Rheumatoid Arthritis
Conditions
Brief summary
This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
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 * Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration * Body weight \</=150 kg * Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment * Patients with inadequate clinical response to a stable dose of non-biologic DMARD
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization * Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis * History of or current inflammatory joint disease other than rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events | 24 weeks | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | Elevations in ALT and AST could indicate hepatotoxicity. |
| Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | Elevations in ALT and AST could indicate hepatotoxicity. |
| Percentage of Participants With Serious Infections | Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6) | A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly |
| Number of Participants With Serious Infections | Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6) | A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly |
| Change From Baseline to Highest Values for ALT and AST | Baseline to Week 24 | Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme. |
| Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol | Baseline to Week 24 | Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL). |
| Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC) | Baseline to Week 24 | ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL. |
| Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | ATP III guidelines classify LDL cholesterol \>160 mg/dL, Total cholesterol \>240 mg/dL, High Density Lipoprotein (HDL) \>60 mg/dL and Triglycerides (TG) \>199 as elevated. |
| Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | ATP III guidelines classify LDL cholesterol \>160 mg/dL , Total cholesterol \>240 mg/dL, HDL \>60 mg/dL and TG \>199 as elevated. |
| Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (\<) 2.6 represents clinical remission, a score of: \<3.2 represents low disease activity (LDA), and a score of \> 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement. |
| Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \< 3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement. |
| Number of Participants Who Achieved LDA By Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement. |
| Percentage of Participants Who Achieved LDA By Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement. |
| Percentage of Participants With All-Cause Discontinuation | 24 weeks | Participants who discontinued treatment due to any reason were included in this measure. |
| Number of Participants Who Achieved Remission (DAS28) By Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement. |
| Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement. |
| Percentage of Participants Achieving Their First Remission Status By Visit | Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement. |
| Disease Activity Score as Measured By DAS28 at Each Visit | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement. |
| Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. |
| Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. . |
| C-Reactive Protein Levels | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL. |
| Erythrocyte Sedimentation Rate | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr). |
| Mean Number of Tender and Swollen Joints | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit. |
| Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected. |
| Participant's Assessment of Pain | Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected. |
| Health Assessment Questionnaire Score (General Score) | Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections. |
| Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8) | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | Tocilizumab 8 mg/kg |
|---|---|
| Age, Continuous | 47.4 years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 45 / 65 |
| serious Total, serious adverse events | 11 / 65 |
Outcome results
Primary
Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was considered treatment emergent if the date of onset of the AE was on or after the date of first dose of study medication. AEs of special interest included Major Adverse Cardiovascular Events (MACE) (including strokes), infections, and infusion reactions. An AE was considered an infection if the preferred term was in the predefined infection AE group term. A serious infection was an infection which was also considered as an AE. An AE was considered an infusion reaction if it occurred during or within 24 hours of an infusion.
Time frame: 24 weeks
Population: The safety population consisted of all participants included in the study who received at least one dose of study medication and who had at least one post-baseline assessment of safety (that is post-baseline laboratory data, vital signs or adverse events).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events | AEs | 90.8 percentage of participants |
| Tocilizumab 8 mg/kg | Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events | SAEs | 9.2 percentage of participants |
| Tocilizumab 8 mg/kg | Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events | AEs of special interest | 52.3 percentage of participants |
Secondary
Change From Baseline to Highest Values for ALT and AST
Elevations in ALT and AST could indicate hepatotoxicity. These enzymes were measured as International Units per Liter (IU/L). The change from baseline was calculated as: baseline value minus the highest value observed post-baseline for each enzyme.
Time frame: Baseline to Week 24
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Highest Values for ALT and AST | ALT | 28.9 IU/L | Standard Deviation 25.2 |
| Tocilizumab 8 mg/kg | Change From Baseline to Highest Values for ALT and AST | AST | 21.3 IU/L | Standard Deviation 37.9 |
Secondary
Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol
Elevations in LDL and total cholesterol could lead to heart disease. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline and was measured as milligrams per deciliter (mg/dL).
