Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA) (NCT NCT00642460)
NCT ID: NCT00642460
Last Updated: 2016-07-25
Results Overview
Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains. Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
112 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2016-07-25
Participant Flow
This study consists of 3 parts. Part I: a 12 week double-blind placebo controlled study followed by Part II: a 92 week single arm open-label extension study followed by Part III: a 3 year open label continuation study.
Participant milestones
| Measure |
Tocilizumab_8 mg/kg
Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.
|
Tocilizumab_12 mg/kg
Tocilizumab 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Tocilizumab Switchers
Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.
|
Participants ≥30 kg
Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Participants <30 kg
Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|---|---|---|---|
|
Part I: 12 Week Double-Blind
STARTED
|
37
|
38
|
37
|
0
|
0
|
0
|
|
Part I: 12 Week Double-Blind
Part I : Intent-to-treat
|
37
|
38
|
37
|
0
|
0
|
0
|
|
Part I: 12 Week Double-Blind
COMPLETED
|
36
|
37
|
36
|
0
|
0
|
0
|
|
Part I: 12 Week Double-Blind
NOT COMPLETED
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
STARTED
|
52
|
40
|
0
|
20
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Part II: Intent-to-treat
|
52
|
40
|
0
|
20
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
COMPLETED
|
43
|
32
|
0
|
17
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
NOT COMPLETED
|
9
|
8
|
0
|
3
|
0
|
0
|
|
Part III: Open-Label Up to Week 260
STARTED
|
0
|
0
|
0
|
0
|
53
|
59
|
|
Part III: Open-Label Up to Week 260
COMPLETED
|
0
|
0
|
0
|
0
|
28
|
38
|
|
Part III: Open-Label Up to Week 260
NOT COMPLETED
|
0
|
0
|
0
|
0
|
25
|
21
|
Reasons for withdrawal
| Measure |
Tocilizumab_8 mg/kg
Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.
|
Tocilizumab_12 mg/kg
Tocilizumab 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Tocilizumab Switchers
Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.
|
Participants ≥30 kg
Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Participants <30 kg
Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|---|---|---|---|
|
Part I: 12 Week Double-Blind
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Part I: 12 Week Double-Blind
Refused Treatment
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Adverse Event
|
4
|
2
|
0
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Death
|
0
|
1
|
0
|
2
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Insufficient therapeutic response
|
2
|
3
|
0
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Refused treatment
|
3
|
1
|
0
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Failure to return
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part II: Open-Label Up to Week 92
Administrative reasons
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Part III: Open-Label Up to Week 260
Adverse Event
|
0
|
0
|
0
|
0
|
7
|
6
|
|
Part III: Open-Label Up to Week 260
Insufficient therapeutic response
|
0
|
0
|
0
|
0
|
3
|
4
|
|
Part III: Open-Label Up to Week 260
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
4
|
1
|
|
Part III: Open-Label Up to Week 260
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Part III: Open-Label Up to Week 260
Other
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Part III: Open-Label Up to Week 260
Death
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Part III: Open-Label Up to Week 260
Administrative reason
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part III: Open-Label Up to Week 260
Refused treatment
|
0
|
0
|
0
|
0
|
8
|
3
|
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.
|
Placebo
n=37 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2 to 5
|
16 years
n=5 Participants
|
11 years
n=7 Participants
|
27 years
n=5 Participants
|
|
Age, Customized
6 to 12
|
33 years
n=5 Participants
|
15 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Age, Customized
13 to 17
|
26 years
n=5 Participants
|
11 years
n=7 Participants
|
37 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population includes all participants who had at least one dose of study drug.
Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains. Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days.
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=37 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever
|
85.3 Percentage of participants
|
24.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline, Week 104Population: Includes only participants on oral corticosteroids at baseline.
Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.
Outcome measures
| Measure |
Tocilizumab
n=55 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
≥20 percent decrease
|
76 Percentage of participants
|
—
|
|
Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
≥50 percent decrease
|
73 Percentage of participants
|
—
|
|
Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
≥75 percent decrease
|
62 Percentage of participants
|
—
|
|
Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
≥90 percent decrease
|
47 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population includes all randomized participants who received at least one dose of study drug.
The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI. At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%.
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=37 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
JIA ACR30 response
|
90.7 Percentage of participants
|
24.3 Percentage of participants
|
|
Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
JIA ACR50 response
|
85.3 Percentage of participants
|
10.8 Percentage of participants
|
|
Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
JIA ACR70 response
|
70.7 Percentage of participants
|
8.1 Percentage of participants
|
|
Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
JIA ACR90 response
|
37.3 Percentage of participants
|
5.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.
Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents 'arthritis inactive' (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. This item is completed by the treating physician.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity
|
-69.6 Percentage change
|
-41.1 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents 'very well' (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being
|
-65.8 Percentage change
|
-1.4 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion. The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient's efficacy and safety data.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis
|
-70.6 Percentage change
|
-37.2 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with 'limitation of motion'.
Outcome measures
| Measure |
Tocilizumab
n=72 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement
|
-51.6 Percentage change
|
-22.5 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate
|
-88.2 Percentage change
|
33.6 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).
Outcome measures
| Measure |
Tocilizumab
n=72 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)
|
-45.6 Percentage change
|
-10.3 Percentage change
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.
Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=24 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12
|
85.4 Percentage of participants
|
20.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.
Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=37 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12
Hemoglobin (n=50,29)
|
80.0 Percentage of participants
|
6.9 Percentage of participants
|
|
Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12
hsC-Reactive Protein (n=72,34)
|
98.6 Percentage of participants
|
5.9 Percentage of participants
|
|
Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12
Platelets (n=52,26)
|
90.4 Percentage of participants
|
3.8 Percentage of participants
|
|
Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12
Leukocytes (n=28,21)
|
75.0 Percentage of participants
|
9.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 6 or Week 8, Week 12Population: Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.
The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12. At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%.
Outcome measures
| Measure |
Tocilizumab
n=70 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=31 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Participants With Concomitant Corticosteroid Reduction
|
24.3 Percentage of participants
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.
Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=73 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=17 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12
|
-41.0 mm
|
-1.1 mm
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders. LOCF rule applied to missing CHAQ-DI Scores at Week 12.
Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12. The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=37 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12
|
77.3 Percentage of participants
Interval 67.9 to 86.8
|
18.9 Percentage of participants
Interval 6.3 to 31.5
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.
Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.
Outcome measures
| Measure |
Tocilizumab
n=22 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=18 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12
|
63.6 Percentage of participants
Interval 43.5 to 83.7
|
11.1 Percentage of participants
Interval 0.0 to 25.6
|
SECONDARY outcome
Timeframe: Baseline, Week 6 and Week 12Population: Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders. LOCF rule applied to missing hemoglobin values at Week 6 and Week 12.
Part I: Percentage of patients who had anemia (hemoglobin \<lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=29 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12
Week 6
|
88.0 Percentage of participants
Interval 79.0 to 97.0
|
3.4 Percentage of participants
Interval 0.0 to 10.1
|
|
Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12
Week 12
|
88.0 Percentage of participants
Interval 79.0 to 97.0
|
3.4 Percentage of participants
Interval 0.0 to 10.1
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.
The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI. At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%.
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104
JIA ACR70 response
|
76.0 Percentage of Participants
|
—
|
|
Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104
JIA ACR90 response
|
61.3 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Week 104Population: Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.
Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.
Outcome measures
| Measure |
Tocilizumab
n=59 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Number of Active Joints at Week 104
|
1.9 Active Joints
Standard Deviation 3.6
|
—
|
SECONDARY outcome
Timeframe: Week 104Population: The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.
Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.
Outcome measures
| Measure |
Tocilizumab
n=76 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Percentage of Participants With no Active Joints at Week 104
|
47.4 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Week 104Population: Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.
Criteria for Inactive Disease: 1\) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (\<20 mm/hour), 4) Physician's global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS).
Outcome measures
| Measure |
Tocilizumab
n=75 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Percentage of Participants With Inactive Disease at Week 104
|
26.7 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.
Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do). The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).
Outcome measures
| Measure |
Tocilizumab
n=112 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104
Baseline (n=112)
|
1.68 Score on a scale
Standard Deviation 0.86
|
—
|
|
Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104
Week 104 (n=57)
|
0.55 Score on a scale
Standard Deviation 0.71
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 104Population: Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.
Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.
Outcome measures
| Measure |
Tocilizumab
n=42 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104
|
60 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: 104 WeeksPopulation: Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)
Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula: Number of Patient Events / Duration in study (years) \* 100. Multiple occurrences of the same AE in one individual are counted.
Outcome measures
| Measure |
Tocilizumab
n=112 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
SAEs
|
23.3 Events per 100 patient year
|
—
|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
Serious infection AEs
|
10.9 Events per 100 patient year
|
—
|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
SAEs related to TCZ
|
7.4 Events per 100 patient year
|
—
|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
Macrophage activation syndrome
|
1.5 Events per 100 patient year
|
—
|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
AEs leading to withdrawal
|
3.0 Events per 100 patient year
|
—
|
|
Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
Deaths
|
1.5 Events per 100 patient year
|
—
|
SECONDARY outcome
Timeframe: Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260Population: The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.
Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.
Outcome measures
| Measure |
Tocilizumab
n=42 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=47 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 152 JIA ACR70 (n=27,28)
|
100.0 percentage of participants
|
96.4 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 152 JIA ACR90 (n=27,28)
|
66.7 percentage of participants
|
78.6 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 164 JIA ACR50 (n=27,24)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 188 JIA ACR90 (n=20,22)
|
45.0 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 248 JIA ACR50 (n=15,17)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 176 JIA ACR90 (n=22,22)
|
63.6 percentage of participants
|
63.6 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 188 JIA ACR30 (n=20,22)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 188 JIA ACR50 (n=20,22)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 188 JIA ACR70 (n=20,22)
|
95.0 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 104 JIA ACR30 (n=42,47)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 104 JIA ACR50 (n=42,47)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 104 JIA ACR70 (n=42,47)
|
92.9 percentage of participants
|
95.7 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 104 JIA ACR90 (n=42,47)
|
81.0 percentage of participants
|
72.3 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 116 JIA ACR30 (n=41,45)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 116 JIA ACR50 (n=41,45)
|
100.0 percentage of participants
|
97.8 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 116 JIA ACR70 (n=41,45)
|
95.1 percentage of participants
|
97.8 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 116 JIA ACR90 (n=41,45)
|
82.9 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 128 JIA ACR30 (n=39,41)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 128 JIA ACR50 (n=39,41)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 128 JIA ACR70 (n=39,41)
|
97.4 percentage of participants
|
97.6 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 128 JIA ACR90 (n=39,41)
|
79.5 percentage of participants
|
82.9 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 200 JIA ACR30 (n=19,19)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 140 JIA ACR30 (n=34,37)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 140 JIA ACR50 (n=34,37)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 140 JIA ACR70 (n=34,37)
|
100.0 percentage of participants
|
94.6 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 140 JIA ACR90 (n=34,37)
|
73.5 percentage of participants
|
75.7 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 152 JIA ACR30 (n=27,28)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 152 JIA ACR50 (n=27,28)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 164 JIA ACR30 (n=27,24)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 164 JIA ACR70 (n=27,24)
|
92.6 percentage of participants
|
95.8 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 164 JIA ACR90 (n=27,24)
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 176 JIA ACR30 (n=22,22)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 176 JIA ACR50 (n=22,22)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 176 JIA ACR70 (n=22,22)
|
100.0 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 200 JIA ACR50 (n=19,19)
|
100.0 percentage of participants
|
94.7 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 200 JIA ACR70 (n=19,19)
|
94.7 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 200 JIA ACR90 (n=19,19)
|
63.2 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 212 JIA ACR30 (n=18,18)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 212 JIA ACR50 (n=18,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 212 JIA ACR70 (n=18,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 212 JIA ACR90 (n=18,18)
|
72.2 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 224 JIA ACR30 (n=17,18)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 224 JIA ACR50 (n=17,18)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 224 JIA ACR70 (n=17,18)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 224 JIA ACR90 (n=17,18)
|
64.7 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 236 JIA ACR30 (n=16,17)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 236 JIA ACR50 (n=16,17)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 236 JIA ACR70 (n=16,17)
|
93.8 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 236 JIA ACR90 (n=16,17)
|
68.8 percentage of participants
|
88.2 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 248 JIA ACR30 (n=15,17)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 248 JIA ACR70 (n=15,17)
|
86.7 percentage of participants
|
94.1 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 248 JIA ACR90 (n=15,17)
|
73.3 percentage of participants
|
70.6 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 260 JIA ACR30 (n=15,15)
|
100.0 percentage of participants
|
93.3 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 260 JIA ACR50 (n=15,15)
|
93.3 percentage of participants
|
93.3 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 260 JIA ACR70 (n=15,15)
|
86.7 percentage of participants
|
93.3 percentage of participants
|
|
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Week 260 JIA ACR90 (n=15,15)
|
60.0 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260Population: The Part III ITT3 population
JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.
