Rheumatoid Arthritis
Conditions
Brief summary
This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * active moderate or severe rheumatoid arthritis; * active disease for \>6 months; * inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.
Exclusion criteria
* rheumatic autoimmune disease other than rheumatoid arthritis; * prior history of, or current inflammatory joint disease other than rheumatoid arthritis; * major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion | Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24 | An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Discontinuing Tocilizumab for Any Reason | Weeks 4, 8, 12, 16, 20 and Final Visit | — |
| Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Weeks 4, 8, 12, 16, 20 and Final Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (\<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference. |
| Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Weeks 4, 8, 12, 16, 20 and Final Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission. |
| Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Weeks 4, 8, 12, 16, 20 and Final Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission. |
| DAS28 Score by Visit | Weeks 4, 8, 12, 16, 20, and Final Visit | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value. |
| Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Weeks 4, 8, 12, 16, 20 and Final Visit | ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein \[CRP\]) |
| Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) | Weeks 4, 8, 12, 16, 20 and Final Visit | — |
| Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Weeks 4, 8, 12, 16, 20 and Final Visit | ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). |
| Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Weeks 4, 8, 12, 16, 20 and Final Visit | ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). |
| C-Reactive Protein (CRP) Levels | Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L). |
| Erythrocyte Sedimentation Rate | Baseline, Weeks 2, 4, 8, 12,16, 20, and 24 | ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement. |
| HAQ-DI Score by Visit | Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24 | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. |
| Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Weeks 4, 8, 12, 16, 20 and Final Visit | HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement. |
| Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Weeks 4, 8, 12, 16, 20 and Final Visit | ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab, 1 Hour Infusions Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks). | 37 |
| Tocilizumab, 31 Minute Infusions Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions. | 39 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Refused treatment | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Tocilizumab, 1 Hour Infusions | Tocilizumab, 31 Minute Infusions | Total |
|---|---|---|---|
| Age, Continuous | 52.65 years STANDARD_DEVIATION 12.71 | 52.46 years STANDARD_DEVIATION 10.47 | 52.55 years STANDARD_DEVIATION 11.54 |
| Sex: Female, Male Female | 35 Participants | 28 Participants | 63 Participants |
| Sex: Female, Male Male | 2 Participants | 11 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 37 | 26 / 39 |
| serious Total, serious adverse events | 2 / 37 | 2 / 39 |
Outcome results
Primary
Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.
Time frame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion | 29.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion | 17.9 percentage of participants |
p-value: 0.238Chi-squared
Secondary
C-Reactive Protein (CRP) Levels
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as Rheumatoid Arthritis. CRP is measured in milligrams per liter (mg/L).
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and Final Visit
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Baseline (n=30,35) | 11.49 mg/L | Standard Deviation 15.39 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Week 16 (n=35,38) | 2.81 mg/L | Standard Deviation 6.86 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Week 8 (n=34,37) | 4.84 mg/L | Standard Deviation 10.98 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Week 20 (n=34,36) | 1.97 mg/L | Standard Deviation 2.52 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Week 4 (n=37,37) | 6.45 mg/L | Standard Deviation 13.52 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Final visit (n=31,34) | 5.42 mg/L | Standard Deviation 13.27 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Week 12 (n=33,36) | 2.94 mg/L | Standard Deviation 5.8 |
| Tocilizumab, 1 Hour Infusions | C-Reactive Protein (CRP) Levels | Screening (n=35,38) | 9.28 mg/L | Standard Deviation 9.64 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Final visit (n=31,34) | 2.26 mg/L | Standard Deviation 4.57 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Screening (n=35,38) | 10.76 mg/L | Standard Deviation 11.88 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Baseline (n=30,35) | 13.68 mg/L | Standard Deviation 26.21 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Week 4 (n=37,37) | 4.29 mg/L | Standard Deviation 8.16 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Week 8 (n=34,37) | 1.93 mg/L | Standard Deviation 2.84 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Week 12 (n=33,36) | 1.78 mg/L | Standard Deviation 3.95 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Week 16 (n=35,38) | 2.08 mg/L | Standard Deviation 4 |
| Tocilizumab, 31 Minute Infusions | C-Reactive Protein (CRP) Levels | Week 20 (n=34,36) | 2.66 mg/L | Standard Deviation 7.89 |
Secondary
DAS28 Score by Visit
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission. Last observation carried forward (LOCF) visit took the last non-missing post-baseline available value.
