Trial Outcomes & Findings for A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis (NCT NCT00988221)

Last Updated: 2017-07-26

Results Overview

JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving \> 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale \[VAS\]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0\[best\]-3\[worst\]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

188 participants

Primary outcome timeframe

Week 16 through Week 40

Results posted on

2017-07-26

Participant Flow

In Part I, patients received either tocilizumab 8 or 10 mg/kg. In Part II, eligible patients were randomized to receive placebo or the same dose of tocilizumab as in Part I of the study. In Part III, patients received the same dose of tocilizumab as in Part I of the study, with adjustments based on weight and change in weight from Baseline.

Participant milestones

Participant milestones
Measure	Tocilizumab 10 mg/kg in Patients Weighing < 30 kg Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing < 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Placebo Patients received placebo to tocilizumab intravenously every 4 weeks.
Part I STARTED	35	34	119	0
Part I COMPLETED	31	24	111	0
Part I NOT COMPLETED	4	10	8	0
Part II STARTED	16	11	55	84
Part II COMPLETED	15	11	52	81
Part II NOT COMPLETED	1	0	3	3
Part III STARTED	30	24	106	0
Part III COMPLETED	29	23	103	0
Part III NOT COMPLETED	1	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab 10 mg/kg in Patients Weighing < 30 kg Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing < 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Placebo Patients received placebo to tocilizumab intravenously every 4 weeks.
Part I Adverse Event	0	1	2	0
Part I Insufficient Therapeutic Response	4	6	5	0
Part I Refused Treatment	0	2	1	0
Part I Lost to Follow-up	0	1	0	0
Part II Adverse Event	1	0	0	1
Part II Withdrawal by Subject	0	0	2	2
Part II Reason not Specified	0	0	1	0
Part III Adverse Event	1	0	1	0
Part III Insufficient Therapeutic Response	0	1	1	0
Part III Refused Treatment	0	0	1	0

Baseline Characteristics

A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab 10 mg/kg in Patients Weighing < 30 kg n=35 Participants Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing < 30 kg n=34 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Total n=188 Participants Total of all reporting groups
Age, Continuous	6.9 years STANDARD_DEVIATION 3.02 • n=5 Participants	7.6 years STANDARD_DEVIATION 2.71 • n=7 Participants	13.1 years STANDARD_DEVIATION 2.78 • n=5 Participants	11.0 years STANDARD_DEVIATION 4.01 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	24 Participants n=7 Participants	90 Participants n=5 Participants	144 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants	44 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16 through Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40)	48.1 Percent of patients Interval 37.0 to 59.0	25.6 Percent of patients Interval 16.0 to 35.0	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening \> 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale \[VAS\]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0\[best\]-3\[worst\]).

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) ACR30 response	88.6 Percent of patients	76.5 Percent of patients	93.3 Percent of patients	89.4 Percent of patients	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) ACR50 response	80.0 Percent of patients	70.6 Percent of patients	87.4 Percent of patients	83.0 Percent of patients	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) ACR70 response	62.9 Percent of patients	41.2 Percent of patients	68.1 Percent of patients	62.2 Percent of patients	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) ACR90 response	31.4 Percent of patients	23.5 Percent of patients	25.2 Percent of patients	26.1 Percent of patients	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

The patient's treating physician provides a rating of the patient's arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'arthritis inactive' (ie, symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. A higher score indicates more disease activity. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16)	-61.48 Percent change Standard Deviation 48.779	-65.20 Percent change Standard Deviation 26.170	-72.61 Percent change Standard Deviation 25.977	-69.19 Percent change Standard Deviation 31.824	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

The patient or parent/guardian, as appropriate, provides a rating of the patient's well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'very well' (ie, symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (ie, maximum arthritis disease activity). A higher score indicates poorer well-being. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part I of the Study (Week 16)	-31.65 Percent change Standard Deviation 120.268	-55.56 Percent change Standard Deviation 42.092	-53.34 Percent change Standard Deviation 58.686	-49.46 Percent change Standard Deviation 72.920	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Joints with active arthritis are defined as joints with swelling present or pain present and limitation of motion. The maximum number of joints with active arthritis is 71. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part I of the Study (Week 16)	-63.36 Percent change Standard Deviation 43.272	-55.57 Percent change Standard Deviation 44.876	-72.96 Percent change Standard Deviation 33.915	-68.15 Percent change Standard Deviation 38.246	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Joints with limitation of movement are defined as joints with limitation of motion. The maximum number of joints with limitation of movement is 67. The joint assessment is performed by an independent assessor who is not the treating physician and who is blinded to all other aspects of the patient's efficacy and safety data. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part I of the Study (Week 16)	-61.83 Percent change Standard Deviation 34.726	-49.87 Percent change Standard Deviation 48.091	-65.96 Percent change Standard Deviation 30.134	-62.42 Percent change Standard Deviation 34.955	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part I of the Study (Week 16)	-70.98 Percent change Standard Deviation 24.530	-21.84 Percent change Standard Deviation 159.592	-70.87 Percent change Standard Deviation 33.400	-62.54 Percent change Standard Deviation 73.384	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Functional ability is assessed with the Childhood Health Assessment Questionnaire (CHAQ-DI) disability index which consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at the End of Part I of the Study (Week 16)	-54.48 Percent change Standard Deviation 37.214	-46.16 Percent change Standard Deviation 50.961	-49.07 Percent change Standard Deviation 45.048	-49.62 Percent change Standard Deviation 44.573	—

