Rheumatoid Arthritis
Conditions
Brief summary
This single arm, open-label study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive intravenous RoActemra/Actemra at a dose of 8 mg/kg every 4 weeks. Anticipated time on study treatment is 96 weeks.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg intravenously, every 4 weeks for 96 weeks
Sponsors
Clalit Health Services
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/=18 years of age * Active moderate to severe rheumatoid arthritis * Inadequate response to \>/=3 DMARDs (non-biologic and/or biologic) * Current treatment at stable dose for \>/=8 weeks * Etanercept discontinued \>/=2 weeks, Anakinra \>/=1 week, Infliximab, Adalimumab, Abatacept, Golimumab, Certolizumab \>/=4 weeks, prior to baseline visit. Patients have discontinued MabThera/Rituxan or Ocrelizumab \>/=16 weeks, and must have proven B-cell repletion
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline * Rheumatic autoimmune disease other than RA * Functional class IV (American College of Rheumatology Classification) * Prior history or current inflammatory joint disease other than RA * Oral corticosteroids at a dose of \>10 mg/day prednisone equivalent * Positive hepatitis B surface antigen (HBsAg) and / or total hepatitis B core antibodies (HBcAb) or hepatitis C virus (HCV) antibody * Current or history of recurrent bacterial, viral, fungal or mycobaterial infection * History of or currently active primary or secondary immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population | Baseline, Week 24 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population | Baseline, Week 48 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population | Baseline, Week 72 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population | Baseline, Week 96 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population | Baseline, Week 24 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population | Baseline, Week 48 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population | Baseline, Week 72 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
| Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population | Baseline, Week 96 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | Weeks 24, 48, 72 and 96 | ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria. |
| Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Baseline; Weeks 20, 44, 72 and 96 | — |
| C-reactive Protein Level | Baseline; Weeks 8, 16, 24, 36 48, 72 and 96 | — |
| Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Baseline; Weeks 24, 48, 72 and 96 | 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement. |
| Participant Assessment of Pain (VAS) | Baseline; Weeks 8, 16, 24, 36 48, 72 and 96 | The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain. |
| Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Baseline; Weeks 24, 48, 72 and 96 | HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Erythrocyte Sedimentation Rate | Baseline; Weeks 8, 16, 24, 36 48, 72 and 96 | — |
| Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 | Weeks 24, 48, 72 and 96 | Remission was defined as DAS28 score less than (\<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity (visual analog scale \[VAS\]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity. |
| Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Baseline, End of the study (up to Week 100) | BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation \[SD\] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated. |
| Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 | Weeks 24, 48, 72 and 96 | Remission was defined as DAS28 score \<2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. |
| Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 | Weeks 24, 48, 72 and 96 | The DAS28 score was a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline \<-1.2. EULAR Moderate response: DAS28 greater than (\>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline \<-0.6 to greater than or equal to (≥) -1.2. |
| Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Weeks 24, 48, 72 and 96 | SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter \[cm\]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0. |
| Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Weeks 24, 48, 72 and 96 | CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0. |
| Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Baseline; Weeks 24, 48, 72 and 96 | 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks. | 145 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | B Cell Depletion | 4 |
| Overall Study | High Parathyroid Hormone Value | 1 |
| Overall Study | Lack of Efficacy | 16 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 6 |
| Overall Study | Participant Non-Compliance | 2 |
| Overall Study | Positive Hepatitis B Core Antibody | 5 |
| Overall Study | Withdrawal by Subject | 9 |
Baseline characteristics
| Characteristic | Tocilizumab |
|---|---|
| Age, Continuous | 53.4 years STANDARD_DEVIATION 13.4 |
| Gender Female | 121 Participants |
| Gender Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 134 / 145 |
| serious Total, serious adverse events | 36 / 145 |
Outcome results
Primary
Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 24
Population: Per Protocol (PP) population: all participants who completed the study. Number of participants analyzed=participants with available data for this outcome. Here 'n' signifies the participants with available data for specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population | Baseline (n=86) | 20.9 units on a scale | Standard Deviation 10.9 |
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 24 in Per Protocol (PP) Population | Change From Baseline at Week 24 (n=80) | 5.0 units on a scale | Standard Deviation 9.7 |
Comparison: Analysis was performed using paired sample t-test for change from baseline.p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 48
Population: ITT population. Number of participants analyzed=participants with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 48 in ITT Population | 6.7 units on a scale | Standard Deviation 10.5 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 48
Population: Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 48 in PP Population | 6.8 units on a scale | Standard Deviation 10.5 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 72
Population: ITT population. Number of participants analyzed=participants with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 72 in ITT Population | 7.1 units on a scale | Standard Deviation 10.7 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 72
Population: Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 72 in PP Population | 7.3 units on a scale | Standard Deviation 10.9 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 96
Population: ITT population. Number of participants analyzed=participants with available data at specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 96 in ITT Population | 7.3 units on a scale | Standard Deviation 10.4 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 96
Population: Per Protocol (PP) population. Number of participants analyzed=participants with available data for specified time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab | Change From Baseline in FACIT Fatigue Score at Week 96 in PP Population | 7.3 units on a scale | Standard Deviation 10.4 |
p-value: <0.0001Paired sample T-test
Primary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score).
Time frame: Baseline, Week 24
Population: ITT population. Number of participants analysed=participants with available data for this endpoint. Here, 'n' signifies participants with available data at specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population | Baseline (n=142) | 21.2 units on a scale | Standard Deviation 11.8 |
| Tocilizumab | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score at Week 24 in Intent-to-treat (ITT) Population | Change From Baseline at Week 24 (n=118) | 5.4 units on a scale | Standard Deviation 9.6 |
Comparison: Analysis was performed using paired sample t-test for change from baseline.p-value: <0.0001Paired sample T-test
Secondary
Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study
BMD was measured by dual energy X-ray absorptiometry (DXA) and T-scores (a standard deviation \[SD\] compared with the peak BMD value of an adult aged from 20 to 30 years) were calculated. Osteopenia was defined by a T-score between -1 and -2.5 SD and osteoporosis as a T-score below -2.5 SD, according to the World Health Organization (WHO) guidelines. T-scores for L1-L4 lumbar spine, total spine, total hip (left), and femoral neck (left) were calculated.
Time frame: Baseline, End of the study (up to Week 100)
