on a scale | Standard Error 2.621 |
| GSK3196165 45 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -20.88 Scores on a scale | Standard Error 2.947 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -20.67 Scores on a scale | Standard Error 2.791 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -22.81 Scores on a scale | Standard Error 2.334 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -9.45 Scores on a scale | Standard Error 1.752 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -20.47 Scores on a scale | Standard Error 2.571 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -14.83 Scores on a scale | Standard Error 2.042 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -16.31 Scores on a scale | Standard Error 2.232 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -14.15 Scores on a scale | Standard Error 1.958 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -22.05 Scores on a scale | Standard Error 2.371 |
| GSK3196165 90 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -5.76 Scores on a scale | Standard Error 1.448 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -12.88 Scores on a scale | Standard Error 1.974 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -17.94 Scores on a scale | Standard Error 2.276 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -23.46 Scores on a scale | Standard Error 2.564 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -5.23 Scores on a scale | Standard Error 1.469 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -16.26 Scores on a scale | Standard Error 2.625 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -21.14 Scores on a scale | Standard Error 2.508 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -13.82 Scores on a scale | Standard Error 2.094 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -10.35 Scores on a scale | Standard Error 1.777 |
| GSK3196165 135 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -21.19 Scores on a scale | Standard Error 3.037 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 1, n=36,36,33,36, 35, 37 | -8.73 Scores on a scale | Standard Error 1.438 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 20,n=8,15,21,25, 18, 35 | -25.58 Scores on a scale | Standard Error 2.158 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 16,n=8,16,21,23, 18, 36 | -24.47 Scores on a scale | Standard Error 2.245 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 8,n=34,33,35,37, 35, 34 | -21.36 Scores on a scale | Standard Error 2.279 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 4,n=33,33,35,36, 36, 36 | -17.14 Scores on a scale | Standard Error 1.965 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 24,n=8,14,21,24, 19, 33 | -25.65 Scores on a scale | Standard Error 2.529 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 2,n=35,34,36,37, 36, 37 | -11.10 Scores on a scale | Standard Error 1.755 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 6,n=35,35,33,37, 34, 36 | -18.37 Scores on a scale | Standard Error 2.065 |
| GSK3196165 180 mg | Change From Baseline in CDAI at All Assessment Time Points | CDAI, Week 12,n=34,35,35,37, 35, 36 | -23.23 Scores on a scale | Standard Error 2.604 |
p-value: 0.03995% CI: [-10.13, -0.27]MMRM
p-value: 0.01295% CI: [-12.82, -1.57]MMRM
p-value: 0.01895% CI: [-12.3, -1.16]MMRM
p-value: 0.06395% CI: [-7.89, 0.2]MMRM
p-value: 0.06795% CI: [-7.95, 0.28]MMRM
p-value: 0.03295% CI: [-8.46, -0.39]MMRM
p-value: 0.10295% CI: [-9.17, 0.84]MMRM
p-value: 0.1795% CI: [-8.43, 1.49]MMRM
p-value: 0.00195% CI: [-14.73, -3.66]MMRM
p-value: 0.06595% CI: [-11.31, 0.35]MMRM
p-value: 0.0595% CI: [-11.69, 0]MMRM
p-value: 0.02495% CI: [-12.38, -0.87]MMRM
p-value: 0.05195% CI: [-12.84, 0.02]MMRM
p-value: 0.00895% CI: [-14.97, -2.22]MMRM
p-value: 0.00795% CI: [-15.06, -2.43]MMRM
p-value: 0.07195% CI: [-14.19, 0.58]MMRM
p-value: 0.00995% CI: [-17.17, -2.44]MMRM
p-value: <0.00195% CI: [-21.17, -6.59]MMRM
p-value: 0.67695% CI: [-9.63, 6.26]MMRM
p-value: 0.1195% CI: [-14.11, 1.44]MMRM
p-value: 0.09995% CI: [-14.12, 1.23]MMRM
p-value: 0.81295% CI: [-7.61, 9.69]MMRM
p-value: 0.20495% CI: [-13.75, 2.96]MMRM
p-value: 0.15795% CI: [-14.09, 2.3]MMRM
p-value: 0.08895% CI: [-20.15, 1.42]MMRM
p-value: 0.00495% CI: [-25.4, -4.83]MMRM
p-value: 0.00495% CI: [-25.01, -4.8]MMRM
p-value: 0.0695% CI: [-7.96, 0.17]MMRM
p-value: <0.00195% CI: [-11.42, -3.36]MMRM
p-value: 0.01695% CI: [-11.06, -1.14]MMRM
p-value: 0.00795% CI: [-11.78, -1.91]MMRM
p-value: 0.00595% CI: [-13.48, -2.37]MMRM
p-value: <0.00195% CI: [-17.74, -6.64]MMRM
p-value: 0.05995% CI: [-11.45, 0.21]MMRM
p-value: <0.00195% CI: [-15.97, -4.38]MMRM
p-value: 0.00295% CI: [-16.75, -4]MMRM
p-value: <0.00195% CI: [-20.18, -7.41]MMRM
p-value: 0.0195% CI: [-17.03, -2.31]MMRM
p-value: <0.00195% CI: [-23.97, -9.3]MMRM
p-value: 0.16595% CI: [-13.37, 2.3]MMRM
p-value: 0.02295% CI: [-16.39, -1.32]MMRM
p-value: 0.12795% CI: [-14.99, 1.89]MMRM
p-value: 0.03495% CI: [-16.67, -0.67]MMRM
p-value: 0.00495% CI: [-25.78, -5.07]MMRM
p-value: <0.00195% CI: [-29.7, -10.06]MMRM
Secondary
Change From Baseline in DAS28(CRP) at All Assessment Time Points
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
Population: ITT Population. Only those participants with data available at specified time points were analyzed (indicated by n=X in category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.37 Scores on a scale | Standard Error 0.138 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.14 Scores on a scale | Standard Error 0.114 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -0.87 Scores on a scale | Standard Error 0.335 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -0.60 Scores on a scale | Standard Error 0.232 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -0.61 Scores on a scale | Standard Error 0.195 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -0.65 Scores on a scale | Standard Error 0.184 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -0.23 Scores on a scale | Standard Error 0.402 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -1.23 Scores on a scale | Standard Error 0.359 |
| Placebo | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -0.45 Scores on a scale | Standard Error 0.169 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.47 Scores on a scale | Standard Error 0.114 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -1.45 Scores on a scale | Standard Error 0.322 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.64 Scores on a scale | Standard Error 0.141 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -0.85 Scores on a scale | Standard Error 0.169 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -1.07 Scores on a scale | Standard Error 0.186 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -1.04 Scores on a scale | Standard Error 0.197 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -1.13 Scores on a scale | Standard Error 0.231 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -1.16 Scores on a scale | Standard Error 0.274 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -1.30 Scores on a scale | Standard Error 0.284 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -1.48 Scores on a scale | Standard Error 0.233 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -1.40 Scores on a scale | Standard Error 0.196 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -1.12 Scores on a scale | Standard Error 0.185 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.44 Scores on a scale | Standard Error 0.117 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -1.86 Scores on a scale | Standard Error 0.261 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -1.76 Scores on a scale | Standard Error 0.288 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -1.81 Scores on a scale | Standard Error 0.26 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -1.01 Scores on a scale | Standard Error 0.167 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.69 Scores on a scale | Standard Error 0.142 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -1.62 Scores on a scale | Standard Error 0.269 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.78 Scores on a scale | Standard Error 0.138 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -1.21 Scores on a scale | Standard Error 0.163 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -1.26 Scores on a scale | Standard Error 0.181 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -1.88 Scores on a scale | Standard Error 0.247 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -1.44 Scores on a scale | Standard Error 0.19 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -1.89 Scores on a scale | Standard Error 0.241 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -1.84 Scores on a scale | Standard Error 0.225 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.52 Scores on a scale | Standard Error 0.114 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -2.00 Scores on a scale | Standard Error 0.263 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -1.64 Scores on a scale | Standard Error 0.265 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -1.51 Scores on a scale | Standard Error 0.194 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.55 Scores on a scale | Standard Error 0.116 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -1.12 Scores on a scale | Standard Error 0.164 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -1.28 Scores on a scale | Standard Error 0.23 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -1.71 Scores on a scale | Standard Error 0.291 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -1.12 Scores on a scale | Standard Error 0.185 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.84 Scores on a scale | Standard Error 0.139 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 2; n=36, 35, 34, 36, 36, 36 | -0.88 Scores on a scale | Standard Error 0.139 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 4; n=32, 33, 34, 36, 36, 36 | -1.46 Scores on a scale | Standard Error 0.164 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 12; n=34, 35, 33, 37, 34, 36 | -1.87 Scores on a scale | Standard Error 0.228 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 6; n=35, 34, 34, 36, 33, 36 | -1.51 Scores on a scale | Standard Error 0.182 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 8; n=34, 33, 34, 37, 35, 32 | -1.72 Scores on a scale | Standard Error 0.196 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 16; n=8, 16, 20, 24, 18, 36 | -1.98 Scores on a scale | Standard Error 0.232 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 24; n=8, 14, 20, 24, 19, 33 | -2.05 Scores on a scale | Standard Error 0.246 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 20; n=8, 15, 20, 25, 19, 36 | -2.03 Scores on a scale | Standard Error 0.221 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at All Assessment Time Points | Week 1; n=35, 36, 33, 35, 34, 37 | -0.63 Scores on a scale | Standard Error 0.112 |
p-value: 0.04695% CI: [-0.64, -0.01]MMRM
p-value: 0.07195% CI: [-0.62, 0.03]MMRM
p-value: 0.02295% CI: [-0.69, -0.05]MMRM
p-value: 0.1695% CI: [-0.67, 0.11]MMRM
p-value: 0.10395% CI: [-0.71, 0.07]MMRM
p-value: 0.03495% CI: [-0.8, -0.03]MMRM
p-value: 0.09695% CI: [-0.87, 0.07]MMRM
p-value: 0.0295% CI: [-1.02, -0.09]MMRM
p-value: 0.00195% CI: [-1.22, -0.29]MMRM
p-value: 0.1195% CI: [-0.93, 0.1]MMRM
p-value: 0.07695% CI: [-0.98, 0.05]MMRM
p-value: 0.0295% CI: [-1.11, -0.1]MMRM
p-value: 0.12895% CI: [-0.97, 0.12]MMRM
p-value: 0.00595% CI: [-1.33, -0.24]MMRM
p-value: 0.00395% CI: [-1.36, -0.29]MMRM
p-value: 0.1195% CI: [-1.17, 0.12]MMRM
p-value: 0.00895% CI: [-1.53, -0.23]MMRM
p-value: <0.00195% CI: [-1.88, -0.6]MMRM
p-value: 0.595% CI: [-1.15, 0.56]MMRM
p-value: 0.02195% CI: [-1.83, -0.15]MMRM
p-value: 0.01795% CI: [-1.83, -0.18]MMRM
p-value: 0.87195% CI: [-0.98, 0.83]MMRM
p-value: 0.1995% CI: [-1.46, 0.29]MMRM
p-value: 0.1395% CI: [-1.51, 0.2]MMRM
p-value: 0.01995% CI: [-2.24, -0.2]MMRM
p-value: 0.00295% CI: [-2.51, -0.55]MMRM
p-value: 0.00595% CI: [-2.34, -0.43]MMRM
p-value: 0.01395% CI: [-0.73, -0.09]MMRM
p-value: 0.00395% CI: [-0.8, -0.17]MMRM
p-value: 0.01795% CI: [-0.86, -0.09]MMRM
p-value: 0.00995% CI: [-0.9, -0.13]MMRM
p-value: 0.00595% CI: [-1.13, -0.2]MMRM
p-value: <0.00195% CI: [-1.48, -0.55]MMRM
p-value: 0.07395% CI: [-0.99, 0.04]MMRM
p-value: 0.00195% CI: [-1.36, -0.34]MMRM
p-value: 0.00195% CI: [-1.43, -0.35]MMRM
p-value: <0.00195% CI: [-1.65, -0.56]MMRM
p-value: 0.03995% CI: [-1.32, -0.03]MMRM
p-value: <0.00195% CI: [-1.91, -0.63]MMRM
p-value: 0.07395% CI: [-1.61, 0.07]MMRM
p-value: 0.00795% CI: [-1.91, -0.3]MMRM
p-value: 0.08395% CI: [-1.65, 0.1]MMRM
