Rheumatoid Arthritis
Conditions
Brief summary
This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.
Interventions
DRUGTocilizumab
8 mg/kg infusion
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, at least 18 years of age, inclusive * Diagnosis of rheumatoid arthritis of at least 6 months duration * Moderate to severe active rheumatoid arthritis (DAS28 \>/=3.2) * Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization * Rheumatic autoimmune disease other than rheumatoid arthritis * Prior history of or current inflammatory joint disease other than rheumatoid arthritis * Functional class IV (ACR criteria) * History of severe allergic reaction to human, humanized or murine monoclonal antibodies * Known active current or history of recurrent infection (including tuberculosis) * Primary or secondary immunodeficiency (history of or currently active) * Body weight \>150 kg * Previous treatment with any cell-depleting therapies * Previous treatment with tocilizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Any Infusion Reaction | Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20 | An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Discontinuing Tocilizumab for Other Reasons | Baseline and Weeks, 4, 8, 12, 16, 20, and 24 | Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed. |
| Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | Baseline and Weeks 4, 8, 12, 16, 20, and 24 | Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of \>1.5 times, or \>3 times, or \>5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits. ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits. |
| Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | Screening and Weeks 4, 8, 12, 16, 20, and 24 | Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines. |
| Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20, and 24 | Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (\<)3.2, and remission was defined as a DAS28 score \<2.6. |
| Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20, and 24 | Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6. |
| Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20, and 24 | Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6. |
| DAS28 Score by Visit Among Participants Who Completed All Visits | Baseline, Weeks, 4, 8, 12, 16, 20, and 24 | Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6. |
| Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE) | Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24 | All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed. |
| Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Weeks, 4, 8, 12, 16, 20, and 24 | ACR50 response is 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). |
| Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20 and 24 | ACR70 response is 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) by Visit Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20 and 24 | ACR90 response is 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). |
| High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24 | hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA. |
| Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Baseline, Weeks 4, 8, 12, 20, and 24 | M-HAQ is a self-reported, valid assessment of functional disability in RA. 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. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. |
| Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Weeks 4, 8. 12, 20, and 24 | M-HAQ is a self-reported, valid assessment of functional disability in RA. 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. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3. |
| Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Weeks 4, 8, 12, 16, 20, and 24 | ACR20 response is 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 (Erythrocyte Sedimentation Rate \[ESR\] or C-Reactive Protein \[CRP\]). |
Countries
Denmark, Iceland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab, Normal Administration Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period. | 22 |
| Tocilizumab, Fast Administration Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions. | 25 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Tocilizumab, Normal Administration | Tocilizumab, Fast Administration | Total |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 11.8 | 59.8 years STANDARD_DEVIATION 13.1 | 58.7 years STANDARD_DEVIATION 12.4 |
| Sex: Female, Male Female | 17 Participants | 20 Participants | 37 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 22 | 17 / 25 |
| serious Total, serious adverse events | 2 / 22 | 0 / 25 |
Outcome results
Primary
Percentage of Participants With Any Infusion Reaction
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.
Time frame: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20
Population: Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants With Any Infusion Reaction | 13.6 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Any Infusion Reaction | 12.0 Percentage of Participants |
95% CI: [-0.2685, 0.2988]
Secondary
DAS28 Score by Visit Among Participants Who Completed All Visits
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Time frame: Baseline, Weeks, 4, 8, 12, 16, 20, and 24
Population: ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 8 (n=18,22) | 2.9 scores on a scale | Standard Deviation 0.8 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 16 (n=18,21) | 2.3 scores on a scale | Standard Deviation 0.4 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 4 (n=18,21) | 3.3 scores on a scale | Standard Deviation 0.8 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 20 (n=18,22) | 2.3 scores on a scale | Standard Deviation 0.6 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 12 (n=18,22) | 2.6 scores on a scale | Standard Deviation 0.9 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 24 (n=18,22) | 2.3 scores on a scale | Standard Deviation 0.6 |
| Tocilizumab, Normal Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Baseline (n=18,21) | 5.0 scores on a scale | Standard Deviation 1.1 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 24 (n=18,22) | 2.5 scores on a scale | Standard Deviation 1 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Baseline (n=18,21) | 5.0 scores on a scale | Standard Deviation 0.9 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 4 (n=18,21) | 3.6 scores on a scale | Standard Deviation 1 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 8 (n=18,22) | 3.1 scores on a scale | Standard Deviation 1.2 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 12 (n=18,22) | 2.4 scores on a scale | Standard Deviation 1 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 16 (n=18,21) | 2.6 scores on a scale | Standard Deviation 1 |
| Tocilizumab, Fast Administration | DAS28 Score by Visit Among Participants Who Completed All Visits | Week 20 (n=18,22) | 2.6 scores on a scale | Standard Deviation 0.9 |
Secondary
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.
Time frame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Screening | 22.8 mg/L | Standard Deviation 19.8 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Baseline | 23.5 mg/L | Standard Deviation 22.7 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 4 | 4.7 mg/L | Standard Deviation 6.6 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 8 | 3.3 mg/L | Standard Deviation 3.3 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 12 | 3.2 mg/L | Standard Deviation 3.4 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 16 | 2.8 mg/L | Standard Deviation 3.1 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 20 | 2.9 mg/L | Standard Deviation 3 |
| Tocilizumab, Normal Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 24 | 3.2 mg/L | Standard Deviation 3.5 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 24 | 3.4 mg/L | Standard Deviation 3.6 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Screening | 25.9 mg/L | Standard Deviation 36 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 12 | 2.6 mg/L | Standard Deviation 3.3 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Baseline | 27.0 mg/L | Standard Deviation 32.1 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 20 | 3.0 mg/L | Standard Deviation 3.2 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 4 | 3.1 mg/L | Standard Deviation 3.4 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 16 | 3.1 mg/L | Standard Deviation 3.3 |
| Tocilizumab, Fast Administration | High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits | Week 8 | 4.5 mg/L | Standard Deviation 3.8 |
Secondary
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
M-HAQ is a self-reported, valid assessment of functional disability in RA. 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. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
Time frame: Baseline, Weeks 4, 8, 12, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 8 | 0.79 scores on a scale | Standard Deviation 0.67 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 16 | 0.82 scores on a scale | Standard Deviation 0.69 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 4 | 0.97 scores on a scale | Standard Deviation 0.64 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 20 | 0.75 scores on a scale | Standard Deviation 0.61 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 12 | 0.80 scores on a scale | Standard Deviation 0.7 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 24 | 0.68 scores on a scale | Standard Deviation 0.63 |
| Tocilizumab, Normal Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Baseline | 1.29 scores on a scale | Standard Deviation 0.71 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 24 | 1.07 scores on a scale | Standard Deviation 0.82 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Baseline | 1.50 scores on a scale | Standard Deviation 0.74 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 4 | 1.10 scores on a scale | Standard Deviation 0.64 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 8 | 0.95 scores on a scale | Standard Deviation 0.68 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 12 | 0.98 scores on a scale | Standard Deviation 0.62 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 16 | 0.94 scores on a scale | Standard Deviation 0.69 |
| Tocilizumab, Fast Administration | Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits | Week 20 | 1.05 scores on a scale | Standard Deviation 0.77 |
Secondary
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
ACR50 response is 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 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 28 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 28 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 50 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 67 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 72 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 55 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 18 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 46 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 73 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 50 Percentage of Participants |
Secondary
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
ACR70 response is 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 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 4 | 11 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 8 | 17 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 12 | 22 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 16 | 11 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 20 | 22 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 24 | 22 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 20 | 18 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 4 | 5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 16 | 27 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 8 | 23 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 24 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits | Week 12 | 36 Percentage of Participants |
Secondary
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
ACR90 response is 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 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 0 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 0 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 0 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 0 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 6 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 0 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 0 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 9 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 9 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 14 Percentage of Participants |
Secondary
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 4 | 22 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 8 | 28 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 12 | 50 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 16 | 78 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 20 | 72 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 24 | 61 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 20 | 59 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 4 | 9 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 16 | 46 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 8 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 24 | 55 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits | Week 12 | 73 Percentage of Participants |
Secondary
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 4 | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 8 | 67 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 12 | 78 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 16 | 94 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 20 | 89 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 24 | 83 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 20 | 73 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 4 | 27 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 16 | 68 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 8 | 55 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 24 | 77 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits | Week 12 | 82 Percentage of Participants |
Secondary
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
ACR20 response is 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 (Erythrocyte Sedimentation Rate \[ESR\] or C-Reactive Protein \[CRP\]).
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 50 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 67 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 72 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 83 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 83 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 89 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 20 | 73 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 4 | 41 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 16 | 77 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 8 | 59 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 24 | 91 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits | Week 12 | 68 Percentage of Participants |
Secondary
Percentage of Participants Discontinuing Tocilizumab for Other Reasons
Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.
Time frame: Baseline and Weeks, 4, 8, 12, 16, 20, and 24
Population: SAS Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Discontinuing Tocilizumab for Other Reasons | 9 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Discontinuing Tocilizumab for Other Reasons | 4 Percentage of Participants |
Secondary
Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)
All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.
Time frame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24
Population: SAS Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE) | 9.0 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE) | 8.0 Percentage of Participants |
Secondary
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (\<)3.2, and remission was defined as a DAS28 score \<2.6.
Time frame: Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 4 | 67 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 8 | 89 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 12 | 89 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 16 | 94 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 20 | 94 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 24 | 89 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 20 | 82 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 4 | 55 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 16 | 77 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 8 | 73 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 24 | 86 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits | Week 12 | 82 Percentage of Participants |
Secondary
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
M-HAQ is a self-reported, valid assessment of functional disability in RA. 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. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
Time frame: Weeks 4, 8. 12, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 4 | 44.4 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 8 | 72.2 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 12 | 72.2 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 16 | 77.8 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 20 | 66.7 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 24 | 72.2 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 20 | 59.1 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 4 | 45.5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 16 | 63.6 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 8 | 59.1 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 24 | 50.0 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits | Week 12 | 54.5 Percentage of Participants |
Secondary
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.
Time frame: Screening and Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Screening | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 4 | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 8 | 50 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 12 | 39 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 16 | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 20 | 39 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 24 | 44 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Screening | 0 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 4 | 11 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 8 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 12 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 16 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 20 | 11 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 24 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Screening | 33 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 4 | 56 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 8 | 61 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 12 | 56 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 16 | 61 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 20 | 61 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 24 | 56 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 12 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Screening | 46 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 16 | 64 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 4 | 55 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 16 | 23 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 8 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 8 | 73 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 12 | 50 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 20 | 32 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 16 | 41 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 24 | 64 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 20 | 36 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 24 | 18 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High HDL (≥1.5 mmol/L), Week 24 | 46 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 12 | 68 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Screening | 14 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Screening | 59 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 4 | 27 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 20 | 59 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High LDL (≥4.1 mmol/L), Week 8 | 32 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits | High total cholesterol (≥5.1 mmol/L), Week 4 | 73 Percentage of Participants |
Secondary
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of \>1.5 times, or \>3 times, or \>5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits. ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Completers with liver enzyme datasets for each analyzed visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 4 | 12 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 8 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 12 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 16 | 6 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 20 | 12 Percentage of Participants |
| Tocilizumab, Normal Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 24 | 24 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 20 | 5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 4 | 5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 16 | 10 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 8 | 10 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 24 | 5 Percentage of Participants |
| Tocilizumab, Fast Administration | Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits | ALT>1.5 ULN, Week 12 | 5 Percentage of Participants |