Rheumatoid Arthritis
Conditions
Brief summary
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.
Interventions
DRUGmethotrexate
stable dose as prescribed
DRUGtocilizumab [RoActemra/Actemra]
8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Active moderate to severe rheumatoid arthritis (RA) * On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks * Oral corticosteroids must have been at stable dose of \</= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug * Body weight \</= 150 kg
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry * Rheumatic autoimmune disease other than RA * Functional class IV according to American College of Rheumatology (ACR) classification * Prior history of or current inflammatory joint disease other then RA * Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline * Treatment with any biologic drug that is used in the treatment or RA * Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * Known active current or history of recurrent infection * History of or currently active primary or secondary immunodeficiency * Positive for HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24 | AEs, SAEs and AESI were recorded from the Screening Visit until the final visit at Week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Weeks 8, 16 and 24 | 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 |
| Swollen and Tender Joint Counts | Baseline, Weeks 8, 16 and 24 | 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. |
| Physician's Global Assessment of Disease Activity | Baseline, Weeks 8, 16 and 24 | 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. |
| Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Baseline, Weeks 8, 16 and 24 | 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. |
| Participant's Global Assessment of Pain | Baseline, Weeks 8, 16 and 24 | 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. |
| CRP Levels | Baseline, Weeks 8, 16 and 24 | CRP is a marker of acute phase inflammation and is measured in mg/L. A negative change from baseline represents an improvement. |
| Erythrocyte Sedimentation Rate (ESR) | Baseline, Weeks 8, 16 and 24 | ESR is a marker of inflammation and is measured in millimeters per hour (mm/hour). A negative change from baseline represents an improvement. |
| Participant's Global Assessment of Disease Activity | Baseline, Weeks 8, 16 and 24 | 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. |
Countries
Bosnia and Herzegovina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Tocilizumab Plus MTX |
|---|---|
| Age, Continuous | 49.76 years STANDARD_DEVIATION 12.37 |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 71 |
| serious Total, serious adverse events | 2 / 71 |
Outcome results
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.
Time frame: Screening Visit, Baseline, Weeks 4, 8, 12, 16, 20 and 24
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Plus MTX | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AESI | 4.2 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | AEs | 14.1 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) | SAE | 2.8 percentage of participants |
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | CRP Levels | Baseline (n=62) | 11.98 mg/L | Standard Deviation 15.04 |
| Tocilizumab Plus MTX | CRP Levels | Week 8 (n=65) | 5.11 mg/L | Standard Deviation 14.12 |
| Tocilizumab Plus MTX | CRP Levels | Change from Baseline to Week 8 (n=61) | -6.68 mg/L | Standard Deviation 17.88 |
| Tocilizumab Plus MTX | CRP Levels | Week 16 (n=67) | 3.84 mg/L | Standard Deviation 11.91 |
| Tocilizumab Plus MTX | CRP Levels | Change from Baseline to Week 16 (n=60) | -8.0 mg/L | Standard Deviation 18.39 |
| Tocilizumab Plus MTX | CRP Levels | Week 24 (n=68) | 5.53 mg/L | Standard Deviation 14.07 |
| Tocilizumab Plus MTX | CRP Levels | Change from Baseline to Week 24 (n=60) | -5.97 mg/L | Standard Deviation 21.12 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Baseline (n=71) | 36.13 mm/hour | Standard Deviation 24.82 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Week 8 (n=71) | 9.04 mm/hour | Standard Deviation 8.83 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Change from Baseline to Week 8 (n=71 | -27.09 mm/hour | Standard Deviation 22.98 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Week 16 (n=71) | 8.71 mm/hour | Standard Deviation 6.39 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Change from Baseline to Week 16 (n=71) | -27.42 mm/hour | Standard Deviation 23.07 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Week 24 (n=69) | 10.3 mm/hour | Standard Deviation 12.81 |
| Tocilizumab Plus MTX | Erythrocyte Sedimentation Rate (ESR) | Change from Baseline to Week 24 (n=69) | -25.72 mm/hour | Standard Deviation 27.54 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; number (n) = number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Baseline (n=71) | 6.28 units on a scale | Standard Deviation 1.06 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Week 8 (n=71) | 3.84 units on a scale | Standard Deviation 1.29 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Change from Baseline to Week 8 (n=71) | -2.44 units on a scale | Standard Deviation 0.98 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Week 16 (n=71) | 3.19 units on a scale | Standard Deviation 1.23 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Change from Baseline to Week 16 (n=71) | -3.09 units on a scale | Standard Deviation 1.01 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Week 24 (n=69) | 2.65 units on a scale | Standard Deviation 1.23 |