p-value: 0.05995% CI: [-1.63, 0.03]MMRM
p-value: 0.00395% CI: [-2.46, -0.5]MMRM
p-value: <0.00195% CI: [-2.75, -0.89]MMRM
Secondary
Change From Baseline in DAS28(CRP) at Week 12
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
Population: ITT Population. Only those participants with data available at the indicated time point were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -5.21 Scores on a scale | Standard Error 2.73 |
| Placebo | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -6.72 Scores on a scale | Standard Error 3.66 |
| Placebo | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -2.35 Scores on a scale | Standard Error 1.093 |
| Placebo | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -2.81 Scores on a scale | Standard Error 1.191 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -4.77 Scores on a scale | Standard Error 1.085 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -14.40 Scores on a scale | Standard Error 3.653 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -4.75 Scores on a scale | Standard Error 2.701 |
| GSK3196165 22.5 mg | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -5.11 Scores on a scale | Standard Error 1.181 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -6.73 Scores on a scale | Standard Error 1.173 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -5.52 Scores on a scale | Standard Error 1.08 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -20.40 Scores on a scale | Standard Error 3.611 |
| GSK3196165 45 mg | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -8.57 Scores on a scale | Standard Error 2.749 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -7.79 Scores on a scale | Standard Error 2.624 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -8.53 Scores on a scale | Standard Error 1.151 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -24.11 Scores on a scale | Standard Error 3.544 |
| GSK3196165 90 mg | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -6.91 Scores on a scale | Standard Error 1.056 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -5.33 Scores on a scale | Standard Error 1.08 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -6.43 Scores on a scale | Standard Error 1.175 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -19.35 Scores on a scale | Standard Error 3.614 |
| GSK3196165 135 mg | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -7.71 Scores on a scale | Standard Error 2.722 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at Week 12 | PtGA | -23.90 Scores on a scale | Standard Error 3.606 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at Week 12 | SJC28 | -8.39 Scores on a scale | Standard Error 1.07 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at Week 12 | TJC28 | -9.13 Scores on a scale | Standard Error 1.167 |
| GSK3196165 180 mg | Change From Baseline in DAS28(CRP) at Week 12 | CRP | -7.21 Scores on a scale | Standard Error 2.659 |
p-value: 0.90595% CI: [-7.13, 8.05]Mixed Model Repeated Measures (MMRM)
p-value: 0.38795% CI: [-11, 4.28]MMRM
p-value: 0.49595% CI: [-10.04, 4.87]MMRM
p-value: 0.1495% CI: [-17.92, 2.55]MMRM
p-value: 0.00995% CI: [-23.85, -3.52]MMRM
p-value: <0.00195% CI: [-27.44, -7.35]MMRM
p-value: 0.11895% CI: [-5.45, 0.62]MMRM
p-value: 0.04195% CI: [-6.2, -0.14]MMRM
p-value: 0.00395% CI: [-6, 0.05]MMRM
p-value: 0.17295% CI: [-5.61, 1.01]MMRM
p-value: 0.0295% CI: [-7.22, -0.62]MMRM
p-value: <0.00195% CI: [-8.98, -2.45]MMRM
p-value: 0.51895% CI: [-10.13, 5.12]MMRM
p-value: 0.59995% CI: [-9.5, 5.49]MMRM
p-value: 0.01595% CI: [-22.78, -2.48]MMRM
p-value: <0.00195% CI: [-27.27, -7.1]MMRM
p-value: 0.05495% CI: [-6, 0.05]MMRM
p-value: <0.00195% CI: [-9.05, -3.02]MMRM
p-value: 0.03195% CI: [-6.92, -0.33]MMRM
p-value: <0.00195% CI: [-9.61, -3.02]MMRM
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points
The FACIT-fatigue questionnaire is a participant reported measure developed to assess fatigue consisting of 13 statements regarding feeling fatigue using a numeric rating scale ranging from 0 to 4. For only two of the items (i.e. Answer 5 \[An5\] and An7) a higher value represents a lower fatigue; 11 of the item scores (i.e. HI7, HI12, An1, An2, An3, An4, An8, An12, An14, An15, An16) have to be reversed by subtracting the captured value from 4 (0 is turned to a 4; 1 into 3; 3 into 1; 4 into 0). After performing the reversals the sum of the non-missing individual items were multiplied by 13 and divided by the number of the non-missing individual items. The final score ranges from 0 to 52 with higher values representing a lower fatigue (i.e. a better quality of life). 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 Weeks 4, 12, 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 3.37 Scores on a scale | Standard Error 1.291 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 3.16 Scores on a scale | Standard Error 1.192 |
| Placebo | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 7.56 Scores on a scale | Standard Error 2.439 |
| GSK3196165 22.5 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 2.51 Scores on a scale | Standard Error 1.191 |
| GSK3196165 22.5 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 8.31 Scores on a scale | Standard Error 1.946 |
| GSK3196165 22.5 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 5.29 Scores on a scale | Standard Error 1.278 |
| GSK3196165 45 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 4.66 Scores on a scale | Standard Error 1.164 |
| GSK3196165 45 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 7.09 Scores on a scale | Standard Error 1.68 |
| GSK3196165 45 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 5.91 Scores on a scale | Standard Error 1.273 |
| GSK3196165 90 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 6.74 Scores on a scale | Standard Error 1.595 |
| GSK3196165 90 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 5.71 Scores on a scale | Standard Error 1.148 |
| GSK3196165 90 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 6.44 Scores on a scale | Standard Error 1.244 |
| GSK3196165 135 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 8.28 Scores on a scale | Standard Error 1.737 |
| GSK3196165 135 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 6.73 Scores on a scale | Standard Error 1.165 |
| GSK3196165 135 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 7.28 Scores on a scale | Standard Error 1.274 |
| GSK3196165 180 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 12,n=34,35,35,37, 35, 36 | 8.70 Scores on a scale | Standard Error 1.262 |
| GSK3196165 180 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 4,n=34,34,36,37, 36, 36 | 5.97 Scores on a scale | Standard Error 1.165 |
| GSK3196165 180 mg | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | 9.43 Scores on a scale | Standard Error 1.443 |
p-value: 0.70195% CI: [-3.97, 2.67]MMRM
p-value: 0.3795% CI: [-1.79, 4.78]MMRM
p-value: 0.12595% CI: [-0.71, 5.81]MMRM
p-value: 0.29295% CI: [-1.66, 5.5]MMRM
p-value: 0.16395% CI: [-1.04, 6.11]MMRM
p-value: 0.08795% CI: [-0.46, 6.61]MMRM
p-value: 0.80895% CI: [-5.4, 6.92]MMRM
p-value: 0.87495% CI: [-6.31, 5.38]MMRM
p-value: 0.7895% CI: [-6.58, 4.95]MMRM
p-value: 0.03395% CI: [0.29, 6.85]MMRM
p-value: 0.09495% CI: [-0.48, 6.1]MMRM
p-value: 0.03295% CI: [0.34, 7.49]MMRM
p-value: 0.00495% CI: [1.77, 8.89]MMRM
p-value: 0.80895% CI: [-5.19, 6.64]MMRM
p-value: 0.51195% CI: [-3.74, 7.48]MMRM
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points
HAQ-DI is 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas;dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Each functional area contains at least two questions. For each question, there is a four level response set that is scored from 0 (without any difficulty) to 3 (unable to do). If aids or devices or physical assistance are used for a specific functional area and the maximum response of this functional area is 0 or 1 the according value is increased to a score of 2. HAQ-DI is only calculated if there are at least 6 functional area scores available. The average of these non-missing functional area scores defines the continuous HAQ-DI score ranging from 0 to 3. 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 Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.17 Scores on a scale | Standard Error 0.062 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.34 Scores on a scale | Standard Error 0.143 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.49 Scores on a scale | Standard Error 0.141 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.26 Scores on a scale | Standard Error 0.091 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.09 Scores on a scale | Standard Error 0.054 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.22 Scores on a scale | Standard Error 0.082 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.35 Scores on a scale | Standard Error 0.139 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.23 Scores on a scale | Standard Error 0.077 |
| Placebo | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.22 Scores on a scale | Standard Error 0.073 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.18 Scores on a scale | Standard Error 0.082 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.08 Scores on a scale | Standard Error 0.054 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.13 Scores on a scale | Standard Error 0.063 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.18 Scores on a scale | Standard Error 0.073 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.22 Scores on a scale | Standard Error 0.077 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.31 Scores on a scale | Standard Error 0.091 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.33 Scores on a scale | Standard Error 0.111 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.37 Scores on a scale | Standard Error 0.112 |
| GSK3196165 22.5 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.32 Scores on a scale | Standard Error 0.116 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.38 Scores on a scale | Standard Error 0.102 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.27 Scores on a scale | Standard Error 0.077 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.16 Scores on a scale | Standard Error 0.062 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.42 Scores on a scale | Standard Error 0.103 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.08 Scores on a scale | Standard Error 0.054 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.41 Scores on a scale | Standard Error 0.104 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.30 Scores on a scale | Standard Error 0.09 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.33 Scores on a scale | Standard Error 0.081 |
| GSK3196165 45 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.17 Scores on a scale | Standard Error 0.072 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.43 Scores on a scale | Standard Error 0.099 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.29 Scores on a scale | Standard Error 0.071 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.57 Scores on a scale | Standard Error 0.098 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.31 Scores on a scale | Standard Error 0.08 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.10 Scores on a scale | Standard Error 0.054 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.51 Scores on a scale | Standard Error 0.097 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.23 Scores on a scale | Standard Error 0.062 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.33 Scores on a scale | Standard Error 0.076 |
| GSK3196165 90 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.37 Scores on a scale | Standard Error 0.89 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.35 Scores on a scale | Standard Error 0.081 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.49 Scores on a scale | Standard Error 0.105 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.29 Scores on a scale | Standard Error 0.072 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.21 Scores on a scale | Standard Error 0.077 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.25 Scores on a scale | Standard Error 0.063 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.42 Scores on a scale | Standard Error 0.107 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.38 Scores on a scale | Standard Error 0.09 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.40 Scores on a scale | Standard Error 0.106 |
