| Primary | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity. | The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| | | Title | Denominators | Categories |
|---|
| Baseline | | | Title | Measurements |
|---|
| - OG0006.35± 1.14
- OG0015.54± 1.14
|
| | Change at Month 6 | | |
| | 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 |
|---|
| | ANCOVA | | 0.3037 | Change in DAS28 at Month 6 was performed using analysis of covariance (ANCOVA) model with baseline DAS28 score and rheumatoid factor (RF) status as covariate values. | | | | | | | | | | | | No | Superiority or Other | | |
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| Primary | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity. | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
|
| Secondary | Efficacy: Mean Change From Baseline in DAS28 at Month 12 | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity. | Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
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| Secondary | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints). | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | number of tender joints | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints). | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | number of tender joints | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints). | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | number of swollen joints | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints). | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | number of swollen joints | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation. | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | millimeter/hour (mm/hr) | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation. | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | mm/hr | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation. | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | milligram/deciliter (mg/dL) | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation. | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Month 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
| |
| Secondary | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population | The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
|
| Secondary | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) | The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. | The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | units on a scale | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
|
| Secondary | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. | The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. | Posted | | Number | | participants | | Baseline up to Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Rituximab | Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | | OG001 | Other Anti-TNF Agent | Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. |
|