An Open-label, Ascending, Repeated Dose-finding Study of... | NCT02776735

ID	Type	Description	Link
U1111-1177-3487	Registry Identifier	ICTRP
2015-003999-79	EudraCT Number

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Sarilumab	Experimental	Participants received one of three ascending dose regimens of sarilumab by subcutaneous (SC) injection based on body weight. All the participants received the selected dose regimen once this was identified. Sarilumab was given during 12-week core treatment phase followed by an extension treatment phase (144 weeks for 73 participants enrolled in dose-finding and second portions and 84 weeks for approximately 29 participants enrolled in third portion)	Drug: Sarilumab

Name	Type	Description	Arm Group Labels	Other Names
Sarilumab	Drug	Pharmaceutical form:Solution Route of administration: Subcutaneous	Sarilumab

Measure	Description	Time Frame
Maximum Serum Concentration (Cmax) of Sarilumab at Week 12	The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.	Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12
Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12	The AUC0-t was defined as area under the concentration in serum versus time curve calculated using the trapezoidal method during a dose interval (tau). The values reported are mean and standard deviation.	Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12
Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12	The Ctrough was defined as concentration observed before treatment administration during repeated dosing from baseline to Week 12. The values reported are mean and standard deviation.	Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

Measure	Description	Time Frame
Cohorts 1 and 3: Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) at Week 12	Serum concentrations of hs-CRP was determined to assess the Pharmacodynamic (PD) effects of sarilumab. The values reported are mean and standard deviation.	Baseline (Day 1) and Week 12
Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156

Name	Affiliation	Role
Clinical Sciences & Operations	Sanofi	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Los Angeles Site Number : 8400416		Los Angeles	California	90027	United States

PubMed Identifier	Type	Citation	Retractions
41235938	Derived	De Benedetti F, Penades IC, Nikishina I, Foeldvari I, Spindler AJ, Kozlova A, Rubio-Perez N, Quartier P, Zuber Z, Barria R, Clemente D, Cornejo GV, Marzan K, Liu N, Xu C, DiMartino S, Giannelou A, Cao-Ghoul F, Akinlade B, Baret-Cormel L. Sarilumab in Polyarticular-Course Juvenile Idiopathic Arthritis: Dose-Finding and 1-Year Analysis of a Phase 2b, Open-Label, Multicenter Study. Arthritis Care Res (Hoboken). 2026 Jun;78(6):749-760. doi: 10.1002/acr.25692. Epub 2026 Mar 24.

ID	Title	Description
FG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kilograms (kg) and <= 60 kg received sarilumab 2 mg/kg subcutaneous (SC) injection once every other week (q2w) for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 12, 2019	Jul 3, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Serum Concentration (Cmax) of Sarilumab at Week 12

The Cmax was defined as maximum serum concentration. The values reported are mean and standard deviation.

The Pharmacokinetic (PK) analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.

Posted

Mean

Standard Deviation

milligram per liter (mg/L)

Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG002	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG003	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG004	Cohort 3: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
OG005	Cohort 3: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).

Units	Counts
Participants	OG0003 OG0015 OG00238 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007.57± 4.14 OG00113.7± 2.52 OG00222.0± 8.07 OG003

Primary

Area Under the Serum Concentration Versus Time Curve Using the Trapezoidal Method During a Dose Interval (AUC0-t) of Sarilumab at Week 12

The AUC0-t was defined as area under the concentration in serum versus time curve calculated using the trapezoidal method during a dose interval (tau). The values reported are mean and standard deviation.

The PK analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.

Posted

Mean

Standard Deviation

day*mg/L

Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Primary

Concentration Before Treatment Administration During Repeated Dosing (Ctrough) of Sarilumab at Week 12

The Ctrough was defined as concentration observed before treatment administration during repeated dosing from baseline to Week 12. The values reported are mean and standard deviation.

The PK analysis set included all participants in the safety population with at least 1 post-dose, non-missing serum concentration value. Only participants with data collected are reported.

Posted

Mean

Standard Deviation

mg/L

Pre-dose on Days 1, 3, 5, 8, 12 and Weeks 2, 4, 8 and 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in High-Sensitivity C-reactive Protein (Hs-CRP) at Week 12

Serum concentrations of hs-CRP was determined to assess the Pharmacodynamic (PD) effects of sarilumab. The values reported are mean and standard deviation.

All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Deviation

mg/L

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG002

Secondary

Cohort 2: Change From Baseline in High-Sensitivity C-reactive Protein at Weeks 12, 24, 48, 96, and 156

Serum concentrations of hs-CRP was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.