| GSK3196165 135 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.13 Scores on a scale | Standard Error 0.054 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 16,n=8,16,21,24, 18, 36 | -0.50 Scores on a scale | Standard Error 0.09 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 8,n=34,34,35,37, 35, 34 | -0.42 Scores on a scale | Standard Error 0.081 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 6,n=35,35,35,37, 36, 36 | -0.43 Scores on a scale | Standard Error 0.076 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 4,n=34,34,36,37, 36, 36 | -0.40 Scores on a scale | Standard Error 0.072 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 2,n=36,35,37,37, 36, 37 | -0.26 Scores on a scale | Standard Error 0.062 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 1,n=36,36,35,36, 36, 37 | -0.17 Scores on a scale | Standard Error 0.053 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 24,n=8,14,21,24, 19, 34 | -0.54 Scores on a scale | Standard Error 0.092 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 12,n=34,35, 35, 37,35, 36 | -0.50 Scores on a scale | Standard Error 0.09 |
| GSK3196165 180 mg | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at All Assessment Time Points | HAQ-DI, Week 20,n=8,15,21,25, 19, 36 | -0.56 Scores on a scale | Standard Error 0.091 |
p-value: 0.98195% CI: [-0.15, 0.15]MMRM
p-value: 0.93895% CI: [-0.14, 0.16]MMRM
p-value: 0.85795% CI: [-0.16, 0.14]MMRM
p-value: 0.59295% CI: [-0.13, 0.22]MMRM
p-value: 0.91795% CI: [-0.16, 0.18]MMRM
p-value: 0.54595% CI: [-0.23, 0.12]MMRM
p-value: 0.70795% CI: [-0.16, 0.24]MMRM
p-value: 0.60395% CI: [-0.15, 0.26]MMRM
p-value: 0.47395% CI: [-0.27, 0.13]MMRM
p-value: 0.98795% CI: [-0.21, 0.22]MMRM
p-value: 0.71395% CI: [-0.25, 0.17]MMRM
p-value: 0.35795% CI: [-0.31, 0.11]MMRM
p-value: 0.74895% CI: [-0.19, 0.26]MMRM
p-value: 0.32795% CI: [-0.34, 0.11]MMRM
p-value: 0.06595% CI: [-0.42, 0.01]MMRM
p-value: 0.23895% CI: [-0.36, 0.09]MMRM
p-value: 0.39595% CI: [-0.32, 0.13]MMRM
p-value: 0.7195% CI: [-0.3, 0.21]MMRM
p-value: 0.7495% CI: [-0.3, 0.21]MMRM
p-value: 0.39895% CI: [-0.36, 0.14]MMRM
p-value: 0.36495% CI: [-0.19, 0.52]MMRM
p-value: 0.50395% CI: [-0.23, 0.46]MMRM
p-value: 0.64795% CI: [-0.42, 0.26]MMRM
p-value: 0.9195% CI: [-0.37, 0.33]MMRM
p-value: 0.6695% CI: [-0.42, 0.26]MMRM
p-value: 0.3495% CI: [-0.5, 0.17]MMRM
p-value: 0.90295% CI: [-0.34, 0.39]MMRM
p-value: 0.68795% CI: [-0.42, 0.28]MMRM
p-value: 0.59995% CI: [-0.44, 0.25]MMRM
p-value: 0.58895% CI: [-0.19, 0.11]MMRM
p-value: 0.25995% CI: [-0.23, 0.06]MMRM
p-value: 0.35895% CI: [-0.26, 0.09]MMRM
p-value: 0.32595% CI: [-0.26, 0.09]MMRM
p-value: 0.47395% CI: [-0.28, 0.13]MMRM
p-value: 0.08595% CI: [-0.38, 0.02]MMRM
p-value: 0.89795% CI: [-0.2, 0.23]MMRM
p-value: 0.07195% CI: [-0.44, 0.02]MMRM
p-value: 0.3495% CI: [-0.38, 0.13]MMRM
p-value: 0.05995% CI: [-0.49, 0.01]MMRM
p-value: 0.60795% CI: [-0.26, 0.44]MMRM
p-value: 0.95995% CI: [-0.34, 0.32]MMRM
p-value: 0.40195% CI: [-0.49, 0.2]MMRM
p-value: 0.20795% CI: [-0.54, 0.12]MMRM
p-value: 0.63795% CI: [-0.44, 0.27]MMRM
p-value: 0.25195% CI: [-0.53, 0.14]MMRM
Secondary
Change From Baseline in Pain Score at All Assessment Time Points
Participants assessed the severity of their current arthritis pain using a 100 unit visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. 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 Weeks 1, 2, 4, 6, 8, 12, 16, 20 and Week 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -12.60 Scores on a scale | Standard Error 6.077 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -13.95 Scores on a scale | Standard Error 5.589 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -13.38 Scores on a scale | Standard Error 6.484 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -2.25 Scores on a scale | Standard Error 2.625 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -6.69 Scores on a scale | Standard Error 3.334 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -3.79 Scores on a scale | Standard Error 2.818 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -3.98 Scores on a scale | Standard Error 3.555 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -5.44 Scores on a scale | Standard Error 3.081 |
| Placebo | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -7.07 Scores on a scale | Standard Error 3.705 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -14.09 Scores on a scale | Standard Error 3.702 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -11.18 Scores on a scale | Standard Error 3.357 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -9.60 Scores on a scale | Standard Error 3.577 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -19.76 Scores on a scale | Standard Error 5.231 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -14.64 Scores on a scale | Standard Error 4.495 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -4.71 Scores on a scale | Standard Error 2.648 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -17.50 Scores on a scale | Standard Error 4.768 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -6.71 Scores on a scale | Standard Error 2.87 |
| GSK3196165 22.5 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -8.47 Scores on a scale | Standard Error 3.107 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -5.02 Scores on a scale | Standard Error 2.656 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -23.52 Scores on a scale | Standard Error 4.62 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -9.77 Scores on a scale | Standard Error 2.797 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -27.12 Scores on a scale | Standard Error 4.068 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -21.22 Scores on a scale | Standard Error 3.659 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -18.55 Scores on a scale | Standard Error 3.517 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -14.71 Scores on a scale | Standard Error 3.319 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -28.56 Scores on a scale | Standard Error 4.361 |
| GSK3196165 45 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -14.83 Scores on a scale | Standard Error 3.029 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -26.46 Scores on a scale | Standard Error 4.187 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -15.05 Scores on a scale | Standard Error 3.262 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -9.96 Scores on a scale | Standard Error 2.626 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -11.37 Scores on a scale | Standard Error 2.791 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -17.65 Scores on a scale | Standard Error 2.995 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -17.92 Scores on a scale | Standard Error 3.461 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -25.25 Scores on a scale | Standard Error 3.593 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -27.44 Scores on a scale | Standard Error 3.87 |
| GSK3196165 90 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -25.45 Scores on a scale | Standard Error 4.409 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -11.63 Scores on a scale | Standard Error 2.829 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -19.07 Scores on a scale | Standard Error 3.662 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -7.18 Scores on a scale | Standard Error 2.637 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -25.80 Scores on a scale | Standard Error 4.549 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -26.61 Scores on a scale | Standard Error 4.756 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -27.86 Scores on a scale | Standard Error 4.179 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -14.05 Scores on a scale | Standard Error 3.306 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -20.49 Scores on a scale | Standard Error 3.523 |
| GSK3196165 135 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -13.39 Scores on a scale | Standard Error 3.036 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 12,n=34, 35,35,37, 35, 36 | -25.01 Scores on a scale | Standard Error 3.65 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 24,n=8,14,21,24, 19, 34 | -30.08 Scores on a scale | Standard Error 4.048 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 8,n=34,34,35,37, 35,34 | -24.38 Scores on a scale | Standard Error 3.541 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 1,n=36,36,35,36, 36,37 | -7.89 Scores on a scale | Standard Error 2.619 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 6,n=35,35,35,37, 36, 36 | -19.12 Scores on a scale | Standard Error 3.311 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 2,n=36,35,37,37,36,37 | -14.22 Scores on a scale | Standard Error 2.81 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 4,n=34,34,36,37, 36,36 | -19.40 Scores on a scale | Standard Error 3.038 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 16,n=8,16,21,24, 18, 16 | -24.48 Scores on a scale | Standard Error 3.807 |
| GSK3196165 180 mg | Change From Baseline in Pain Score at All Assessment Time Points | Week 20,n=8,15,21,25, 19,36 | -27.17 Scores on a scale | Standard Error 3.584 |
p-value: 0.51195% CI: [-9.81, 4.9]MMRM
p-value: 0.46195% CI: [-10.13, 4.6]MMRM
p-value: 0.03995% CI: [-15.03, -0.39]MMRM
p-value: 0.46995% CI: [-10.86, 5.01]MMRM
p-value: 0.13395% CI: [-13.82, 1.85]MMRM
p-value: 0.05795% CI: [-15.4, 0.23]MMRM
p-value: 0.4995% CI: [-11.67, 5.61]MMRM
p-value: 0.03195% CI: [-17.91, -0.86]MMRM
p-value: 0.00595% CI: [-20.67, -3.74]MMRM
p-value: 0.34595% CI: [-13.83, 4.85]MMRM
p-value: 0.0995% CI: [-17.3, 1.26]MMRM
p-value: 0.07495% CI: [-17.55, 0.83]MMRM
p-value: 0.26895% CI: [-15.57, 4.34]MMRM
p-value: 0.00495% CI: [-24.43, -4.7]MMRM
p-value: 0.00595% CI: [-23.72, -4.16]MMRM
p-value: 0.18295% CI: [-17.36, 3.32]MMRM
p-value: 0.00795% CI: [-24.42, -3.87]MMRM
p-value: <0.00195% CI: [-28.35, -8.01]MMRM
p-value: 0.52795% CI: [-20.15, 10.36]MMRM
p-value: 0.03495% CI: [-30.72, -1.19]MMRM
p-value: 0.06295% CI: [-28.42, 0.7]MMRM
p-value: 0.92495% CI: [-14.85, 13.47]MMRM
p-value: 0.05895% CI: [-26.82, 0.48]MMRM
p-value: 0.04995% CI: [-26.91, -0.08]MMRM
p-value: 0.44595% CI: [-22.84, 10.07]MMRM
p-value: 0.20595% CI: [-25.87, 5.58]MMRM
p-value: 0.12595% CI: [-27.55, 3.41]MMRM
p-value: 0.18795% CI: [-12.26, 2.41]MMRM
p-value: 0.1395% CI: [-12.93, 1.67]MMRM
p-value: 0.05195% CI: [-15.72, 0.03]MMRM
p-value: 0.00995% CI: [-18.27, -2.6]MMRM
p-value: 0.06895% CI: [-16.47, 0.58]MMRM
p-value: 0.00195% CI: [-22.47, -5.44]MMRM
p-value: 0.11895% CI: [-16.62, 1.89]MMRM
p-value: 0.00995% CI: [-21.68, -3.19]MMRM
p-value: 0.00195% CI: [-26.38, -6.65]MMRM
p-value: <0.00195% CI: [-30.27, -10.52]MMRM
p-value: 0.02295% CI: [-22.27, -1.73]MMRM
p-value: <0.00195% CI: [-28.18, -7.7]MMRM
p-value: 0.08495% CI: [-28.18, 1.79]MMRM
p-value: 0.09995% CI: [-26.02, 2.27]MMRM
p-value: 0.04895% CI: [-27.68, -0.14]MMRM
p-value: 0.04895% CI: [-26.32, -0.13]MMRM
p-value: 0.10295% CI: [-29.11, 2.64]MMRM
p-value: 0.0395% CI: [-31.79, -1.62]MMRM
Secondary
Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points