Outcome measures
| Measure |
Tocilizumab
n=89 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 116 JIA ACR 70 (n=86)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 164 JIA ACR50 (n=51)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 104 JIA ACR 30 (n=89)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 104 JIA ACR 50 (n=89)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 104 JIA ACR 70 (n=89)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 104 JIA ACR 90 (n=89)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 116 JIA ACR 30 (n=86)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 116 JIA ACR 50 (n=86)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 116 JIA ACR 90 (n=86)
|
NA percentage of participants
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 128 JIA ACR 30 (n=80)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 128 JIA ACR 50 (n=80)
|
98.8 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 128 JIA ACR 70 (n=80)
|
91.3 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 128 JIA ACR 90 (n=80)
|
68.8 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 140 JIA ACR30 (n=71)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 140 JIA ACR50 (n=71)
|
98.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 140 JIA ACR70 (n=71)
|
93.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 140 JIA ACR90 (n=71)
|
66.2 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 152 JIA ACR30 (n=55)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 152 JIA ACR50 (n=55)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 152 JIA ACR70 (n=55)
|
94.5 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 152 JIA ACR90 (n=55)
|
60.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 164 JIA ACR30 (n=51)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 164 JIA ACR70 (n=51)
|
92.2 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 164 JIA ACR90 (n=51)
|
56.9 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 176 JIA ACR30 (n=44)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 176 JIA ACR50 (n=44)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 176 JIA ACR70 (n=44)
|
88.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 176 JIA ACR90 (n=44)
|
52.3 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 188 JIA ACR30 (n=42)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 188 JIA ACR50 (n=42)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 188 JIA ACR70 (n=42)
|
88.1 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 188 JIA ACR90 (n=42)
|
50.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 200 JIA ACR30 (n=38)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 200 JIA ACR50 (n=38)
|
97.4 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 200 JIA ACR70 (n=38)
|
86.8 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 200 JIA ACR90 (n=38)
|
52.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 212 JIA ACR30 (n=36)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 212 JIA ACR50 (n=36)
|
97.2 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 212 JIA ACR70 (n=36)
|
88.9 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 212 JIA ACR90 (n=36)
|
55.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 224 JIA ACR30 (n=35)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 224 JIA ACR50 (n=35)
|
94.3 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 224 JIA ACR70 (n=35)
|
91.4 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 224 JIA ACR90 (n=35)
|
68.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 236 JIA ACR30 (n=33)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 236 JIA ACR50 (n=33)
|
93.9 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 236 JIA ACR70 (n=33)
|
90.9 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 236 JIA ACR90 (n=33)
|
72.7 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 248 JIA ACR30 (n=32)
|
100.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 248 JIA ACR50 (n=32)
|
93.8 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 248 JIA ACR70 (n=32)
|
87.5 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 248 JIA ACR90 (n=32)
|
65.6 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 260 JIA ACR30 (n=30)
|
96.7 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 260 JIA ACR50 (n=30)
|
93.3 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 260 JIA ACR70 (n=30)
|
80.0 percentage of participants
|
—
|
|
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Week 260 JIA ACR90 (n=30)
|
56.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.