| Tocilizumab Plus MTX | Mean Disease Activity Score Based on 28 Joint Count (DAS28) by Visit | Change from Baseline to Week 24 (n=69) | -3.62 units on a scale | Standard Deviation 1.22 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Baseline (n=71) | 70 mm | Standard Deviation 16.84 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Week 8 (n=71) | 42.87 mm | Standard Deviation 20.67 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Change from Baseline to Week 8 (n=71) | -27.13 mm | Standard Deviation 21.6 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Week 16 (n=71) | 33.20 mm | Standard Deviation 21.16 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Change from Baseline to Week 16 (n=71) | -36.80 mm | Standard Deviation 22.43 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Week 24 (n=69) | 24.56 mm | Standard Deviation 20.15 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Disease Activity | Change from Baseline to Week 24 (n=69) | -45.30 mm | Standard Deviation 22.74 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Change from Baseline to Week 24 (n=69) | -44.04 mm | Standard Deviation 25.11 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Week 24 (n=69) | 25.54 mm | Standard Deviation 21.37 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Baseline (n=71) | 69.73 mm | Standard Deviation 17.6 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Week 8 (n=71) | 42.34 mm | Standard Deviation 19.25 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Change from Baseline to Week 8 (n=71) | -27.39 mm | Standard Deviation 19.44 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Week 16 (n=71) | 33.94 mm | Standard Deviation 21.05 |
| Tocilizumab Plus MTX | Participant's Global Assessment of Pain | Change from Baseline to Week 16 (n=71) | -35.79 mm | Standard Deviation 21.52 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon 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
Time frame: Weeks 8, 16 and 24
Population: ITT Population; n= number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 8 CR (n=71) | 14.1 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 8 LDA (n=71) | 31.0 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 16 CR (n=71) | 39.4 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 16 LDA (n=71) | 49.3 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 24 CR (n=69) | 47.8 percentage of participants |
| Tocilizumab Plus MTX | Percentage of Participants Achieving Low Disease Activity (LDA) and Clinical Remission (CR) as Assessed Using DAS28 | Week 24 LDA (n=69) | 71.0 percentage of participants |
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n=number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Baseline (n=71) | 67.44 mm | Standard Deviation 17.72 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Week 8 (n=71) | 35.99 mm | Standard Deviation 20.53 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Change from Baseline to Week 8 (n=71) | -31.45 mm | Standard Deviation 17.76 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Week 16 (n=71) | 26.48 mm | Standard Deviation 20.48 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Change from Baseline to Week 16 (n=71) | -40.97 mm | Standard Deviation 20.7 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Week 24 (n=69) | 19.28 mm | Standard Deviation 17.48 |
| Tocilizumab Plus MTX | Physician's Global Assessment of Disease Activity | Change from Baseline to Week 24 (n=69) | -48.09 mm | Standard Deviation 19.69 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test
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.
Time frame: Baseline, Weeks 8, 16 and 24
Population: ITT Population; n= number of participants analyzed for the given parameter at the specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in TJC from Baseline to Week 16 (n=71) | -17.49 Joints | Standard Deviation 11.02 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 24 TJC (n=69) | 5.03 Joints | Standard Deviation 5.97 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Baseline SJC (n=71) | 19.48 Joints | Standard Deviation 10.97 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 8 SJC (n=71) | 6.72 Joints | Standard Deviation 5.76 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in SJC from Baseline to Week 8 (n=71) | -12.76 Joints | Standard Deviation 10.93 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 16 SJC (n=71) | 3.73 Joints | Standard Deviation 4.88 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in SJC from Baseline to Week 16 (n=71) | -15.75 Joints | Standard Deviation 9.59 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 24 SJC (n=69) | 2.43 Joints | Standard Deviation 4.12 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in SJC from Baseline to Week 24 (n=69) | -16.83 Joints | Standard Deviation 9.51 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Baseline TJC (n=71) | 24.62 Joints | Standard Deviation 11.84 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 8 TJC (n=71) | 10.59 Joints | Standard Deviation 8.38 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in TJC from Baseline to Week 8 (n=71) | -14.03 Joints | Standard Deviation 12.21 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Week 16 TJC (n=71) | 7.12 Joints | Standard Deviation 7.25 |
| Tocilizumab Plus MTX | Swollen and Tender Joint Counts | Change in TJC from Baseline to Week 24 (n=69) | -19.48 Joints | Standard Deviation 10.27 |
Comparison: Change from Baseline to Week 8p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 16p-value: <0.0005Wilcoxon signed rank test
Comparison: Change from Baseline to Week 24p-value: <0.0005Wilcoxon signed rank test