Posted

Mean

Standard Deviation

mg/L

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Change From Baseline in Interleukin-6 (IL-6) at Week 12

Serum concentrations of IL-6 was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

All treated population included participants who signed informed consent and received at least 1 dose of the study treatment. Only participants with data collected at Baseline and Week 12 are reported.

Posted

Mean

Standard Deviation

nanogram (ng)/L

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG002

Secondary

Change From Baseline in Total Soluble Interleukin-6 Receptor (sIL-6R) at Week 12

Serum concentrations of sIL-6R was determined to assess the PD effects of sarilumab. The values reported are mean and standard deviation.

Posted

Mean

Standard Deviation

ng/mL

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG002

Secondary

Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology (JIA ACR) 30 Response at Week 12

JIA ACR30 response was defined as a participant with at least 3 out of the 6 JIA core set variables with >= 30% improvement from baseline with no more than 1 of the remaining variables worsened by >= 30%.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

Posted

Number

percentage of participants with response

Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 30 Response at Weeks 12, 24, 48, 96, and 156

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Participants in Cohorts 1 and 3 only participated in portion 1 and then switched to Dose 2 after the dose is selected. Therefore, only Cohort 2 participants analyzed at baseline and specific time points are reported.

Posted

Number

percentage of participants with response

Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Week 12

JIA ACR50 response was defined as a participant with at least 3 out of the 6 JIA core set variables with >= 50% improvement from baseline with no more than 1 of the remaining variables worsened by >= 30%.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

Posted

Number

percentage of participants with response

Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 50 Response at Weeks 12, 24, 48, 96, and 156

Posted

Number

percentage of participants with response

Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Week 12

JIA ACR70 response was defined as a participant with at least 3 out of the 6 JIA core set variables with >= 70% improvement from baseline with no more than 1 of the remaining variables worsened by >= 30%.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

Posted

Number

percentage of participants with response

Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 70 Response at Weeks 12, 24, 48, 96, and 156

Posted

Number

percentage of participants with response

Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Week 12

JIA ACR90 response was defined as a participant with at least 3 out of the 6 JIA core set variables with >= 90% improvement from baseline with no more than 1 of the remaining variables worsened by >= 30%.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

Posted

Number

percentage of participants with response

Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 90 Response at Weeks 12, 24, 48, 96, and 156

Posted

Number

percentage of participants with response

Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Week 12

JIA ACR100 response was defined as a participant with at least 3 out of the 6 JIA core set variables with >= 100% improvement from baseline with no more than 1 of the remaining variables worsened by >= 30%.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at Week 12 are reported.

Posted

Number

percentage of participants with response

Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Percentage of Participants With Juvenile Idiopatic Arthritis American College of Rheumatology 100 Response at Weeks 12, 24, 48, 96, and 156

Posted

Number

percentage of participants with response

Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Week 12

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using visual analog scale (VAS), Childhood Health Questionnaire Disability Index (CHAQ-DI) and hs-CRP. Activity joint count-71 was calculated as sum (joints with active arthritis)*(71/number of joints with assessment).

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

joint

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Activity Joint Count-71, at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

joint

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Week 12

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

joint

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Limited Motion Joint Count, at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

joint

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Week 12

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total 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). Higher scores indicate worse outcome.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Childhood Health Assessment Questionnaire Disability Index, at Weeks 12, 24, 48, 96, and 156

The JIA ACR components included joints with active arthritis (0 to 71 joints), joints with limited motion (0 to 67 joints), physician global assessment of disease activity and participant/parent assessment of overall well-being using VAS, CHAQ-DI and hs-CRP. The CHAQ questionnaire consists of 30 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities. Each domain is scored on a 4 point scale ranges from 0 to 3: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). An additional response of "not applicable" is available to indicate activities the participant is unable to perform because he/she is too young. The CHAQ-DI total 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). Higher scores indicate worse outcome.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Week 12

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

mg/L

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, C-Reactive Protein, at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

mg/L

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Week 12

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Physician Global Assessment of Disease Activity, at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg

Secondary

Cohorts 1 and 3: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Week 12

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Change From Baseline in Juvenile Idiopatic Arthritis American College of Rheumatology Component, Participant/Parent Assessment of Overall Well-Being, at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
OG001	Cohort 2: < 30 kg and >= 10 kg

Secondary

Cohorts 1 and 3: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score (JADAS-27) at Week 12