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number of participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | L1-L4: Baseline (n=40) | -0.81 T-score | Standard Deviation 1.35 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | L1-L4: Change From Baseline at End (n=22) | -0.05 T-score | Standard Deviation 0.39 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Total Spine: Baseline (n=109) | -1.13 T-score | Standard Deviation 1.33 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Total Spine: Change From Baseline at End (n=65) | 0.04 T-score | Standard Deviation 0.5 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Total Hip-Left: Baseline (n=124) | -0.67 T-score | Standard Deviation 1.16 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Total Hip-Left: Change From Baseline at End (n=76) | 0.10 T-score | Standard Deviation 0.37 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Neck-Left: Baseline (n=137) | -1.11 T-score | Standard Deviation 1.17 |
| Tocilizumab | Change From Baseline in Bone Mineral Density (BMD) in Lumbar Spine, Total Hip and Femoral Neck Regions at End of Study | Neck-Left: Change From Baseline at End (n=85) | -0.05 T-score | Standard Deviation 0.36 |
Comparison: Comparison of L1-L4 T-scoresp-value: 0.3778ANCOVA
Comparison: Comparison of Total spine T-scorep-value: 0.1541ANCOVA
Comparison: Comparison of Total hip - left T-scorep-value: 0.789ANCOVA
Comparison: Comparison of Femoral neck - left T-scores.p-value: 0.7094ANCOVA
Secondary
Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96
HAQ: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Baseline; Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Baseline (n=138) | 1.8 units on a scale | Standard Deviation 0.7 |
| Tocilizumab | Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Change From Baseline at Week 24 (n=112) | -0.4 units on a scale | Standard Deviation 0.6 |
| Tocilizumab | Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Change From Baseline at Week 48 (n=92) | -0.4 units on a scale | Standard Deviation 0.6 |
| Tocilizumab | Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Change From Baseline at Week 72 (n=73) | -0.4 units on a scale | Standard Deviation 0.6 |
| Tocilizumab | Change From Baseline in Health Assessment Questionnaire (HAQ) at Weeks 24, 48, 72, and 96 | Change From Baseline at Week 96 (n=81) | -0.5 units on a scale | Standard Deviation 0.6 |
Secondary
Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96
Time frame: Baseline; Weeks 20, 44, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Baseline (n=138) | 12.4 gram per deciliter | Standard Deviation 1.4 |
| Tocilizumab | Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Change From Baseline at Week 20 (n=122) | 0.7 gram per deciliter | Standard Deviation 1 |
| Tocilizumab | Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Change From Baseline at Week 44 (n=91) | 1.2 gram per deciliter | Standard Deviation 1.2 |
| Tocilizumab | Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Change From Baseline at Week 72 (n=73) | 1.0 gram per deciliter | Standard Deviation 1.1 |
| Tocilizumab | Change From Baseline in Hemoglobin at Weeks 20, 44, 72 and 96 | Change From Baseline at Week 96 (n=80) | 1.2 gram per deciliter | Standard Deviation 1.3 |
Secondary
Change From Baseline in SJC At Weeks 24, 48, 72, and 96
66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from baseline indicated improvement.
Time frame: Baseline; Weeks 24, 48, 72 and 96
Population: ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Baseline (n=145) | 11.0 swollen joints | Standard Deviation 6.6 |
| Tocilizumab | Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 24 (n=124) | -7.3 swollen joints | Standard Deviation 6.7 |
| Tocilizumab | Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 48 (n=99) | -7.3 swollen joints | Standard Deviation 6.4 |
| Tocilizumab | Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 72 (n=79) | -7.6 swollen joints | Standard Deviation 6.8 |
| Tocilizumab | Change From Baseline in SJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 96 (n=84) | -7.8 swollen joints | Standard Deviation 6.8 |
Comparison: Change from baseline at Week 24p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 48p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 72p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 96p-value: <0.0001Wilcoxon Signed Rank Test
Secondary
Change From Baseline in TJC At Weeks 24, 48, 72, and 96