Outcome measures
| Measure |
Tocilizumab
n=53 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=59 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Doses of Oral Corticosteroids
Baseline (n=53,59)
|
0.203 mg/kg/day
Standard Deviation 0.1572
|
0.356 mg/kg/day
Standard Deviation 0.1397
|
|
Part III: Doses of Oral Corticosteroids
Week 104 (n=45,48)
|
0.020 mg/kg/day
Standard Deviation 0.0455
|
0.047 mg/kg/day
Standard Deviation 0.0869
|
|
Part III: Doses of Oral Corticosteroids
Week 224 (n=18,19)
|
0.017 mg/kg/day
Standard Deviation 0.0279
|
0.075 mg/kg/day
Standard Deviation 0.1399
|
|
Part III: Doses of Oral Corticosteroids
Week 116 (n=42,46)
|
0.022 mg/kg/day
Standard Deviation 0.0464
|
0.046 mg/kg/day
Standard Deviation 0.0831
|
|
Part III: Doses of Oral Corticosteroids
Week 128 (n=41,42)
|
0.022 mg/kg/day
Standard Deviation 0.0449
|
0.058 mg/kg/day
Standard Deviation 0.1635
|
|
Part III: Doses of Oral Corticosteroids
Week 140 (n=34,38)
|
0.031 mg/kg/day
Standard Deviation 0.0625
|
0.051 mg/kg/day
Standard Deviation 0.1112
|
|
Part III: Doses of Oral Corticosteroids
Week 152 (n=28,31)
|
0.021 mg/kg/day
Standard Deviation 0.0388
|
0.060 mg/kg/day
Standard Deviation 0.1125
|
|
Part III: Doses of Oral Corticosteroids
Week 164 (n=28,25)
|
0.018 mg/kg/day
Standard Deviation 0.0349
|
0.068 mg/kg/day
Standard Deviation 0.1179
|
|
Part III: Doses of Oral Corticosteroids
Week 176 (n=25,23)
|
0.019 mg/kg/day
Standard Deviation 0.0383
|
0.073 mg/kg/day
Standard Deviation 0.1327
|
|
Part III: Doses of Oral Corticosteroids
Week 188 (n=21,22)
|
0.020 mg/kg/day
Standard Deviation 0.0366
|
0.075 mg/kg/day
Standard Deviation 0.1275
|
|
Part III: Doses of Oral Corticosteroids
Week 200 (n=20,20)
|
0.017 mg/kg/day
Standard Deviation 0.0284
|
0.083 mg/kg/day
Standard Deviation 0.1397
|
|
Part III: Doses of Oral Corticosteroids
Week 212 (n=19,19)
|
0.016 mg/kg/day
Standard Deviation 0.0274
|
0.077 mg/kg/day
Standard Deviation 0.1449
|
|
Part III: Doses of Oral Corticosteroids
Week 236 (n=17,18)
|
0.018 mg/kg/day
Standard Deviation 0.0283
|
0.077 mg/kg/day
Standard Deviation 0.1436
|
|
Part III: Doses of Oral Corticosteroids
Week 248 (n=16,18)
|
0.020 mg/kg/day
Standard Deviation 0.0290
|
0.076 mg/kg/day
Standard Deviation 0.1429
|
|
Part III: Doses of Oral Corticosteroids
Week 260 (n=16,18)
|
0.019 mg/kg/day
Standard Deviation 0.0282
|
0.079 mg/kg/day
Standard Deviation 0.1486
|
SECONDARY outcome
Timeframe: Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits. Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=46 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 248 (n=13,18)
|
46.0 percentage of participants
|
61.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 104 (n=38,46)
|
66.0 percentage of participants
|
67.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 116 (n=36,44)
|
67.0 percentage of participants
|
68.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 128 (n=35,40)
|
69.0 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 140 (n=31,36)
|
68 percentage of participants
|
67 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 152 (n=25,30)
|
64.0 percentage of participants
|
57.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 164 (n=25,24)
|
68.0 percentage of participants
|
58.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 176 (n=22,22)
|
68.0 percentage of participants
|
64.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 188 (n=18,21)
|
61.0 percentage of participants
|
57.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 200 (n=17,20)
|
59.0 percentage of participants
|
60.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 212 (n=16,19)
|
56.0 percentage of participants
|
63.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 224 (n=15,19)
|
53.0 percentage of participants
|
63.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 236 (n=14,18)
|
50.0 percentage of participants
|
61.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Week 260 (n=13,18)
|
46.0 percentage of participants
|
61.0 percentage of participants
|
SECONDARY outcome
Timeframe: Every 2 weeks from Week 104 to Week 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits. Baseline considered first dose of study treatment.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=46 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 144 >75% decrease (n=28,36)
|
71.4 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 148 >50% decrease (n=27,35)
|
96.3 percentage of participants
|
85.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 154 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
70.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 162 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
70.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 164 >20% decrease (n=24,24)
|
100.0 percentage of participants
|
95.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 166 >20% decrease (n=24,22)
|
100.0 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 170 >50% decrease (n=22,22)
|
95.5 percentage of participants
|
81.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 170 >90% decrease (n=22,22)
|
77.3 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 172 >90% decrease (n=22,22)
|
77.3 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 174 >75% decrease (n=22,22)
|
77.3 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 176 >75% decrease (n=19,22)
|
73.7 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 178 >75% decrease (n=19,22)
|
73.7 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 182 >20% decrease (n=18,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 182 >50% decrease (n=18,22)
|
94.4 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 184 >75% decrease (n=18,22)
|
72.2 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 186 >50% decrease (n=18,22)
|
94.4 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 186 >75% decrease (n=18,22)
|
72.2 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 200 >50% decrease (n=17,20)
|
94.1 percentage of participants
|
85.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 204 >50% decrease (n=17,20)
|
94.1 percentage of participants
|
85.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 216 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
94.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 216 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 216 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 218 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 218 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 234 >20% decrease (n=14,18)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 242 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 242 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 250 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 252 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 254 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 256 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 256 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 256 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 164 >50% decrease (n=24,24)
|
95.8 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 164 >75% decrease (n=24,24)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 164 >90% decrease (n=24,24)
|
75.0 percentage of participants
|
70.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 166 >50% decrease (n=24,22)
|
95.8 percentage of participants
|
81.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 166 >75% decrease (n=24,22)
|
75.0 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 166 >90% decrease (n=24,22)
|
75.0 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 156 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
85.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 156 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 156 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
70.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 158 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 158 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 158 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 158 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
70.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 160 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 160 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
85.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 160 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 160 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
70.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 162 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 162 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
81.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 162 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 168 >20% decrease (n=24,22)
|
100.0 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 168 >50% decrease (n=24,22)
|
95.8 percentage of participants
|
81.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 168 >75% decrease (n=24,22)
|