SF-36 is a generic health survey containing 36 questions covering 8 domains of health. SF-36 yields an 8-scale profile of functional health and well-being scores as well as PCS and MCS health summary scores. The version 2, 1-week recall questionnaire was used. Recoding, calculations and standardization were done as per the User's manual of SF-36. Domain scores were only calculated if less than half of the item scores were missing. All raw domain scores were transformed on a 0-100 scale (transformed domain scores) and then standardized into norm-based scores using Z-score. Following the transformation of the 8 domain scores into z-scores, the MCS and PCS were aggregated (AGG) using weights as PCS/MCS = 50 + (AGG\_PHYS \*10/AGG\_MENT \*10). High score (worse outcome) and low score (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 Weeks 4, 12, 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 3.36 Scores on a scale | Standard Error 1.488 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 6.93 Scores on a scale | Standard Error 2.1 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 2.07 Scores on a scale | Standard Error 2.248 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 5.34 Scores on a scale | Standard Error 2.058 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 3.42 Scores on a scale | Standard Error 1.203 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 1.86 Scores on a scale | Standard Error 1.046 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 4.19 Scores on a scale | Standard Error 1.445 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 4.56 Scores on a scale | Standard Error 1.27 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 2.27 Scores on a scale | Standard Error 1.601 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 2.98 Scores on a scale | Standard Error 1.39 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 2.44 Scores on a scale | Standard Error 1.102 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 2.27 Scores on a scale | Standard Error 1.512 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 2.15 Scores on a scale | Standard Error 1.128 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 4.34 Scores on a scale | Standard Error 1.529 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 1.78 Scores on a scale | Standard Error 1.079 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 4.85 Scores on a scale | Standard Error 1.595 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 4.15 Scores on a scale | Standard Error 2.58 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 4.37 Scores on a scale | Standard Error 1.489 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 8.31 Scores on a scale | Standard Error 2.841 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 3.90 Scores on a scale | Standard Error 1.294 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 2.52 Scores on a scale | Standard Error 1.071 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 6.38 Scores on a scale | Standard Error 2.235 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 5.66 Scores on a scale | Standard Error 2.674 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 4.68 Scores on a scale | Standard Error 2.775 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 3.30 Scores on a scale | Standard Error 1.206 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 3.64 Scores on a scale | Standard Error 1.451 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 4.07 Scores on a scale | Standard Error 2.56 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 3.54 Scores on a scale | Standard Error 1.558 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 2.81 Scores on a scale | Standard Error 2.619 |
| Placebo | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 1.91 Scores on a scale | Standard Error 1.389 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 2.46 Scores on a scale | Standard Error 1.048 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 5.19 Scores on a scale | Standard Error 1.574 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 1.95 Scores on a scale | Standard Error 1.512 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 6.57 Scores on a scale | Standard Error 2.102 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 3.01 Scores on a scale | Standard Error 1.124 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 5.16 Scores on a scale | Standard Error 1.255 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 7.65 Scores on a scale | Standard Error 1.738 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 3.97 Scores on a scale | Standard Error 1.208 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 5.80 Scores on a scale | Standard Error 1.375 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 6.29 Scores on a scale | Standard Error 1.7 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 6.16 Scores on a scale | Standard Error 1.429 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 4.88 Scores on a scale | Standard Error 1.192 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 3.77 Scores on a scale | Standard Error 1.449 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 7.03 Scores on a scale | Standard Error 1.631 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 2.94 Scores on a scale | Standard Error 1.386 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 2.86 Scores on a scale | Standard Error 1.488 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 4.86 Scores on a scale | Standard Error 1.542 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 4.50 Scores on a scale | Standard Error 2.039 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 2.41 Scores on a scale | Standard Error 1.071 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 4.87 Scores on a scale | Standard Error 1.581 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 5.41 Scores on a scale | Standard Error 2.221 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 5.43 Scores on a scale | Standard Error 1.28 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 7.01 Scores on a scale | Standard Error 1.996 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 1.27 Scores on a scale | Standard Error 1.079 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 3.07 Scores on a scale | Standard Error 1.09 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 4.90 Scores on a scale | Standard Error 1.513 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 5.36 Scores on a scale | Standard Error 1.762 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 6.62 Scores on a scale | Standard Error 2.175 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 3.09 Scores on a scale | Standard Error 1.488 |
| GSK3196165 22.5 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 4.13 Scores on a scale | Standard Error 2.073 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 7.87 Scores on a scale | Standard Error 1.871 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 3.81 Scores on a scale | Standard Error 1.453 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 5.99 Scores on a scale | Standard Error 1.368 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 4.83 Scores on a scale | Standard Error 1.514 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 5.00 Scores on a scale | Standard Error 1.535 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 5.68 Scores on a scale | Standard Error 1.174 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 6.36 Scores on a scale | Standard Error 1.755 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 7.83 Scores on a scale | Standard Error 1.854 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 3.08 Scores on a scale | Standard Error 1.452 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 6.27 Scores on a scale | Standard Error 1.481 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 6.24 Scores on a scale | Standard Error 1.043 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 6.16 Scores on a scale | Standard Error 1.794 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 6.63 Scores on a scale | Standard Error 1.404 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 6.09 Scores on a scale | Standard Error 1.777 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 6.72 Scores on a scale | Standard Error 1.273 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 6.28 Scores on a scale | Standard Error 1.251 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 9.20 Scores on a scale | Standard Error 1.682 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 5.49 Scores on a scale | Standard Error 1.575 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 4.04 Scores on a scale | Standard Error 1.097 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 2.77 Scores on a scale | Standard Error 1.055 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 4.34 Scores on a scale | Standard Error 1.507 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 5.52 Scores on a scale | Standard Error 1.57 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 4.30 Scores on a scale | Standard Error 1.088 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 5.48 Scores on a scale | Standard Error 1.352 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 7.10 Scores on a scale | Standard Error 1.421 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 5.05 Scores on a scale | Standard Error 1.02 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 5.84 Scores on a scale | Standard Error 1.186 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 6.52 Scores on a scale | Standard Error 1.49 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 5.44 Scores on a scale | Standard Error 1.475 |
| GSK3196165 45 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 4.52 Scores on a scale | Standard Error 1.413 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 4.47 Scores on a scale | Standard Error 1.007 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 4.62 Scores on a scale | Standard Error 1.471 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 2.82 Scores on a scale | Standard Error 1.434 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 3.62 Scores on a scale | Standard Error 1.395 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 4.36 Scores on a scale | Standard Error 1.704 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 6.37 Scores on a scale | Standard Error 1.389 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 2.84 Scores on a scale | Standard Error 1.455 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 4.54 Scores on a scale | Standard Error 1.334 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 5.15 Scores on a scale | Standard Error 1.158 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 4.52 Scores on a scale | Standard Error 1.773 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 1.90 Scores on a scale | Standard Error 1.039 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 4.60 Scores on a scale | Standard Error 1.42 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 4.77 Scores on a scale | Standard Error 1.539 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 7.16 Scores on a scale | Standard Error 1.426 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 3.42 Scores on a scale | Standard Error 1.684 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 3.02 Scores on a scale | Standard Error 1.061 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 3.35 Scores on a scale | Standard Error 1.432 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 7.80 Scores on a scale | Standard Error 1.335 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 5.44 Scores on a scale | Standard Error 1.029 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 4.84 Scores on a scale | Standard Error 1.159 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 7.65 Scores on a scale | Standard Error 1.758 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 4.66 Scores on a scale | Standard Error 1.501 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 5.49 Scores on a scale | Standard Error 1.221 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 5.98 Scores on a scale | Standard Error 1.333 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 5.99 Scores on a scale | Standard Error 1.243 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 4.56 Scores on a scale | Standard Error 1.082 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 7.50 Scores on a scale | Standard Error 1.408 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 5.10 Scores on a scale | Standard Error 1.532 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 3.02 Scores on a scale | Standard Error 1.669 |
| GSK3196165 90 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 7.36 Scores on a scale | Standard Error 1.593 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 4.02 Scores on a scale | Standard Error 1.097 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 6.01 Scores on a scale | Standard Error 1.277 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 3.49 Scores on a scale | Standard Error 1.413 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 4.68 Scores on a scale | Standard Error 1.576 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 4.96 Scores on a scale | Standard Error 1.844 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 5.84 Scores on a scale | Standard Error 1.373 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 7.40 Scores on a scale | Standard Error 1.539 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 4.80 Scores on a scale | Standard Error 1.021 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 5.31 Scores on a scale | Standard Error 1.188 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 7.50 Scores on a scale | Standard Error 1.454 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 4.52 Scores on a scale | Standard Error 1.453 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 5.51 Scores on a scale | Standard Error 1.535 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 5.42 Scores on a scale | Standard Error 1.817 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 5.97 Scores on a scale | Standard Error 1.046 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 8.87 Scores on a scale | Standard Error 1.752 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 3.43 Scores on a scale | Standard Error 1.053 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 3.14 Scores on a scale | Standard Error 1.087 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 3.84 Scores on a scale | Standard Error 1.562 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 5.18 Scores on a scale | Standard Error 1.179 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 4.96 Scores on a scale | Standard Error 1.451 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 5.93 Scores on a scale | Standard Error 1.57 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 6.06 Scores on a scale | Standard Error 1.863 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 5.99 Scores on a scale | Standard Error 1.253 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 7.59 Scores on a scale | Standard Error 1.538 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 5.22 Scores on a scale | Standard Error 1.476 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 6.32 Scores on a scale | Standard Error 1.508 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 7.97 Scores on a scale | Standard Error 1.951 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 6.55 Scores on a scale | Standard Error 1.352 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 6.83 Scores on a scale | Standard Error 1.421 |
