| Secondary | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | DAS28 was calculated using the 28 joints count, the C-reactive protein levels (CRP) and participant's global assessment (PtGA) of disease activity. The following formula was used to determine DAS28. DAS28 (equals) = 0.56 × (square root of) √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100- millimeter [mm] visual analog scale [ VAS]). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. | ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | units on a scale | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| | | Title | Denominators | Categories |
|---|
| Baseline (n=71) | | | | Week 8 (n=71) | | | | Change from Baseline to Week 8 (n=71) | | |
| | 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 |
|---|
| Change from Baseline to Week 8 | Wilcoxon signed rank test | | <0.0005 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | | | Change from Baseline to Week 16 | Wilcoxon signed rank test |
|
| Secondary | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | DAS28 was calculated using the 28 joints count, the CRP and PtGA of disease activity. The following formula was used to determine DAS28. DAS28 = 0.56 × √(TJC28) + 0.28 × √(SJC28) + 0.36 × ln(CRP+1) + 0.014 × GH + 0.96 where, TJC28 = tender joint count on 28 joints, SJC28 = swollen joint count on 28 joints, ln = natural log, CRP = C-reactive protein (mg/L), and GH = general health, determined by participant's global assessment of disease activity (100-mm VAS). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Participants were considered to have low disease activity when DAS28 was less than or equal to (≤) 3.2 and in clinical remission when DAS28 scores were less than (<) 2.6 | ITT Population; n= number of participants analyzed for the given parameter at the specified time point | Posted | | Number | | percentage of participants | | Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | Swollen and Tender Joint Counts | 66 and 68 joints were assessed by the physician for tenderness or swelling respectively. The joints were counted as tender/not tender (tender=1; not tender=0) and swollen/not swollen (swollen=1; not swollen=0) and scored. The scores ranged from 0 to 66 for TJC and 0 to 68 for SJC. A negative change from baseline represents an improvement. | ITT Population; n= number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | Joints | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | Physician's Global Assessment of Disease Activity | Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement. | ITT Population; n=number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | mm | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | Participant's Global Assessment of Disease Activity | Participant's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The distance in mm from the left edge of the scale was measured. Higher scores indicated higher disease activity. A negative change from baseline represents an improvement. | ITT Population; n=number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | mm | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | Participant's Global Assessment of Pain | Participant's global assessment of pain was performed using a 100 mm VAS ranging from no pain (0) at the left edge to unbearable pain (100) at the right edge. The distance in mm from the left edge of the scale was measured. A negative change from baseline represents an improvement. | ITT Population; n=number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | mm | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | CRP Levels | CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement. | ITT Population; n=number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Secondary | Erythrocyte Sedimentation Rate (ESR) | ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement. | ITT Population; n=number of participants analyzed for the given parameter at the specified time point | Posted | | Mean | Standard Deviation | mm/hour | | Baseline, Weeks 8, 16 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |
| Primary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24. | Safety Analysis Population: All participants enrolled in the study who received at least 1 dose of study medication and had at least 1 post-baseline assessment of safety (such as laboratory data, vital signs, or AEs) were included. | Posted | | Number | | percentage of participants | | Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Tocilizumab Plus MTX | Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion. |
| |