SECONDARY outcome

Timeframe: Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

The JADAS-27 is derived from the following components: Physician's global assessment of disease activity on a 0-100 mm visual analog scale (VAS)/10, patient/parent's global assessment of overall well-being on a 0-100 mm VAS/10, normalized erythrocyte sedimentation rate (ESR) (if ESR is ≤ 20 then set to 0, if ≥ 120 then set to 10, and if \> 20 and \< 120 then apply formula \[ESR-20\]/10), and number of joints (maximum of 27) with active arthritis (cervical spine, left/right elbow, left/right wrist, left/right MCP1-3, left/right PIP1-5, left/right hips, left/right knee and left/right ankle). The scores for the first 3 components range from 0-10; the score for the final component ranges from 0-27. The overall JADAS-27 score ranges from 0-57. A higher score indicates more disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Juvenile Arthritis Disease Activity Score (JADAS-27) at the End of Part I of the Study (Week 16)	9.08 Units on a scale Standard Deviation 8.882	12.25 Units on a scale Standard Deviation 10.277	7.83 Units on a scale Standard Deviation 7.122	8.82 Units on a scale Standard Deviation 8.198	—

SECONDARY outcome

Timeframe: Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Pain Visual Analogue Scale (VAS) Score at the End of Part I of the Study (Week 16)	21.9 Units on a scale Standard Deviation 21.66	24.1 Units on a scale Standard Deviation 23.94	20.3 Units on a scale Standard Deviation 21.13	21.2 Units on a scale Standard Deviation 21.65	—

SECONDARY outcome

Timeframe: Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

A patient is judged to have inactive disease if all of the following criteria are met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (\< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10.

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=34 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With Inactive Disease at the End of Part I of the Study (Week 16)	20.0 Percent of patients	8.8 Percent of patients	18.5 Percent of patients	17.0 Percent of patients	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=19 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=46 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=78 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With an Elevated C-reactive Protein Concentration at Baseline That Had Normalized at the End of Part I of the Study (Week 16)	76.9 Percent of patients	63.2 Percent of patients	87.0 Percent of patients	79.5 Percent of patients	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=26 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=73 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=122 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With an Elevated Erythrocyte Sedimentation Rate at Baseline That Had Normalized at the End of Part I of the Study (Week 16)	82.6 Percent of patients	57.7 Percent of patients	87.7 Percent of patients	80.3 Percent of patients	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

Platelets were measured in blood samples taken from the patients.

Outcome measures

Outcome measures
Measure	Placebo n=13 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=18 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=43 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=74 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With an Elevated Platelet Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)	84.6 Percent of patients	55.6 Percent of patients	86.0 Percent of patients	78.4 Percent of patients	—

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Intent-to-treat patient population-1: All patients who were randomized into Part I of the study and received at least 1 dose of tocilizumab.

White blood cells were measured in blood samples taken from the patients.

Outcome measures

Outcome measures
Measure	Placebo n=3 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=3 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=2 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=8 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With an Elevated White Blood Count at Baseline That Had Normalized at the End of Part I of the Study (Week 16)	66.7 Percent of patients	66.7 Percent of patients	100.0 Percent of patients	75.0 Percent of patients	—

SECONDARY outcome

Timeframe: Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40) ACR90 response	23.5 Percent of patients Interval 14.0 to 33.0	45.1 Percent of patients Interval 34.0 to 56.0	—	—	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40) ACR30 response	54.3 Percent of patients Interval 43.0 to 65.0	74.4 Percent of patients Interval 65.0 to 84.0	—	—	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40) ACR50 response	51.9 Percent of patients Interval 41.0 to 63.0	73.2 Percent of patients Interval 64.0 to 83.0	—	—	—
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at the End of Part II of the Study (Week 40) ACR70 response	42.0 Percent of patients Interval 31.0 to 53.0	64.6 Percent of patients Interval 54.0 to 75.0	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part II of the Study (Week 40)	-38.2 Units on a scale Standard Deviation 24.77	-45.6 Units on a scale Standard Deviation 21.47	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at the End of Part II of the Study (Week 40)	-32.4 Units on a scale Standard Deviation 28.57	-31.1 Units on a scale Standard Deviation 28.52	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at the End of Part II of the Study (Week 40)	-11.5 Joints Standard Deviation 12.77	-14.5 Joints Standard Deviation 11.14	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at the End of Part II of the Study (Week 40)	-8.1 Joints Standard Deviation 9.90	-10.2 Joints Standard Deviation 8.97	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at the End of Part II of the Study (Week 40)	-14.0 mm/hour Standard Deviation 28.46	-25.2 mm/hour Standard Deviation 21.97	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

The Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward imputation for missing values.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) at the End of Part II of the Study (Week 40)	-0.724 Units on a scale Standard Deviation 0.6905	-0.804 Units on a scale Standard Deviation 0.6534	—	—	—