The JADAS is used for assessment of disease activity, and it includes 4 measures: Physician global assessment of disease activity (VAS range: 0 to10; where 0= no activity and 10= maximum activity), parent/participant global assessment of well-being (VAS range: 0 to 10; where 0= no activity and10= maximum activity), count of joints with active disease (range: 0 to 27; where 0= no activity and 27= maximum activity), and index of inflammation determined by hs-CRP or ESR (normalized scale range: 0 to 10; where 0= no disease activity and 10= maximum disease activity). The JADAS total score is calculated as the simple sum of the scores of its 4 components. The total score ranges from 0 to 57 where 0= no disease activity and 57= maximum disease activity. Higher scores indicate higher disease activity. Clinical JADAS-27 is without CRP or ESR component and score ranges from 0 to 47 where 0= no disease activity and 47= maximum disease activity.

The efficacy analysis set included all participants who received at least 1 dose of sarilumab. Only participants analyzed at baseline and Week 12 are reported.

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Week 12

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Cohort 2: Mean Change From Baseline in Juvenile Arthritis Disease Activity Score at Weeks 12, 24, 48, 96, and 156

Posted

Mean

Standard Error

units on a scale

Baseline (Day 1) and Weeks 12, 24, 48, 96, and 156

ID	Title	Description
OG000	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)

An adverse events (AEs) is any untoward medical occurrence in a participant or in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. An SAE is any untoward medical occurrence that at any dose results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event. TEAEs are defined as AEs that develop or worsen during the on-treatment period [that is, from the time of first dose of study treatment up to 6 weeks after the last administration of the study treatment].

The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.

Posted

Count of Participants

Participants

From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Secondary

Number of Participants With Local Site Reactions

Participants were observed for at least 30 minutes after each study treatment administration either on site or at home and any local reactions were noted in the diary regardless of being clinically significant.

The Safety analysis set included all participants who received at least 1 dose or part of a dose of the study treatment, analyzed according to the treatment actually received.

Posted

Count of Participants

Participants

From the first administration of study treatment (Day 1) up to end of treatment period, maximum of 156 weeks for portions 1 and 2 and 96 weeks for portion 3

