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A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642460
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : October 26, 2011
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Juvenile Idiopathic Arthritis
Interventions Drug: tocilizumab [RoActemra/Actemra]
Drug: Placebo
Drug: Non-steroidal anti-inflammatory drugs (NSAIDs)
Drug: methotrexate
Drug: corticosteroids
Enrollment 112
Recruitment Details  
Pre-assignment Details This study consists of 3 parts. Part I: a 12 week double-blind placebo controlled study followed by Part II: a 92 week single arm open-label extension study followed by Part III: a 3 year open label continuation study.
Arm/Group Title Tocilizumab_8 mg/kg Tocilizumab_12 mg/kg Placebo Tocilizumab Switchers Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description

Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Period Title: Part I: 12 Week Double-Blind
Started 37 38 37 0 0 0
Part I : Intent-to-treat 37 38 37 0 0 0
Completed 36 37 36 0 0 0
Not Completed 1 1 1 0 0 0
Reason Not Completed
Adverse Event             0             1             1             0             0             0
Refused Treatment             1             0             0             0             0             0
Period Title: Part II: Open-Label Up to Week 92
Started 52 [1] 40 0 [2] 20 [3] 0 0
Part II: Intent-to-treat 52 40 0 20 0 0
Completed 43 32 0 17 0 0
Not Completed 9 8 0 3 0 0
Reason Not Completed
Adverse Event             4             2             0             0             0             0
Death             0             1             0             2             0             0
Insufficient therapeutic response             2             3             0             0             0             0
Refused treatment             3             1             0             0             0             0
Failure to return             0             1             0             0             0             0
Administrative reasons             0             0             0             1             0             0
[1]
Includes Participants who received Open-Label in Part II or Open-Label escape therapy in Part I.
[2]
Placebo group received open-label Tocilizumab 8 mg/kg or 12 mg/kg based on body weight in Part II.
[3]
19 Participants switched from 12 mg/kg to 8 mg/kg and 1 Participant switched from 8mg/kg to 12 mg/kg
Period Title: Part III: Open-Label Up to Week 260
Started 0 0 0 0 53 59
Completed 0 0 0 0 28 38
Not Completed 0 0 0 0 25 21
Reason Not Completed
Adverse Event             0             0             0             0             7             6
Insufficient therapeutic response             0             0             0             0             3             4
Withdrawal by Subject             0             0             0             0             4             1
Lost to Follow-up             0             0             0             0             1             1
Other             0             0             0             0             2             2
Death             0             0             0             0             0             3
Administrative reason             0             0             0             0             0             1
Refused treatment             0             0             0             0             8             3
Arm/Group Title Tocilizumab Placebo Total
Hide Arm/Group Description

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Total of all reporting groups
Overall Number of Baseline Participants 75 37 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 75 participants 37 participants 112 participants
2 to 5 16 11 27
6 to 12 33 15 48
13 to 17 26 11 37
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants 37 participants 112 participants
Female
39
  52.0%
17
  45.9%
56
  50.0%
Male
36
  48.0%
20
  54.1%
56
  50.0%
1.Primary Outcome
Title Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever
Hide Description

Percentage of participants with ≥30% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity Visual Analog Scale (VAS), 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) Childhood Health Assessment Questionnaire- Disability Index (CHAQ-DI) consisting of 30 questions in 8 domains.

Absence of fever was defined as no diary temperature recording ≥37.5° Celsius in the preceding seven days.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population includes all participants who had at least one dose of study drug.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75 37
Measure Type: Number
Unit of Measure: Percentage of participants
85.3 24.3
2.Primary Outcome
Title Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
Hide Description Percentage of participants with ≥20 percent, ≥50 percent, ≥75 percent and ≥90 percent decreases in oral corticosteroid dose (mg/kg/day) from baseline.
Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Includes only participants on oral corticosteroids at baseline.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: Percentage of participants
≥20 percent decrease 76
≥50 percent decrease 73
≥75 percent decrease 62
≥90 percent decrease 47
3.Secondary Outcome
Title Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
Hide Description

The six JIA ACR components consist of: 1) Physician's global assessment of disease activity, 2) Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.

At an assessment visit a JIA ACR30/50/70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 30%/50%/70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population includes all randomized participants who received at least one dose of study drug.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75 37
Measure Type: Number
Unit of Measure: Percentage of participants
JIA ACR30 response 90.7 24.3
JIA ACR50 response 85.3 10.8
JIA ACR70 response 70.7 8.1
JIA ACR90 response 37.3 5.4
4.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity
Hide Description Physician's Global Assessment of disease activity is a Visual Analog Scale. The scale is 0 to 100 mm horizontal scale, the extreme left end of the line represents 'arthritis inactive' (i.e. symptom-free and no arthritis symptoms) and the extreme right end represents 'arthritis very active'. This item is completed by the treating physician.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. Last observation carried forward (LOCF) rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 73 17
Measure Type: Number
Unit of Measure: Percentage change
-69.6 -41.1
5.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being
Hide Description The Parent/Patient global assessment of overall well-being is a VAS. The scale is a 0 to 100 mm horizontal scale, the extreme left end of the line represents 'very well' (i.e. symptom-free and no arthritis disease activity) and the extreme right end represents 'very poor' (i.e. maximum arthritis disease activity). This item is completed by the patient or parent/guardian as appropriate.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 73 17
Measure Type: Number
Unit of Measure: Percentage change
-65.8 -1.4
6.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis
Hide Description

The maximum number of joints with active arthritis is 71 and these are defined as those in the joint assessment with: swelling present or pain present and limitation of motion.

The joint assessment is performed by an independent assessor, who is not the treating physician, blinded to all other aspects of the patient's efficacy and safety data.

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 73 17
Measure Type: Number
Unit of Measure: Percentage change
-70.6 -37.2
7.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement
Hide Description The maximum number of joints with limitation of movement is 67 and these are defined as those in the joint assessment with 'limitation of motion'.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 72 17
Measure Type: Number
Unit of Measure: Percentage change
-51.6 -22.5
8.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate
Hide Description Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured in mm/hour.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 73 17
Measure Type: Number
Unit of Measure: Percentage change
-88.2 33.6
9.Secondary Outcome
Title Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)
Hide Description

Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).

The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing JIA ACR core set components at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 72 17
Measure Type: Number
Unit of Measure: Percentage change
-45.6 -10.3
10.Secondary Outcome
Title Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12
Hide Description Fever free was defined as no diary temperature recording ≥37.5° Celsius in the preceding fourteen days.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who had a fever due to Systemic Juvenile Idiopathic Arthritis at baseline.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 41 24
Measure Type: Number
Unit of Measure: Percentage of participants
85.4 20.8
11.Secondary Outcome
Title Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12
Hide Description Percentage of participants with a change from an elevated hsCRP value at baseline to a normal hsCRP value at week 12; a change from anemia (low Hemoglobin) at baseline to a normal hemoglobin value at week 12; a change from thrombocytosis (elevated platelets) at baseline to a normal platelet value at week 12; a change from leukocytosis (elevated white blood cell count) at baseline to a normal white blood cell count at week 12.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population includes all randomized participants who received at least one dose of study drug. 'n' in each of the categories is the number of participants with data available at baseline and week 12 for analyses.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75 37
Measure Type: Number
Unit of Measure: Percentage of participants
hsC-Reactive Protein (n=72,34) 98.6 5.9
Hemoglobin (n=50,29) 80.0 6.9
Platelets (n=52,26) 90.4 3.8
Leukocytes (n=28,21) 75.0 9.5
12.Secondary Outcome
Title Part I: Percentage of Participants With Concomitant Corticosteroid Reduction
Hide Description

The percentage of participants receiving oral corticosteroids(CS) with a JIA ACR70 response at week 6 or Week 8 who reduced their oral CS dose by at least 20% without subsequent JIA ACR30 flare or occurrence of systemic symptoms at week 12.

At an assessment visit a JIA ACR70 response is defined as: At least three of the six JIA ACR core components improving by at least 70% and no more than one of the remaining JIA ACR core components worsening by more than 30%.