Time frame: Weeks 4, 8, 12, 16, 20, and Final Visit
Population: ITT Population; n (number)=number of participants analyzed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | LOCF visit (n=37,38) | 2.92 units on a scale | Standard Deviation 1.56 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Baseline visit (n=36,38) | 5.75 units on a scale | Standard Deviation 1.18 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Week 4 (n=36,25) | 4.28 units on a scale | Standard Deviation 1.33 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Week 8 (n=32,35) | 4.14 units on a scale | Standard Deviation 1.54 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Week 12 (n=32,35) | 3.30 units on a scale | Standard Deviation 1.32 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Week 16 (n=32,35) | 3.07 units on a scale | Standard Deviation 1.5 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Week 20 (n=32,34) | 2.78 units on a scale | Standard Deviation 1.33 |
| Tocilizumab, 1 Hour Infusions | DAS28 Score by Visit | Final visit (n=28,31) | 2.72 units on a scale | Standard Deviation 1.4 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Final visit (n=28,31) | 2.19 units on a scale | Standard Deviation 1.06 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | LOCF visit (n=37,38) | 2.37 units on a scale | Standard Deviation 1.13 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Week 12 (n=32,35) | 2.66 units on a scale | Standard Deviation 1.04 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Baseline visit (n=36,38) | 5.32 units on a scale | Standard Deviation 1.14 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Week 20 (n=32,34) | 2.41 units on a scale | Standard Deviation 1.22 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Week 4 (n=36,25) | 3.62 units on a scale | Standard Deviation 1.27 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Week 16 (n=32,35) | 2.64 units on a scale | Standard Deviation 1.18 |
| Tocilizumab, 31 Minute Infusions | DAS28 Score by Visit | Week 8 (n=32,35) | 3.05 units on a scale | Standard Deviation 1.2 |
Secondary
Erythrocyte Sedimentation Rate
ESR is an acute phase reactant measured in mm/hr. Reduction in ESR indicates improvement.
Time frame: Baseline, Weeks 2, 4, 8, 12,16, 20, and 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Screening (n=37,37) | 37.70 mm/hr | Standard Deviation 25.19 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Week 12 (n=32,35) | 12.19 mm/hr | Standard Deviation 16.63 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Week 16 (n=33,36) | 11.97 mm/hr | Standard Deviation 15.39 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Final visit (n=30,33) | 12.00 mm/hr | Standard Deviation 13.77 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Baseline (n=30,30) | 42.53 mm/hr | Standard Deviation 28.6 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Week 4 (n=36,29) | 15.03 mm/hr | Standard Deviation 16.16 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Week 8 (n=33,36) | 15.36 mm/hr | Standard Deviation 17.06 |
| Tocilizumab, 1 Hour Infusions | Erythrocyte Sedimentation Rate | Week 20 (n=33,34) | 13.83 mm/hr | Standard Deviation 19.91 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Final visit (n=30,33) | 6.70 mm/hr | Standard Deviation 5.59 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Week 8 (n=33,36) | 8.67 mm/hr | Standard Deviation 8.82 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Screening (n=37,37) | 31.19 mm/hr | Standard Deviation 18.62 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Week 12 (n=32,35) | 6.77 mm/hr | Standard Deviation 6.47 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Week 4 (n=36,29) | 11.41 mm/hr | Standard Deviation 8.93 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Week 16 (n=33,36) | 6.50 mm/hr | Standard Deviation 6.22 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Week 20 (n=33,34) | 6.29 mm/hr | Standard Deviation 6.76 |
| Tocilizumab, 31 Minute Infusions | Erythrocyte Sedimentation Rate | Baseline (n=30,30) | 30.40 mm/hr | Standard Deviation 17.78 |
Secondary
HAQ-DI Score by Visit
HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24
Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Week 8 (n=35,37) | 1.3 units on a scale | Standard Deviation 0.8 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Week 12 (n=31,36) | 1.1 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Week 16 (n=33,38) | 1.0 units on a scale | Standard Deviation 0.8 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Week 20 (n=35,37) | 1.0 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Baseline (n=37,37) | 1.6 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Week 4 (n=37,37) | 1.4 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 1 Hour Infusions | HAQ-DI Score by Visit | Final visit (n=35,35) | 0.9 units on a scale | Standard Deviation 0.8 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Week 20 (n=35,37) | 0.8 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Week 8 (n=35,37) | 0.9 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Baseline (n=37,37) | 1.4 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Week 12 (n=31,36) | 0.8 units on a scale | Standard Deviation 0.6 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Final visit (n=35,35) | 0.8 units on a scale | Standard Deviation 0.7 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Week 16 (n=33,38) | 0.8 units on a scale | Standard Deviation 0.6 |
| Tocilizumab, 31 Minute Infusions | HAQ-DI Score by Visit | Week 4 (n=37,37) | 1.0 units on a scale | Standard Deviation 0.6 |
Secondary
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response)
ACR50 response defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 4 | 11.4 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 12 | 35.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Final visit | 54.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 8 | 26.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 20 | 65.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 16 | 53.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 20 | 45.5 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Final visit | 45.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 4 | 20.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 8 | 39.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 12 | 47.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) | Week 16 | 45.5 percentage of participants |
Comparison: Week 4p-value: 0.377Chi-squared
Comparison: Week 8p-value: 0.387Chi-squared
Comparison: Week 12p-value: 0.304Chi-squared
Comparison: Week 16p-value: 0.509Chi-squared
Comparison: Week 20p-value: 0.11Chi-squared
Comparison: Final visitp-value: 0.504Chi-squared
Secondary
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response)
ACR70 response defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 4 | 0.0 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 8 | 12.1 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 12 | 22.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 16 | 25.1 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 20 | 33.3 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Final visit | 38.2 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 20 | 29.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 4 | 2.9 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 16 | 28.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 8 | 14.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Final visit | 30.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) | Week 12 | 28.6 percentage of participants |