Time frame: Baseline to Week 24
Population: Safety population; number of participants analyzed signifies participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol | LDL | 29.1 mg/dL | Standard Deviation 27.2 |
| Tocilizumab 8 mg/kg | Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol | Total Cholesterol | 39.8 mg/dL | Standard Deviation 29.7 |
Secondary
Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)
ANC is a measure of number of neutrophil granulocytes. An ANC less than 500 cells per microliter (cells/µL) is defined as neutropenia and significantly increases risk of infection. The change from baseline was calculated as: baseline value minus the highest value observed post-baseline. ANC was measured in cells/µL.
Time frame: Baseline to Week 24
Population: Safety population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC) | -3.04 cells/µL | Standard Deviation 2.5 |
Secondary
C-Reactive Protein Levels
CRP is an inflammatory marker used to measure inflammation in RA and is measured as mg/dL.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 1 (n=59) | 3.5 mg/dL | Standard Deviation 6.2 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 2 (n=53) | 2.3 mg/dL | Standard Deviation 3.2 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 3 (n=53) | 1.0 mg/dL | Standard Deviation 2.2 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 4 (n=58) | 0.6 mg/dL | Standard Deviation 0.9 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 5 (n=57) | 0.6 mg/dL | Standard Deviation 1.3 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 6 (n=58) | 1.0 mg/dL | Standard Deviation 4.2 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 7 (n=52) | 0.8 mg/dL | Standard Deviation 1.6 |
| Tocilizumab 8 mg/kg | C-Reactive Protein Levels | Visit 8 (n=58) | 0.5 mg/dL | Standard Deviation 0.8 |
Comparison: Change from Visit 1 to Visit 2p-value: 0.169Wilcoxon Signed Rank test.
Comparison: Change from Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change from Visit 3 to Visit 4p-value: 0.053Wilcoxon Signed Rank test.
Comparison: Change from Visit 4 to Visit 5p-value: 0.514Wilcoxon Signed Rank test.
Comparison: Change from Visit 5 to Visit 6p-value: 0.064Wilcoxon Signed Rank test.
Comparison: Change from Visit 6 to Visit 7p-value: 0.038Wilcoxon Signed Rank test.
Comparison: Change from Visit 7 to Visit 8p-value: 0.064Wilcoxon Signed Rank test.
Comparison: Change from Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Disease Activity Score as Measured By DAS28 at Each Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population. n = participants who were evaluable for specified category
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 1 (n=60) | 5.6 units on a scale | Standard Deviation 0.9 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 2 (n=58) | 5.6 units on a scale | Standard Deviation 1.1 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 3 (n=57) | 3.1 units on a scale | Standard Deviation 1.4 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 4 (n=56) | 2.3 units on a scale | Standard Deviation 1 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 5 (n=57) | 2.0 units on a scale | Standard Deviation 1.3 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 6 (n=57) | 1.8 units on a scale | Standard Deviation 1.1 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 7 (n=54) | 1.7 units on a scale | Standard Deviation 1 |
| Tocilizumab 8 mg/kg | Disease Activity Score as Measured By DAS28 at Each Visit | Visit 8 (n=60) | 1.6 units on a scale | Standard Deviation 1 |
Comparison: Change from Visit 1 to Visit 2p-value: 0.929Wilcoxon Signed Rank test.
Comparison: Change from Visit 2 to 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change from Visit 3 to Visit 4p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change from Visit 4 to Visit 5p-value: 0.05Wilcoxon Signed Rank test.
Comparison: Change from Visit 5 to Visit 6p-value: 0.165Wilcoxon Signed Rank test.
Comparison: Change from Visit 6 to Visit 7p-value: 0.133Wilcoxon Signed Rank test.
Comparison: Change from Visit 7 to Visit 8p-value: 0.217Wilcoxon Signed Rank test.
Comparison: Change from Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Erythrocyte Sedimentation Rate
ESR is an inflammatory marker used to measure inflammation in RA and is measured as millimeters per hour (mm/hr).