SECONDARY outcome

Timeframe: Baseline to Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

The patient or parent/guardian, as appropriate, provides a rating of the patient's pain (also called a discomfort index) on a 0 to 100 mm horizontal scale. The extreme left end of the line represents 'no pain' and the extreme right end represents 'very extreme pain'. A higher score indicates more pain. A negative change score indicates improvement. Change from baseline was calculated using last observation carried forward (LOCF) imputation for missing values. The analysis was adjusted for the randomization stratification factors background use of methotrexate and background use of oral corticosteroids, and the pain visual analog scale score at Baseline. The adjusted means from the fitted model are presented.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at the End of Part II of the Study (Week 40)	-30.2 Units on a scale Standard Deviation 27.12	-31.5 Units on a scale Standard Deviation 31.76	—	—	—

SECONDARY outcome

Timeframe: Week 40

Population: Intent-to-treat population-2: All eligible patients completing Part I of the study who were randomized into Part II of the study and received at least 1 dose of tocilizumab in Part II.

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With Inactive Disease at the End of Part II of the Study (Week 40)	17.3 Percent of patients Interval 9.0 to 26.0	36.6 Percent of patients Interval 26.0 to 47.0	—	—	—

SECONDARY outcome

Timeframe: Week 2 to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 104 - ACR90 Response	88.9 Percent of patients	71.4 Percent of patients	72.7 Percent of patients	67.3 Percent of patients	70.7 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 2 - ACR30 Response	55.6 Percent of patients	42.9 Percent of patients	45.5 Percent of patients	54.5 Percent of patients	52.4 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 2 - ACR50 Response	33.3 Percent of patients	42.9 Percent of patients	18.2 Percent of patients	34.5 Percent of patients	32.9 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 2 - ACR70 Response	11.1 Percent of patients	0.0 Percent of patients	9.1 Percent of patients	12.7 Percent of patients	11.0 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 2 - ACR90 Response	0.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 52 - ACR30 Response	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	96.4 Percent of patients	97.6 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 52 - ACR50 Response	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	94.5 Percent of patients	95.1 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 52 - ACR70 Response	100.0 Percent of patients	85.7 Percent of patients	72.7 Percent of patients	87.3 Percent of patients	86.6 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 52 - ACR90 Response	88.9 Percent of patients	57.1 Percent of patients	54.5 Percent of patients	65.5 Percent of patients	65.9 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 104 - ACR30 Response	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	94.5 Percent of patients	95.1 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 104 - ACR50 Response	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	87.3 Percent of patients	90.2 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Weeks 2, 52, and 104 Week 104 - ACR70 Response	88.9 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	83.6 Percent of patients	86.6 Percent of patients

SECONDARY outcome

Timeframe: Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to non-safety reasons are classified as non-responders. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward.

A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening \> 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0\[best\]-3\[worst\]). Results are reported for the subgroups: Previous biologic treatment (yes/no), concomitant methotrexate use (yes/no), rheumatoid factor (positive/negative), concomitant oral corticosteroid use (yes/no). Last observation carried forward was applied to missing components at visits.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use:Yes - ACR30(n=2,3,5,23,33)	100.0 Percent of patients	100.0 Percent of patients	80.0 Percent of patients	91.3 Percent of patients	90.9 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: Yes - ACR30 (n=1,1,0,25,27)	100.0 Percent of patients	100.0 Percent of patients	0.0 Percent of patients	96.0 Percent of patients	96.3 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: Yes - ACR50 (n=1,1,0,25,27)	100.0 Percent of patients	100.0 Percent of patients	0.0 Percent of patients	80.0 Percent of patients	81.5 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: Yes - ACR70 (n=1,1,0,25,27)	0.0 Percent of patients	100.0 Percent of patients	0.0 Percent of patients	72.0 Percent of patients	70.4 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: Yes - ACR90 (n=1,1,0,25,27)	0.0 Percent of patients	100.0 Percent of patients	0.0 Percent of patients	48.0 Percent of patients	48.1 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: No - ACR30 (n=8 6,11,30,55)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	93.3 Percent of patients	94.5 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: No - ACR50 (n=8,6,11,30,55)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	93.3 Percent of patients	94.5 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: No - ACR70 (n=8,6,11,30,55)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	93.3 Percent of patients	94.5 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Previous Biologic Use: No - ACR90 (n=8,6,11,30,55)	100.0 Percent of patients	66.7 Percent of patients	72.7 Percent of patients	83.3 Percent of patients	81.8 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: Yes - ACR30 (n=7,7,11,42,67)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	95.2 Percent of patients	95.5 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: Yes - ACR50 (n=7,7,11,42,67)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	88.1 Percent of patients	91.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: Yes - ACR70 (n=7,7,11,42,67)	100.0 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	83.3 Percent of patients	88.1 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: Yes - ACR90 (n=7,7,11,42,67)	100.0 Percent of patients	71.4 Percent of patients	72.7 Percent of patients	73.8 Percent of patients	76.1 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: No - ACR30 (n=2,0,0,13,15)	100.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	92.3 Percent of patients	93.3 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: No - ACR50 (n=2,0,0,13,15)	100.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	84.6 Percent of patients	86.7 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: No - ACR70 (n=2,0,0,13,15)	50.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	84.6 Percent of patients	80.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Methotrexate Use: No - ACR90 (n=2,0,0,13,15)	50.0 Percent of patients	0.0 Percent of patients	0.0 Percent of patients	46.2 Percent of patients	46.7 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: Yes - ACR50 (2,3,5,23,33)	100.0 Percent of patients	100.0 Percent of patients	80.0 Percent of patients	91.3 Percent of patients	90.9 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: Yes - ACR70 (2,3,5,23,33)	100.0 Percent of patients	100.0 Percent of patients	80.0 Percent of patients	82.6 Percent of patients	84.8 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: Yes - ACR90 (2,3,5,23,33)	100.0 Percent of patients	66.7 Percent of patients	80.0 Percent of patients	65.2 Percent of patients	69.7 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: No - ACR30 (7,4,6,32,49)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	96.9 Percent of patients	98.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: No - ACR50 (7,4,6,32,49)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	84.4 Percent of patients	89.8 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: No - ACR70 (7,4,6,32,49)	85.7 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	84.4 Percent of patients	87.8 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Oral Corticosteroid Use: No - ACR90 (7,4,6,32,49)	85.7 Percent of patients	75.0 Percent of patients	66.7 Percent of patients	68.8 Percent of patients	71.4 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Positive - ACR30 (0,2,2,23,27)	0.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	95.7 Percent of patients	96.3 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Positive - ACR50 (0,2,2,23,27)	0.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	91.3 Percent of patients	92.6 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Positive - ACR70 (0,2,2,23,27)	0.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	91.3 Percent of patients	92.6 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Positive - ACR90 (0,2,2,23,27)	0.0 Percent of patients	50.0 Percent of patients	100.0 Percent of patients	78.3 Percent of patients	77.8 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Negative - ACR30 (9,5,7,29,50)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	93.1 Percent of patients	96.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Negative - ACR50 (9,5,7,29,50)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	82.8 Percent of patients	90.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Negative - ACR70 (9,5,7,29,50)	88.9 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	75.9 Percent of patients	84.0 Percent of patients
Percent of Patients With 4 Baseline Disease Characteristics Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 Rheumatoid Factor: Negative - ACR90 (9,5,7,29,50)	88.9 Percent of patients	80.0 Percent of patients	85.7 Percent of patients	58.6 Percent of patients	70.0 Percent of patients

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Only patients with non-missing data were included in the analysis.

The JADAS-71 is composed of 4 components: Physician global assessment of disease activity on a visual analog scale (VAS) (range = 0-10, left end of the line = arthritis inactive, ie, symptom-free and no arthritis symptoms; right end = arthritis very active), patient/parent global assessment of overall well-being on a VAS (range = 0-10, left end of the line = very well, ie, symptom-free and no arthritis disease activity; right end = very poor, ie, maximum arthritis disease activity), normalized erythrocyte sedimentation rate (ESR) (range = 0-10, If ESR is ≤ 20 mm/h, set to 0. If ≥ 120 mm/h, set to 10 mm/h. If \> 20 mm/h and \< 120 mm/h, apply formula: \[ESR - 20 mm/h\]/10 mm/h), and a count of active arthritis (swelling present or pain present and limitation of motion) in 71 selected joints (range=0-71). The JADAS-71 is the sum of the 4 component scores and ranges from 0-101. A higher score indicates more arthritis disease activity. A positive change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=51 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=76 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Juvenile Arthritis Disease Activity Score-71 (JADAS-71) at Week 104	-31.40 Units on a scale Standard Deviation 17.471	-24.17 Units on a scale Standard Deviation 14.856	-25.42 Units on a scale Standard Deviation 13.142	-25.70 Units on a scale Standard Deviation 12.200	-26.05 Units on a scale Standard Deviation 12.941

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. The analysis excluded patients without a Baseline assessment or who had withdrawn.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=51 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=76 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at Week 104	-97.65 Percent change Standard Deviation 2.689	-96.01 Percent change Standard Deviation 9.862	-90.42 Percent change Standard Deviation 16.306	-87.58 Percent change Standard Deviation 27.588	-89.70 Percent change Standard Deviation 23.747

SECONDARY outcome

Timeframe: Baseline to Week 104

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=51 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=76 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Patient/Parent Global Assessment of Overall Well-being at Week 104	-97.01 Percent change Standard Deviation 5.323	-38.23 Percent change Standard Deviation 75.749	-83.06 Percent change Standard Deviation 25.986	-75.81 Percent change Standard Deviation 42.143	-75.35 Percent change Standard Deviation 43.779

SECONDARY outcome

Timeframe: Baseline to Week 104

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=52 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=77 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Active Arthritis at Week 104	-98.57 Percent change Standard Deviation 3.780	-88.22 Percent change Standard Deviation 24.908	-76.43 Percent change Standard Deviation 44.956	-88.60 Percent change Standard Deviation 24.043	-87.73 Percent change Standard Deviation 27.088

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded. Patients without a Baseline assessment are excluded.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=52 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=77 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Number of Joints With Limitation of Movement at Week 104	-98.57 Percent change Standard Deviation 3.780	-81.81 Percent change Standard Deviation 32.048	-76.66 Percent change Standard Deviation 55.781	-79.88 Percent change Standard Deviation 26.831	-81.30 Percent change Standard Deviation 31.729

SECONDARY outcome

Timeframe: Baseline to Week 104

Erythrocyte sedimentation rate, an acute phase protein, was measured using a kit furnished by the study central laboratory. A negative change score indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=52 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=77 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Erythrocyte Sedimentation Rate (ESR) at Week 104	-84.42 Percent change Standard Deviation 13.141	-89.21 Percent change Standard Deviation 4.682	-74.06 Percent change Standard Deviation 31.967	-73.85 Percent change Standard Deviation 29.073	-76.24 Percent change Standard Deviation 27.263

SECONDARY outcome

Timeframe: Baseline to Week 104

Outcome measures

Outcome measures
Measure	Placebo n=7 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=52 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=77 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Functional Ability at Week 104	-96.03 Percent change Standard Deviation 10.499	-79.50 Percent change Standard Deviation 18.622	-78.58 Percent change Standard Deviation 29.821	-73.34 Percent change Standard Deviation 38.745	-76.71 Percent change Standard Deviation 34.696

SECONDARY outcome

Timeframe: Baseline to Week 104

The CHAQ-DI consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. If aids and devices listed in the questionnaire or assistance from a person are required to perform a task, a domain score of 0 or 1 is increased to 2; if the domain score is 2 or 3, the domain score is not adjusted. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A minimally important improvement is an improvement ≥ 0.13 over Baseline. Patients who withdrew due to non-safety reasons are classified as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104 Week 16	77.8 Percent of patients	85.7 Percent of patients	81.8 Percent of patients	76.4 Percent of patients	78.0 Percent of patients
Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104 Week 40	88.9 Percent of patients	100.0 Percent of patients	81.8 Percent of patients	78.2 Percent of patients	81.7 Percent of patients
Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104 Week 52	88.9 Percent of patients	100.0 Percent of patients	81.8 Percent of patients	80.0 Percent of patients	82.9 Percent of patients
Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104 Week 80	88.9 Percent of patients	100.0 Percent of patients	90.9 Percent of patients	80.0 Percent of patients	84.1 Percent of patients
Percent of Patients With a Minimally Important Improvement in the Children's Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Weeks 16, 40, 52, 80, and 104 Week 104	88.9 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	80.0 Percent of patients	85.4 Percent of patients

SECONDARY outcome

Timeframe: Baseline to Week 104

C-reactive protein (CRP), an acute phase protein, was measured in blood samples with a high-sensitivity CRP (hs-CRP) test using laser nephelometry.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=9 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=53 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=78 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
C-reactive Protein Levels From Baseline to Week 104 Week 16 (n=9, 6, 7, 53, 75)	1.726 mg/L Standard Deviation 2.7395	0.220 mg/L Standard Deviation 0.0400	1.077 mg/L Standard Deviation 1.1247	1.137 mg/L Standard Deviation 3.2472	1.129 mg/L Standard Deviation 2.9042
C-reactive Protein Levels From Baseline to Week 104 Week 40 (n=7, 7, 11, 51, 76)	3.709 mg/L Standard Deviation 9.0383	2.286 mg/L Standard Deviation 5.5183	1.591 mg/L Standard Deviation 2.6187	1.451 mg/L Standard Deviation 5.9168	1.756 mg/L Standard Deviation 5.8029
C-reactive Protein Levels From Baseline to Week 104 Week 52 (n=8, 7, 10, 52, 77)	3.405 mg/L Standard Deviation 8.6491	0.267 mg/L Standard Deviation 0.1325	4.584 mg/L Standard Deviation 10.4573	0.882 mg/L Standard Deviation 2.4335	1.569 mg/L Standard Deviation 5.0838
C-reactive Protein Levels From Baseline to Week 104 Week 80 (n=8, 7, 10, 51, 76)	2.329 mg/L Standard Deviation 5.9286	0.623 mg/L Standard Deviation 0.6096	4.867 mg/L Standard Deviation 13.0151	0.718 mg/L Standard Deviation 1.5474	1.425 mg/L Standard Deviation 5.2250
C-reactive Protein Levels From Baseline to Week 104 Week 104 (n=7, 7, 11, 50, 75)	0.249 mg/L Standard Deviation 0.0949	0.200 mg/L Standard Deviation 0.0000	1.259 mg/L Standard Deviation 2.8519	2.032 mg/L Standard Deviation 6.5732	1.581 mg/L Standard Deviation 5.4965

SECONDARY outcome

Timeframe: Baseline to Week 104

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104 Week 52 (n=8, 7, 1, 52, 78)	-47.8 Units on a scale Standard Deviation 14.46	-24.0 Units on a scale Standard Deviation 26.59	-29.6 Units on a scale Standard Deviation 28.39	-35.5 Units on a scale Standard Deviation 29.07	-34.9 Units on a scale Standard Deviation 27.76
Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104 Week 2 (n=9, 7, 10, 52, 78)	-11.4 Units on a scale Standard Deviation 13.16	-4.4 Units on a scale Standard Deviation 13.13	-6.1 Units on a scale Standard Deviation 20.98	-10.3 Units on a scale Standard Deviation 21.44	-9.4 Units on a scale Standard Deviation 19.80
Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104 Week 40 (n=8, 7, 11, 52, 78)	-44.0 Units on a scale Standard Deviation 12.29	-24.7 Units on a scale Standard Deviation 27.76	-27.9 Units on a scale Standard Deviation 35.85	-33.9 Units on a scale Standard Deviation 31.64	-33.3 Units on a scale Standard Deviation 30.44
Change From Baseline in the Pain Visual Analogue Scale (VAS) Score at Weeks 2, 40, 52, and 104 Week 104 (n=7, 7, 11, 51, 76)	-48.9 Units on a scale Standard Deviation 16.71	-30.7 Units on a scale Standard Deviation 31.63	-27.1 Units on a scale Standard Deviation 39.51	-34.5 Units on a scale Standard Deviation 34.59	-34.4 Units on a scale Standard Deviation 33.72

SECONDARY outcome

Timeframe: Week 16 to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients With Inactive Disease From Week 16 to Week 104 Week 16	11.1 Percent of patients	42.9 Percent of patients	18.2 Percent of patients	20.0 Percent of patients	20.7 Percent of patients
Percent of Patients With Inactive Disease From Week 16 to Week 104 Week 40	44.4 Percent of patients	42.9 Percent of patients	45.5 Percent of patients	38.2 Percent of patients	40.2 Percent of patients
Percent of Patients With Inactive Disease From Week 16 to Week 104 Week 52	66.7 Percent of patients	57.1 Percent of patients	45.5 Percent of patients	50.9 Percent of patients	52.4 Percent of patients
Percent of Patients With Inactive Disease From Week 16 to Week 104 Week 80	66.7 Percent of patients	57.1 Percent of patients	54.5 Percent of patients	56.4 Percent of patients	57.3 Percent of patients
Percent of Patients With Inactive Disease From Week 16 to Week 104 Week 104	66.7 Percent of patients	71.4 Percent of patients	54.5 Percent of patients	63.6 Percent of patients	63.4 Percent of patients

SECONDARY outcome

Timeframe: Week 40 to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.

A patient was in clinical remission if they had inactive disease at all visits in the 6 months prior to and including the visit assessment day. A patient was judged to have inactive disease if all of the following criteria were met: Number of joints with active arthritis = 0; absence of active uveitis, defined by the adverse event preferred terms 'uveitis' and 'intermediate uveitis'; normal erythrocyte sedimentation rate (\< 20 mm/hour regardless of age and sex); and physician's global assessment of overall well-being visual analog scale score ≤ 10. Patients who withdrew due to non-safety reasons are classified as non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients in Clinical Remission From Week 40 to 104 Week 52	22.2 Percent of patients	14.3 Percent of patients	18.2 Percent of patients	18.2 Percent of patients	18.3 Percent of patients
Percent of Patients in Clinical Remission From Week 40 to 104 Week 104	55.6 Percent of patients	57.1 Percent of patients	27.3 Percent of patients	34.5 Percent of patients	37.8 Percent of patients
Percent of Patients in Clinical Remission From Week 40 to 104 Week 40	0.0 Percent of patients	14.3 Percent of patients	0.0 Percent of patients	7.3 Percent of patients	6.1 Percent of patients
Percent of Patients in Clinical Remission From Week 40 to 104 Week 80	55.6 Percent of patients	42.9 Percent of patients	36.4 Percent of patients	25.5 Percent of patients	31.7 Percent of patients

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Continuous tocilizumab population: Patients randomized to tocilizumab in Part II of the study and who therefore received tocilizumab throughout the study. Patients who withdrew due to safety have their last available response prior to withdrawal carried forward. Last observation carried forward applied to missing core components at visits.

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=7 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=11 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=55 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration < 2 Years - ACR30 (n=4,1,4,17,26)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	88.2 Percent of patients	92.3 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration < 2 Years - ACR50 (n=4,1,4,17,26)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	82.4 Percent of patients	88.5 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration ≥ 2 Years - ACR90 (n=5,6,7,38,56)	80.0 Percent of patients	66.7 Percent of patients	57.1 Percent of patients	63.2 Percent of patients	64.3 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration < 2 Years - ACR70 (n=4,1,4,17,26)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	82.4 Percent of patients	88.5 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration < 2 Years - ACR90 (n=4,1,4,17,26)	100.0 Percent of patients	100.0 Percent of patients	100.0 Percent of patients	76.5 Percent of patients	84.6 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration ≥ 2 Years - ACR30 (n=5,6,7,38,56)	100.0 Percent of patients	100.0 Percent of patients	85.7 Percent of patients	97.4 Percent of patients	96.4 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration ≥ 2 Years - ACR50 (n=5,6,7,38,56)	100.0 Percent of patients	100.0 Percent of patients	85.7 Percent of patients	89.5 Percent of patients	91.1 Percent of patients
Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses at Week 104 by Duration of Disease (< 2 Years, ≥ 2 Years) Disease Duration ≥ 2 Years - ACR70 (n=5,6,7,38,56)	80.0 Percent of patients	100.0 Percent of patients	85.7 Percent of patients	84.2 Percent of patients	85.7 Percent of patients

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: All exposure safety population: All patients randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.

Due to the different types of corticosteroid medications available, the prednisone equivalent was used in the calculation of the oral corticosteroid dose. Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=13 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=34 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=119 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Oral Corticosteroid Dose at Baseline, Week 52, and Week 104 Baseline (n=22, 13, 34, 119, 188)	0.041 mg/kg/day Standard Deviation 0.0704	0.095 mg/kg/day Standard Deviation 0.0836	0.079 mg/kg/day Standard Deviation 0.0802	0.055 mg/kg/day Standard Deviation 0.0708	0.061 mg/kg/day Standard Deviation 0.0743
Oral Corticosteroid Dose at Baseline, Week 52, and Week 104 Week 52 (n=17, 13, 24, 105, 159)	0.021 mg/kg/day Standard Deviation 0.0474	0.064 mg/kg/day Standard Deviation 0.0599	0.037 mg/kg/day Standard Deviation 0.0591	0.032 mg/kg/day Standard Deviation 0.0490	0.034 mg/kg/day Standard Deviation 0.0518
Oral Corticosteroid Dose at Baseline, Week 52, and Week 104 Week 104 (n=16, 13, 23, 103, 155)	0.014 mg/kg/day Standard Deviation 0.0418	0.028 mg/kg/day Standard Deviation 0.0497	0.019 mg/kg/day Standard Deviation 0.0412	0.020 mg/kg/day Standard Deviation 0.0558	0.020 mg/kg/day Standard Deviation 0.0518

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. Each visit includes patients with a non-missing assessment at the time point. Patients who previously withdrew are excluded.

Values are based on the average daily dose on the study day and if not available the last observation carried forward is used.

Outcome measures

Outcome measures
Measure	Placebo n=22 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=13 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=34 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=119 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=188 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Methotrexate Dose at Baseline, Week 52, and Week 104 Week 104 (n=16, 13, 23, 103, 155)	8.342 mg/m^2/week Standard Deviation 5.2618	11.858 mg/m^2/week Standard Deviation 14.3458	10.050 mg/m^2/week Standard Deviation 4.6316	6.855 mg/m^2/week Standard Deviation 5.0401	7.902 mg/m^2/week Standard Deviation 6.4332
Methotrexate Dose at Baseline, Week 52, and Week 104 Baseline (n=22, 13, 34, 118, 187)	11.304 mg/m^2/week Standard Deviation 6.7521	17.562 mg/m^2/week Standard Deviation 17.0864	12.146 mg/m^2/week Standard Deviation 5.2822	8.768 mg/m^2/week Standard Deviation 5.5387	10.292 mg/m^2/week Standard Deviation 7.3586
Methotrexate Dose at Baseline, Week 52, and Week 104 Week 52 (n=17, 13, 24, 105, 159)	9.247 mg/m^2/week Standard Deviation 5.6513	15.568 mg/m^2/week Standard Deviation 15.2521	11.216 mg/m^2/week Standard Deviation 4.6890	8.326 mg/m^2/week Standard Deviation 4.9825	9.453 mg/m^2/week Standard Deviation 6.6963

SECONDARY outcome

Timeframe: Baseline to Week 104

Population: Growth population: All participants who received at least 1 dose of tocilizumab but who did not take the growth hormone somatotropin.

The height Standard Deviation Score was calculated using the following formula: (Observed height - median of the reference population)/standard deviation of the reference population. The reference population was defined as that of the same sex and age to the nearest completed year and month using the World Health Organization norms. A negative score indicates less height than the reference population.

Outcome measures

Outcome measures
Measure	Placebo n=84 Participants Patients received placebo to tocilizumab intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg n=82 Participants Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=187 Participants Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 or 10 mg/kg Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Height Standard Deviation Score at Baseline, Week 52, and Week 104 Baseline	-0.57 Standard deviation score Standard Deviation 1.005	-0.33 Standard deviation score Standard Deviation 1.290	-0.51 Standard deviation score Standard Deviation 1.219	—	—
Height Standard Deviation Score at Baseline, Week 52, and Week 104 Week 104	-0.34 Standard deviation score Standard Deviation 0.954	-0.01 Standard deviation score Standard Deviation 1.150	-0.18 Standard deviation score Standard Deviation 1.066	—	—
Height Standard Deviation Score at Baseline, Week 52, and Week 104 Week 52	-0.51 Standard deviation score Standard Deviation 1.004	-0.15 Standard deviation score Standard Deviation 1.216	-0.33 Standard deviation score Standard Deviation 1.125	—	—

Adverse Events

Tocilizumab 10 mg/kg in Patients Weighing < 30 kg

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Tocilizumab 8 mg/kg in Patients Weighing < 30 kg

Serious events: 4 serious events

Other events: 25 other events

Deaths: 0 deaths

Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg

Serious events: 17 serious events

Other events: 102 other events

Deaths: 0 deaths

All Tocilizumab Patients

Serious events: 26 serious events

Other events: 157 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab 10 mg/kg in Patients Weighing < 30 kg n=22 participants at risk Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.	Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg n=13 participants at risk Patients weighing \< 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.	Tocilizumab 8 mg/kg in Patients Weighing < 30 kg n=34 participants at risk Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 participants at risk Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=188 participants at risk Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Infections and infestations Pneumonia	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Bronchitis	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Cellulitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Varicella	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Neck injury	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Congenital, familial and genetic disorders Familial mediterranean fever	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Eye disorders Uveitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Constipation	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Nervous system disorders Benign intracranial hypertension	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Psychiatric disorders Psychosomatic disease	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Renal and urinary disorders Calculus urinary	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Appendicitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Epstein-Barr Virus Infection	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Paronychia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Pyelonephritis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Tonsillitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Viral infection	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Scleroderma	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.

Other adverse events

Other adverse events
Measure	Tocilizumab 10 mg/kg in Patients Weighing < 30 kg n=22 participants at risk Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.	Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg n=13 participants at risk Patients weighing \< 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.	Tocilizumab 8 mg/kg in Patients Weighing < 30 kg n=34 participants at risk Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg n=119 participants at risk Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	All Tocilizumab Patients n=188 participants at risk Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
Infections and infestations Nasopharyngitis	31.8% 7/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	14.7% 5/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	26.9% 32/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	23.9% 45/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Upper respiratory tract infection	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	11.8% 4/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	14.3% 17/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	12.2% 23/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Pharyngitis	18.2% 4/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.8% 3/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.1% 18/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	13.8% 26/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Rhinitis	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	14.7% 5/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 7/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.0% 15/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Juvenile arthritis	27.3% 6/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	23.1% 3/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	17.6% 6/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	31.1% 37/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	27.7% 52/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Nausea	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	12.6% 15/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	9.0% 17/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	11.8% 14/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	9.0% 17/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Vomiting	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.8% 3/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	10.1% 12/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	9.0% 17/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Abdominal pain	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	10.1% 12/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.5% 16/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 4/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	17.6% 6/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	10.9% 13/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	13.3% 25/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.8% 3/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	12.6% 15/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	10.1% 19/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Nervous system disorders Headache	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	23.1% 3/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	14.7% 5/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	18.5% 22/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	16.5% 31/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Rash	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.8% 3/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 7/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 11/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Ear infection	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.4% 10/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.0% 15/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Gastroenteritis	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	8.8% 3/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 7/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 11/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Influenza	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 7/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 11/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Sinusitis	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.2% 5/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.3% 10/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Arthralgia	13.6% 3/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.2% 5/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.3% 10/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	6.7% 8/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.3% 10/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Bronchitis	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.3% 8/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Urinary tract infection	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.3% 8/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Oral herpes	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.7% 7/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Pharyngotonsillitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.7% 7/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Otitis media	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Pneumonia	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Respiratory tract infection viral	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.4% 4/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Respiratory tract infection	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Viral infection	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Laryngitis	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Varicella	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	15.4% 2/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Infection parasitic	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Mumps	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Abscess	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Abscess limb	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Muscle abscess	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Infections and infestations Skin bacterial infection	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Muscle disorder	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Mouth ulceration	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.7% 7/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Aphthous stomatitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Gastrointestinal disorders Dental caries	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Epistaxis	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.2% 5/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.3% 8/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Renal and urinary disorders Rhinorrhoea	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.4% 4/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.2% 6/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Nervous system disorders Dizziness	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 7/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.3% 8/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.2% 6/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.2% 5/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.2% 6/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Skin and subcutaneous tissue disorders Prurigo	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Ligament sprain	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.5% 3/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.7% 7/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Arthropod bite	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.2% 6/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Contusion	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Thermal burn	4.5% 1/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Fall	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.6% 3/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Eye disorders Conjunctivitis	9.1% 2/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.8% 9/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Eye disorders Iridocyclitis	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Ear and labyrinth disorders Ear pain	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.0% 6/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	4.3% 8/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
General disorders Pyrexia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	5.9% 2/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.4% 4/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.7% 7/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Investigations Transaminases increased	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	3.4% 4/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.7% 5/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Vascular disorders Hypotension	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.9% 1/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.7% 2/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	2.1% 4/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.84% 1/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	1.1% 2/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/22 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	7.7% 1/13 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/34 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.00% 0/119 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.	0.53% 1/188 • All exposure safety population: All participants randomized into Part I of the study who received at least 1 infusion of tocilizumab and had at least 1 post-baseline safety assessment or event. The patients were exposed to weight-adjusted doses for the 104 week duration of the study with the exception of those patients randomized in Part II (Weeks 16-40) to receive placebo. Adverse events (AE) are reported for all participants and by the various weight-based dose groups. AEs which occurred in the placebo group in Part II are not included.

Additional Information

Medical Communications

Hoffman-La Roche

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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.
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Restriction type: OTHER