| Primary | Percentage of Participants Achieving Disease Activity Score 28 (DAS28) Low Disease Activity | The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2. | Intent-to-treat (ITT) population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward was applied for missing data. | Posted | | Number | | percentage of participants | | Baseline to Week 24 (Weeks 4, 8, 12, 16, 20, 24) | | | | ID | Title | Description |
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| OG000 | Tocilizumab | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
| | | Title | Denominators | Categories |
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| Week 4 | | | | Week 8 | | |
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| Primary | Time to DAS28 Low Disease Activity | Time to DAS28 Low Disease Activity was defined as the time in days from the first infusion of study drug to the achievement of a DAS28 Score <3.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2. | Intent-to-treat population included all participants who received at least one dose of study drug and had data for at least one follow-up variable available. Last observation carried forward. | Posted | | Mean | 95% Confidence Interval | days | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Percentage of Participants Achieving DAS28 Clinically Significant Improvement | DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. | Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward. | Posted | | Number | | percentage of participants | | Baseline, Weeks 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Time to DAS28 Clinically Significant Improvement | Time to DAS28 Clinically Significant Improvement was the Time in days from the first infusion of study drug to the achievement of a DAS28 score reduction of at least 1.2 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2. | Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward. | Posted | | Mean | 95% Confidence Interval | days | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Percentage of Participants Achieving DAS28 Remission | DAS28 Remission was defined as a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. | Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward. | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Time to DAS28 Remission | Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score < 2.6 units. The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. | Intent-to-treat population included all participants who received study drug and had at least 1 follow-up variable. Last observation carried forward. | Posted | | Mean | 95% Confidence Interval | days | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Disease Activity Score 28 (DAS28) | The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Low Disease Activity was defined as a DAS28 score of < 3.2. | Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time-point. Last observation carried forward. | Posted | | Mean | Standard Deviation | score on a scale | | Weeks 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | C-Reactive Protein (CRP) | Blood was collected for C-Reactive Protein (CRP), a test for inflammation, at Weeks 4, 8, 12, 16, 20 and 24 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). | Participants from the intent-to-treat population, all participants who received study drug and had data for at least one follow-up variable, with data available for the given timepoint. | Posted | | Mean | Standard Deviation | mg/L | | Weeks 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Erythrocyte Sedimentation Rate (ESR) | Blood was collected for Erythrocyte Sedimentation Rate (ESR), a test to assess inflammation, at Weeks 4, 8, 12, 16, 20, 24 and was analyzed at a central laboratory. ESR was measured in millimeters/hour (mm/hr). | Participants from the intent-to-treat population, all participants who received study drug and had at least 1 follow-up variable, with data available at the given time point. Last observation carried forward. | Posted | | Mean | Standard Deviation | mm/hr | | Weeks 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With AE and SAE Related Discontinuation | The number of participants who stopped using the study drug because of an AE or a SAE. 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. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events. A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Serious Infections | A serious infection was an infection that qualified as a Serious Adverse Event (SAE). A SAE was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | 24 Weeks | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Elevated AST (SGOT) and ALT (SGPT) | Blood was collected for aspartate aminotransferase (serum glutamic oxaloacetic transaminase) [AST/SGOT] and alanine aminotransferase (serum glutamic pyruvic transaminase) [ALT/SGPT], liver function tests, and were analyzed at a central laboratory. The number of participants with High AST (SGOT) or ALT (SGPT) levels at Week 24 is reported. | Participants from the safety population, all participants who received study drug and had at least 1 post-dose safety assessment, with data available for analysis. | Posted | | Number | | participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Elevated Total Cholesterol According to ATPIII Guidelines | Blood samples were collected for Total Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Desirable ( < 200), Borderline High (200- 239) or High (≥ 240). The number of participants categorized Borderline High or High at each time-point is reported. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Elevated HDL Cholesterol According to ATPIII Guidelines | Blood samples were collected for High Density Lipoprotein (HDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the HDL Total Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Low (< 40) or High (≥ 60). The number of participants with category High at each time-point is reported. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Elevated LDL Cholesterol According to ATPIII Guidelines | Blood samples were collected for Low Density Lipoprotein (LDL) Cholesterol and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the LDL Cholesterol level in milligram/deciliter (mg/dL) was categorized as: Optimal (< 100), Near Optimal/Above Optimal (100- 129), Borderline High (130- 159), High (160-189) or Very High (≥ 190). The number of participants categorized Borderline High, High or Very High at each time-point is reported. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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| Secondary | Number of Participants With Elevated Triglyceride According to ATPIII Guidelines | Blood samples were collected for Triglyceride and were sent to a central laboratory for analysis. According to Adult Treatment Profile III (ATPIII) guidelines the Triglyceride level in milligram/deciliter (mg/dL) was categorized as: Normal (< 150), Borderline High (150- 199), High (200- 499) or Very High (≥ 500). The number of participants categorized Borderline High, High or Very High at each time-point is reported. | Safety population included all participants who received study drug and had post-dose safety data available. | Posted | | Number | | participants | | Weeks 0 (Baseline), 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
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| OG000 | Tocilizumab Monotherapy | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). | | OG001 | Tocilizumab + MTX | Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion. |
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