ID	Title	Description
OG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
OG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG0032 events1 affected6 at risk EG0041 events1 affected6 at risk EG0050 events0 affected6 at risk EG0064 events3 affected31 at risk EG0070 events0 affected5 at risk EG0080 events0 affected5 at risk EG0090 events0 affected9 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDra 26.1	Systematic Assessment	EG0003 events3 affected7 at risk EG00123 events10 affected42 at risk EG0021 events1 affected4 at risk EG003
Cardiovascular Disorder	Cardiac disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Keratitis	Eye disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Uveitis	Eye disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Aphthous Ulcer	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Constipation	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Dental Discomfort	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Mouth Ulceration	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0014 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Nausea	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Pulpless Tooth	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Vomiting	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Administration Site Erythema	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Fatigue	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Gait Disturbance	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Injection Site Erythema	General disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG00120 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Injection Site Haemorrhage	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Injection Site Pruritus	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Injection Site Reaction	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Injection Site Urticaria	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Malaise	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pyrexia	General disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Allergy To Arthropod Bite	Immune system disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Acute Sinusitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Bronchitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Covid-19	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Cellulitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Conjunctivitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Conjunctivitis Bacterial	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Cystitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0004 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Dengue Fever	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Ear Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Eczema Impetiginous	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Escherichia Urinary Tract Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0022 events1 affected4 at risk EG003
Gastritis Viral	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Gastroenteritis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0015 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Gastrointestinal Bacterial Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Gastrointestinal Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Groin Abscess	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Impetigo	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Infected Bite	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Infectious Mononucleosis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Influenza	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Laryngitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Molluscum Contagiosum	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Nasopharyngitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG00121 events11 affected42 at risk EG0020 events0 affected4 at risk EG003
Oral Candidiasis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Oral Herpes	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0014 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Otitis Externa	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Otitis Media	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Otitis Media Acute	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Paronychia	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Pharyngitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0016 events6 affected42 at risk EG0020 events0 affected4 at risk EG003
Pharyngitis Bacterial	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pneumonia	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pyelonephritis Acute	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Respiratory Syncytial Virus Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Rhinitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0002 events2 affected7 at risk EG0017 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Scarlet Fever	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Sinobronchitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Sinusitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Tinea Pedis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Tonsillitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0012 events2 affected42 at risk EG0021 events1 affected4 at risk EG003
Tracheitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG00010 events4 affected7 at risk EG00110 events6 affected42 at risk EG0025 events3 affected4 at risk EG003
Upper Respiratory Tract Infection Bacterial	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Varicella	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Viral Pharyngitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0002 events1 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Accidental Overdose	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0015 events4 affected42 at risk EG0020 events0 affected4 at risk EG003
Arthropod Bite	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0014 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Hand Fracture	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Ligament Sprain	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0014 events2 affected42 at risk EG0022 events2 affected4 at risk EG003
Thermal Burn	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Traumatic Haematoma	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0016 events5 affected42 at risk EG0020 events0 affected4 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Blood Bilirubin Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Blood Pressure Systolic Decreased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Eosinophil Count Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Lymphocyte Count Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Mean Cell Volume Decreased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Monocyte Count Decreased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Monocyte Count Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Neutrophil Count Decreased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0012 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Transaminases Increased	Investigations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0013 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Juvenile Idiopathic Arthritis	Musculoskeletal and connective tissue disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0013 events3 affected42 at risk EG0020 events0 affected4 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Dizziness	Nervous system disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Headache	Nervous system disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Affective Disorder	Psychiatric disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Major Depression	Psychiatric disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0014 events2 affected42 at risk EG0020 events0 affected4 at risk EG003
Increased Bronchial Secretion	Respiratory, thoracic and mediastinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Ingrowing Nail	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Pityriasis Alba	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Rash Papular	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0021 events1 affected4 at risk EG003
Skin Reaction	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Urticaria Chronic	Skin and subcutaneous tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Essential Hypertension	Vascular disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
BG001	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection q2w until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection q2w in extension phase (portion 1: up to 144 weeks in extension phase).
BG002	Cohort 2: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 3 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
BG003	Cohort 2: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants continued to receive 4 mg/kg SC injection q2w in extension phase (portions 1 and 2: up to 144 weeks in extension phase and portion 3: up to 84 weeks in extension phase).
BG004	Cohort 3: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 3 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
BG005	Cohort 3: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants continued to receive 2.5 mg/kg SC injection qw until the selected dose was found and then switched to selected dose of 4 mg/kg SC injection qw in extension phase (portion 1: up to 144 weeks in extension phase).
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	7	2	7	7	7
EG001	Cohort 2 (From Baseline): >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w during the entire treatment period.	42	3	42	39	42
EG002	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	4	0	4	4	4
EG003	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 3 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	6	0	6	5	6
EG004	Cohort 3: >= 30 kg and <= 60 kg	Participants with body weight >= 30 kg and <= 60 kg received sarilumab 2 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	6	0	6	5	6
EG005	Cohort 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection q2w for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	6	0	6	6	6
EG006	Cohort 2 (From Baseline): < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w during the entire treatment period.	31	3	31	29	31
EG007	Cohort 1 Portion 1, Post Dose-adjustment From Dose 1: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 1 to selected Dose 2.	5	0	5	5	5
EG008	Cohort 3 Portion 1, Post Dose-adjustment From Dose 3: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 4 mg/kg SC injection q2w after switched from Dose/Cohort 3 to selected Dose 2.	5	0	5	5	5
EG009	Cohort 3: < 30 kg and >= 10 kg	Participants with body weight < 30 kg and >= 10 kg received sarilumab 2.5 mg/kg SC injection qw for 12 weeks in core treatment phase. Eligible participants entered extension phase (up to 144 weeks) and continued to receive 2 mg/kg SC injection q2w until the selected dose 2 (3 mg/kg) was defined.	9	0	9	9	9

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Inguinal Hernia	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG0030 events0 affected6 at risk EG0040 events0 affected6 at risk EG0050 events0 affected6 at risk EG0061 events1 affected31 at risk EG0070 events0 affected5 at risk EG0080 events0 affected5 at risk EG0090 events0 affected9 at risk
Pancreatic Pseudocyst	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Acute Sinusitis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Bone Tuberculosis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Infectious Mononucleosis	Infections and infestations	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Ligament Rupture	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Meniscus Injury	Injury, poisoning and procedural complications	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Juvenile Idiopathic Arthritis	Musculoskeletal and connective tissue disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected42 at risk EG0020 events0 affected4 at risk EG003
Syncope	Nervous system disorders	MedDra 26.1	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDra 26.1	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected42 at risk EG0020 events0 affected4 at risk EG003