75.0 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 168 >90% decrease (n=24,22)
|
75.0 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 170 >20% decrease (n=22,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 170 >75% decrease (n=22,22)
|
77.3 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 172 >20% decrease (n=22,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 172 >50% decrease (n=22,22)
|
95.5 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 172 >75% decrease (n=22,22)
|
77.3 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 174 >20% decrease (n=22,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 174 >50% decrease (n=22,22)
|
95.5 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 174 >90% decrease (n=22,22)
|
77.3 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 176 >20% decrease (n=19,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 176 >50% decrease (n=19,22)
|
94.7 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 176 >90% decrease (n=19,22)
|
73.7 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 178 >20% decrease (n=19,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 178 >50% decrease (n=19,22)
|
94.7 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 178 >90% decrease (n=19,22)
|
73.7 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 180 >20% decrease (n=19,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 180 >50% decrease (n=19,22)
|
94.7 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 180 >75% decrease (n=19,22)
|
73.7 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 180 >90% decrease (n=19,22)
|
73.7 percentage of participants
|
63.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 182 >75% decrease (n=18,22)
|
72.2 percentage of participants
|
68.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 182 >90% decrease (n=18,22)
|
72.2 percentage of participants
|
63.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 184 >20% decrease (n=18,22)
|
100.0 percentage of participants
|
90.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 184 >50% decrease (n=18,22)
|
94.4 percentage of participants
|
86.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 184 >90% decrease (n=18,22)
|
72.2 percentage of participants
|
63.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 186 >20% decrease (n=18,22)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 186 >90% decrease (n=18,22)
|
72.2 percentage of participants
|
63.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 188 >20% decrease (n=18,21)
|
100.0 percentage of participants
|
90.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 188 >50% decrease (n=18,21)
|
94.4 percentage of participants
|
90.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 188 >75% decrease (n=18,21)
|
72.2 percentage of participants
|
71.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 188 >90% decrease (n=18,21)
|
72.2 percentage of participants
|
61.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 190 >20% decrease (n=18,21)
|
100.0 percentage of participants
|
95.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 190 >50% decrease (n=18,21)
|
94.4 percentage of participants
|
85.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 190 >75% decrease (n=18,21)
|
72.2 percentage of participants
|
66.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 190 >90% decrease (n=18,21)
|
72.2 percentage of participants
|
61.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 192 >20% decrease (n=18,21)
|
100.0 percentage of participants
|
95.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 192 >50% decrease (n=18,21)
|
94.4 percentage of participants
|
81.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 192 >75% decrease (n=18,21)
|
72.2 percentage of participants
|
66.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 192 >90% decrease (n=18,21)
|
72.2 percentage of participants
|
61.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 194 >20% decrease (n=18,20)
|
100.0 percentage of participants
|
95.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 194 >50% decrease (n=18,20)
|
94.4 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 194 >75% decrease (n=18,20)
|
72.2 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 194 >90% decrease (n=18,20)
|
72.2 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 196 >20% decrease (n=18,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 196 >50% decrease (n=18,20)
|
94.4 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 196 >75% decrease (n=18,20)
|
72.2 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 196 >90% decrease (n=18,20)
|
72.2 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 198 >20% decrease (n=18,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 198 >50% decrease (n=18,20)
|
94.4 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 198 >75% decrease (n=18,20)
|
72.2 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 198 >90% decrease (n=18,20)
|
72.2 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 200 >20% decrease (n=17,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 200 >75% decrease (n=17,20)
|
76.5 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 200 >90% decrease (n=17,20)
|
70.6 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 202 >20% decrease (n=17,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 202 >50% decrease (n=17,20)
|
94.1 percentage of participants
|
85.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 202 >75% decrease (n=17,20)
|
76.5 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 202 >90% decrease (n=17,20)
|
70.6 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 204 >20% decrease (n=17,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 204 >70% decrease (n=17,20)
|
76.5 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 204 >90% decrease (n=17,20)
|
70.6 percentage of participants
|
65.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 206 >20% decrease (n=16,20)
|
100.0 percentage of participants
|
85.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 206 >50% decrease (n=16,20)
|
93.8 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 206 >75% decrease (n=16,20)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 206 >90% decrease (n=16,20)
|
68.8 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 208 >20% decrease (n=16,20)
|
100.0 percentage of participants
|
90.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 208 >50% decrease (n=16,20)
|
93.8 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 208 >75% decrease (n=16,20)
|
75.0 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 208 >90% decrease (n=16,20)
|
68.8 percentage of participants
|
70.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 210 >20% decrease (n=16,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 210 >50% decrease (n=16,19)
|
93.8 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 210 >75% decrease (n=16,19)
|
81.3 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 210 >90% decrease (n=16,19)
|
75.0 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 212 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 212 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 212 >75% decrease (n=15,19)
|
73.3 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 212 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 214 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 214 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 214 >75% decrease (n=15,19)
|
73.3 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 214 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 216 >75% decrease (n=15,19)
|
73.3 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 218 >75% decrease (n=15,19)
|
80.0 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 218 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 220 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 220 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 220 >75% decrease (n=15,19)
|
80.0 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 220 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 222 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 222 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 222 >75% decrease (n=15,19)
|
80.0 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 222 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 224 >20% decrease (n=15,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 224 >50% decrease (n=15,19)
|
93.3 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 224 >75% decrease (n=15,19)
|
80.0 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 224 >90% decrease (n=15,19)
|
73.3 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 226 >20% decrease (n=14,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 226 >50% decrease (n=14,19)
|
92.9 percentage of participants
|
84.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 226 >75% decrease (n=14,19)
|
78.6 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 226 >90% decrease (n=14,19)
|