| GSK3196165 135 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 8.04 Scores on a scale | Standard Error 1.924 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 24,n=8,14,21,24,19,34 | 7.82 Scores on a scale | Standard Error 1.504 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 24,n=8,14,21,24,19,34 | 5.42 Scores on a scale | Standard Error 1.265 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General health, Week 12,n=34,35,35,37,35,36 | 4.73 Scores on a scale | Standard Error 1.077 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | General Health, Week 4,n=34,34,36,37,36,36 | 3.72 Scores on a scale | Standard Error 1.054 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 24,n=8,14,21,24,19,34 | 9.35 Scores on a scale | Standard Error 1.387 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 12,n=34,35,35,37,35,36 | 5.72 Scores on a scale | Standard Error 1.558 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 12,n=34,35,35,37,35,36 | 8.69 Scores on a scale | Standard Error 1.491 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 12,n=34,35,35,37,35,36 | 7.34 Scores on a scale | Standard Error 1.263 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Bodily pain, Week 4,n=34,34,36,37,36,36, | 7.60 Scores on a scale | Standard Error 1.045 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 24,n=8,14,21,24,19,34 | 7.86 Scores on a scale | Standard Error 1.503 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 12,n=34,35,35,37,35,36, | 6.79 Scores on a scale | Standard Error 1.521 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Mental health, Week 4,n=34,34,36,37,36,36 | 3.69 Scores on a scale | Standard Error 1.413 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 24,n=8,14,21,24,19,34 | 8.60 Scores on a scale | Standard Error 1.551 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | MCS, Week 4,n=34,34,36,37,36,36, | 3.46 Scores on a scale | Standard Error 1.453 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 24,n=8,14,21,24,19,34 | 6.99 Scores on a scale | Standard Error 1.211 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS, Week 4,n=34,34,36,37,36,36, | 5.97 Scores on a scale | Standard Error 1.028 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | PCS Week 12,n=34,35,35,37,35,36 | 6.97 Scores on a scale | Standard Error 1.182 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 4,n=34,34,36,37,36,36 | 5.25 Scores on a scale | Standard Error 1.353 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 12,n=34,35,35,37,35,36 | 7.76 Scores on a scale | Standard Error 1.358 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Social functioning, Week 4,n=34,34,36,37,36,36 | 5.67 Scores on a scale | Standard Error 1.475 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 24,n=8,14,21,24,19,34 | 7.25 Scores on a scale | Standard Error 1.25 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 4,n=34,34,36,37,36,36 | 5.75 Scores on a scale | Standard Error 1.18 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 24,n=8,14,21,24,19,34 | 7.81 Scores on a scale | Standard Error 1.56 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 12,n=34,35,35,37,35,36 | 7.91 Scores on a scale | Standard Error 1.241 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role physical, Week 4,n=34,34,36,37,36,36 | 4.80 Scores on a scale | Standard Error 1.099 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Vitality, Week 12,n=34,35,35,37,35,36 | 8.16 Scores on a scale | Standard Error 1.408 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 24,n=8,14,21,24,19,34 | 8.18 Scores on a scale | Standard Error 1.518 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 12,n=34,35,35,37,35,36 | 7.54 Scores on a scale | Standard Error 1.552 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Role emotional, Week 4,n=34,34,36,37,36,36 | 3.77 Scores on a scale | Standard Error 1.451 |
| GSK3196165 180 mg | Change From Baseline in Physical and Mental Component Scores (PCS, MCS) and in Domain Scores of Short Form 36 (SF-36) at All Assessment Time Points | Physical functioning, Week 24,n=8,14,21,24,19,34 | 7.58 Scores on a scale | Standard Error 1.309 |
p-value: 0.68395% CI: [-2.31, 3.52]MMRM
p-value: 0.0395% CI: [0.31, 6.07]MMRM
p-value: 0.07495% CI: [-0.25, 5.47]MMRM
p-value: 0.3995% CI: [-1.88, 4.8]MMRM
p-value: 0.15495% CI: [-0.91, 5.75]MMRM
p-value: 0.30295% CI: [-1.56, 5.02]MMRM
p-value: 0.52195% CI: [-3.5, 6.88]MMRM
p-value: 0.60695% CI: [-3.63, 6.2]MMRM
p-value: 0.3295% CI: [-2.41, 7.32]MMRM
p-value: 0.81195% CI: [-4.65, 3.64]MMRM
p-value: 0.8395% CI: [-3.65, 4.55]MMRM
p-value: 0.79595% CI: [-4.61, 3.54]MMRM
p-value: 0.54895% CI: [-3, 5.64]MMRM
p-value: 0.50595% CI: [-2.85, 5.77]MMRM
p-value: 0.60595% CI: [-3.15, 5.39]MMRM
p-value: 0.89595% CI: [-6.03, 6.9]MMRM
p-value: 0.46195% CI: [-3.84, 8.42]MMRM
p-value: 0.73295% CI: [-7.1, 4.99]MMRM
p-value: 0.94195% CI: [-3.11, 2.88]MMRM
p-value: 0.01395% CI: [0.78, 6.67]MMRM
p-value: 0.05195% CI: [-0.01, 5.84]MMRM
p-value: 0.40395% CI: [-2.07, 5.12]MMRM
p-value: 0.12295% CI: [-0.76, 6.4]MMRM
p-value: 0.24795% CI: [-1.45, 5.62]MMRM
p-value: 0.38495% CI: [-3.61, 9.32]MMRM
p-value: 0.10595% CI: [-1.07, 11.16]MMRM
p-value: 0.2995% CI: [-2.76, 9.17]MMRM
p-value: 0.73895% CI: [-3.52, 2.5]MMRM
p-value: 0.51395% CI: [-1.99, 3.97]MMRM
p-value: 0.93495% CI: [-2.83, 3.08]MMRM
p-value: 0.68795% CI: [-2.43, 3.68]MMRM
p-value: 0.23395% CI: [-1.2, 4.91]MMRM
p-value: 0.70895% CI: [-2.44, 3.59]MMRM
p-value: 0.2595% CI: [-2.34, 8.93]MMRM
p-value: 0.30795% CI: [-2.57, 8.09]MMRM
p-value: 0.34595% CI: [-2.74, 7.79]MMRM
p-value: 0.9595% CI: [-0.19, 0.52]MMRM
p-value: 0.66495% CI: [-3.11, 4.87]MMRM
p-value: 0.99495% CI: [-3.99, 3.96]MMRM
p-value: 0.2595% CI: [-1.84, 7.03]MMRM
p-value: 0.15495% CI: [-1.22, 7.64]MMRM
p-value: 0.26295% CI: [-1.88, 6.89]MMRM
p-value: 0.69395% CI: [-5.28, 7.93]MMRM
p-value: 0.30295% CI: [-2.98, 9.54]MMRM
p-value: 0.84495% CI: [-5.54, 6.77]MMRM
p-value: 0.69895% CI: [-2.71, 4.04]MMRM
p-value: 0.15995% CI: [-0.94, 5.7]MMRM
p-value: 0.3695% CI: [-1.76, 4.83]MMRM
p-value: 0.15195% CI: [-1.04, 6.69]MMRM
p-value: 0.12495% CI: [-0.83, 6.86]MMRM
p-value: 0.1295% CI: [-0.79, 6.8]MMRM
p-value: 0.81495% CI: [-5.98, 4.7]MMRM
p-value: 0.87395% CI: [-5.49, 4.67]MMRM
p-value: 0.92895% CI: [-4.8, 5.26]MMRM
p-value: 0.54195% CI: [-5.44, 2.86]MMRM
p-value: 0.53595% CI: [-5.39, 2.81]MMRM
p-value: 0.6295% CI: [-5.1, 3.05]MMRM
p-value: 0.88195% CI: [-4.08, 4.76]MMRM
p-value: 0.76795% CI: [-3.74, 5.07]MMRM
p-value: 0.91395% CI: [-4.12, 4.61]MMRM
p-value: 0.7995% CI: [-5.81, 7.63]MMRM
p-value: 0.87695% CI: [-5.86, 6.87]MMRM
p-value: 0.68495% CI: [-7.59, 4.99]MMRM
p-value: 0.58895% CI: [-2.28, 4.01]MMRM
p-value: 0.22995% CI: [-1.21, 5]MMRM
p-value: 0.12595% CI: [-0.67, 5.49]MMRM
p-value: 0.73695% CI: [-2.92, 4.12]MMRM
p-value: 0.33895% CI: [-1.8, 5.23]MMRM
p-value: 0.695% CI: [-2.55, 4.4]MMRM
p-value: 0.65795% CI: [-4.34, 6.86]MMRM
p-value: 0.96595% CI: [-5.41, 5.17]MMRM
p-value: 0.67595% CI: [-4.14, 6.37]MMRM
p-value: 0.8895% CI: [-4.54, 3.89]MMRM
p-value: 0.13595% CI: [-1, 7.33]MMRM
p-value: 0.78595% CI: [-3.56, 4.71]MMRM
p-value: 0.79795% CI: [-3.69, 4.8]MMRM
p-value: >0.99995% CI: [-4.23, 4.23]MMRM
p-value: 0.89695% CI: [-3.91, 4.46]MMRM
p-value: 0.42495% CI: [-10.02, 4.24]MMRM
p-value: 0.89895% CI: [-7.16, 6.29]MMRM
p-value: 0.2695% CI: [-10.42, 2.84]MMRM
p-value: 0.60395% CI: [-2.85, 4.9]MMRM
p-value: 0.06895% CI: [-0.26, 7.39]MMRM
p-value: 0.17495% CI: [-1.17, 6.43]MMRM
p-value: 0.33495% CI: [-2.04, 5.98]MMRM
p-value: 0.15395% CI: [-1.09, 6.91]MMRM
p-value: 0.27995% CI: [-1.78, 6.13]MMRM
p-value: 0.58495% CI: [-5.04, 8.91]MMRM
p-value: 0.34695% CI: [-3.44, 9.73]MMRM
p-value: 0.3795% CI: [-3.55, 9.48]MMRM
p-value: 0.04595% CI: [0.06, 5.83]MMRM
p-value: 0.00695% CI: [1.22, 7.01]MMRM
p-value: 0.26495% CI: [-1.44, 5.23]MMRM
p-value: 0.03795% CI: [0.22, 6.88]MMRM
p-value: 0.39295% CI: [-2.81, 7.14]MMRM
p-value: 0.49395% CI: [-3.09, 6.39]MMRM
p-value: 0.57795% CI: [-2.94, 5.26]MMRM
p-value: 0.96495% CI: [-4.01, 4.2]MMRM
p-value: 0.3795% CI: [-2.35, 6.28]MMRM
p-value: 0.13895% CI: [-1.05, 7.54]MMRM
p-value: 0.66795% CI: [-4.85, 7.56]MMRM
p-value: 0.20395% CI: [-4.85, 7.56]MMRM
p-value: 0.02395% CI: [0.49, 6.41]MMRM
p-value: <0.00195% CI: [2.14, 8.03]MMRM
p-value: 0.24995% CI: [-1.49, 5.7]MMRM
p-value: 0.05995% CI: [-0.13, 6.99]MMRM
p-value: 0.13495% CI: [-1.47, 10.9]MMRM
p-value: 0.07895% CI: [-0.58, 10.97]MMRM
p-value: 0.27595% CI: [-1.32, 4.62]MMRM
p-value: 0.19995% CI: [-1.03, 4.91]MMRM
p-value: 0.65495% CI: [-2.36, 3.74]MMRM
p-value: 0.13895% CI: [-0.74, 5.33]MMRM
p-value: 0.51695% CI: [-3.62, 7.17]MMRM
p-value: 0.19895% CI: [-1.77, 8.46]MMRM
p-value: 0.94195% CI: [-4.15, 3.84]MMRM
p-value: 0.97995% CI: [-3.94, 4.05]MMRM
p-value: 0.28795% CI: [-2.03, 6.84]MMRM
p-value: 0.12595% CI: [-0.96, 7.85]MMRM
p-value: 0.50395% CI: [-4.18, 8.49]MMRM
p-value: 0.09995% CI: [-0.96, 10.98]MMRM
p-value: 0.26895% CI: [-1.45, 5.21]MMRM
p-value: 0.14795% CI: [-0.87, 5.77]MMRM
p-value: 0.14595% CI: [-0.99, 6.73]MMRM
p-value: 0.01495% CI: [0.97, 8.61]MMRM
p-value: 0.85695% CI: [-4.66, 5.61]MMRM
p-value: 0.79395% CI: [-4.24, 5.55]MMRM
p-value: 0.77895% CI: [-3.51, 4.69]MMRM
p-value: 0.77395% CI: [-4.7, 3.5]MMRM
p-value: 0.63195% CI: [-3.34, 5.49]MMRM
p-value: 0.2395% CI: [-1.71, 7.07]MMRM
p-value: 0.90195% CI: [-6.03, 6.84]MMRM
p-value: 0.41295% CI: [-3.54, 8.59]MMRM
p-value: 0.23495% CI: [-1.22, 4.98]MMRM
p-value: 0.09495% CI: [-0.46, 5.77]MMRM
p-value: 0.42395% CI: [-2.08, 4.94]MMRM
p-value: 0.06195% CI: [-0.16, 6.86]MMRM
p-value: 0.65795% CI: [-4.16, 6.57]MMRM
p-value: 0.73795% CI: [-4.22, 5.95]MMRM
p-value: 0.16595% CI: [-1.22, 7.11]MMRM
p-value: 0.10995% CI: [-0.77, 7.56]MMRM
p-value: 0.35995% CI: [-2.26, 6.21]MMRM
p-value: 0.04395% CI: [0.14, 8.56]MMRM
p-value: 0.92395% CI: [-7.15, 6.49]MMRM
p-value: 0.92795% CI: [-6.11, 6.7]MMRM
p-value: 0.01895% CI: [0.82, 8.46]MMRM
p-value: 0.08795% CI: [-0.49, 7.17]MMRM
p-value: 0.19395% CI: [-1.35, 6.64]MMRM
p-value: 0.05195% CI: [-0.01, 7.95]MMRM
p-value: 0.32195% CI: [-3.31, 10.02]MMRM
p-value: 0.32895% CI: [-3.18, 9.44]MMRM
Secondary
Change From Baseline in SDAI at All Assessment Time Points
SDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician and acute phase reactants. The SDAI utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal-phalangeal I-V, proximal interphalangeal I-V and knees. It is calculated using the following formula: SDAI = TJC28 + SJC28 + GH + GP + CRP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment, GP= physician assessment of disease activity using a 10 centimetre \[cm\] visual analogue scale \[VAS\] with 0 = best, 10 = worst), and CRP= C reactive Protein (in mg/L). It ranges between 0.1 and 86. High score indicates worse outcome, low score indicates 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 Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -17.47 Scores on a scale | Standard Error 3.523 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -7.05 Scores on a scale | Standard Error 2.729 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -8.70 Scores on a scale | Standard Error 2.132 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -4.56 Scores on a scale | Standard Error 1.821 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -8.08 Scores on a scale | Standard Error 2.349 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -1.53 Scores on a scale | Standard Error 1.47 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -5.40 Scores on a scale | Standard Error 4.484 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -15.64 Scores on a scale | Standard Error 3.222 |
| Placebo | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -5.53 Scores on a scale | Standard Error 2.095 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -16.67 Scores on a scale | Standard Error 2.835 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -13.95 Scores on a scale | Standard Error 2.712 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -14.66 Scores on a scale | Standard Error 2.367 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -12.30 Scores on a scale | Standard Error 2.092 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -8.62 Scores on a scale | Standard Error 1.848 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -16.05 Scores on a scale | Standard Error 3.569 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -14.36 Scores on a scale | Standard Error 2.152 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -5.62 Scores on a scale | Standard Error 1.466 |
| GSK3196165 22.5 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -17.53 Scores on a scale | Standard Error 2.707 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -5.20 Scores on a scale | Standard Error 1.527 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -12.81 Scores on a scale | Standard Error 2.073 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -17.23 Scores on a scale | Standard Error 2.353 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -22.64 Scores on a scale | Standard Error 2.605 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -14.99 Scores on a scale | Standard Error 2.163 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -17.41 Scores on a scale | Standard Error 2.741 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -23.17 Scores on a scale | Standard Error 2.621 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -21.77 Scores on a scale | Standard Error 3.165 |
| GSK3196165 45 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -9.28 Scores on a scale | Standard Error 1.851 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -21.07 Scores on a scale | Standard Error 2.945 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -21.20 Scores on a scale | Standard Error 2.64 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -22.91 Scores on a scale | Standard Error 2.484 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -10.03 Scores on a scale | Standard Error 1.804 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -23.47 Scores on a scale | Standard Error 2.437 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -16.95 Scores on a scale | Standard Error 2.281 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -5.86 Scores on a scale | Standard Error 1.47 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -15.50 Scores on a scale | Standard Error 2.095 |
| GSK3196165 90 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -14.76 Scores on a scale | Standard Error 2.037 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -13.97 Scores on a scale | Standard Error 2.042 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -24.06 Scores on a scale | Standard Error 2.67 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -11.22 Scores on a scale | Standard Error 1.819 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -21.28 Scores on a scale | Standard Error 3.2 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -19.26 Scores on a scale | Standard Error 2.329 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -15.70 Scores on a scale | Standard Error 2.165 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -6.31 Scores on a scale | Standard Error 1.495 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -16.73 Scores on a scale | Standard Error 2.708 |
| GSK3196165 135 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -21.68 Scores on a scale | Standard Error 2.632 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 16,n=8,16,20,23, 18, 36 | -25.08 Scores on a scale | Standard Error 2.351 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 2,n=35,34,34,36,36,36 | -11.40 Scores on a scale | Standard Error 1.808 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 12,n=34,35,33,37, 34, 36 | -23.90 Scores on a scale | Standard Error 2.676 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 8,n=34,33,34,37, 35, 32 | -22.09 Scores on a scale | Standard Error 2.358 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 20,n=8,15,20,25, 18, 35 | -26.17 Scores on a scale | Standard Error 2.263 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 1,n=35,36,32,35, 34, 37 | -9.30 Scores on a scale | Standard Error 1.448 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 24,n=8,14,20,24, 19, 33 | -26.27 Scores on a scale | Standard Error 2.667 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 4,n=32,33,34,35, 36, 36 | -18.03 Scores on a scale | Standard Error 2.032 |
| GSK3196165 180 mg | Change From Baseline in SDAI at All Assessment Time Points | SDAI, Week 6,n=35,34,33,36,32, 36 | -18.86 Scores on a scale | Standard Error 2.109 |
p-value: 0.0595% CI: [-8.18, 0]MMRM
p-value: 0.08695% CI: [-7.84, 0.52]MMRM
p-value: 0.03895% CI: [-8.43, -0.23]MMRM
p-value: 0.11995% CI: [-9.18, 1.05]MMRM
p-value: 0.07195% CI: [-9.85, 0.4]MMRM
p-value: 0.03495% CI: [-10.53, -0.42]MMRM
p-value: 0.02395% CI: [-12.61, -0.94]MMRM
p-value: 0.01495% CI: [-13.09, -1.47]MMRM
p-value: 0.00295% CI: [-14.99, -3.47]MMRM
p-value: 0.06395% CI: [-11.62, 0.32]MMRM
p-value: 0.0495% CI: [-12.28, -0.3]MMRM
p-value: 0.02495% CI: [-12.69, -0.9]MMRM
p-value: 0.0595% CI: [-13.15, -0.01]MMRM
p-value: 0.00695% CI: [-15.71, -2.6]MMRM
p-value: 0.00795% CI: [-15.32, -2.41]MMRM
p-value: 0.07495% CI: [-14.49, 0.68]MMRM
p-value: 0.00895% CI: [-17.99, -2.74]MMRM
p-value: <0.00195% CI: [-21.64, -6.67]MMRM
p-value: 0.65695% CI: [-10.19, 6.43]MMRM
p-value: 0.09395% CI: [-15.19, 1.19]MMRM
p-value: 0.07695% CI: [-15.3, 0.78]MMRM
p-value: 0.8695% CI: [-8.14, 9.74]MMRM
p-value: 0.19695% CI: [-14.4, 2.99]MMRM
p-value: 0.16495% CI: [-14.48, 2.48]MMRM
p-value: 0.06695% CI: [-21.99, 0.69]MMRM
p-value: 0.00395% CI: [-27.25, -5.49]MMRM
p-value: 0.00495% CI: [-26.3, -5.03]MMRM
p-value: 0.02495% CI: [-8.91, -0.65]MMRM
p-value: <0.00195% CI: [-11.84, -3.7]MMRM
p-value: 0.0195% CI: [-11.74, -1.6]MMRM
p-value: 0.00895% CI: [-11.91, -1.78]MMRM
p-value: 0.00495% CI: [-14.2, -2.67]MMRM
p-value: <0.00195% CI: [-18.26, -6.75]MMRM
p-value: 0.02295% CI: [-12.99, -1.01]MMRM
p-value: <0.00195% CI: [-16.07, -4.24]MMRM
p-value: <0.00195% CI: [-17.7, -4.66]MMRM
p-value: <0.00195% CI: [-20.57, -7.44]MMRM
p-value: 0.01395% CI: [-17.26, -2.11]MMRM
p-value: <0.00195% CI: [-24.39, -9.32]MMRM
p-value: 0.14995% CI: [-14.24, 2.18]MMRM
p-value: 0.01995% CI: [-17.32, -1.55]MMRM
p-value: 0.13895% CI: [-15.32, 2.14]MMRM
p-value: 0.0495% CI: [-16.99, -0.42]MMRM
p-value: 0.00595% CI: [-26.77, -4.98]MMRM
p-value: <0.00195% CI: [-31.2, -10.53]MMRM
Secondary
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is associated with liver injury and impaired liver function or any other situations as per Medical or Scientific judgment. Overall AEs and SAEs for the entire study duration until follow-up have been presented.
Time frame: Up to 62 weeks
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 26 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 1 Participants |
| GSK3196165 22.5 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 2 Participants |
| GSK3196165 22.5 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 24 Participants |
| GSK3196165 45 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 26 Participants |
| GSK3196165 45 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 1 Participants |
| GSK3196165 90 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 28 Participants |
| GSK3196165 90 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 2 Participants |
| GSK3196165 135 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 28 Participants |
| GSK3196165 135 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 2 Participants |
| GSK3196165 180 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any SAE | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Any AE | 24 Participants |
Secondary
Number of Participants With Opportunistic Infections
An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Opportunistic infections were categorized as AE of special interest. The number of participants with overall opportunistic infections have been presented.
Time frame: Up to 62 weeks
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Opportunistic Infections | 0 Participants |
| GSK3196165 22.5 mg | Number of Participants With Opportunistic Infections | 0 Participants |
| GSK3196165 45 mg | Number of Participants With Opportunistic Infections | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Opportunistic Infections | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Opportunistic Infections | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Opportunistic Infections | 0 Participants |
Secondary
Number of Participants With Pulmonary Events
Pulmonary assessments were performed to determine the number of participants with pulmonary events including persistent cough, persistent dyspnea, and persistent Diffusing capacity of the lung for carbon monoxide (DLCO). Persistent is defined as any event with duration \>=15 days. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants experiencing pulmonary events have been reported.
Time frame: Up to 62 weeks
Population: ITT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Pulmonary Events | Persistent Dyspnea | 1 Participants |
| Placebo | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 2 Participants |
| Placebo | Number of Participants With Pulmonary Events | Persistent Cough | 1 Participants |
| GSK3196165 22.5 mg | Number of Participants With Pulmonary Events | Persistent Dyspnea | 0 Participants |
| GSK3196165 22.5 mg | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 3 Participants |
| GSK3196165 22.5 mg | Number of Participants With Pulmonary Events | Persistent Cough | 0 Participants |
| GSK3196165 45 mg | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 1 Participants |
| GSK3196165 45 mg | Number of Participants With Pulmonary Events | Persistent Dyspnea | 0 Participants |
| GSK3196165 45 mg | Number of Participants With Pulmonary Events | Persistent Cough | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Pulmonary Events | Persistent Cough | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Pulmonary Events | Persistent Dyspnea | 1 Participants |
| GSK3196165 90 mg | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Pulmonary Events | Persistent Cough | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Pulmonary Events | Persistent Dyspnea | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 3 Participants |
| GSK3196165 180 mg | Number of Participants With Pulmonary Events | Persistent Cough | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Pulmonary Events | Persistent DLCO decrease >15% from Baseline | 1 Participants |
| GSK3196165 180 mg | Number of Participants With Pulmonary Events | Persistent Dyspnea | 0 Participants |
Secondary
Number of Participants With Serious Infections
An AE is any untoward medical occurrence in a participant or clinical investigation participants, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious infections were categorized as AE of special interest. The number of participants with overall serious infections have been presented.
Time frame: Up to 62 weeks
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Serious Infections | 0 Participants |
| GSK3196165 22.5 mg | Number of Participants With Serious Infections | 1 Participants |
| GSK3196165 45 mg | Number of Participants With Serious Infections | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Serious Infections | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Serious Infections | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Serious Infections | 0 Participants |
Secondary
Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry
Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen, that is called as blood oxygen saturation. Baseline was defined as the last available assessment prior to the start of study treatment. The number of participants with blood oxygen level \< 80%, 80% to \<90% and \>=90% have been reported.
Time frame: Up to 62 weeks
Population: ITT Population. Only those participants with data available at specified time point were analyzed (represented by n=x in category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| Placebo | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| Placebo | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 37 Participants |
| GSK3196165 22.5 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 22.5 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 22.5 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 36 Participants |
| GSK3196165 45 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 45 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 37 Participants |
| GSK3196165 45 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 90 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 37 Participants |
| GSK3196165 135 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 135 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 35 Participants |
| GSK3196165 135 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 1 Participants |
| GSK3196165 180 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | 80% to <90%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | < 80%; n=37, 36, 37, 37, 36, 37 | 0 Participants |
| GSK3196165 180 mg | Number of Participants With Worst-case Post-Baseline Results for Pulse Oximetry | >= 90%; n=37, 36, 37, 37, 36, 37 | 37 Participants |
Secondary
Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points
DAS28(CRP) scores were categorized using EULAR response criteria. Response at a given time point was defined based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to Baseline. The definition of no response, moderate response and good response was as follows: Current DAS28 \<=3.2 and DAS28 decrease from Baseline (\>1.2=good response), (\>0.6 to \<=1.2 = moderate response) and (\<=0.6 =no response). Current DAS28 \>3.2 to \<=5.1 and DAS28 decrease from Baseline value (\>1.2 =moderate response), (\>0.6 to \<=1.2 = moderate response) and (\<=0.6 =no response). Current DAS28 \>5.1 and DAS28 decrease from Baseline value (\>1.2=moderate response), (\>0.6 to \<=1.2 = no response) and (\<=0.6 =no response). If the post-Baseline DAS28(CRP) score was missing, then the corresponding EULAR category was set to missing.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 24 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 16 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 22 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 22 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 5 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 16 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 14 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 16 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 3 Percentage of participants |
| Placebo | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 32 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 19 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 46 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 43 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 43 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 35 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 35 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 22 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 46 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 32 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 46 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 38 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 51 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 51 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 59 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 22 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 54 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 43 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 51 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 46 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 65 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 65 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 68 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 59 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 54 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 38 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 24 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 43 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 46 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 43 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 19 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 32 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 59 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 43 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 49 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 43 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 16 | 73 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 20 | 73 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 6 | 65 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 1 | 27 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 44 | 59 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 4 | 68 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 40 | 65 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 12 | 76 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 8 | 68 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 28 | 78 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 36 | 73 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 52 | 51 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 48 | 65 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 32 | 73 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 24 | 70 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 2 | 38 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points | Week 62 (follow-up) | 54 Percentage of participants |
p-value: 0.03795% CI: [1.1, 31.4]Regression, Logistic
p-value: 0.14495% CI: [-3.1, 24.7]Regression, Logistic
p-value: 0.03395% CI: [3.3, 34.5]Regression, Logistic
p-value: 0.43795% CI: [-11.3, 22.2]Regression, Logistic
p-value: 0.75595% CI: [-13.5, 18.9]Regression, Logistic
p-value: 0.02395% CI: [5.2, 43.4]Regression, Logistic
p-value: 0.00695% CI: [9.8, 49.7]Regression, Logistic
p-value: 0.03995% CI: [2, 41.2]Regression, Logistic
p-value: 0.00895% CI: [9.8, 49.7]Regression, Logistic
p-value: 0.04495% CI: [0.4, 42.8]Regression, Logistic
p-value: 0.08395% CI: [-2.2, 40]Regression, Logistic
95% CI: [5.8, 48.3]
95% CI: [-11.2, 32.8]
95% CI: [5.2, 48.9]
95% CI: [10.9, 54]
95% CI: [0.9, 42.4]
95% CI: [8.9, 50.6]
95% CI: [25.9, 66]
95% CI: [-6.8, 33.8]
95% CI: [11.6, 53.3]
95% CI: [17.2, 58.5]
95% CI: [-0.5, 38.4]
95% CI: [15.1, 55.1]
95% CI: [29.2, 68.1]
95% CI: [-3, 35.4]
95% CI: [9.8, 49.7]
95% CI: [17.9, 57.8]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [4.7, 33.2]
95% CI: [4.7, 33.2]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [4.7, 33.2]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [4.7, 33.2]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [-6.3, 11.7]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [-1.1, 28.1]
95% CI: [5.6, 37.7]
95% CI: [0.2, 37.6]
95% CI: [5.2, 43.4]
95% CI: [7.1, 46.9]
95% CI: [32.2, 70.5]
95% CI: [0.4, 42.8]
95% CI: [19.9, 61.2]
95% CI: [5.2, 48.9]
95% CI: [13.8, 56.5]
95% CI: [6.2, 47.9]
95% CI: [34.9, 73.2]
95% CI: [0.9, 42.4]
95% CI: [31.8, 70.9]
95% CI: [7.1, 46.9]
95% CI: [38.2, 75.4]
95% CI: [7.1, 46.9]
95% CI: [35.1, 73]
95% CI: [0.5, 26.5]
95% CI: [61.4, 89.9]
95% CI: [0.5, 26.5]
95% CI: [55, 85.5]
95% CI: [0.5, 26.5]
95% CI: [55, 85.5]
95% CI: [0.5, 26.5]
95% CI: [45.9, 78.4]
95% CI: [0.5, 26.5]
95% CI: [40.1, 73.4]
95% CI: [0.5, 26.5]
95% CI: [45.9, 78.4]
95% CI: [0.5, 26.5]
95% CI: [31.7, 65.6]
95% CI: [0.5, 26.5]
95% CI: [34.5, 68.2]
Secondary
Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission
CDAI combines information relating to the number of swollen and tender joints, in addition to a measure of general health from both the participants and the physician. CDAI 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: CDAI =TJC28 + SJC28 + GH + GP Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity and GP=physician assessment of disease activity using a 10 cm visual analogue scale with 0 = best, 100 = worst). It ranges between 0 and 76. High score indicates worse outcome, low score indicates better outcome. Remission was achieved for a non-missing CDAI value \<=2.8.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 3 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 3 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 0 Percentage of participants |
| Placebo | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 32 | 11 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 20 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 36 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 16 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 12 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 40 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 8 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 6 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 48 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 44 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 4 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 62 (follow-up) | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 2 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 52 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 28 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 24 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants in Clinical Disease Activity Index (CDAI) Remission | CDAI, Week 1 | 0 Percentage of participants |
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-7.9, 2.5]
95% CI: [-7.9, 2.5]
95% CI: [-7.4, 7.4]
95% CI: [-7.9, 2.5]
95% CI: [-7.9, 2.5]
95% CI: [-3.2, 19.4]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [4.3, 28.1]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [2.5, 24.5]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [2.5, 24.5]
95% CI: [-2.5, 7.9]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-7.4, 7.4]
95% CI: [-7.4, 7.4]
95% CI: [-7.4, 7.4]
95% CI: [-6.3, 11.7]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [4.3, 28.1]
95% CI: [-1.9, 12.7]
Secondary
Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points
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)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 5 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 22 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 27 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 24 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 62 (follow-up) | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 1 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 2 | 1 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 4 | 4 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 6 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 8 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 12 | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 16 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 28 | 22 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 20 | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 24 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 32 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 36 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 40 | 24 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 44 | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 48 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points | Week 52 | 14 Percentage of participants |
95% CI: [-1.9, 12.7]
95% CI: [-10.3, 10.3]
95% CI: [-12.7, 1.9]
95% CI: [-10.3, 10.3]
95% CI: [-7.9, 2.5]
95% CI: [-6.3, 11.7]
95% CI: [-1.4, 23]
95% CI: [-4.8, 15.6]
95% CI: [-6.3, 11.7]
95% CI: [6.8, 36.4]
95% CI: [-2.5, 7.9]
95% CI: [2.5, 24.5]
95% CI: [12.7, 41.3]
95% CI: [-7.9, 2.5]
95% CI: [0.5, 26.5]
95% CI: [2.6, 29.9]
95% CI: [-6.3, 11.7]
95% CI: [0.5, 26.5]
95% CI: [2.6, 29.9]
95% CI: [-7.4, 7.4]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [-6.3, 11.7]
95% CI: [4.7, 33.2]
95% CI: [-1.4, 23]
95% CI: [-6.3, 11.7]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [2.5, 24.5]
95% CI: [-6.3, 11.7]
95% CI: [-1.4, 23]
95% CI: [0.5, 26.5]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [2.5, 24.5]
95% CI: [-6.3, 11.7]
95% CI: [-1.4, 23]
95% CI: [-3.2, 19.4]
95% CI: [-7.9, 2.5]
95% CI: [-4.8, 15.6]
95% CI: [-7.4, 7.4]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-11.7, 6.3]
95% CI: [-8.7, 14.1]
95% CI: [-6.3, 11.7]
95% CI: [-4.8, 15.6]
95% CI: [-7.4, 7.4]
95% CI: [0.5, 26.5]
95% CI: [-1.9, 12.7]
95% CI: [6.3, 31.5]
95% CI: [-1.4, 23]
95% CI: [0.5, 26.5]
95% CI: [-1.4, 23]
95% CI: [-1.4, 23]
95% CI: [-1.4, 23]
95% CI: [4.7, 33.2]
95% CI: [-3.2, 19.4]
95% CI: [2.6, 29.9]
95% CI: [0.5, 26.5]
95% CI: [2.6, 29.9]
95% CI: [0.8, 20.8]
95% CI: [10.5, 38.1]
95% CI: [-1.4, 23]
95% CI: [0.5, 26.5]
95% CI: [2.5, 24.5]
95% CI: [6.3, 31.5]
95% CI: [-1.4, 23]
95% CI: [-1.4, 23]
95% CI: [-3.2, 19.4]
95% CI: [2.6, 29.9]
Secondary
Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points
The ACR definition for calculating improvement in rheumatoid arthritis is calculated as a 20% improvement (ACR20) in both tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: participant and physician global assessments, participant's assessment of arthritis pain, disability, and an acute-phase reactant (i.e. CRP value). Similarly, ACR50 and ACR70 were calculated with the respective percent improvement. The specific components of the ACR assessments are as follows: Tender/Painful Joint count 68 (TJC68), Swollen Joint Count 66 (SJC66), Participant's Assessment of Arthritis Pain, Participant's Global Assessment of Arthritis Disease Activity, Physician's Global Assessment of Arthritis, CRP (mg/L) and Health Assessment Questionnaire - Disability Index (HAQ-DI). For all visits, if any of the component scores were missing, then those scores were considered as not having met the criteria for improvement.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 16 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 16 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 11 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 22 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 11 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 8 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 8 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 16 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 11 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 8 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 8 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 14 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 3 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 0 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 5 Percentage of participants |
| Placebo | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 11 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 24 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 22 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 35 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 30 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 11 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 24 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 11 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 24 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 19 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 11 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 24 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 8 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 32 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 35 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 41 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 27 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 30 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 41 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 46 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 27 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 38 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 24 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 41 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 27 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 22 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 22 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 19 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 16 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 54 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 30 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 51 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 32 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 24 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 46 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 27 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 57 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 51 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 19 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 22 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 32 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 16 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 32 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 24 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 46 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 19 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 41 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 24 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 24 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 35 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 16 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 35 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 30 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 41 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 41 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 27 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 49 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 38 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 50 | 38 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 20 | 46 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 20 | 68 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 20 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 20 | 59 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 70 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 20 | 54 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 50 | 27 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 50 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 20 | 51 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 70 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 50 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 52, ACR 70 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 50 | 30 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 50 | 35 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 50 | 24 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 20 | 43 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 50 | 22 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 70 | 22 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 20 | 59 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 50 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 70 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 28, ACR 20 | 68 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 1, ACR 70 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 50 | 22 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 2, ACR 70 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 70 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 50 | 35 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 70 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 20 | 54 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 70 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 20, ACR 70 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 70 | 11 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 20 | 43 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 12, ACR 20 | 51 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 50 | 32 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 50 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 16, ACR 70 | 11 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 50 | 27 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 24, ACR 70 | 19 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 70 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 40, ACR 70 | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 36, ACR 20 | 59 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 8, ACR 20 | 51 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 4, ACR 20 | 46 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 70 | 16 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 44, ACR 20 | 54 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 32, ACR 50 | 30 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 62 (follow-up), ACR 50 | 27 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 48, ACR 20 | 57 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With American College of Rheumatology's (ACR) 20/50/70 Response Rates at All Assessment Time Points | Week 6, ACR 50 | 14 Percentage of participants |
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [-1.1, 28.1]
95% CI: [-5.1, 21.3]
95% CI: [-3.1, 24.7]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-0.7, 16.9]
95% CI: [-0.2, 32.6]
95% CI: [9.3, 44.7]
95% CI: [6.9, 41.8]
95% CI: [-10.3, 10.3]
95% CI: [-10.3, 10.3]
95% CI: [-7, 17.8]
95% CI: [-2.5, 7.9]
95% CI: [-9.3, 30.9]
95% CI: [-11.7, 27.9]
95% CI: [-9.3, 30.9]
95% CI: [-17.8, 7]
95% CI: [-16, 10.6]
95% CI: [-14.1, 14.1]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-10.1, 26.3]
95% CI: [4.5, 44.1]
95% CI: [9.8, 49.7]
95% CI: [-3.2, 19.4]
95% CI: [-1.4, 23]
95% CI: [2.6, 29.9]
95% CI: [-7.9, 2.5]
95% CI: [-7.4, 7.4]
95% CI: [-3.2, 19.4]
95% CI: [6, 42.7]
95% CI: [11, 48.4]
95% CI: [21.6, 59.5]
95% CI: [-10.6, 16]
95% CI: [2.1, 35.7]
95% CI: [-0.2, 32.6]
95% CI: [-11.7, 6.3]
95% CI: [-5.1, 21.3]
95% CI: [-1.1, 28.1]
95% CI: [-5.4, 32.4]
95% CI: [9.8, 49.7]
95% CI: [15.1, 55.1]
95% CI: [-2.4, 29.4]
95% CI: [2.1, 35.7]
95% CI: [2.1, 35.7]
95% CI: [-11.7, 6.3]
95% CI: [-5.1, 21.3]
95% CI: [-1.1, 28.1]
95% CI: [-10.1, 26.3]
95% CI: [2, 41.2]
95% CI: [17.9, 57.8]
95% CI: [-10.6, 16]
95% CI: [-0.2, 32.6]
95% CI: [-2.4, 29.4]
95% CI: [-11.7, 6.3]
95% CI: [-3.1, 24.7]
95% CI: [-5.1, 21.3]
95% CI: [-6.9, 28.5]
95% CI: [7.7, 46.3]
95% CI: [23.8, 62.6]
95% CI: [-14.1, 14.1]
95% CI: [-1.2, 33.7]
95% CI: [1.1, 36.7]
95% CI: [-10.3, 10.3]
95% CI: [-5.1, 21.3]
95% CI: [-5.1, 21.3]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [-1.4, 23]
95% CI: [-1.4, 23]
95% CI: [-4.8, 15.6]
95% CI: [4.7, 33.2]
95% CI: [4.7, 33.2]
95% CI: [-4.8, 15.6]
95% CI: [4.7, 33.2]
95% CI: [0.5, 26.5]
95% CI: [-6.3, 11.7]
95% CI: [2.6, 29.9]
95% CI: [-1.4, 23]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [0.5, 26.5]
95% CI: [-6.3, 11.7]
95% CI: [2.6, 29.9]
95% CI: [-3.2, 19.4]
95% CI: [-1.9, 12.7]
95% CI: [6.3, 31.5]
95% CI: [0.8, 20.8]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [4.7, 33.2]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [-1.4, 23]
95% CI: [-6.3, 11.7]
95% CI: [0.5, 26.5]
95% CI: [-1.4, 23]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [0.5, 26.5]
95% CI: [-2.5, 7.9]
95% CI: [6.3, 31.5]
95% CI: [0.8, 20.8]
95% CI: [-4.8, 15.6]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [0.5, 26.5]
95% CI: [2.6, 29.9]
95% CI: [2.6, 29.9]
95% CI: [-1.9, 12.7]
95% CI: [6.3, 31.5]
95% CI: [-0.7, 16.9]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [-1.9, 12.7]
95% CI: [4.3, 28.1]
95% CI: [0.8, 20.8]
95% CI: [-4.8, 15.6]
95% CI: [0.5, 26.5]
95% CI: [-3.2, 19.4]
95% CI: [-6.3, 11.7]
95% CI: [0.5, 26.5]
95% CI: [-4.8, 15.6]
95% CI: [-7.9, 2.5]
95% CI: [0.5, 26.5]
95% CI: [-7.4, 7.4]
95% CI: [-1.9, 12.7]
95% CI: [6.3, 31.5]
95% CI: [12.7, 46.8]
95% CI: [20.3, 55.4]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [19.5, 56.1]
95% CI: [19.5, 56.1]
95% CI: [-8.7, 14.1]
95% CI: [-8.7, 14.1]
95% CI: [-1.9, 12.7]
95% CI: [-6.8, 33.8]
95% CI: [3.5, 45.2]
95% CI: [-12.2, 17.6]
95% CI: [-12.2, 17.6]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [12.4, 52.4]
95% CI: [15.1, 55.1]
95% CI: [6.8, 36.4]
95% CI: [2.6, 29.9]
95% CI: [-4.8, 15.6]
95% CI: [-4.8, 15.6]
95% CI: [11, 48.4]
95% CI: [21.6, 59.5]
95% CI: [4.5, 38.8]
95% CI: [-2.4, 29.4]
95% CI: [-8.7, 14.1]
95% CI: [-7, 17.8]
95% CI: [4.5, 44.1]
95% CI: [32.2, 70.5]
95% CI: [2.1, 35.7]
95% CI: [-2.4, 29.4]
95% CI: [-7, 17.8]
95% CI: [2, 41.2]
95% CI: [23.5, 63]
95% CI: [6.9, 41.8]
95% CI: [4.5, 38.8]
95% CI: [3.3, 34.5]
95% CI: [-1.1, 28.1]
95% CI: [7.7, 46.3]
95% CI: [26.7, 65.2]
95% CI: [-3.6, 30.6]
95% CI: [-1.2, 33.7]
95% CI: [-1.1, 28.1]
95% CI: [-1.1, 28.1]
95% CI: [0.5, 26.5]
95% CI: [48.9, 80.8]
95% CI: [0.5, 26.5]
95% CI: [6.8, 36.4]
95% CI: [-3.2, 19.4]
95% CI: [-1.4, 23]
95% CI: [0.5, 26.5]
95% CI: [34.5, 68.2]
95% CI: [0.5, 26.5]
95% CI: [11.4, 42.7]
95% CI: [-1.4, 23]
95% CI: [0.8, 20.8]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [40.1, 73.4]
95% CI: [0.5, 26.5]
95% CI: [16.2, 48.7]
95% CI: [4.3, 28.1]
95% CI: [2.5, 24.5]
95% CI: [0.5, 26.5]
95% CI: [34.5, 68.2]
95% CI: [-1.4, 23]
95% CI: [13.8, 45.7]
95% CI: [-3.2, 19.4]
95% CI: [0.5, 26.5]
95% CI: [0.5, 26.5]
95% CI: [34.5, 68.2]
95% CI: [-1.4, 23]
95% CI: [18.7, 51.6]
95% CI: [6.3, 31.5]
95% CI: [0.5, 26.5]
95% CI: [37.3, 70.9]
95% CI: [0.5, 26.5]
95% CI: [16.2, 48.7]
95% CI: [2.5, 24.5]
95% CI: [8.4, 34.9]
95% CI: [0.5, 26.5]
95% CI: [31.7, 65.6]
95% CI: [0.5, 26.5]
95% CI: [9.1, 39.6]
95% CI: [2.5, 24.5]
95% CI: [2.5, 24.5]
95% CI: [0.5, 26.5]
95% CI: [23.7, 57.3]
95% CI: [0.5, 26.5]
95% CI: [9.1, 39.6]
95% CI: [-1.4, 23]
95% CI: [2.6, 29.9]
Secondary
Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points
Boolean-based remission was achieved if all of the following requirements were met at the same time: TJC68 \<= 1,SJC66 \<= 1,CRP \<= 1mg/dL, PtGA \<= 10. If one of the components was missing at an individual assessment point, Boolean-based remission for that assessment was set to missing.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 32 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 28 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 24 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 20 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 48 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 16 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 12 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 8 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 62 (follow-up) | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 52 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 6 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 40 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 36 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 2 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Boolean-based ACR/EULAR Remission Rates at All Assessment Time Points | Boolean based ACR/EULAR, Week 44 | 5 Percentage of participants |
95% CI: [-2.5, 7.9]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [0.4, 42.8]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
Secondary
Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points
Index-based remission was achieved if the following requirement was met: SDAI \<= 3.3. If the SDAI value was missing at an individual assessment point, Index-based remission for that assessment was set to missing.
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 3 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 0 Percentage of participants |
| Placebo | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 3 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 5 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 0 Percentage of participants |
| GSK3196165 22.5 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 3 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 8 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 11 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 14 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 5 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 45 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 14 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 8 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 5 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 3 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 11 Percentage of participants |
| GSK3196165 90 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 0 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 3 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 8 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 14 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 11 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 5 Percentage of participants |
| GSK3196165 135 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 32 | 11 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 28 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 24 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 1 | 0 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 48 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 20 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 16 | 5 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 12 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 8 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 62 (follow-up) | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 52 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 6 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 4 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 40 | 14 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 2 | 3 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 44 | 8 Percentage of participants |
| GSK3196165 180 mg | Percentage of Participants With Index-based ACR/EULAR Remission Rates at All Assessment Time Points | Index based ACR/EULAR, Week 36 | 5 Percentage of participants |
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-7.9, 2.5]
95% CI: [-7.9, 2.5]
95% CI: [-7.4, 7.4]
95% CI: [-7.9, 2.5]
95% CI: [-7.9, 2.5]
95% CI: [-7.4, 7.4]
95% CI: [-1.9, 68.2]
95% CI: [-2.5, 7.9]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [0.8, 20.8]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [0.8, 20.8]
95% CI: [2.5, 24.5]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [0.8, 20.8]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-2.5, 7.9]
95% CI: [-7.4, 7.4]
95% CI: [-7.4, 7.4]
95% CI: [-7.4, 7.4]
95% CI: [-7.4, 7.4]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-2.5, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [2.5, 24.5]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [0.8, 20.8]
95% CI: [-2.5, 7.9]
95% CI: [-1.9, 12.7]
95% CI: [-0.7, 16.9]
95% CI: [-1.9, 12.7]
95% CI: [2.5, 24.5]
Secondary
Time to First DAS28(CRP) Remission
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). Median time, to remission has been presented.
Time frame: Up to Week 62
Population: ITT Population. Only those participants with data available at the time of assessment were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to First DAS28(CRP) Remission | 9.10 Weeks |
| GSK3196165 22.5 mg | Time to First DAS28(CRP) Remission | 12.05 Weeks |
| GSK3196165 45 mg | Time to First DAS28(CRP) Remission | 16.10 Weeks |
| GSK3196165 90 mg | Time to First DAS28(CRP) Remission | 8.10 Weeks |
| GSK3196165 135 mg | Time to First DAS28(CRP) Remission | 19.90 Weeks |
| GSK3196165 180 mg | Time to First DAS28(CRP) Remission | 18.20 Weeks |