68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from baseline indicated improvement.
Time frame: Baseline; Weeks 24, 48, 72 and 96
Population: ITT population. Here, 'n' signifies the number of participants with available data at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Baseline (n=145) | 22.8 tender joints | Standard Deviation 14.2 |
| Tocilizumab | Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 48 (n=99) | -15.2 tender joints | Standard Deviation 13.4 |
| Tocilizumab | Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 72 (n=79) | -13.9 tender joints | Standard Deviation 14.5 |
| Tocilizumab | Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 96 (n=84) | -14.5 tender joints | Standard Deviation 12.4 |
| Tocilizumab | Change From Baseline in TJC At Weeks 24, 48, 72, and 96 | Change From Baseline at Week 24 (n=124) | -13.4 tender joints | Standard Deviation 13.5 |
Comparison: Change from baseline at Week 96p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 24p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 48p-value: <0.0001Wilcoxon Signed Rank Test
Comparison: Change from baseline at Week 72p-value: <0.0001Wilcoxon Signed Rank Test
Secondary
C-reactive Protein Level
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | C-reactive Protein Level | Baseline (n=133) | 2.8 milligram per deciliter | Standard Deviation 5.6 |
| Tocilizumab | C-reactive Protein Level | Week 8 (n=114) | 0.3 milligram per deciliter | Standard Deviation 1.2 |
| Tocilizumab | C-reactive Protein Level | Week 16 (n=116) | 0.3 milligram per deciliter | Standard Deviation 0.6 |
| Tocilizumab | C-reactive Protein Level | Week 24 (n=112) | 0.2 milligram per deciliter | Standard Deviation 0.6 |
| Tocilizumab | C-reactive Protein Level | Week 36 (n=87) | 0.3 milligram per deciliter | Standard Deviation 0.8 |
| Tocilizumab | C-reactive Protein Level | Week 48 (n=89) | 0.2 milligram per deciliter | Standard Deviation 0.3 |
| Tocilizumab | C-reactive Protein Level | Week 72 (n=64) | 0.2 milligram per deciliter | Standard Deviation 0.6 |
| Tocilizumab | C-reactive Protein Level | Week 96 (n=75) | 0.5 milligram per deciliter | Standard Deviation 1.1 |
Secondary
Erythrocyte Sedimentation Rate
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Erythrocyte Sedimentation Rate | Baseline (n=138) | 45.3 millimeter per hour | Standard Deviation 27.1 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 8 (n=125) | 10.6 millimeter per hour | Standard Deviation 11.6 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 16 (n=122) | 11.3 millimeter per hour | Standard Deviation 14.9 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 24 (n=118) | 8.8 millimeter per hour | Standard Deviation 8.8 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 36 (n=99) | 9.8 millimeter per hour | Standard Deviation 12 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 48 (n=96) | 8.3 millimeter per hour | Standard Deviation 10.7 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 72 (n=76) | 9.0 millimeter per hour | Standard Deviation 9.5 |
| Tocilizumab | Erythrocyte Sedimentation Rate | Week 96 (n=74) | 7.4 millimeter per hour | Standard Deviation 8.4 |
Secondary
Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96
Remission was defined as DAS28 score less than (\<) 2.6. The DAS28 score was a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity (visual analog scale \[VAS\]: 0=no disease activity to 100=maximum disease activity) and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. In case of missing ESR value, C-Reactive Protein (CRP) was used to calculate DAS28. Higher scores represented higher disease activity.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 | Week 24 (n=115) | 35 participants |
| Tocilizumab | Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 | Week 48 (n=95) | 37 participants |
| Tocilizumab | Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 | Week 72 (n=73) | 27 participants |
| Tocilizumab | Number of Participants Achieving Remission According to Disease Activity Score 28 (DAS28) at Weeks 24, 48, 72, and 96 | Week 96 (n=72) | 33 participants |
Secondary
Participant Assessment of Pain (VAS)
The mean score of pain as assessed by participants using a 100-mm horizontal VAS, where the left endpoint (0) indicated No pain, and the right endpoint (100) indicated Unbearable pain. Higher score indicated higher pain.
Time frame: Baseline; Weeks 8, 16, 24, 36 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab | Participant Assessment of Pain (VAS) | Baseline (n=143) | 70.3 mm | Standard Deviation 22.3 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 8 (n=136) | 51.6 mm | Standard Deviation 26.7 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 16 (n=132) | 53.0 mm | Standard Deviation 28.5 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 24 (n=123) | 49.4 mm | Standard Deviation 26.8 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 36 (n=104) | 44.7 mm | Standard Deviation 28.5 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 48 (n=100) | 46.3 mm | Standard Deviation 28.8 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 72 (n=76) | 42.3 mm | Standard Deviation 27.9 |
| Tocilizumab | Participant Assessment of Pain (VAS) | Week 96 (n=82) | 44.9 mm | Standard Deviation 28 |
Secondary
Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96
ACR20 response: ≥20% improvement in TJC; ≥20% improvement in SJC; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and either CRP or ESR. ACR50 response required ≥50% improvement in the above criteria and ACR70 response required ≥70% improvement in the above criteria.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies the number participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR20: Week 24 (n=121) | 48.8 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR20: Week 48 (n=96) | 63.5 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR20: Week 72 (n=76) | 60.5 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR20: Week 96 (n=81) | 58.0 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR50: Week 24 (n=121) | 24.8 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR50: Week 48 (n=96) | 28.1 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR50: Week 72 (n=76) | 34.2 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR50: Week 96 (n=81) | 35.8 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR70: Week 24 (n=121) | 11.6 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR70: Week 48 (n=96) | 15.6 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR70: Week 72 (n=76) | 21.1 percentage of partcipants |
| Tocilizumab | Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR50 and ACR70 Response at Weeks 24, 48, 72, and 96 | ACR70: Week 96 (n=81) | 21.0 percentage of partcipants |
Secondary
Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96
Remission was defined as DAS28 score \<2.6. The DAS28 score was a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 | Week 24 (n=115) | 30.4 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 | Week 48 (n=95) | 38.9 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 | Week 72 (n=73) | 37.0 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission According to DAS28 at Weeks 24, 48, 72, and 96 | Week 96 (n=72) | 45.8 percentage of participants |
Secondary
Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96
CDAI was calculated by a simple numerical sum of tender and swollen joint count (based on 28-joint assessment) and the patient and physician global disease assessment (VAS 0-10 cm). CDAI total score 0-76; higher scores = greater effect due to disease activity. Remission was defined as CDAI score ≤2.8. Low disease activity was defined as CDAI score ≤10.0.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 24 (n=120) | 6.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 24 (n=120) | 37.5 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 48 (n=97) | 9.3 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 48 (n=97) | 36.1 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 72 (n=75) | 10.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 72 (n=75) | 42.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 96 (n=80) | 17.5 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Clinical Disease Activity Index (CDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 96 (n=80) | 47.5 percentage of participants |
Secondary
Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96
SDAI was calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity (VAS 0-10 centimeter \[cm\]), and level of CRP. SDAI total score 0-86; higher scores = greater effect due to disease activity. Remission was defined as SDAI score ≤3.3. Low disease activity was defined as SDAI score ≤11.0.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 24 (n=107) | 10.3 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 24 (n=107) | 41.1 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 48 (n=86) | 11.6 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 48 (n=86) | 39.5 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 72 (n=60) | 16.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 72 (n=60) | 51.7 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Remission at Week 96 (n=72) | 13.9 percentage of participants |
| Tocilizumab | Percentage of Participants Achieving Remission and Low Disease Activity According to Simplified Disease Activity Index (SDAI) at Weeks 24, 48, 72, and 96 | Low Disease Activity at Week 96 (n=72) | 44.5 percentage of participants |
Secondary
Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96
The DAS28 score was a measure of the participant's disease activity calculated using the TJC \[28 joints\], SJC \[28 joints\], patient's global assessment of disease activity (VAS: 0=no disease activity to 100=maximum disease activity) and the ESR for a total possible score of 0 to approximately 10. In case of missing ESR value, CRP was used to calculate DAS28. Higher scores represented higher disease activity. EULAR Good response: DAS28 ≤3.2 and a change from Baseline \<-1.2. EULAR Moderate response: DAS28 greater than (\>) 3.2 to less than or equal to (≤) 5.1 or a change from Baseline \<-0.6 to greater than or equal to (≥) -1.2.
Time frame: Weeks 24, 48, 72 and 96
Population: ITT population. Number of participants analyzed=participants with available data for this endpoint. Here, 'n' signifies number of participants with available data for specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab | Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 | Week 24 (n=114) | 94.8 percentage of participants |
| Tocilizumab | Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 | Week 48 (n=94) | 94.7 percentage of participants |
| Tocilizumab | Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 | Week 72 (n=73) | 90.4 percentage of participants |
| Tocilizumab | Percentage of Participants With DAS28 Good or Moderate European League Against Rheumatism (EULAR) Response at Weeks 24, 48, 72 and 96 | Week 96 (n=72) | 94.5 percentage of participants |