71.4 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 228 >20% decrease (n=14,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 228 >50% decrease (n=14,19)
|
92.9 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 228 >75% decrease (n=14,19)
|
78.6 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 228 >90% decrease (n=14,19)
|
71.4 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 230 >20% decrease (n=14,19)
|
100.0 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 230 >50% decrease (n=14,19)
|
92.9 percentage of participants
|
89.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 230 >75% decrease (n=14,19)
|
78.6 percentage of participants
|
78.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 230 >90% decrease (n=14,19)
|
71.4 percentage of participants
|
73.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 232 >20% decrease (n=14,18)
|
100.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 232 >50% decrease (n=14,18)
|
92.9 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 232 >75% decrease (n=14,18)
|
78.6 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 232 >90% decrease (n=14,18)
|
71.4 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 234 >50% decrease (n=14,18)
|
92.9 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 234 >75% decrease (n=14,18)
|
78.6 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 234 >90% decrease (n=14,18)
|
71.4 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 236 >20% decrease (n=14,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 236 >50% decrease (n=14,18)
|
92.9 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 236 >75% decrease (n=14,18)
|
78.6 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 236 >90% decrease (n=14,18)
|
71.4 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 238 >20% decrease (n=14,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 238 >50% decrease (n=14,18)
|
92.9 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 238 >75% decrease (n=14,18)
|
78.6 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 238 >90% decrease (n=14,18)
|
71.4 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 240 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 240 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 240 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 240 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 242 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 242 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 244 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 244 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 244 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 244 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 246 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 246 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 246 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 246 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 248 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 248 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 248 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 248 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 250 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 250 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 250 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 104 >20% decrease (n=38,46)
|
100.0 percentage of participants
|
97.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 104 >50% decrease (n=38,46)
|
94.7 percentage of participants
|
91.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 104 >75% decrease (n=38,46)
|
84.2 percentage of participants
|
82.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 104 >90% decrease (n=38,46)
|
71.1 percentage of participants
|
71.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 106 >20% decrease (n=37,46)
|
100.0 percentage of participants
|
97.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 106 >50% decrease (n=37,46)
|
91.9 percentage of participants
|
91.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 106 >75% decrease (n=37,46)
|
83.8 percentage of participants
|
82.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 106 >90% decrease (n=37,46)
|
70.3 percentage of participants
|
71.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 108 >20% decrease (n=37,45)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 108 >50% decrease (n=37,45)
|
89.2 percentage of participants
|
91.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 108 >75% decrease (n=37,45)
|
81.1 percentage of participants
|
84.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 108 >90% decrease (n=37,45)
|
70.3 percentage of participants
|
73.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 110 >20% decrease (n=36,44)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 110 >50% decrease (n=36,44)
|
88.9 percentage of participants
|
93.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 110 >75% decrease (n=36,44)
|
80.6 percentage of participants
|
84.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 110 >90% decrease (n=36,44)
|
72.2 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 112 >20% decrease (n=36,44)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 112 >50% decrease (n=36,44)
|
88.9 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 112 >75% decrease (n=36,44)
|
80.6 percentage of participants
|
81.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 112 >90% decrease (n=36,44)
|
72.2 percentage of participants
|
75.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 114 >20% decrease (n=36,44)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 114 >50% decrease (n=36,44)
|
88.9 percentage of participants
|
95.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 114 >75% decrease (n=36,44)
|
80.6 percentage of participants
|
79.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 114 >90% decrease (n=36,44)
|
72.2 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 116 >20% decrease (n=35,44)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 116 >50% decrease (n=35,44)
|
91.4 percentage of participants
|
93.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 116 >75% decrease (n=35,44)
|
80.0 percentage of participants
|
79.5 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 116 >90% decrease (n=35,44)
|
71.4 percentage of participants
|
72.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 118 >20% decrease (n=35,43)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 118 >50% decrease (n=35,43)
|
88.6 percentage of participants
|
93.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 118 >75% decrease (n=35,43)
|
80.0 percentage of participants
|
81.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 118 >90% decrease (n=35,43)
|
71.4 percentage of participants
|
74.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 120 >20% decrease (n=35,43)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 120 >50% decrease (n=35,43)
|
88.6 percentage of participants
|
93.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 120 >75% decrease (n=35,43)
|
80.0 percentage of participants
|
83.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 120 >90% decrease (n=35,43)
|
74.3 percentage of participants
|
76.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 122 >20% decrease (n=35,43)
|
97.1 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 122 >50% decrease (n=35,43)
|
88.6 percentage of participants
|
93.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 122>75% decrease (n=35,43)
|
77.1 percentage of participants
|
81.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 122 >90% decrease (n=35,43)
|
74.3 percentage of participants
|
74.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 124 >20% decrease (n=35,43)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 124 >50% decrease (n=35,43)
|
94.3 percentage of participants
|
93.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 124 >75% decrease (n=35,43)
|
80.0 percentage of participants
|
83.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 124 >90% decrease (n=35,43)
|
77.1 percentage of participants
|
74.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 126 >20% decrease (n=35,43)
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 126 >50% decrease (n=35,43)
|
94.3 percentage of participants
|
90.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 126 >75% decrease (n=35,43)
|
80.0 percentage of participants
|
81.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 126 >90% decrease (n=35,43)
|
77.1 percentage of participants
|
74.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 128 >20% decrease (n=35,39)
|
100.0 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 128 >50% decrease (n=35,39)
|
91.4 percentage of participants
|
89.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 128 >75% decrease (n=35,39)
|
80.0 percentage of participants
|
82.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 128 >90% decrease (n=35,39)
|
77.1 percentage of participants
|
71.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 130 >20% decrease (n=35,39)