Time Frame Week 6 or Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) who were taking oral corticosteroids.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 70 31
Measure Type: Number
Unit of Measure: Percentage of participants
24.3 3.2
13.Secondary Outcome
Title Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12
Hide Description Participants rated their pain by placing a horizontal line on a Visual Analog Scale on a scale of 0 (no pain)- 100 mm (severe pain). The score at 12 weeks minus the score at baseline. A negative number indicates improvement.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population who had Pain VAS data available at baseline and week 12. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are excluded. LOCF rule applied to missing pain VAS at Week 12.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 73 17
Measure Type: Number
Unit of Measure: mm
-41.0 -1.1
14.Secondary Outcome
Title Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12
Hide Description

Percentage of patients who had at least a 0.13 improvement in CHAQ-DI score from Baseline to Week 12.

The CHAQ-DI questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).

Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

Intent-to-treat Population. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.

LOCF rule applied to missing CHAQ-DI Scores at Week 12.

Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75 37
Measure Type: Number
Unit of Measure: Percentage of participants
77.3 18.9
15.Secondary Outcome
Title Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12
Hide Description Percentage of participants who had a rash characteristic of sJIA in the 14 days prior to the baseline visit but no rash characteristic of sJIA in the 14 days preceding the Week 12 visit day.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent-to-treat population for whom data was available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.
Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 22 18
Measure Type: Number
Unit of Measure: Percentage of participants
63.6 11.1
16.Secondary Outcome
Title Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12
Hide Description Part I: Percentage of patients who had anemia (hemoglobin <lower level normal based on sex and age) at Baseline and a ≥10 g/L increase in hemoglobin at Week 6 and at Week 12.
Time Frame Baseline, Week 6 and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description

Participants from the Intent-to-treat population for whom hemoglobin data available. Patients who withdrew, received escape medication, or for whom the endpoint cannot be determined are classified as non-responders.

LOCF rule applied to missing hemoglobin values at Week 6 and Week 12.

Arm/Group Title Tocilizumab Placebo
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 50 29
Measure Type: Number
Unit of Measure: Percentage of participants
Week 6 88.0 3.4
Week 12 88.0 3.4
17.Secondary Outcome
Title Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104
Hide Description

The six JIA ACR components consist of: 1)Physician's global assessment of disease activity, 2)Parent/Patient global assessment of overall well-being, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI.

At an assessment visit a JIA ACR70/90 response in comparison to Baseline is defined as: At least three of the six JIA ACR core components improving by at least 70%/90% and no more than one of the remaining JIA ACR core components worsening by more than 30%.

Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat population who reached the time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been non-responders.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Percentage of Participants
JIA ACR70 response 76.0
JIA ACR90 response 61.3
18.Secondary Outcome
Title Part II: Number of Active Joints at Week 104
Hide Description Seventy-one joints were assessed for signs of active arthritis. The mean number of joints with signs of active arthritis is reported.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat population who reached this time point. No data imputation is applied and patients with missing data are excluded.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Active Joints
1.9  (3.6)
19.Secondary Outcome
Title Part II: Percentage of Participants With no Active Joints at Week 104
Hide Description Seventy-one joints were assessed for signs of active arthritis. The percentage of participants with no signs of active arthritis is reported.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat population in Part II includes 112 participants who received at least one dose of study drug. Only those participants who reached this time point are included in the analyses.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 76
Measure Type: Number
Unit of Measure: Percentage of Participants
47.4
20.Secondary Outcome
Title Part II: Percentage of Participants With Inactive Disease at Week 104
Hide Description

Criteria for Inactive Disease:

1) No joints with active arthritis, 2) No fever, rash, serositis, splenomegaly, hepatomegaly (by physical exam) or generalized lymphadenopathy attributable to systemic juvenile idiopathic arthritis (sJIA), 3) Normal Erythrocyte Sedimentation Rate (<20 mm/hour), 4) Physician's global assessment of disease activity Visual Analog Scale (VAS) indicates no disease activity (where no disease activity is considered to be a score ≤10 mm on a 100 mm VAS).

Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat population who reached time point plus patients who withdrew because of insufficient therapeutic response and are assumed to have been nonresponders.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: Percentage of Participants
26.7
21.Secondary Outcome
Title Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104
Hide Description

Functional ability is assessed using the CHAQ-DI. The questionnaire consists of 30 questions referring to eight domains; dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain has at least two component questions and if applicable to the patient there are four possible responses (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, 3 = unable to do).

The CHAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score. This overall score ranges from 0 (best) to 3 (worst).

Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 112
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline (n=112) 1.68  (0.86)
Week 104 (n=57) 0.55  (0.71)
22.Secondary Outcome
Title Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104
Hide Description Percentage is based on only those participants who were on oral corticosteroid at baseline and reached a nominal visit day on which dose was calculated.
Time Frame Baseline, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to Treat population who withdrew have been excluded at post withdrawal visits.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 42
Measure Type: Number
Unit of Measure: Percentage of Participants
60
23.Secondary Outcome
Title Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104
Hide Description

Rate of SAEs, Rate of Serious Infection AEs, Rate of Related SAEs (remotely, possibly, probably) to Tocilizumab (TCZ), Rate of Macrophage Activation Syndrome, Rate of AEs leading to withdrawal and Rate of deaths per 100 patient years (PY) were calculated using the formula:

Number of Patient Events / Duration in study (years) * 100.

Multiple occurrences of the same AE in one individual are counted.

Time Frame 104 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population- all participants who received at least one dose of study drug and had 1 post-baseline safety assessment. Includes all safety data in the database up to the week 104 infusion based on the date of randomization for each patient. (Last date was 31 May 2011)
Arm/Group Title Tocilizumab
Hide Arm/Group Description:

Tocilizumab 8 mg/kg (for patients >=30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1 and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 112
Measure Type: Number
Unit of Measure: Events per 100 patient year
SAEs 23.3
Serious infection AEs 10.9
SAEs related to TCZ 7.4
Macrophage activation syndrome 1.5
AEs leading to withdrawal 3.0
Deaths 1.5
24.Secondary Outcome
Title Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Hide Description Percentage of participants with ≥30%, 50%, 70%, and 90% improvement in ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.
Time Frame Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
The Part III intent-to-treat (ITT3) population consists of all participants who entered into Part III of the study and received at least one administration of tocilizumab during Part III.
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 42 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 104 JIA ACR30 (n=42,47) 100.0 100.0
Week 104 JIA ACR50 (n=42,47) 100.0 100.0
Week 104 JIA ACR70 (n=42,47) 92.9 95.7
Week 104 JIA ACR90 (n=42,47) 81.0 72.3
Week 116 JIA ACR30 (n=41,45) 100.0 100.0
Week 116 JIA ACR50 (n=41,45) 100.0 97.8
Week 116 JIA ACR70 (n=41,45) 95.1 97.8
Week 116 JIA ACR90 (n=41,45) 82.9 80.0
Week 128 JIA ACR30 (n=39,41) 100.0 100.0
Week 128 JIA ACR50 (n=39,41) 100.0 100.0
Week 128 JIA ACR70 (n=39,41) 97.4 97.6
Week 128 JIA ACR90 (n=39,41) 79.5 82.9
Week 140 JIA ACR30 (n=34,37) 100.0 100.0
Week 140 JIA ACR50 (n=34,37) 100.0 100.0
Week 140 JIA ACR70 (n=34,37) 100.0 94.6
Week 140 JIA ACR90 (n=34,37) 73.5 75.7
Week 152 JIA ACR30 (n=27,28) 100.0 100.0
Week 152 JIA ACR50 (n=27,28) 100.0 100.0
Week 152 JIA ACR70 (n=27,28) 100.0 96.4
Week 152 JIA ACR90 (n=27,28) 66.7 78.6
Week 164 JIA ACR30 (n=27,24) 100.0 100.0
Week 164 JIA ACR50 (n=27,24) 100.0 100.0
Week 164 JIA ACR70 (n=27,24) 92.6 95.8
Week 164 JIA ACR90 (n=27,24) 66.7 75.0
Week 176 JIA ACR30 (n=22,22) 100.0 100.0
Week 176 JIA ACR50 (n=22,22) 100.0 100.0
Week 176 JIA ACR70 (n=22,22) 100.0 95.5
Week 176 JIA ACR90 (n=22,22) 63.6 63.6
Week 188 JIA ACR30 (n=20,22) 100.0 100.0
Week 188 JIA ACR50 (n=20,22) 100.0 100.0
Week 188 JIA ACR70 (n=20,22) 95.0 95.5
Week 188 JIA ACR90 (n=20,22) 45.0 72.7
Week 200 JIA ACR30 (n=19,19) 100.0 100.0
Week 200 JIA ACR50 (n=19,19) 100.0 94.7
Week 200 JIA ACR70 (n=19,19) 94.7 89.5
Week 200 JIA ACR90 (n=19,19) 63.2 78.9
Week 212 JIA ACR30 (n=18,18) 100.0 100.0
Week 212 JIA ACR50 (n=18,18) 100.0 94.4
Week 212 JIA ACR70 (n=18,18) 100.0 94.4
Week 212 JIA ACR90 (n=18,18) 72.2 77.8
Week 224 JIA ACR30 (n=17,18) 100.0 100.0
Week 224 JIA ACR50 (n=17,18) 100.0 88.9
Week 224 JIA ACR70 (n=17,18) 100.0 88.9
Week 224 JIA ACR90 (n=17,18) 64.7 83.3
Week 236 JIA ACR30 (n=16,17) 100.0 100.0
Week 236 JIA ACR50 (n=16,17) 100.0 100.0
Week 236 JIA ACR70 (n=16,17) 93.8 100.0
Week 236 JIA ACR90 (n=16,17) 68.8 88.2
Week 248 JIA ACR30 (n=15,17) 100.0 100.0
Week 248 JIA ACR50 (n=15,17) 100.0 100.0
Week 248 JIA ACR70 (n=15,17) 86.7 94.1
Week 248 JIA ACR90 (n=15,17) 73.3 70.6
Week 260 JIA ACR30 (n=15,15) 100.0 93.3
Week 260 JIA ACR50 (n=15,15) 93.3 93.3
Week 260 JIA ACR70 (n=15,15) 86.7 93.3
Week 260 JIA ACR90 (n=15,15) 60.0 66.7
25.Secondary Outcome
Title Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Hide Description JIA ACR core set consisting of 6 components: 1) Physician's global assessment of disease activity VAS, 2) Parent/Patient global assessment of overall well-being VAS, 3) Maximum number of joints with active arthritis, 4) Number of joints with limitation of movement, 5) Erythrocyte Sedimentation Rate, and 6) CHAQ-DI consisting of 30 questions in 8 domains.
Time Frame Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
The Part III ITT3 population
Arm/Group Title All Participants Treated With Tocilizumab
Hide Arm/Group Description:

Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: percentage of participants
Week 104 JIA ACR 30 (n=89) NA [1] 
Week 104 JIA ACR 50 (n=89) NA [1] 
Week 104 JIA ACR 70 (n=89) NA [1] 
Week 104 JIA ACR 90 (n=89) NA [1] 
Week 116 JIA ACR 30 (n=86) NA [1] 
Week 116 JIA ACR 50 (n=86) NA [1] 
Week 116 JIA ACR 70 (n=86) NA [1] 
Week 116 JIA ACR 90 (n=86) NA [1] 
Week 128 JIA ACR 30 (n=80) 100.0
Week 128 JIA ACR 50 (n=80) 98.8
Week 128 JIA ACR 70 (n=80) 91.3
Week 128 JIA ACR 90 (n=80) 68.8
Week 140 JIA ACR30 (n=71) 100.0
Week 140 JIA ACR50 (n=71) 98.6
Week 140 JIA ACR70 (n=71) 93.0
Week 140 JIA ACR90 (n=71) 66.2
Week 152 JIA ACR30 (n=55) 100.0
Week 152 JIA ACR50 (n=55) 100.0
Week 152 JIA ACR70 (n=55) 94.5
Week 152 JIA ACR90 (n=55) 60.0
Week 164 JIA ACR30 (n=51) 100.0
Week 164 JIA ACR50 (n=51) 100.0
Week 164 JIA ACR70 (n=51) 92.2
Week 164 JIA ACR90 (n=51) 56.9
Week 176 JIA ACR30 (n=44) 100.0
Week 176 JIA ACR50 (n=44) 100.0
Week 176 JIA ACR70 (n=44) 88.6
Week 176 JIA ACR90 (n=44) 52.3
Week 188 JIA ACR30 (n=42) 100.0
Week 188 JIA ACR50 (n=42) 100.0
Week 188 JIA ACR70 (n=42) 88.1
Week 188 JIA ACR90 (n=42) 50.0
Week 200 JIA ACR30 (n=38) 100.0
Week 200 JIA ACR50 (n=38) 97.4
Week 200 JIA ACR70 (n=38) 86.8
Week 200 JIA ACR90 (n=38) 52.6
Week 212 JIA ACR30 (n=36) 100.0
Week 212 JIA ACR50 (n=36) 97.2
Week 212 JIA ACR70 (n=36) 88.9
Week 212 JIA ACR90 (n=36) 55.6
Week 224 JIA ACR30 (n=35) 100.0
Week 224 JIA ACR50 (n=35) 94.3
Week 224 JIA ACR70 (n=35) 91.4
Week 224 JIA ACR90 (n=35) 68.6
Week 236 JIA ACR30 (n=33) 100.0
Week 236 JIA ACR50 (n=33) 93.9
Week 236 JIA ACR70 (n=33) 90.9
Week 236 JIA ACR90 (n=33) 72.7
Week 248 JIA ACR30 (n=32) 100.0
Week 248 JIA ACR50 (n=32) 93.8
Week 248 JIA ACR70 (n=32) 87.5
Week 248 JIA ACR90 (n=32) 65.6
Week 260 JIA ACR30 (n=30) 96.7
Week 260 JIA ACR50 (n=30) 93.3
Week 260 JIA ACR70 (n=30) 80.0
Week 260 JIA ACR90 (n=30) 56.7
[1]
Week 104 is the start of Part III. The first 6 month maintenance data starts at Week 128 (24 weeks after Week 104)
26.Secondary Outcome
Title Part III: Doses of Oral Corticosteroids
Hide Description Oral corticosteroid values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the the visit of withdrawal and all subsequent visits.
Time Frame Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 53 59
Mean (Standard Deviation)
Unit of Measure: mg/kg/day
Baseline (n=53,59) 0.203  (0.1572) 0.356  (0.1397)
Week 104 (n=45,48) 0.020  (0.0455) 0.047  (0.0869)
Week 116 (n=42,46) 0.022  (0.0464) 0.046  (0.0831)
Week 128 (n=41,42) 0.022  (0.0449) 0.058  (0.1635)
Week 140 (n=34,38) 0.031  (0.0625) 0.051  (0.1112)
Week 152 (n=28,31) 0.021  (0.0388) 0.060  (0.1125)
Week 164 (n=28,25) 0.018  (0.0349) 0.068  (0.1179)
Week 176 (n=25,23) 0.019  (0.0383) 0.073  (0.1327)
Week 188 (n=21,22) 0.020  (0.0366) 0.075  (0.1275)
Week 200 (n=20,20) 0.017  (0.0284) 0.083  (0.1397)
Week 212 (n=19,19) 0.016  (0.0274) 0.077  (0.1449)
Week 224 (n=18,19) 0.017  (0.0279) 0.075  (0.1399)
Week 236 (n=17,18) 0.018  (0.0283) 0.077  (0.1436)
Week 248 (n=16,18) 0.020  (0.0290) 0.076  (0.1429)
Week 260 (n=16,18) 0.019  (0.0282) 0.079  (0.1486)
27.Secondary Outcome
Title Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Hide Description

Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.

Baseline considered first dose of study treatment. Data presented up to entry into the Alternative Dosing Schedule.

Time Frame Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 38 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 104 (n=38,46) 66.0 67.0
Week 116 (n=36,44) 67.0 68.0
Week 128 (n=35,40) 69.0 70.0
Week 140 (n=31,36) 68 67
Week 152 (n=25,30) 64.0 57.0
Week 164 (n=25,24) 68.0 58.0
Week 176 (n=22,22) 68.0 64.0
Week 188 (n=18,21) 61.0 57.0
Week 200 (n=17,20) 59.0 60.0
Week 212 (n=16,19) 56.0 63.0
Week 224 (n=15,19) 53.0 63.0
Week 236 (n=14,18) 50.0 61.0
Week 248 (n=13,18) 46.0 61.0
Week 260 (n=13,18) 46.0 61.0
28.Secondary Outcome
Title Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Hide Description

Values summarized are based on average daily dose on the nominal study day. The prednisone equivalent is used in calculation of oral corticosteroid dose. Participants who withdrew are excluded at the timepoint of this event and at all subsequent visits.

Baseline considered first dose of study treatment.

Time Frame Every 2 weeks from Week 104 to Week 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 38 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 104 >20% decrease (n=38,46) 100.0 97.8
Week 104 >50% decrease (n=38,46) 94.7 91.3
Week 104 >75% decrease (n=38,46) 84.2 82.6
Week 104 >90% decrease (n=38,46) 71.1 71.7
Week 106 >20% decrease (n=37,46) 100.0 97.8
Week 106 >50% decrease (n=37,46) 91.9 91.3
Week 106 >75% decrease (n=37,46) 83.8 82.6
Week 106 >90% decrease (n=37,46) 70.3 71.7
Week 108 >20% decrease (n=37,45) 100.0 100.0
Week 108 >50% decrease (n=37,45) 89.2 91.1
Week 108 >75% decrease (n=37,45) 81.1 84.4
Week 108 >90% decrease (n=37,45) 70.3 73.3
Week 110 >20% decrease (n=36,44) 100.0 100.0
Week 110 >50% decrease (n=36,44) 88.9 93.2
Week 110 >75% decrease (n=36,44) 80.6 84.1
Week 110 >90% decrease (n=36,44) 72.2 75.0
Week 112 >20% decrease (n=36,44) 100.0 100.0
Week 112 >50% decrease (n=36,44) 88.9 95.5
Week 112 >75% decrease (n=36,44) 80.6 81.8
Week 112 >90% decrease (n=36,44) 72.2 75.0
Week 114 >20% decrease (n=36,44) 100.0 100.0
Week 114 >50% decrease (n=36,44) 88.9 95.5
Week 114 >75% decrease (n=36,44) 80.6 79.5
Week 114 >90% decrease (n=36,44) 72.2 72.7
Week 116 >20% decrease (n=35,44) 100.0 100.0
Week 116 >50% decrease (n=35,44) 91.4 93.2
Week 116 >75% decrease (n=35,44) 80.0 79.5
Week 116 >90% decrease (n=35,44) 71.4 72.7
Week 118 >20% decrease (n=35,43) 100.0 100.0
Week 118 >50% decrease (n=35,43) 88.6 93.0
Week 118 >75% decrease (n=35,43) 80.0 81.4
Week 118 >90% decrease (n=35,43) 71.4 74.4
Week 120 >20% decrease (n=35,43) 100.0 100.0
Week 120 >50% decrease (n=35,43) 88.6 93.0
Week 120 >75% decrease (n=35,43) 80.0 83.7
Week 120 >90% decrease (n=35,43) 74.3 76.7
Week 122 >20% decrease (n=35,43) 97.1 100.0
Week 122 >50% decrease (n=35,43) 88.6 93.0
Week 122>75% decrease (n=35,43) 77.1 81.4
Week 122 >90% decrease (n=35,43) 74.3 74.4
Week 124 >20% decrease (n=35,43) 100.0 100.0
Week 124 >50% decrease (n=35,43) 94.3 93.0
Week 124 >75% decrease (n=35,43) 80.0 83.7
Week 124 >90% decrease (n=35,43) 77.1 74.4
Week 126 >20% decrease (n=35,43) 100.0 100.0
Week 126 >50% decrease (n=35,43) 94.3 90.7
Week 126 >75% decrease (n=35,43) 80.0 81.4
Week 126 >90% decrease (n=35,43) 77.1 74.4
Week 128 >20% decrease (n=35,39) 100.0 97.4
Week 128 >50% decrease (n=35,39) 91.4 89.7
Week 128 >75% decrease (n=35,39) 80.0 82.1
Week 128 >90% decrease (n=35,39) 77.1 71.8
Week 130 >20% decrease (n=35,39) 100.0 97.4
Week 130 >50% decrease (n=35,39) 91.4 89.7
Week 130 >75% decrease (n=35,39) 80.0 87.2
Week 130 >90% decrease (n=35,39) 80.0 74.4
Week 132 >20% decrease (n=35,39) 100.0 97.4
Week 132 >50% decrease (n=35,39) 91.4 87.2
Week 132 >75% decrease (n=35,39) 80.0 84.6
Week 132 >90% decrease (n=35,39) 80.0 71.8
Week 134 >20% decrease (n=35,39) 94.3 97.4
Week 134 >50% decrease (n=35,39) 88.6 87.2
Week 134 >75% decrease (n=35,39) 77.1 84.6
Week 134 >90% decrease (n=35,39) 77.1 71.8
Week 136 >20% decrease (n=34,39) 97.1 97.4
Week 136 >50% decrease (n=34,39) 91.2 89.7
Week 136 >75% decrease (n=34,39) 76.5 84.6
Week 136 >90% decrease (n=34,39) 76.5 71.8
Week 138 >20% decrease (n=34,39) 94.1 97.4
Week 138 >50% decrease (n=34,39) 88.2 89.7
Week 138 >75% decrease (n=34,39) 76.5 84.6
Week 138 >90% decrease (n=34,39) 76.5 71.8
Week 140 >20% decrease (n=29,36) 93.1 97.2
Week 140 >50% decrease (n=29,36) 86.2 88.9
Week 140 >75% decrease (n=29,36) 72.4 83.3
Week 140 >90% decrease (n=29,36) 72.4 72.2
Week 142 >20% decrease (n=29,36) 93.1 97.2
Week 142 >50% decrease (n=29,36) 86.2 88.9
Week 142 >75% decrease (n=29,36) 72.4 83.3
Week 142 >90% decrease (n=29,36) 69.0 72.2
Week 144 >20% decrease (n=28,36) 92.9 97.2
Week 144 >50% decrease (n=28,36) 89.3 88.9
Week 144 >75% decrease (n=28,36) 71.4 83.3
Week 144 >90% decrease (n=28,36) 67.9 72.2
Week 146 >20% decrease (n=28,36) 96.4 97.2
Week 146 >50% decrease (n=28,36) 92.9 86.1
Week 146 >75% decrease (n=28,36) 75.0 80.6
Week 146 >90% decrease (n=28,36) 71.4 66.7
Week 148 >20% decrease (n=27,35) 100.0 97.1
Week 148 >50% decrease (n=27,35) 96.3 85.7
Week 148 >75% decrease (n=27,35) 77.8 80.0
Week 148 >90% decrease (n=27,35) 74.1 65.7
Week 150 >20% decrease (n=25,35) 100.0 97.1
Week 150 >50% decrease (n=25,35) 96.0 88.6
Week 150 >75% decrease (n=25,35) 76.0 80.0
Week 150 >90% decrease (n=25,35) 76.0 68.6
Week 152 >20% decrease (n=25,27) 100.0 96.3
Week 152 >50% decrease (n=25,27) 96.0 85.2
Week 152 >75% decrease (n=25,27) 76.0 77.8
Week 152 >90% decrease (n=25,27) 76.0 63.0
Week 154 >20% decrease (n=25,27) 100.0 96.3
Week 154 >50% decrease (n=25,27) 96.0 88.9
Week 154 >75% decrease (n=25,27) 76.0 77.8
Week 154 >90% decrease (n=25,27) 76.0 70.4
Week 156 >20% decrease (n=25,27) 100.0 96.3
Week 156 >50% decrease (n=25,27) 96.0 85.2
Week 156 >75% decrease (n=25,27) 76.0 77.8
Week 156 >90% decrease (n=25,27) 76.0 70.4
Week 158 >20% decrease (n=25,27) 100.0 96.3
Week 158 >50% decrease (n=25,27) 96.0 88.9
Week 158 >75% decrease (n=25,27) 76.0 77.8
Week 158 >90% decrease (n=25,27) 76.0 70.4
Week 160 >20% decrease (n=25,27) 100.0 96.3
Week 160 >50% decrease (n=25,27) 96.0 85.2
Week 160 >75% decrease (n=25,27) 76.0 77.8
Week 160 >90% decrease (n=25,27) 76.0 70.4
Week 162 >20% decrease (n=25,27) 100.0 96.3
Week 162 >50% decrease (n=25,27) 96.0 81.5
Week 162 >75% decrease (n=25,27) 76.0 77.8
Week 162 >90% decrease (n=25,27) 76.0 70.4
Week 164 >20% decrease (n=24,24) 100.0 95.8
Week 164 >50% decrease (n=24,24) 95.8 83.3
Week 164 >75% decrease (n=24,24) 75.0 75.0
Week 164 >90% decrease (n=24,24) 75.0 70.8
Week 166 >20% decrease (n=24,22) 100.0 95.5
Week 166 >50% decrease (n=24,22) 95.8 81.8
Week 166 >75% decrease (n=24,22) 75.0 72.7
Week 166 >90% decrease (n=24,22) 75.0 68.2
Week 168 >20% decrease (n=24,22) 100.0 95.5
Week 168 >50% decrease (n=24,22) 95.8 81.8
Week 168 >75% decrease (n=24,22) 75.0 72.7
Week 168 >90% decrease (n=24,22) 75.0 68.2
Week 170 >20% decrease (n=22,22) 100.0 90.9
Week 170 >50% decrease (n=22,22) 95.5 81.8
Week 170 >75% decrease (n=22,22) 77.3 72.7
Week 170 >90% decrease (n=22,22) 77.3 68.2
Week 172 >20% decrease (n=22,22) 100.0 90.9
Week 172 >50% decrease (n=22,22) 95.5 90.9
Week 172 >75% decrease (n=22,22) 77.3 72.7
Week 172 >90% decrease (n=22,22) 77.3 68.2
Week 174 >20% decrease (n=22,22) 100.0 90.9
Week 174 >50% decrease (n=22,22) 95.5 90.9
Week 174 >75% decrease (n=22,22) 77.3 72.7
Week 174 >90% decrease (n=22,22) 77.3 68.2
Week 176 >20% decrease (n=19,22) 100.0 90.9
Week 176 >50% decrease (n=19,22) 94.7 90.9
Week 176 >75% decrease (n=19,22) 73.7 72.7
Week 176 >90% decrease (n=19,22) 73.7 68.2
Week 178 >20% decrease (n=19,22) 100.0 90.9
Week 178 >50% decrease (n=19,22) 94.7 90.9
Week 178 >75% decrease (n=19,22) 73.7 72.7
Week 178 >90% decrease (n=19,22) 73.7 68.2
Week 180 >20% decrease (n=19,22) 100.0 90.9
Week 180 >50% decrease (n=19,22) 94.7 90.9
Week 180 >75% decrease (n=19,22) 73.7 68.2
Week 180 >90% decrease (n=19,22) 73.7 63.6
Week 182 >20% decrease (n=18,22) 100.0 90.9
Week 182 >50% decrease (n=18,22) 94.4 90.9
Week 182 >75% decrease (n=18,22) 72.2 68.2
Week 182 >90% decrease (n=18,22) 72.2 63.6
Week 184 >20% decrease (n=18,22) 100.0 90.9
Week 184 >50% decrease (n=18,22) 94.4 86.4
Week 184 >75% decrease (n=18,22) 72.2 68.2
Week 184 >90% decrease (n=18,22) 72.2 63.6
Week 186 >20% decrease (n=18,22) 100.0 90.0
Week 186 >50% decrease (n=18,22) 94.4 90.9
Week 186 >75% decrease (n=18,22) 72.2 68.2
Week 186 >90% decrease (n=18,22) 72.2 63.6
Week 188 >20% decrease (n=18,21) 100.0 90.5
Week 188 >50% decrease (n=18,21) 94.4 90.5
Week 188 >75% decrease (n=18,21) 72.2 71.4
Week 188 >90% decrease (n=18,21) 72.2 61.9
Week 190 >20% decrease (n=18,21) 100.0 95.2
Week 190 >50% decrease (n=18,21) 94.4 85.7
Week 190 >75% decrease (n=18,21) 72.2 66.7
Week 190 >90% decrease (n=18,21) 72.2 61.9
Week 192 >20% decrease (n=18,21) 100.0 95.2
Week 192 >50% decrease (n=18,21) 94.4 81.0
Week 192 >75% decrease (n=18,21) 72.2 66.7
Week 192 >90% decrease (n=18,21) 72.2 61.9
Week 194 >20% decrease (n=18,20) 100.0 95.0
Week 194 >50% decrease (n=18,20) 94.4 80.0
Week 194 >75% decrease (n=18,20) 72.2 70.0
Week 194 >90% decrease (n=18,20) 72.2 65.0
Week 196 >20% decrease (n=18,20) 100.0 90.0
Week 196 >50% decrease (n=18,20) 94.4 80.0
Week 196 >75% decrease (n=18,20) 72.2 70.0
Week 196 >90% decrease (n=18,20) 72.2 65.0
Week 198 >20% decrease (n=18,20) 100.0 90.0
Week 198 >50% decrease (n=18,20) 94.4 80.0
Week 198 >75% decrease (n=18,20) 72.2 70.0
Week 198 >90% decrease (n=18,20) 72.2 65.0
Week 200 >20% decrease (n=17,20) 100.0 90.0
Week 200 >50% decrease (n=17,20) 94.1 85.0
Week 200 >75% decrease (n=17,20) 76.5 75.0
Week 200 >90% decrease (n=17,20) 70.6 65.0
Week 202 >20% decrease (n=17,20) 100.0 90.0
Week 202 >50% decrease (n=17,20) 94.1 85.0
Week 202 >75% decrease (n=17,20) 76.5 75.0
Week 202 >90% decrease (n=17,20) 70.6 65.0
Week 204 >20% decrease (n=17,20) 100.0 90.0
Week 204 >50% decrease (n=17,20) 94.1 85.0
Week 204 >70% decrease (n=17,20) 76.5 75.0
Week 204 >90% decrease (n=17,20) 70.6 65.0
Week 206 >20% decrease (n=16,20) 100.0 85.0
Week 206 >50% decrease (n=16,20) 93.8 75.0
Week 206 >75% decrease (n=16,20) 75.0 75.0
Week 206 >90% decrease (n=16,20) 68.8 70.0
Week 208 >20% decrease (n=16,20) 100.0 90.0
Week 208 >50% decrease (n=16,20) 93.8 80.0
Week 208 >75% decrease (n=16,20) 75.0 75.0
Week 208 >90% decrease (n=16,20) 68.8 70.0
Week 210 >20% decrease (n=16,19) 100.0 89.5
Week 210 >50% decrease (n=16,19) 93.8 84.2
Week 210 >75% decrease (n=16,19) 81.3 78.9
Week 210 >90% decrease (n=16,19) 75.0 73.7
Week 212 >20% decrease (n=15,19) 100.0 89.5
Week 212 >50% decrease (n=15,19) 93.3 84.2
Week 212 >75% decrease (n=15,19) 73.3 78.9
Week 212 >90% decrease (n=15,19) 73.3 73.7
Week 214 >20% decrease (n=15,19) 100.0 89.5
Week 214 >50% decrease (n=15,19) 93.3 84.2
Week 214 >75% decrease (n=15,19) 73.3 78.9
Week 214 >90% decrease (n=15,19) 73.3 73.7
Week 216 >20% decrease (n=15,19) 100.0 94.7
Week 216 >50% decrease (n=15,19) 93.3 84.2
Week 216 >75% decrease (n=15,19) 73.3 78.9
Week 216 >90% decrease (n=15,19) 73.3 73.7
Week 218 >20% decrease (n=15,19) 100.0 89.5
Week 218 >50% decrease (n=15,19) 93.3 84.2
Week 218 >75% decrease (n=15,19) 80.0 78.9
Week 218 >90% decrease (n=15,19) 73.3 73.7
Week 220 >20% decrease (n=15,19) 100.0 89.5
Week 220 >50% decrease (n=15,19) 93.3 84.2
Week 220 >75% decrease (n=15,19) 80.0 78.9
Week 220 >90% decrease (n=15,19) 73.3 73.7
Week 222 >20% decrease (n=15,19) 100.0 89.5
Week 222 >50% decrease (n=15,19) 93.3 84.2
Week 222 >75% decrease (n=15,19) 80.0 78.9
Week 222 >90% decrease (n=15,19) 73.3 73.7
Week 224 >20% decrease (n=15,19) 100.0 89.5
Week 224 >50% decrease (n=15,19) 93.3 84.2
Week 224 >75% decrease (n=15,19) 80.0 78.9
Week 224 >90% decrease (n=15,19) 73.3 73.7
Week 226 >20% decrease (n=14,19) 100.0 89.5
Week 226 >50% decrease (n=14,19) 92.9 84.2
Week 226 >75% decrease (n=14,19) 78.6 78.9
Week 226 >90% decrease (n=14,19) 71.4 73.7
Week 228 >20% decrease (n=14,19) 100.0 89.5
Week 228 >50% decrease (n=14,19) 92.9 89.5
Week 228 >75% decrease (n=14,19) 78.6 78.9
Week 228 >90% decrease (n=14,19) 71.4 73.7
Week 230 >20% decrease (n=14,19) 100.0 89.5
Week 230 >50% decrease (n=14,19) 92.9 89.5
Week 230 >75% decrease (n=14,19) 78.6 78.9
Week 230 >90% decrease (n=14,19) 71.4 73.7
Week 232 >20% decrease (n=14,18) 100.0 88.9
Week 232 >50% decrease (n=14,18) 92.9 88.9
Week 232 >75% decrease (n=14,18) 78.6 77.8
Week 232 >90% decrease (n=14,18) 71.4 72.2
Week 234 >20% decrease (n=14,18) 100.0 88.9
Week 234 >50% decrease (n=14,18) 92.9 88.9
Week 234 >75% decrease (n=14,18) 78.6 77.8
Week 234 >90% decrease (n=14,18) 71.4 72.2
Week 236 >20% decrease (n=14,18) 100.0 94.4
Week 236 >50% decrease (n=14,18) 92.9 88.9
Week 236 >75% decrease (n=14,18) 78.6 77.8
Week 236 >90% decrease (n=14,18) 71.4 72.2
Week 238 >20% decrease (n=14,18) 100.0 94.4
Week 238 >50% decrease (n=14,18) 92.9 88.9
Week 238 >75% decrease (n=14,18) 78.6 77.8
Week 238 >90% decrease (n=14,18) 71.4 72.2
Week 240 >20% decrease (n=13,18) 100.0 94.4
Week 240 >50% decrease (n=13,18) 92.3 88.9
Week 240 >75% decrease (n=13,18) 76.9 77.8
Week 240 >90% decrease (n=13,18) 69.2 72.2
Week 242 >20% decrease (n=13,18) 100.0 94.4
Week 242 >50% decrease (n=13,18) 92.3 88.9
Week 242 >75% decrease (n=13,18) 76.9 77.8
Week 242 >90% decrease (n=13,18) 69.2 72.2
Week 244 >20% decrease (n=13,18) 100.0 94.4
Week 244 >50% decrease (n=13,18) 92.3 88.9
Week 244 >75% decrease (n=13,18) 76.9 77.8
Week 244 >90% decrease (n=13,18) 69.2 72.2
Week 246 >20% decrease (n=13,18) 100.0 94.4
Week 246 >50% decrease (n=13,18) 92.3 88.9
Week 246 >75% decrease (n=13,18) 76.9 77.8
Week 246 >90% decrease (n=13,18) 69.2 72.2
Week 248 >20% decrease (n=13,18) 100.0 94.4
Week 248 >50% decrease (n=13,18) 92.3 88.9
Week 248 >75% decrease (n=13,18) 76.9 77.8
Week 248 >90% decrease (n=13,18) 69.2 72.2
Week 250 >20% decrease (n=13,18) 100.0 94.4
Week 250 >50% decrease (n=13,18) 92.3 83.3
Week 250 >75% decrease (n=13,18) 76.9 77.8
Week 250 >90% decrease (n=13,18) 69.2 72.2
Week 252 >20% decrease (n=13,18) 100.0 94.4
Week 252 >50% decrease (n=13,18) 92.3 83.3
Week 252 >75% decrease (n=13,18) 76.9 77.8
Week 252 >90% decrease (n=13,18) 69.2 72.2
Week 254 >20% decrease (n=13,18) 100.0 94.4
Week 254 >50% decrease (n=13,18) 92.3 83.3
Week 254 >75% decrease (n=13,18) 76.9 77.8
Week 254 >90% decrease (n=13,18) 69.2 72.2
Week 256 >20% decrease (n=13,18) 100.0 94.4
Week 256 >50% decrease (n=13,18) 92.3 83.3
Week 256 >75% decrease (n=13,18) 76.9 77.8
Week 256 >90% decrease (n=13,18) 69.2 72.2
Week 258 >20% decrease (n=13,18) 100.0 94.4
Week 258 >50% decrease (n=13,18) 92.3 83.3
Week 258 >75% decrease (n=13,18) 76.9 77.8
Week 258 >90% decrease (n=13,18) 69.2 72.2
Week 260 >20% decrease (n=13,18) 100.0 94.4
Week 260 >50% decrease (n=13,18) 92.3 88.9
Week 260 >75% decrease (n=13,18) 76.9 77.8
Week 260 >90% decrease (n=13,18) 69.2 72.2
29.Secondary Outcome
Title Part III: Percentage of Participants With Inactive Disease
Hide Description

Participants who previously withdrew are excluded.

Responders are participants who met all of the following criteria for inactive disease at the visit assessment day:

i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.

iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA.

v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex. vi. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS.

Data presented up to the point of entry into the Alternative Dosing Schedule.

Time Frame Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 42 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 104 (n=42,47) 45.2 46.8
Week 116 (n=41,46) 48.8 43.5
Week 128 (n=40,43) 55.0 48.8
Week 140 (n=38,40) 55.3 45.0
Week 152 (n=27,35) 33.3 54.3
Week 164 (n=27,25) 37.0 28.0
Week 176 (n=24,22) 41.7 36.4
Week 188 (n=21,22) 23.8 31.8
Week 200 (n=19,21) 42.1 14.3
Week 212 (n=18,18 55.6 44.4
Week 224 (n=17,18) 47.1 44.4
Week 236 (n=16,17) 43.8 29.4
Week 248 (n=15,17) 26.7 41.2
Week 260 (n=15,15) 46.7 6.7
30.Secondary Outcome
Title Part III: Percentage of Participants in Clinical Remission
Hide Description

Patients who previously withdrew are excluded Responders are patients who met all of the following criteria for inactive disease at all visits in the 6 months (180 days) prior to and including the visit assessment day: i. Number of active joints = 0. ii. Absence of lymphadenopathy, hepatomegaly or splenomegaly in the nearest non-missing physical examination prior to or after the week assessment day. This could include results outside of the time window.

iii. Absence of symptomatic serositis adverse event. iv. In the 14 days preceding the week assessment day no fever (temperature >=37.5 C) or rash characteristic of sJIA. v. Normal ESR as defined by an ESR <20 mm/hr regardless of age and sex.

vi. iv. Physician global assessment VAS <=10. LOCF rule applied to missing number of active joints, ESR and Physician global assessment VAS. ESR = Erythrocyte Sedimentation Rate. VAS = Visual Analogue Scale. Data presented up to the point of entry into the Alternative Dosing Schedule.

Time Frame Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 41 47
Measure Type: Number
Unit of Measure: percentage of participants
Week 116 (n=41,47) 14.6 17.4
Week 128 (n=40,43) 32.5 23.3
Week 140 (n=38,40) 34.2 25.0
Week 152 (n=27,35) 25.9 25.7
Week 164 (n=27,25) 22.2 16.0
Week 176 (n=24,22) 16.7 13.6
Week 188 (n=21,22) 14.3 9.1
Week 200 (n=19,21) 15.8 4.8
Week 212 (n=18,18) 16.7 5.6
Week 224 (n=17,18) 29.4 11.1
Week 236 (n=16,17) 25.0 29.4
Week 248 (n=15,17) 13.3 23.5
Week 260 (n=15,15) 13.3 6.7
31.Secondary Outcome
Title Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Hide Description

There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:

Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day

Time Frame Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 41 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 116 (n=41,46) 12.2 17.4
Week 128 (n=40,43) 32.5 20.9
Week 140 (n=38,40) 28.9 20.0
Week 152 (n=27,35) 18.5 20.0
Week 164 (n=27,25) 18.5 12.0
Week 176 (n=24,22) 16.7 9.1
Week 188 (n=21,22) 14.3 4.5
Week 200 (n=19,21) 10.5 4.8
Week 212 (n=18,18) 11.1 5.6
Week 224 (n=17,18) 23.5 11.1
Week 236 (n=16,17) 25.0 23.5
Week 248 (n=15,17) 6.7 17.6
Week 260 (n=15,15) 6.7 6.7
32.Secondary Outcome
Title Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Hide Description

There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:

Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day

Time Frame Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 41 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 116 (n=41,46) 7.3 8.7
Week 128 (n=40,43) 20.0 11.6
Week 140 (n=38,40) 18.4 5.0
Week 152 (n=27,35) 3.7 2.9
Week 164 (n=27,25) 3.7 4.0
Week 176 (n=24,22) 4.2 0.0
Week 188 (n=21,22) 4.8 0.0
Week 200 (n=19,21) 5.3 4.8
Week 212 (n=18,18) 5.6 5.6
Week 224 (n=17,18) 5.9 5.6
Week 236 (n=16,17) 12.5 5.9
Week 248 (n=15,17) 0.0 5.9
Week 260 (n=15,15) 0.0 0.0
33.Secondary Outcome
Title Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Hide Description

There were 4 levels of clinical remission defined while the patient remained on tocilizumab as defined below.. After level 1, each successive level required that all the previous level criteria be met:

Level 1: inactive disease criteria have been met at all assessments in the last 6 months (180 days) preceding the timepoint assessment day Level 2: level 1 criteria and no oral corticosteroids received in the last 6 months (180 days) preceding the timepoint assessment day Level 3: level 2 criteria and no methotrexate received in the last 6 months (180 days) preceding the timepoint assessment day Level 4: level 3 criteria and no NSAIDs received for sJIA in the last 6 months (180 days) preceding the timepoint assessment day

Time Frame Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 41 46
Measure Type: Number
Unit of Measure: percentage of participants
Week 116 (n=41,46) 4.9 8.7
Week 128 (n=40,43) 15.0 9.3
Week 140 (n=38,40) 15.8 5.0
Week 152 (n=27,35) 0.0 2.9
Week 164 (n=27,25) 0.0 0.0
Week 176 (n=24,22) 4.2 0.0
Week 188 (n=21,22) 4.8 0.0
Week 200 (n=19,21) 5.3 0.0
Week 212 (n=18,18) 5.6 0.0
Week 224 (n=17,18) 5.9 0.0
Week 236 (n=16,17) 12.5 0.0
Week 248 (n=15,17) 0.0 0.0
Week 260 (n=15,15) 0.0 0.0
34.Secondary Outcome
Title Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260
Hide Description Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.
Time Frame Every 2 weeks from Week 104 to 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
35.Secondary Outcome
Title Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.
Hide Description Human antibodies against human antibodies (HAHA), anti-tocilizumab antibodies were assessed by immunogenicity techniques from blood samples drawn every two weeks during Part III of the study.
Time Frame Every 2 weeks from Week 104 to 260
Hide Outcome Measure Data
Hide Analysis Population Description
ITT3 population; n=number of participants contributing to the specific statistic
Arm/Group Title Participants ≥30 kg Participants <30 kg
Hide Arm/Group Description:

Tocilizumab 8 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Tocilizumab 12 mg/kg iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Overall Number of Participants Analyzed 45 47
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
Time Frame AE onset between time of very first drug intake and date of last contact or 30 days after very last drug intake. 30 days after 12 weeks of treatment in Part I, 30 days after up to Week 104 in Part II and 30 days after up to Week 260 in Part III .
Adverse Event Reporting Description Note: Adverse Events (AEs) reported in the All Tocilizumab (Part I, Part II and Part III) arm are cumulative to Week 260 and include AEs previously reported in the Tocilizumab_8 mg/kg (Part I) and Tocilizumab_12 mg/kg (Part I) arms that occurred in the 12 week treatment period.
 
Arm/Group Title All Tocilizumab (Part I, Part II and Part III)
Hide Arm/Group Description Tocilizumab either 8 mg/kg (participants ≥ 30 kg) or 12 mg/kg (participants <30 kg) iv every 2 weeks for 12 weeks in Part I, every 2 weeks for 92 weeks in Part II and every 2 weeks for 156 weeks in Part III.
All-Cause Mortality
All Tocilizumab (Part I, Part II and Part III)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Tocilizumab (Part I, Part II and Part III)
Affected / at Risk (%)
Total   48/112 (42.86%) 
Blood and lymphatic system disorders   
Histiocytosis haematophagic * 1  5/112 (4.46%) 
Lymphadenitis  2  1/112 (0.89%) 
Cardiac disorders   
Cardiac failure * 1  1/112 (0.89%) 
Gastrointestinal disorders   
Abdominal pain  2  1/112 (0.89%) 
Constipation * 1  1/112 (0.89%) 
Diarrhoea  2  1/112 (0.89%) 
Gastritis * 1  1/112 (0.89%) 
Vomiting  2  1/112 (0.89%) 
General disorders   
Drug intolerance  2  1/112 (0.89%) 
Influenza like illness * 1  1/112 (0.89%) 
Hepatobiliary disorders   
Hypertransaminasaemia * 1  1/112 (0.89%) 
Immune system disorders   
Anaphylactic reaction  2  1/112 (0.89%) 
Infections and infestations   
Arthritis bacterial * 3  1/112 (0.89%) 
Bronchopneumonia * 1  1/112 (0.89%) 
Cellulitis * 1  1/112 (0.89%) 
Device related sepsis  2  1/112 (0.89%) 
Gastroenteritis * 1  5/112 (4.46%) 
Gastroenteritis viral * 1  1/112 (0.89%) 
Herpes zoster * 1  3/112 (2.68%) 
Kidney infection * 1  1/112 (0.89%) 
Lower respiratory tract infection  2  2/112 (1.79%) 
Otitis media * 1  1/112 (0.89%) 
Pharyngitis  2  1/112 (0.89%) 
Pharyngotonsillitis * 1  1/112 (0.89%) 
Pneumonia * 1  5/112 (4.46%) 
Pulmonary tuberculosis  2  1/112 (0.89%) 
Sepsis * 1  2/112 (1.79%) 
Tonsillitis * 1  1/112 (0.89%) 
Upper respiratory tract infection * 1  1/112 (0.89%) 
Varicella * 3  5/112 (4.46%) 
Injury, poisoning and procedural complications   
Femur fracture * 1  1/112 (0.89%) 
Forearm fracture * 1  1/112 (0.89%) 
Fracture * 1  1/112 (0.89%) 
Joint dislocation * 1  1/112 (0.89%) 
Road traffic accident * 1  1/112 (0.89%) 
Spinal fracture  2  1/112 (0.89%) 
Tendon rupture  2  1/112 (0.89%) 
Ulna fracture * 1  1/112 (0.89%) 
Investigations   
Liver function test abnormal * 1  1/112 (0.89%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/112 (0.89%) 
Hyperkalaemia  2  1/112 (0.89%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/112 (0.89%) 
Arthritis * 1  1/112 (0.89%) 
Juvenile idiopathic arthritis * 1  1/112 (0.89%) 
Pain in extremity * 1  1/112 (0.89%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute Lymphocytic leukaemia  2  1/112 (0.89%) 
Pregnancy, puerperium and perinatal conditions   
Pregnancy  2  1/112 (0.89%) 
Psychiatric disorders   
Abnormal behaviour * 1  1/112 (0.89%) 
Self injurious behavior  2  1/112 (0.89%) 
Reproductive system and breast disorders   
Testicular torsion * 1  1/112 (0.89%) 
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  1/112 (0.89%) 
Pulmonary veno-occlusive disease * 1  1/112 (0.89%) 
Skin and subcutaneous tissue disorders   
Angioedema * 3  1/112 (0.89%) 
Panniculitis * 1  1/112 (0.89%) 
Urticaria * 3  1/112 (0.89%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (17.0)
2
Term from vocabulary, MedDRA (14.0)
3
Term from vocabulary, MedDRA (12.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.68%
All Tocilizumab (Part I, Part II and Part III)
Affected / at Risk (%)
Total   112/112 (100.00%) 
Blood and lymphatic system disorders   
Neutropenia * 1  25/112 (22.32%) 
Leukopenia * 3  11/112 (9.82%) 
Lymphadenopathy  2  6/112 (5.36%) 
Lymphadenitis  2  4/112 (3.57%) 
Ear and labyrinth disorders   
Ear pain  2  11/112 (9.82%) 
Middle ear effusion * 3  4/112 (3.57%) 
Eye disorders   
Cataract  2  4/112 (3.57%) 
Chalazion * 3  3/112 (2.68%) 
Gastrointestinal disorders   
Diarrhoea * 1  29/112 (25.89%) 
Vomiting * 1  29/112 (25.89%) 
Abdominal pain * 1  16/112 (14.29%) 
Gastrointestinal disorder * 1  6/112 (5.36%) 
Nausea * 3  26/112 (23.21%) 
Abdominal pain upper * 3  15/112 (13.39%) 
Dental Caries * 3  6/112 (5.36%) 
Abdominal discomfort  2  3/112 (2.68%) 
General disorders   
Pyrexia * 1  11/112 (9.82%) 
Influenza like illness * 1  10/112 (8.93%) 
Fatigue * 3  6/112 (5.36%) 
Local swelling  2  5/112 (4.46%) 
Pain  2  4/112 (3.57%) 
Infections and infestations   
Upper Respiratory Tract Infection * 1  49/112 (43.75%) 
Nasopharyngitis * 1  53/112 (47.32%) 
Gastroenteritis viral * 1  9/112 (8.04%) 
Pharyngitis * 1  20/112 (17.86%) 
Gastroenteritis * 2  28/112 (25.00%) 
Ear infection * 2  18/112 (16.07%) 
Rhinitis * 3  19/112 (16.96%) 
Impetigo * 2  14/112 (12.50%) 
Viral infection * 2  16/112 (14.29%) 
Otitis media * 2  14/112 (12.50%) 
Viral upper respiratory tract infection * 3  12/112 (10.71%) 
Bronchitis * 3  11/112 (9.82%) 
Otitis externa * 3  8/112 (7.14%) 
Tonsillitis * 3  9/112 (8.04%) 
Urinary tract infection * 3  10/112 (8.93%) 
Conjunctivitis * 3  12/112 (10.71%) 
Sinusitis * 3  10/112 (8.93%) 
Influenza * 3  9/112 (8.04%) 
Paronychia * 3  7/112 (6.25%) 
Herpes Zoster * 3  6/112 (5.36%) 
Laryngitis * 3  6/112 (5.36%) 
Cellulitis  2  5/112 (4.46%) 
Skin infection  2  5/112 (4.46%) 
Tinea pedis * 3  5/112 (4.46%) 
Varicella  2  4/112 (3.57%) 
Otitis media acute * 3  3/112 (2.68%) 
Pneumonia * 3  3/112 (2.68%) 
Injury, poisoning and procedural complications   
Contusion * 3  10/112 (8.93%) 
Excoriation * 3  8/112 (7.14%) 
Joint injury * 3  7/112 (6.25%) 
Traumatic haematoma * 3  7/112 (6.25%) 
Ligament Sprain  2  13/112 (11.61%) 
Limb Injury * 3  8/112 (7.14%) 
Fall * 3  7/112 (6.25%) 
Wound * 3  6/112 (5.36%) 
Arthropod bite  2  17/112 (15.18%) 
Hand fracture  2  5/112 (4.46%) 
Laceration * 3  5/112 (4.46%) 
Infusion related reaction  2  4/112 (3.57%) 
Muscle strain * 3  4/112 (3.57%) 
Thermal burn  2  4/112 (3.57%) 
Investigations   
Transaminases increased * 3  11/112 (9.82%) 
Neutrophil count decreased  2  5/112 (4.46%) 
Platelet count decreased * 3  5/112 (4.46%) 
Alanine aminotransferase increased * 3  4/112 (3.57%) 
Musculoskeletal and connective tissue disorders   
Juvenile idiopathic arthritis * 1  31/112 (27.68%) 
Back pain * 1  12/112 (10.71%) 
Arthralgia * 3  25/112 (22.32%) 
Musculoskeletal pain * 3  11/112 (9.82%) 
Pain in extremity * 3  12/112 (10.71%) 
Neck pain * 3  9/112 (8.04%) 
Joint Swelling  2  7/112 (6.25%) 
Arthritis  2  5/112 (4.46%) 
Musculoskeletal stiffness  2  4/112 (3.57%) 
Osteoporosis  2  3/112 (2.68%) 
Nervous system disorders   
Headache * 1  25/112 (22.32%) 
Dizziness * 1  6/112 (5.36%) 
Migraine  2  3/112 (2.68%) 
Renal and urinary disorders   
Haematuria * 1  5/112 (4.46%) 
Reproductive system and breast disorders   
Dysmenorrhoea * 1  3/112 (2.68%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain * 1  24/112 (21.43%) 
Cough * 1  45/112 (40.18%) 
Epistaxis * 3  9/112 (8.04%) 
Nasal congestion * 3  10/112 (8.93%) 
Rhinorrhoea  2  7/112 (6.25%) 
Skin and subcutaneous tissue disorders   
Urticaria * 1  8/112 (7.14%) 
Rash * 3  22/112 (19.64%) 
Eczema * 3  10/112 (8.93%) 
Prurigo * 3  8/112 (7.14%) 
Dry skin  2  5/112 (4.46%) 
Pruritus  2  4/112 (3.57%) 
Dermatitis atopic  2  3/112 (2.68%) 
Dermatitis contact * 3  3/112 (2.68%) 
Erythema  2  3/112 (2.68%) 
Vascular disorders   
Haematoma * 3  7/112 (6.25%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.0)
2
Term from vocabulary, MedDRA (14.0)
3
Term from vocabulary, MedDRA (17.0)

This study consists of 3 parts:

Part I: a 12 week double-blind placebo controlled study is complete. Part II: a 92 week single arm open-label extension study- CSR completed Dec. 2011.

Part III: a 3 year open label continuation study is ongoing.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642460    
Other Study ID Numbers: WA18221
2007-000872-18
First Submitted: March 19, 2008
First Posted: March 25, 2008
Results First Submitted: September 16, 2011
Results First Posted: October 26, 2011
Last Update Posted: July 25, 2016