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 6 (n=57) | 7.8 mm/hr | Standard Deviation 8.2 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 1 (n=60) | 35.4 mm/hr | Standard Deviation 22.9 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 2 (n=58) | 36.4 mm/hr | Standard Deviation 24.1 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 3 (n=57) | 12.3 mm/hr | Standard Deviation 13.3 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 4 (n=56) | 8.0 mm/hr | Standard Deviation 9.3 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 5 (n=58) | 7.8 mm/hr | Standard Deviation 9.4 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 7 (n=54) | 6.3 mm/hr | Standard Deviation 5.4 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate | Visit 8 (n=60) | 8.6 mm/hr | Standard Deviation 13.8 |
Comparison: Change from Visit 1 to Visit 2p-value: 0.981Wilcoxon Signed Rank test.
Comparison: Change from Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change from Visit 3 to Visit 4p-value: 0.005Wilcoxon Signed Rank test.
Comparison: Change from Visit 4 to Visit 5p-value: 0.566Wilcoxon Signed Rank test.
Comparison: Change from Visit 5 to Visit 6p-value: 0.264Wilcoxon Signed Rank test.
Comparison: Change from Visit 6 to Visit 7p-value: 0.126Wilcoxon Signed Rank test.
Comparison: Change from Visit 7 to Visit 8p-value: 0.779Wilcoxon Signed Rank test.
p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Health Assessment Questionnaire Score (General Score)
The Stanford HAQ disability index is a participant completed questionnaire specific for RA. It consists of 20 questions referring to 8 component sections: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. The questionnaire was provided in validated translation into the local languages at the participating sites and was scored. Every question in each section was scored at a scale from 0 to 3 by the participant where 0 = able to perform the activity without any difficulty and 3 = unable to perform the activity. General score was calculated as an average of the 8 sections.
Time frame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 2 | 1.3 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 3 | 0.8 units on a scale | Standard Deviation 0.8 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 4 | 0.6 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 5 | 0.5 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 6 | 0.4 units on a scale | Standard Deviation 0.6 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 7 | 0.4 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire Score (General Score) | Visit 8 | 0.4 units on a scale | Standard Deviation 0.6 |
Comparison: Change between Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change between Visit 3 to Visit 4p-value: 0.002Wilcoxon Signed Rank test.
Comparison: Change between Visit 4 to Visit 5p-value: 0.078Wilcoxon Signed Rank test.
Comparison: Change between Visit 5 to Visit 6p-value: 0.349Wilcoxon Signed Rank test.
Comparison: Change between Visit 6 to Visit 7p-value: 0.722Wilcoxon Signed Rank test.
Comparison: Change between Visit 7 to Visit 8p-value: 0.224Wilcoxon Signed Rank test.
Secondary
Mean Number of Tender and Swollen Joints
Participants were asked to classify 28 joints as tender or not tender and swollen or not swollen to count the total number of tender and swollen joints by visit.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 6 SJC | 0.5 joints | Standard Deviation 1.3 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 1 TJC | 15.1 joints | Standard Deviation 9.6 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 1 SJC | 5.5 joints | Standard Deviation 4.7 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 2 TJC | 16.0 joints | Standard Deviation 11.5 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 2 SJC | 5.7 joints | Standard Deviation 5.2 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 3 TJC | 6.1 joints | Standard Deviation 7.4 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 3 SJC | 1.9 joints | Standard Deviation 3.2 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 4 TJC | 3.3 joints | Standard Deviation 4.8 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 4 SJC | 0.8 joints | Standard Deviation 1.6 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 5 TJC | 2.7 joints | Standard Deviation 4.7 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 5 SJC | 0.5 joints | Standard Deviation 1.1 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 6 TJC | 2.0 joints | Standard Deviation 4.4 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 7 TJC | 1.8 joints | Standard Deviation 3.2 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 7 SJC | 0.6 joints | Standard Deviation 1.6 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 8 TJC | 1.3 joints | Standard Deviation 2.6 |
| Tocilizumab 8 mg/kg | Mean Number of Tender and Swollen Joints | Visit 8 SJC | 0.4 joints | Standard Deviation 1.2 |
Comparison: Change in Sensitive Joints Visit 1 to Visit 2p-value: 0.41Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 3 to Visit 4p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 4 to Visit 5p-value: 0.021Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 5 to Visit 6p-value: 0.003Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 6 to Visit7p-value: 0.827Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 7 to Visit 8p-value: 0.093Wilcoxon Signed Rank test.
Comparison: Change in Sensitive Joints from Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 1 to Visit 2p-value: 0.792Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 3 to Visit 4p-value: 0.002Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 4 to Visit 5p-value: 0.374Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 5 to Visit 6p-value: 0.518Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 6 to Visit 7p-value: 0.744Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 7 to Visit 8p-value: 0.048Wilcoxon Signed Rank test.
Comparison: Change in Swollen Joints from Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
ACR20/50/70/90 response: greater than or equal to (≥) 20/50/70/90 percent (%) improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit.
Time frame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR20 | 20 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR50 | 12 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR70 | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR90 | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR20 | 37 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR50 | 25 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR70 | 14 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR90 | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR20 | 33 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR50 | 26 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR70 | 18 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR90 | 4 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR20 | 32 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR50 | 26 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR70 | 20 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR90 | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR20 | 27 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR50 | 23 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR70 | 17 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR90 | 4 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR20 | 32 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR50 | 28 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR70 | 18 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR90 | 6 participants |
Secondary
Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
The DAS28 is a combined index for measuring disease activity in Rheumatoid Arthritis (RA). The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of less than (\<) 2.6 represents clinical remission, a score of: \<3.2 represents low disease activity (LDA), and a score of \> 5.1 represents severe disease. A reduction from previous visit of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: Intent- to- Treat (ITT) Population: all enrolled participants who received at least one dose of study medication. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 1 - Visit 2 (n=55) | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 2 - Visit 3 (n=55) | 48 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 3 - Visit 4 (n=54) | 18 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 4 - Visit 5 (n=53) | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 5 - Visit 6 (n=54) | 2 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 6 - Visit 7 (n=53) | 4 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit | Visit 7 - Visit 8 (n=53) | 1 participants |
Secondary
Number of Participants Who Achieved LDA By Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 1 (n=60) | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 2 (n=58) | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 3 (n=57) | 32 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 4 (n=56) | 45 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 5 (n=57) | 48 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 6 (n=57) | 50 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 7 (n=54) | 51 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved LDA By Visit | Visit 8 (n=60) | 55 participants |
Secondary
Number of Participants Who Achieved Remission (DAS28) By Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population. Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit (n=60) | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 2 (n=58) | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 3 (n=57) | 24 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 4 (n=56) | 35 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 5 (n=57) | 43 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 6 (n=57) | 46 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 7 (n=54) | 45 participants |
| Tocilizumab 8 mg/kg | Number of Participants Who Achieved Remission (DAS28) By Visit | Visit 8 (n=60) | 51 participants |
Secondary
Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
Elevations in ALT and AST could indicate hepatotoxicity.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 1) >1.5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 1) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 1) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 2) >1.5 ULN | 2 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 2) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 2) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 3) >1.5 ULN | 8 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 3) >3 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 3) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 4) >1.5 ULN | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 4) >3 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 4) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 5) >1.5 ULN | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 5) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 5) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 6) >1.5 ULN | 3 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 6) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 6) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 7) >1.5 ULN | 10 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 7) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 7) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 8) >1.5 ULN | 12 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 8) >3 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | ALT (Visit 8) >5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 1) >1.5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 1) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 1) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 2) >1.5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 2) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 2) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 3) >1.5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 3) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 3) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 4) >1.5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 4) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 4) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 5) >1.5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 5) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 5) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 6) >1.5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 6) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 6) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 7) >1.5 ULN | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 7) >3 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 7) >5 ULN | 0 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 8) >1.5 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 8) >3 ULN | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN | AST (Visit 8) >5 ULN | 1 participants |
Secondary
Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
ATP III guidelines classify LDL cholesterol \>160 mg/dL, Total cholesterol \>240 mg/dL, High Density Lipoprotein (HDL) \>60 mg/dL and Triglycerides (TG) \>199 as elevated.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: Safety population; Number (n) equals (=) number of participants analyzed at the specified visit for the given parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 1 LDL >160 (n=62) | 3 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 1 Total Cholesterol >240 (n=62) | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 1 HDL >60 (n=63) | 20 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 1 TG>199 (n=63) | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 2 LDL >160 (n=57) | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 2 Total Cholesterol >240 (n=59) | 3 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 2 HDL >60 (n=62) | 17 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 2 TG>199 (n=59) | 9 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 3 LDL >160 (n=60) | 6 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 3 Total Cholesterol >240 (n=64) | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 3 HDL >60 (n=62) | 25 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 3 TG>199 (n=63) | 14 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 4 LDL >160 (n=55) | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 4 Total Cholesterol >240 (n=61) | 11 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 4 HDL >60 (n=58) | 24 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 4 TG>199 (n=58) | 12 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 5 LDL >160 (n=62) | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 5 Total Cholesterol >240 (n=63) | 10 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 5 HDL >60 (n=63) | 29 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 5 TG>199 (n=63) | 11 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 6 LDL >160 (n=59) | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 6 Total Cholesterol >240 (n=62) | 10 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 6 HDL >60 (n=62) | 29 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 6 TG>199 (n=62) | 13 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 7 LDL >160 (n=62) | 5 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 7 Total Cholesterol >240 (n=62) | 7 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 7 HDL >60 (n=62) | 26 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 7 TG>199 (n=62) | 10 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 8 LDL >160 (n=61) | 8 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 8 Total Cholesterol >240 (n=62) | 12 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 8 HDL >60 (n=62) | 30 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines | Visit 8 TG>199 (n=61) | 8 participants |
Secondary
Number of Participants With Serious Infections
A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly
Time frame: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Participants With Serious Infections | Visit 3 | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Serious Infections | Visit 4 | 1 participants |
| Tocilizumab 8 mg/kg | Number of Participants With Serious Infections | Visit 6 | 1 participants |
Secondary
Participant's Assessment of Pain
VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.
Time frame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 2 | 66.4 mm | Standard Deviation 20.8 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 3 | 38.8 mm | Standard Deviation 26.7 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 4 | 25.6 mm | Standard Deviation 22.6 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 5 | 22.7 mm | Standard Deviation 21.8 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 6 | 23.0 mm | Standard Deviation 23.9 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 7 | 17.8 mm | Standard Deviation 17.9 |
| Tocilizumab 8 mg/kg | Participant's Assessment of Pain | Visit 8 | 15.3 mm | Standard Deviation 16.5 |
Comparison: Change between Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change between Visit 3 to Visit 4p-value: <0.001Wilcoxon Signed Rank test.
Comparison: Change between Visit 4 to Visit 5p-value: 0.254Wilcoxon Signed Rank test.
Comparison: Change between Visit 5 to Visit 6p-value: 0.138Wilcoxon Signed Rank test.
Comparison: Change between Visit 6 to Visit 7p-value: 0.002Wilcoxon Signed Rank test.
Comparison: Change between Visit 7 to Visit 8p-value: 0.104Wilcoxon Signed Rank test.
Comparison: Change between Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
VAS is a visual scale of 100 mm for the assessment of disease activity by participants or investigator. Disease activity/pain increases while approaching 100 mm. For the screening visit (baseline visit) there's only investigator assessment data, for other visits participant's pain assessment, participant's disease activity assessment and investigator's disease activity assessment parameters were collected.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 1 IN | 70.1 mm | Standard Deviation 16 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 2 PT | 70.3 mm | Standard Deviation 17.7 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 2 IN | 68.3 mm | Standard Deviation 16.7 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 3 PT | 41.8 mm | Standard Deviation 24.7 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 3 IN | 33.3 mm | Standard Deviation 21.5 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 4 PT | 25.3 mm | Standard Deviation 20.1 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 4 IN | 20.6 mm | Standard Deviation 14.1 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 5 PT | 24.1 mm | Standard Deviation 20.6 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 5 IN | 16.9 mm | Standard Deviation 13.8 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 6 PT | 23.1 mm | Standard Deviation 21.9 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 6 IN | 16.9 mm | Standard Deviation 16.7 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 7 PT | 18.3 mm | Standard Deviation 18.6 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 7 IN | 14.9 mm | Standard Deviation 14.4 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 8 PT | 16.2 mm | Standard Deviation 17.3 |
| Tocilizumab 8 mg/kg | Participant's (PT) and Investigator's (IN) Assessment of Disease Activity | Visit 8 IN | 12.5 mm | Standard Deviation 14.1 |
Comparison: PT assessment Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 3 to Visit 4p-value: <0.001Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 4 to Visit 5p-value: 0.075Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 5 to Visit 6p-value: 0.119Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 6 to Visit 7p-value: 0.007Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 7 to Visit 8p-value: 0.047Wilcoxon Signed Rank test.
Comparison: PT assessment Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 2 to Visit 3p-value: <0.001Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 3 to Visit 4p-value: <0.001Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 4 to Visit 5p-value: 0.001Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 5 to Visit 6p-value: 0.084Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 6 to Visit 7p-value: 0.272Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 7 to Visit 8p-value: 0.02Wilcoxon Signed Rank test.
Comparison: IN assessment Visit 2 to Visit 8p-value: <0.001Wilcoxon Signed Rank test.
Secondary
Percentage of Participants Achieving Their First Remission Status By Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 3 | 40.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 4 | 25.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 5 | 15.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 6 | 5.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 7 | 3.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | In Visit 8 | 3.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving Their First Remission Status By Visit | Never Achieved Remission | 8.3 Percentage of participants |
Secondary
Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
ACR20/50/70/90 response: ≥ 20/50/70/90 % improvement in TJC; ≥20/50/70/90% improvement in SJC; and ≥20/50/70/90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). Improvements were assessed on the basis of prior visit. .
Time frame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population; number of participants analyzed = participants who were evaluable for this outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR20 | 33.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR50 | 20.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR70 | 8.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 2 to Visit 3 ACR90 | 0.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR20 | 61.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR50 | 41.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR70 | 23.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 4 ACR90 | 1.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 3 to Visit 5 ACR20 | 55.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR50 | 43.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR70 | 30.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 4 to Visit 5 ACR90 | 6.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR20 | 53.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR50 | 43.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR70 | 33.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 5 to Visit 6 ACR90 | 11.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR20 | 45.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR50 | 38.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR70 | 28.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 6 to Visit 7 ACR90 | 6.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR20 | 53.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR50 | 46.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR70 | 30.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response | Visit 7 to Visit 8 ACR90 | 10.0 Percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \< 3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 1 - Visit 2 (n=55) | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 2 - Visit 3 (n=55) | 87.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 3 - Visit 4 (n=54) | 33.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 4 - Visit 5 (n=53) | 13.2 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 5 - Visit 6 (n=54) | 3.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 6 - Visit 7 (n=53) | 7.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit | Visit 7 - Visit 8 (n=53) | 1.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved LDA By Visit
TThe DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 represents LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome and n = number of participants who were evaluable for the specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 1 (n=60) | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 2 (n=58) | 1.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 3 (n=57) | 56.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 4 (n=56) | 80.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 5 (n=57) | 84.2 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 6 (n=57) | 87.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 7 (n=54) | 94.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved LDA By Visit | Visit 8 (n=60) | 91.7 percentage of participants |
Secondary
Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT population. Here, number of participants analyzed = participants who were evaluable for this outcome and n = participants who were evaluable for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 1 (n=60) | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 2 (n=58) | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 3 (n=57) | 42.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 4 (n=56) | 62.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 5 (n=57) | 75.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 6 (n=57) | 80.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 7 (n=54) | 83.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Who Achieved Remission (DAS28) At Every Visit | Visit 8 (n=60) | 85.0 percentage of participants |
Secondary
Percentage of Participants With All-Cause Discontinuation
Participants who discontinued treatment due to any reason were included in this measure.
Time frame: 24 weeks
Population: Safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With All-Cause Discontinuation | 0.0 percentage of participants |
Secondary
Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
Elevations in ALT and AST could indicate hepatotoxicity.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 7) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 6) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 1) 1.5 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 1) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 1) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 2) >1.5 ULN | 3.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 2) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 2) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 3) >1.5 ULN | 12.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 3) >3 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 3)> 5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 4) >1.5 ULN | 7.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 4) >3 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 4)> 5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 5) >1.5 ULN | 10.8 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 5) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 5) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 6)> 1.5 ULN | 4.6 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 6) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 7) > 1.5 ULN | 15.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 7) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 7) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 8) >1.5 ULN | 18.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 8) >3 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | ALT (Visit 8) >5 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 1) >1.5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 1) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 1) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 2) >1.5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 2) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 2) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 3) >1.5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 3) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 3) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 4) >1.5 ULN | 4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 4) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 4) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 5) >1.5 ULN | 4.2 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 5) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 5) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 6) >1.5 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 6) >3 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 6) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 7) >1.5 ULN | 7.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 7) >5 ULN | 0.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 8) >1.5 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 8) >3 ULN | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN | AST (Visit 8) >5 ULN | 1.5 percentage of participants |
Secondary
Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
ATP III guidelines classify LDL cholesterol \>160 mg/dL , Total cholesterol \>240 mg/dL, HDL \>60 mg/dL and TG \>199 as elevated.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: Safety population; n = number of participants analyzed at the specified visit for the given parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 1 LDL >160 (n=62) | 4.8 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 1 Total Cholesterol >240 (n=62) | 8.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 1 HDL >60 (n=63) | 31.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 1 TG>199 (n=63) | 11.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 2 LDL >160 (n=57) | 1.8 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 2 Total Cholesterol >240 (n=59) | 5.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 2 HDL >60 (n=62) | 27.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 2 TG>199 (n=59) | 15.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 3 LDL >160 (n=60) | 10.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 3 Total Cholesterol >240 (n=64) | 10.9 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 3 HDL >60 (n=62) | 40.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 3 TG>199 (n=63) | 22.2 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 4 LDL >160 (n=55) | 7.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 4 Total Cholesterol >240 (n=61) | 18.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 4 HDL >60 (n=58) | 41.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 4 TG>199 (n=58) | 20.7 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 5 LDL >160 (n=62) | 11.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 5 Total Cholesterol >240 (n=63) | 15.9 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 5 HDL >60 (n=63) | 46.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 5 TG>199 (n=63) | 17.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 6 LDL >160 (n=59) | 8.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 6 Total Cholesterol >240 (n=62) | 16.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 6 HDL >60 (n=62) | 46.8 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 6 TG>199 (n=62) | 21.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 7 LDL >160 (n=62) | 8.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 7 Total Cholesterol >240 (n=62) | 11.3 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 7 HDL >60 (n=62) | 41.9 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 7 TG>199 (n=62) | 16.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 8 LDL >160 (n=61) | 13.1 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 8 Total Cholesterol >240 (n=62) | 19.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 8 HDL >60 (n=62) | 48.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Elevations in Lipids According to ATP III Guidelines | Visit 8 TG>199 (n=61) | 13.1 percentage of participants |
Secondary
Percentage of Participants With Serious Infections
A serious infection was an infection which was also considered as an SAE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly
Time frame: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With Serious Infections | Visit 3 | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Serious Infections | Visit 4 | 1.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With Serious Infections | Visit 6 | 1.5 percentage of participants |
Secondary
Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen and tender joint counts, acute phase response, and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS. The index is calculated using the following formula: DAS28 = 0.56 x (TJC28)\^0.5 + 0.28 x (SJC28)\^0.5 + 0.70 x In(ESR) + 0.014 x GH Where TJC28 = tender joint count on 28 joints, SJCz8 = swollen joint count on 28 joints, ın = natural log, ESR = erythrocyte sedimentation rate and GH = general health (participant's global assessment of disease activity). DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of \< 2.6 represents clinical remission, a score of: \<3.2 LDA, and a score of \> 5.1 represents severe disease. A reduction of at least 1.2 units from previous visit in DAS28 is considered to be a clinically meaningful improvement.
Time frame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Population: ITT Population; Number of participants analyzed = participants who were evaluable for this outcome
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 1 | 0.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 2 | 1.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 3 | 51.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 4 | 28.3 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 5 | 10.0 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 6 | 1.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 7 | 1.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Visit 8 | 1.7 Percentage of participants |
| Tocilizumab 8 mg/kg | Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed | Never Acheived LDA | 3.3 Percentage of participants |