|
100.0 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 130 >50% decrease (n=35,39)
|
91.4 percentage of participants
|
89.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 130 >75% decrease (n=35,39)
|
80.0 percentage of participants
|
87.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 130 >90% decrease (n=35,39)
|
80.0 percentage of participants
|
74.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 132 >20% decrease (n=35,39)
|
100.0 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 132 >50% decrease (n=35,39)
|
91.4 percentage of participants
|
87.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 132 >75% decrease (n=35,39)
|
80.0 percentage of participants
|
84.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 132 >90% decrease (n=35,39)
|
80.0 percentage of participants
|
71.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 134 >20% decrease (n=35,39)
|
94.3 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 134 >50% decrease (n=35,39)
|
88.6 percentage of participants
|
87.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 134 >75% decrease (n=35,39)
|
77.1 percentage of participants
|
84.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 134 >90% decrease (n=35,39)
|
77.1 percentage of participants
|
71.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 136 >20% decrease (n=34,39)
|
97.1 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 136 >50% decrease (n=34,39)
|
91.2 percentage of participants
|
89.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 136 >75% decrease (n=34,39)
|
76.5 percentage of participants
|
84.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 136 >90% decrease (n=34,39)
|
76.5 percentage of participants
|
71.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 138 >20% decrease (n=34,39)
|
94.1 percentage of participants
|
97.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 138 >50% decrease (n=34,39)
|
88.2 percentage of participants
|
89.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 138 >75% decrease (n=34,39)
|
76.5 percentage of participants
|
84.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 138 >90% decrease (n=34,39)
|
76.5 percentage of participants
|
71.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 140 >20% decrease (n=29,36)
|
93.1 percentage of participants
|
97.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 140 >50% decrease (n=29,36)
|
86.2 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 140 >75% decrease (n=29,36)
|
72.4 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 140 >90% decrease (n=29,36)
|
72.4 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 142 >20% decrease (n=29,36)
|
93.1 percentage of participants
|
97.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 142 >50% decrease (n=29,36)
|
86.2 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 142 >75% decrease (n=29,36)
|
72.4 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 142 >90% decrease (n=29,36)
|
69.0 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 144 >20% decrease (n=28,36)
|
92.9 percentage of participants
|
97.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 144 >50% decrease (n=28,36)
|
89.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 144 >90% decrease (n=28,36)
|
67.9 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 146 >20% decrease (n=28,36)
|
96.4 percentage of participants
|
97.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 146 >50% decrease (n=28,36)
|
92.9 percentage of participants
|
86.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 146 >75% decrease (n=28,36)
|
75.0 percentage of participants
|
80.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 146 >90% decrease (n=28,36)
|
71.4 percentage of participants
|
66.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 148 >20% decrease (n=27,35)
|
100.0 percentage of participants
|
97.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 148 >75% decrease (n=27,35)
|
77.8 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 148 >90% decrease (n=27,35)
|
74.1 percentage of participants
|
65.7 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 150 >20% decrease (n=25,35)
|
100.0 percentage of participants
|
97.1 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 150 >50% decrease (n=25,35)
|
96.0 percentage of participants
|
88.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 150 >75% decrease (n=25,35)
|
76.0 percentage of participants
|
80.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 150 >90% decrease (n=25,35)
|
76.0 percentage of participants
|
68.6 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 152 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 152 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
85.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 152 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 152 >90% decrease (n=25,27)
|
76.0 percentage of participants
|
63.0 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 154 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 154 >50% decrease (n=25,27)
|
96.0 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 154 >75% decrease (n=25,27)
|
76.0 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 156 >20% decrease (n=25,27)
|
100.0 percentage of participants
|
96.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 252 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 252 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 252 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 254 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 254 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 254 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 256 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 258 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 258 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
83.3 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 258 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 258 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 260 >20% decrease (n=13,18)
|
100.0 percentage of participants
|
94.4 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 260 >50% decrease (n=13,18)
|
92.3 percentage of participants
|
88.9 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 260 >75% decrease (n=13,18)
|
76.9 percentage of participants
|
77.8 percentage of participants
|
|
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Week 260 >90% decrease (n=13,18)
|
69.2 percentage of participants
|
72.2 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Participants who previously withdrew are excluded. Responders are participants who met all of the following criteria for inactive disease at the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window. iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature \>=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR \<20 mm/hr regardless of age and sex. vi. Physician global assessment VAS \<=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. Data presented up to the point of entry into the Alternative Dosing Schedule.
Outcome measures
| Measure |
Tocilizumab
n=42 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=47 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants With Inactive Disease
Week 140 (n=38,40)
|
55.3 percentage of participants
|
45.0 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 176 (n=24,22)
|
41.7 percentage of participants
|
36.4 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 212 (n=18,18
|
55.6 percentage of participants
|
44.4 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 104 (n=42,47)
|
45.2 percentage of participants
|
46.8 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 116 (n=41,46)
|
48.8 percentage of participants
|
43.5 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 128 (n=40,43)
|
55.0 percentage of participants
|
48.8 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 152 (n=27,35)
|
33.3 percentage of participants
|
54.3 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 164 (n=27,25)
|
37.0 percentage of participants
|
28.0 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 188 (n=21,22)
|
23.8 percentage of participants
|
31.8 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 200 (n=19,21)
|
42.1 percentage of participants
|
14.3 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 224 (n=17,18)
|
47.1 percentage of participants
|
44.4 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 236 (n=16,17)
|
43.8 percentage of participants
|
29.4 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 248 (n=15,17)
|
26.7 percentage of participants
|
41.2 percentage of participants
|
|
Part III: Percentage of Participants With Inactive Disease
Week 260 (n=15,15)
|
46.7 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window. iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature \>=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR \<20 mm/hr regardless of age and sex. vi. iv. Physician global assessment VAS \<=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule.
