| Primary | Percentage of Participants With 20% Improvement in American College of Rheumatology Criteria (ACR20) at Week 12 Superiority Comparison With Placebo | ACR20 is calculated as a 20% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. | | OG003 | Pooled Placebo | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo + csDMARD administered by weekly subcutaneous injection until Week 12. The placebo arms are pooled into a single placebo arm. |
| | Units | Counts |
|---|
| Participants | - OG000156
- OG001158
- OG002156
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00044.8± 4.19
- OG00150.7± 4.12
- OG00257.5± 4.19
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis is that there is no difference between 90 mg dose of GSK3196165 and placebo in the proportion of participants achieving ACR20 response at Week 12 versus the alternative hypothesis that the 90 mg dose of GSK3196165 differs from placebo in the proportion of participants with ACR20 response at Week 12 | Regression, Logistic | OR and corresponding 95%CI are generated from logistic regression model adjusted for Baseline, Treatment Group, Previously Failed Medical Category. | 0.2868 | | Odds Ratio (OR) | 1.38 | | | 2-Sided | .95 | 0.76 | 2.48 | | | | | Superiority | |
|
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) (Versus Placebo) at Week 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily living activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. Overall HAQ-DI score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD |
|
| Secondary | Percentage of Participants With Clinical Disease Activity Index (CDAI) Total Score <=10 (CDAI Low Disease Activity [LDA]) at Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD |
|
| Secondary | Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score <=10. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With CDAI Total Score <=10 (CDAI LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. LDA is achieved when CDAI total score <=10. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo +csDMARD until Week 12 later switched to GSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in CDAI Total Score at Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. A negative CDAI total score change from baseline indicates an improvement in disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD |
|
| Secondary | Change From Baseline in CDAI Total Score at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in CDAI Total Score at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in Arthritis Pain Visual Analogue Scale (VAS) at Week 12 | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Score on scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Change From Baseline in Arthritis Pain VAS at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Arthritis Pain VAS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD |
|
| Secondary | Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28),Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With CDAI Total Score <=2.8 (CDAI Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With ACR20 at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With ACR20 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | ACR20 is calculated as a 20% improvement from Baseline in TJC68 and SJC66 and a 20% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With 50% Improvement in American College of Rheumatology Criteria (ACR50) at Week 12 | ACR50 is calculated as a 50% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With ACR50 at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With ACR50 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | ACR50 is calculated as a 50% improvement from Baseline in TJC68 and SJC66 and a 50% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With 70% Improvement in American College of Rheumatology Criteria (ACR70) at Week 12 | ACR70 is calculated as a 70% improvement from Baseline in Tender Joint Count 68 (TJC68) and Swollen Joint Count 66 (SJC66) and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale (VAS) with values from 0=best to 100=worst), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS with values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS with values from 0=no pain and 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP)). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With ACR70 at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With ACR70 at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | ACR70 is calculated as a 70% improvement from Baseline in TJC68 and SJC66 and a 70% improvement in 3 of the following 5 measures: Patient's Global Assessment of Arthritis Disease Activity (PtGA), Physician Global Assessment of Arthritis Disease Activity (PhGA) (VAS values from 0=best to 100=worst), Patient Assessment of Arthritis Pain (VAS values from 0=no pain to 100=most severe pain), Health Assessment Questionnaire-Disability Index (HAQ-DI) (0=least difficulty to 3=extreme difficulty) and an acute-phase reactant (high sensitivity C-reactive Protein mg/L (hsCRP). | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <=3.2 (DAS28-CRP LDA) at Week 12 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | |
|
| Secondary | Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With DAS28-CRP <=3.2 (DAS28-CRP LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP<=3.2 . A negative change from baseline in DAS28-CRP indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28 Erythrocyte Sedimentation Rate (ESR) <=3.2 (DAS28-ESR LDA) at Week 12 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | |
|
| Secondary | Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28-ESR <=3.2 (DAS28-ESR LDA) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Low disease activity (LDA) is achieved when DAS28-ESR<=3.2. A negative change from baseline in DAS28-ESR indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 12 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The DAS28-CRP arthritis is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-CRP <2.6. A negative change from baseline in DAS28-CRP indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) at Week 12 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With DAS28-ESR <2.6 (DAS28-ESR Remission) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With a Good/Moderate European League Against Rheumatism (EULAR) Response at Week 12 | DAS28-CRP and DAS28-ESR scores categorized using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1). For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1). | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD |
|
| Secondary | Percentage of Participants With a Good/Moderate EULAR Response at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | DAS28-CRP and DAS28-ESR scores categorised using EULAR response criteria. Response based on the combination of current DAS28 score and the improvement in the current DAS28 score relative to baseline (Good response = DAS28 change >1.2 with current DAS28 ≤3.2; Moderate response = DAS28 change >0.6 with current DAS28 >3.2-5.1; Non-response = DAS28 change ≤0.6 and current DAS28 >5.1). | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Percentage of Participants With ACR/EULAR Remission at Week 12 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (hsCRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Percentage of Participants With ACR/EULAR Remission at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Percentage of Participants With ACR/EULAR Remission at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) ≤ 1, Swollen Joint Count 66 (SJC66) ≤ 1, high sensitivity C-reactive Protein (CRP) ≤ 1mg/dl and patient's global assessment of disease activity (PtGA) ≤ 10. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Number | | Percentage of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 |
|
| Secondary | Change From Baseline in DAS28-CRP and DAS28-ESR at Week 12 | DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 |
|
| Secondary | Change From Baseline in DAS28-CRP and DAS28-ESR at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using Swollen Joint Count 28 (TJC28), Tender Joint Count 28 (TJC28), high sensitivity C-reactive Protein (hsCRP in mg/L)/Erythrocyte sedimentation rate (ESR in mm/hr (mm/hour) and patient's global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, with higher scores indicating more disease activity. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in HAQ-DI at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in HAQ-DI at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the difficulty of a participant in eight domains of daily activities: Dressing & grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, Common daily activities. HAQ-DI score was computed as sum of the domain scores divided by the number of domains answered. The total possible score ranges from 0=least difficulty to 3=extreme difficulty. Higher overall score indicates greater disability. A negative change from baseline indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 12 | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in FACIT-Fatigue at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD |
|
| Secondary | Change From Baseline in FACIT-Fatigue at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. A positive change from baseline in FACIT-fatigue indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | |
|
| Secondary | Change From Baseline in Subject-completed Medical Outcomes Study Short-Form 36 (SF-36) Physical Component Scores (PCS) at Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in SF-36 PCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | |
|
| Secondary | Change From Baseline in SF-36 PCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The PCS is an aggregate score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. T-score scale was used for PCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall physical heath. Quality Metrics software was used for scoring for SF-36. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD |
|
| Secondary | Change From Baseline in SF-36 Mental Component Scores (MCS) at Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participants were randomized into. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in SF-36 MCS at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | |
|
| Secondary | Change From Baseline in SF-36 MCS at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The score for a domain was an average of the individual question scores, which were scaled 0-100; higher score represents better health. The MCS is an aggregated score derived from 4 domains (social functioning, vitality, mental health, and role-emotional domains) representing overall mental health. T-score scale was used for MCS with mean of 50 and SD of 10; higher score represents better health. A positive change from baseline indicates an improvement in overall mental health. Quality Metrics software was used for scoring for SF-36. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12. Analysis was performed using multiple imputation method to handle missing data. | Posted | | Least Squares Mean | Standard Error | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD |
|
| Secondary | Change From Baseline in SF-36 Domain Scores at Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention and for whom data available for specific parameters. This population was based on the treatment the participants were randomized into. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD |
|
| Secondary | Change From Baseline in SF-36 Domain Scores at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in SF-36 Domain Scores at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | The Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are scaled between 0 to 100, where higher score represents better health. A positive change from baseline indicates an improvement. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | Scores on a scale | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | |
|
| Secondary | Incidence of Adverse Events (AEs), Serious Adverse Event (SAEs), Adverse Events of Special Interest (AESI) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Pooled Placebo collected data till Week 12. Placebo + csDMARD and GSK3196165 90 mg + csDMARD, Placebo + csDMARD and GSK3196165 150 mg + csDMARD, Placebo + csDMARD and Sarilumab 200 mg or placebo + csDMARD collected data from Week 12 to 24. GSK3196165 90 mg + csDMARD, GSK3196165 150 mg + csDMARD, Sarilumab 200 mg or placebo + csDMARD collected data till Week 24 | Posted | | Count of Participants | | Participants | | Up to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD |
|
| Secondary | Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Neutrophil, Lymphocyte, Platelet Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in hematology parameters including neutrophil, lymphocyte, platelet count. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD |
|
| Secondary | Change From Baseline in White Blood Cell (WBC) Count (Giga Cells Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | |
|
| Secondary | Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in WBC Count (Giga Cells Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in hematology parameter WBC count. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | 10^9/L (Giga cells per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo +csDMARD until Week 12 later switched toSarilumab200mg +csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 12 | Blood samples was collected for the assessment of change from baseline in hematology parameter hemoglobin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Hemoglobin Level (Grams Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in in hematology parameter hemoglobin level. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Placebo +csDMARD until Week 12 later switched toSarilumab200mg +csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP) Gamma-glutamyl Transferase(GGT) Levels (International Units Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameters including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase (GGT) levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | IU/L (International units per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels. | The analysis was performed on Safety Set that includes all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | IU/L (International units per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in AST, ALT, AP, GGT Levels (International Units Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameters including AST, ALT, AP, GGT levels. | The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | IU/L (International units per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD |
|
| Secondary | Change From Baseline in Albumin Level (Grams Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level. | The analysis was performed on Safety set that includes all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Albumin Level (Grams Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameter albumin level. | The analysis was performed on Safety set that includes all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | g/L (Grams per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | |
|
| Secondary | Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameter total bilirubin level. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the ITT Set that includes all randomized participants who received at least one dose of study intervention. This population was based on the treatment the participant was randomized to. | Posted | | Mean | Standard Deviation | umol/L (Micromoles per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | |
|
| Secondary | Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | umol/L (Micromoles per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Total Bilirubin (Micromoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in laboratory parameter bilirubin level. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | umol/L (Micromoles per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | |
|
| Secondary | Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12. | Posted | | | | | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 |
|
| Secondary | Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Total Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in lipid profile of total cholesterol levels. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | |
|
| Secondary | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol (Millimoles Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12. | Posted | | | | | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
|
| Secondary | Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Fasting Lipid Profile: LDL Cholesterol, HDL Cholesterol (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile including LDL cholesterol, HDL cholesterol levels. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD |
|
| Secondary | Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 12 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | Blood samples were collected at indicated time points as per schedule of assessment in the protocol. The Objectives and Endpoints section incorrectly states that Change from baseline in key laboratory parameters at Week 12 was a secondary objective, however for the lipid panel, there is no corresponding time point in the schedule of assessment. Consequently, the only objective that can be assessed for the lipid panel is Week 4 and not at Week 12. | Posted | | | | | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 |
|
| Secondary | Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Secondary | Change From Baseline in Fasting Lipid Profile Triglycerides (Millimoles Per Liter) at Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in fasting lipid profile triglycerides levels. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD | |
|
| Other Pre-specified | Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 12 | Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels. For the purpose of all analyses up to week 12, the placebo arms were pooled into a single placebo arm to primarily serve as a reference for the comparison of active treatment arms. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Day 01) and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD |
|
| Other Pre-specified | Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Treatment Arms That Started Study Intervention From Day 1 | Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels. | The analysis was performed on all randomized participants who received study intervention from Day 01 to Week 24 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Day 01) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
|
| Other Pre-specified | Change From Baseline 4-beta-hydroxy Cholesterol, Cholesterol at (Millimoles Per Liter) Week 24 for Placebo Switched Arms That Started Study Intervention From Week 12 | Blood samples was collected for the assessment of change from baseline in lipid profile parameter including 4-beta-hydroxycholesterol, cholesterol levels. | The analysis was performed on all randomized participants who switched from placebo to study intervention at Week 12 and for whom data available for specific parameters. | Posted | | Mean | Standard Deviation | mmol/L (Millimoles per liter) | | Baseline (Week 12) and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Placebo + csDMARD and GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 90 mg +csDMARD administered by weekly subcutaneous injection. | | OG001 | Placebo + csDMARD and GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to(<=)84 years received Placebo +csDMARD until Week 12 later switched toGSK3196165 150 mg +csDMARD administered by weekly subcutaneous injection. | | OG002 | Placebo + csDMARD and Sarilumab 200mg + csDMARD |
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| Secondary | Number of Participants With National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) >=Grade 3 Hematological/Clinical Chemistry Abnormalities for Treatment Arms That Started Study Intervention From Day 1 | Number of participants who reported NCI-CTCAE Grade 3 or higher for hematological and clinical chemistry abnormalities were summarized. | The analysis was performed on the randomized participants who received at least one dose of study treatment and for whom data available for specific parameters. Pooled Placebo collected data till Week 12. Placebo+csDMARD and GSK3196165 90mg+csDMARD, Placebo+csDMARD and GSK3196165 150mg+csDMARD, Placebo+csDMARD and Sarilumab 200mg or placebo+csDMARD collected data from Week 12 to 24. GSK3196165 90mg+csDMARD, GSK3196165 150mg+csDMARD, Sarilumab 200mg or placebo+csDMARD collected data till Week 24. | Posted | | Count of Participants | | Participants | | Up to Week 24 | | | | ID | Title | Description |
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| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. |
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| Secondary | Concentrations of Granulocyte-macrophage Colony Stimulating Factor (GM-CSF) Autoantibody | Blood samples were collected for markers which may influence rheumatoid arthritis. Concentrations of GM-CSF autoantibodies was determined. | The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received. | Posted | | Mean | Standard Deviation | ug/L (microgram per liter) | | At baseline | | | | ID | Title | Description |
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| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
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| Secondary | Number of Participants With Anti-GSK3196165 Antibodies | Blood samples were collected for anti-GSK3196165 antibodies detection assay using tiered testing schema: screening, confirmation and titration steps was used for immunogenicity analysis. | The analysis was performed on the safety set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the participants actually received. | Posted | | Count of Participants | | Participants | | Up to Week 24 | | | | ID | Title | Description |
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| OG000 | GSK3196165 90mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 90 mg + csDMARD administered by weekly subcutaneous injection. | | OG001 | GSK3196165 150mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received GSK3196165 150 mg + csDMARD administered by weekly subcutaneous injection. | | OG002 | Sarilumab 200mg + csDMARD | Participants between the ages of greater than or equal to (>=)18 years and less than or equal to (<=)84 years received Sarilumab 200 mg + csDMARD administered by subcutaneous injection of sarilumab every other week plus with placebo injection in the intervening weeks to maintain the blind. |
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