Comparison: Week 4p-value: 0.327Chi-squared
Comparison: Week 8p-value: 0.786Chi-squared
Comparison: Week 12p-value: 0.482Chi-squared
Comparison: Week 16p-value: 0.68Chi-squared
Comparison: Week 20p-value: 0.69Chi-squared
Comparison: Final Visitp-value: 0.516Chi-squared
Secondary
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response)
ACR90 response defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 12 | 3.1 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Final visit | 12.1 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 4 | 0.0 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 8 | 2.9 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 20 | 8.8 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 16 | 3.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Final visit | 11.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 8 | 2.9 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 12 | 5.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 20 | 5.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 16 | 11.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) | Week 4 | 0.0 percentage of participants |
Comparison: Week 12p-value: 0.587Chi-squared
Comparison: Week 16p-value: 0.184Chi-squared
Comparison: Week 20p-value: 0.6Chi-squared
Comparison: Final Visitp-value: 0.937Chi-squared
Comparison: Week 8p-value: 0.97Chi-squared
Secondary
Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission.
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 4 | 11.1 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 8 | 18.8 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 12 | 34.4 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 16 | 40.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 20 | 56.3 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Final visit | 46.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 20 | 58.8 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 4 | 20.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 16 | 51.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 8 | 34.3 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Final visit | 74.2 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) | Week 12 | 57.1 percentage of participants |
Secondary
Percentage of Participants Achieving a DAS28 Score <3.2 by Visit
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hr), and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2=low disease activity, DAS28 \>3.2 to 5.1=moderate to high disease activity; DAS28 \<2.6=remission.
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 4 | 22.2 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 8 | 25.0 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 12 | 46.9 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 16 | 59.4 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 20 | 68.8 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Final visit | 64.3 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 20 | 79.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 4 | 32.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 16 | 77.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 8 | 60.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Final visit | 80.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving a DAS28 Score <3.2 by Visit | Week 12 | 77.1 percentage of participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response)
ACR20 response defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (ESR or C-Reactive Protein \[CRP\])
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 8 | 51.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 16 | 74.2 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 4 | 26.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 20 | 81.8 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Final visit | 70.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 12 | 60.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Final visit | 64.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 4 | 48.5 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 8 | 59.4 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 12 | 69.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 16 | 60.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) | Week 20 | 54.5 percentage of participants |
Comparison: Week 4p-value: 0.121Chi-squared
Comparison: Week 8p-value: 0.809Chi-squared
Comparison: Week 12p-value: 0.367Chi-squared
Comparison: Week 16p-value: 0.339Chi-squared
Comparison: Week 20p-value: 0.017Chi-squared
Comparison: Final visitp-value: 0.451Chi-squared
Secondary
Percentage of Participants Discontinuing Tocilizumab for Any Reason
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Discontinuing Tocilizumab for Any Reason | 2.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Discontinuing Tocilizumab for Any Reason | 2.6 percentage of participants |
Secondary
Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) | 2.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) | 0.0 percentage of participants |
Secondary
Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity; DAS28 less than (\<) 2.6 = remission. A reduction of at least 1.2 units was considered a clinically significant difference.
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 4 | 56.7 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 8 | 58.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 12 | 77.8 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 16 | 88.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 20 | 88.9 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Final visit | 80.8 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 20 | 84.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 4 | 61.9 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 16 | 88.0 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 8 | 74.1 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Final visit | 91.7 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit | Week 12 | 92.3 percentage of participants |
Secondary
Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI
HAQ-DI is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ-DI scores range: 0-3: without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation. An improvement of 0.22 units in HAQ-DI was considered to be a clinically significant improvement.
Time frame: Weeks 4, 8, 12, 16, 20 and Final Visit
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 12 | 64.5 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 4 | 48.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 20 | 68.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 16 | 72.7 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Final visit | 68.6 percentage of participants |
| Tocilizumab, 1 Hour Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 8 | 62.9 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Final visit | 61.8 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 16 | 52.8 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 4 | 48.6 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 8 | 54.3 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 12 | 58.8 percentage of participants |
| Tocilizumab, 31 Minute Infusions | Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI | Week 20 | 54.3 percentage of participants |