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=47 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants in Clinical Remission
Week 116 (n=41,47)
|
14.6 percentage of participants
|
17.4 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 188 (n=21,22)
|
14.3 percentage of participants
|
9.1 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 212 (n=18,18)
|
16.7 percentage of participants
|
5.6 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 224 (n=17,18)
|
29.4 percentage of participants
|
11.1 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 236 (n=16,17)
|
25.0 percentage of participants
|
29.4 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 128 (n=40,43)
|
32.5 percentage of participants
|
23.3 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 140 (n=38,40)
|
34.2 percentage of participants
|
25.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 152 (n=27,35)
|
25.9 percentage of participants
|
25.7 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 164 (n=27,25)
|
22.2 percentage of participants
|
16.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 176 (n=24,22)
|
16.7 percentage of participants
|
13.6 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 200 (n=19,21)
|
15.8 percentage of participants
|
4.8 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 248 (n=15,17)
|
13.3 percentage of participants
|
23.5 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission
Week 260 (n=15,15)
|
13.3 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met: Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=46 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 140 (n=38,40)
|
28.9 percentage of participants
|
20.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 152 (n=27,35)
|
18.5 percentage of participants
|
20.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 116 (n=41,46)
|
12.2 percentage of participants
|
17.4 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 128 (n=40,43)
|
32.5 percentage of participants
|
20.9 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 164 (n=27,25)
|
18.5 percentage of participants
|
12.0 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 176 (n=24,22)
|
16.7 percentage of participants
|
9.1 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 188 (n=21,22)
|
14.3 percentage of participants
|
4.5 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 200 (n=19,21)
|
10.5 percentage of participants
|
4.8 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 212 (n=18,18)
|
11.1 percentage of participants
|
5.6 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 224 (n=17,18)
|
23.5 percentage of participants
|
11.1 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 236 (n=16,17)
|
25.0 percentage of participants
|
23.5 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 248 (n=15,17)
|
6.7 percentage of participants
|
17.6 percentage of participants
|
|
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Week 260 (n=15,15)
|
6.7 percentage of participants
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met: Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=46 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 200 (n=19,21)
|
5.3 percentage of participants
|
4.8 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 152 (n=27,35)
|
3.7 percentage of participants
|
2.9 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 116 (n=41,46)
|
7.3 percentage of participants
|
8.7 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 128 (n=40,43)
|
20.0 percentage of participants
|
11.6 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 140 (n=38,40)
|
18.4 percentage of participants
|
5.0 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 164 (n=27,25)
|
3.7 percentage of participants
|
4.0 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 176 (n=24,22)
|
4.2 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 188 (n=21,22)
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 212 (n=18,18)
|
5.6 percentage of participants
|
5.6 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 224 (n=17,18)
|
5.9 percentage of participants
|
5.6 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 236 (n=16,17)
|
12.5 percentage of participants
|
5.9 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 248 (n=15,17)
|
0.0 percentage of participants
|
5.9 percentage of participants
|
|
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Week 260 (n=15,15)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260Population: ITT3 population; n=number of participants contributing to the specific statistic
There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met: Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day
Outcome measures
| Measure |
Tocilizumab
n=41 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=46 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 116 (n=41,46)
|
4.9 percentage of participants
|
8.7 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 128 (n=40,43)
|
15.0 percentage of participants
|
9.3 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 140 (n=38,40)
|
15.8 percentage of participants
|
5.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 152 (n=27,35)
|
0.0 percentage of participants
|
2.9 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 164 (n=27,25)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 176 (n=24,22)
|
4.2 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 188 (n=21,22)
|
4.8 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 200 (n=19,21)
|
5.3 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 212 (n=18,18)
|
5.6 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 224 (n=17,18)
|
5.9 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 236 (n=16,17)
|
12.5 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 248 (n=15,17)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Week 260 (n=15,15)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Every 2 weeks from Week 104 to 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.
Outcome measures
| Measure |
Tocilizumab
n=45 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=47 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Every 2 weeks from Week 104 to 260Population: ITT3 population; n=number of participants contributing to the specific statistic
Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.
Outcome measures
| Measure |
Tocilizumab
n=45 Participants
Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients \<30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
Placebo
n=47 Participants
Placebo iv every 2 weeks for 12 weeks in Part 1.
Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
|
|---|---|---|
|
Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
All Tocilizumab (Part I, Part II and Part III)
Serious events: 48 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Tocilizumab (Part I, Part II and Part III)
n=112 participants at risk
Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants \<30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
|
|---|---|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Cardiac disorders
Cardiac failure
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Constipation
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Gastritis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Drug intolerance
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Influenza like illness
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Arthritis bacterial
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Bronchopneumonia
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Cellulitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Device related sepsis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Gastroenteritis
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Herpes zoster
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Kidney infection
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.8%
2/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Otitis media
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pharyngitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pneumonia
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Sepsis
|
1.8%
2/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Tonsillitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Varicella
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Investigations
Liver function test abnormal
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic leukaemia
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Psychiatric disorders
Self injurious behavior
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary veno-occlusive disease
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.89%
1/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
Other adverse events
| Measure |
All Tocilizumab (Part I, Part II and Part III)
n=112 participants at risk
Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants \<30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
|
|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
43.8%
49/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
47.3%
53/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Gastroenteritis viral
|
8.0%
9/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pharyngitis
|
17.9%
20/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Pyrexia
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Influenza like illness
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
22.3%
25/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.9%
29/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
25.9%
29/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
16/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Renal and urinary disorders
Haematuria
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
27.7%
31/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
12/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Nervous system disorders
Headache
|
22.3%
25/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Nervous system disorders
Dizziness
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
21.4%
24/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.2%
45/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
8/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Gastroenteritis
|
25.0%
28/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Ear infection
|
16.1%
18/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Rhinitis
|
17.0%
19/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Impetigo
|
12.5%
14/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Viral infection
|
14.3%
16/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Otitis media
|
12.5%
14/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.7%
12/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Bronchitis
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Otitis externa
|
7.1%
8/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Tonsillitis
|
8.0%
9/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Urinary tract infection
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Nausea
|
23.2%
26/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
13.4%
15/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.3%
25/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.7%
12/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.0%
9/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Contusion
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.1%
8/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
19.6%
22/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
7.1%
8/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.0%
9/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Investigations
Transaminases increased
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Conjunctivitis
|
10.7%
12/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Vascular disorders
Haematoma
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Sinusitis
|
8.9%
10/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Influenza
|
8.0%
9/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Paronychia
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Herpes Zoster
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Laryngitis
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Dental Caries
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
11.6%
13/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
7.1%
8/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
7/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Wound
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Fatigue
|
5.4%
6/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
15.2%
17/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Local swelling
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
General disorders
Pain
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Laceration
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Investigations
Neutrophil count decreased
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Investigations
Platelet count decreased
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Investigations
Alanine aminotransferase increased
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Nervous system disorders
Migraine
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Eye disorders
Cataract
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Eye disorders
Chalazion
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Ear and labyrinth disorders
Ear pain
|
9.8%
11/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Cellulitis
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Skin infection
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Tinea pedis
|
4.5%
5/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Varicella
|
3.6%
4/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Otitis media acute
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
|
Infections and infestations
Pneumonia
|
2.7%
3/112 • AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab\_8 mg/kg (Part I) and Tocilizumab\_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER