## Protocol Section
### Identification Module
**NCT ID:** NCT01904279

**Acronym:** JIGSAW 117

**Brief Title:** A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)

**Official Title:** A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis

#### Organization Study ID Info
**ID:** WA28117
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2012-003486-18
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-06-14

**Type:** ACTUAL

**Last Update Submit Date:** 2017-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-03-16

**Type:** ACTUAL

**Results First Submit Date:** 2017-01-24

**Results First Submit QC Date:** 2017-01-24

#### Start Date
**Date:** 2013-07

**Status Verified Date:** 2017-05

#### Study First Post Date
**Date:** 2013-07-22
**Type:** ESTIMATED
**Study First Submit Date:** 2013-06-14
**Study First Submit QC Date:** 2013-07-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

### Conditions Module

**Conditions:**

- Juvenile Idiopathic Arthritis

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants with body weight less than (\<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.

**Intervention Names:**

- Drug: Tocilizumab

**Label:** TCZ SC 162 mg Q3W

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants with body weight greater than or equal to (\>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.

**Intervention Names:**

- Drug: Tocilizumab

**Label:** TCZ SC 162 mg Q2W

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TCZ SC 162 mg Q2W

- TCZ SC 162 mg Q3W

**Description:** Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks

**Name:** Tocilizumab

**Other Names:**

- RoActemra/Actemra

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.

**Measure:** Minimum Serum Concentration (Cmin) of TCZ at Steady State

**Time Frame:** Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.

**Measure:** Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment

**Time Frame:** Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.

**Measure:** Maximum Serum Concentration (Cmax) of TCZ at Steady State

**Time Frame:** Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

#### Secondary Outcomes

**Description:** IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.

**Measure:** Change From Baseline in Serum Interleukin-6 (IL-6) Levels

**Time Frame:** Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52

**Measure:** Change From Baseline in Soluble IL-6 Receptor Levels

**Time Frame:** Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52

**Measure:** Change From Baseline in C-Reactive Protein (CRP) Levels

**Time Frame:** Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52

**Description:** The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.

**Measure:** Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

**Time Frame:** Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52

**Measure:** Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential

**Time Frame:** Baseline up to Week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
* Diagnosis of pJIA according to International League of Associations for Rheumatology classification
* Rheumatoid factor (RF)-positive pJIA
* RF-negative pJIA
* Extended oligoarticular JIA with a polyarticular course
* History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
* Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
* Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator
* Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

* Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
* Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
* pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 \[JADAS-71\] less than or equal to (\< / =) 3.8)
* Participants who are wheelchair-bound or bedridden
* Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
* Lack of recovery from recent surgery or an interval of \<6 weeks since surgery at the time of the screening visit
* Females who are pregnant, lactating, or intending to become pregnant during study conduct
* Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
* Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
* History of alcohol, drug, or chemical abuse within 6 months of screening
* Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
* History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
* Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
* History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
* Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
* History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
* History of or current cancer or lymphoma
* Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
* Active uveitis at screening
* Inadequate hematologic, renal or liver function
* Prior stem cell transplant at any time

**Maximum Age:** 17 Years

**Minimum Age:** 1 Year

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hartford

**Country:** United States

**State:** Connecticut

**Zip:** 06106

**Location 2:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Zip:** 60611

**Location 3:**

**City:** Chicago

**Country:** United States

**State:** Illinois

**Zip:** 60637

**Location 4:**

**City:** Hackensack

**Country:** United States

**State:** New Jersey

**Zip:** 07601

**Location 5:**

**City:** Charlotte

**Country:** United States

**State:** North Carolina

**Zip:** 28203

**Location 6:**

**City:** Durham

**Country:** United States

**State:** North Carolina

**Zip:** 27710

**Location 7:**

**City:** Cincinnati

**Country:** United States

**State:** Ohio

**Zip:** 45229-3039

**Location 8:**

**City:** Tulsa

**Country:** United States

**State:** Oklahoma

**Zip:** 74135

**Location 9:**

**City:** Salt Lake City

**Country:** United States

**State:** Utah

**Zip:** 84109

**Location 10:**

**City:** Seattle

**Country:** United States

**State:** Washington

**Zip:** 98105

**Location 11:**

**City:** Buenos Aires

**Country:** Argentina

**Zip:** 1270

**Location 12:**

**City:** Westmead

**Country:** Australia

**State:** New South Wales

**Zip:** 2145

**Location 13:**

**City:** Parkville

**Country:** Australia

**State:** Victoria

**Zip:** 3052

**Location 14:**

**City:** Rio de Janeiro

**Country:** Brazil

**State:** RJ

**Zip:** 20551-030

**Location 15:**

**City:** Rio de Janeiro

**Country:** Brazil

**State:** RJ

**Zip:** 21941-912

**Location 16:**

**City:** Sao Paulo

**Country:** Brazil

**State:** SP

**Zip:** 05403-000

**Location 17:**

**City:** Sao Paulo

**Country:** Brazil

**State:** SP

**Zip:** 22793-080

**Location 18:**

**City:** Calgary

**Country:** Canada

**State:** Alberta

**Zip:** T3B 6A8

**Location 19:**

**City:** Ottawa

**Country:** Canada

**State:** Ontario

**Zip:** K1H 8L1

**Location 20:**

**City:** Toronto

**Country:** Canada

**State:** Ontario

**Zip:** M5G 1X8

**Location 21:**

**City:** Le Kremlin Bicêtre

**Country:** France

**Zip:** 94275

**Location 22:**

**City:** Berlin

**Country:** Germany

**Zip:** 13353

**Location 23:**

**City:** Freiburg

**Country:** Germany

**Zip:** 79106

**Location 24:**

**City:** Sankt Augustin

**Country:** Germany

**Zip:** 53757

**Location 25:**

**City:** Roma

**Country:** Italy

**State:** Lazio

**Zip:** 00165

**Location 26:**

**City:** Genova

**Country:** Italy

**State:** Liguria

**Zip:** 16147

**Location 27:**

**City:** Firenze

**Country:** Italy

**State:** Toscana

**Zip:** 50139

**Location 28:**

**City:** Monterrey

**Country:** Mexico

**Zip:** 64460

**Location 29:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 115522

**Location 30:**

**City:** Moscow

**Country:** Russian Federation

**Zip:** 119991

**Location 31:**

**City:** Esplugas de Llobregat

**Country:** Spain

**State:** Barcelona

**Zip:** 08950

**Location 32:**

**City:** Madrid

**Country:** Spain

**Zip:** 28034

**Location 33:**

**City:** Madrid

**Country:** Spain

**Zip:** 28046

**Location 34:**

**City:** Bristol

**Country:** United Kingdom

**Zip:** BS2 8BJ

**Location 35:**

**City:** Liverpool

**Country:** United Kingdom

**Zip:** L12 2AP

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.

**PMID:** 33506875

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000003240

- Term: Connective Tissue Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M4479

- Name: Arthritis, Juvenile

- Relevance: HIGH

- As Found: Juvenile Idiopathic Arthritis

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6464

- Name: Connective Tissue Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

- ID: D000001171

- Term: Arthritis, Juvenile

### Misc Info Module

#### Removed Countries

- Country: Peru

- Country: Poland

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Safety population

#### Event Groups

**Group ID:** EG000

**Title:** TCZ SC 162 mg Q3W

**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.

**ID:** EG000

**Other Num Affected:** 23

**Other Num at Risk:** 27

**Serious Number Affected:** 1

**Serious Number At Risk:** 27

**Title:** TCZ SC 162 mg Q3W

**Group ID:** EG001

**Title:** TCZ SC 162 mg Q2W

**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.

**ID:** EG001

**Other Num Affected:** 22

**Other Num at Risk:** 25

**Serious Number Affected:** 2

**Serious Number At Risk:** 25

**Title:** TCZ SC 162 mg Q2W

**Frequency Threshold:** 5

#### Other Events

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Ear Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Abdominal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Aphthous Ulcer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection Site Erythema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection Site Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection Site Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection Site Pruritus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Injection Site Swelling

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Vessel Puncture Site Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Bronchitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Ear Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Gastroenteritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Impetigo

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Influenza

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Nasophryngitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Otitis Media

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Paronychia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Rhinitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Upper Respiratory Tract Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Viral Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Alanine Aminotransferase Increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (19.0)

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Back Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Joint Swelling

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Juvenile Idiopathic Arthritis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Neck Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Pain in extremity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Skin Papilloma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (19.0)

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Cough

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Epistaxis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Oropharyngeal Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Alopecia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Dermatitis Atopic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Eczema

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Rash

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (19.0)

**Term:** Haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (19.0)

#### Serious Events

**Term:** Arthralgia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 27

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 25

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 27

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 25

**Term:** Croup infectious

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 27

**Group ID:** EG001

**Num At Risk:** 25

**Term:** Varicella

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (19.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 27

**Group ID:** EG001

**Num At Risk:** 25

**Time Frame:** Baseline up to Week 56

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 27

**Group ID:** BG001

**Value:** 25

**Group ID:** BG002

**Value:** 52

**Units:** Participants

### Group

**ID:** BG000

**Title:** TCZ SC 162 mg Q3W

**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.

### Group

**ID:** BG001

**Title:** TCZ SC 162 mg Q2W

**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.1

**Value:** 5.5

#### Measurement

**Group ID:** BG001

**Spread:** 2.7

**Value:** 13.9

#### Measurement

**Group ID:** BG002

**Spread:** 4.9

**Value:** 9.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 36

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** Safety population included all participants who received at least one dose of treatment and who had at least one post-dose safety assessment.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffmann-La Roche
**Phone:** 800-821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.21
- **Spread:** 
- **Upper Limit:** 52.25
- **Value:** 13.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.19
- **Spread:** 
- **Upper Limit:** 23.75
- **Value:** 12.71
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1465
- **Spread:** 
- **Upper Limit:** 7708
- **Value:** 2998
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 324
- **Spread:** 
- **Upper Limit:** 3098
- **Value:** 1933
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 39.37
- **Spread:** 
- **Upper Limit:** 121.13
- **Value:** 62.44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.56
- **Spread:** 
- **Upper Limit:** 50.3
- **Value:** 29.74
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 278.376
- **Upper Limit:** 
- **Value:** 77.569
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.24
- **Upper Limit:** 
- **Value:** 10.567
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 108.157
- **Upper Limit:** 
- **Value:** -15.309
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.555
- **Upper Limit:** 
- **Value:** 4.575
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 116.587
- **Upper Limit:** 
- **Value:** -16.181
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.33
- **Upper Limit:** 
- **Value:** 11.932
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 15
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 157.295
- **Upper Limit:** 
- **Value:** 17.998
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.935
- **Upper Limit:** 
- **Value:** 23.223
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 186.212
- **Upper Limit:** 
- **Value:** 17.265
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 64.907
- **Upper Limit:** 
- **Value:** 35.263
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 49.964
- **Upper Limit:** 
- **Value:** 21.751
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 198.038
- **Upper Limit:** 
- **Value:** -12.801
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.322
- **Upper Limit:** 
- **Value:** 15.944
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 271.409
- **Upper Limit:** 
- **Value:** -0.412
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 34.515
- **Upper Limit:** 
- **Value:** 17.841
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 294.169
- **Upper Limit:** 
- **Value:** -45.569
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 28.727
- **Upper Limit:** 
- **Value:** 17.236
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 16
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 65.094
- **Upper Limit:** 
- **Value:** 32.644
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.026
- **Upper Limit:** 
- **Value:** 14.66
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 14
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 318.217
- **Upper Limit:** 
- **Value:** -46.575
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 31.747
- **Upper Limit:** 
- **Value:** 24.478
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
- **Group ID:** OG001
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 53.23
- **Upper Limit:** 
- **Value:** 27.934
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 285.831
- **Upper Limit:** 
- **Value:** -53.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 82.547
- **Upper Limit:** 
- **Value:** 36.06
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 16
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 280.041
- **Upper Limit:** 
- **Value:** -42.836
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 22.712
- **Upper Limit:** 
- **Value:** 19.397
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 299.59
- **Upper Limit:** 
- **Value:** -51.899
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.247
- **Upper Limit:** 
- **Value:** 20.642
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 15
- **Group ID:** OG001
- **Value:** 19
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.665
- **Upper Limit:** 
- **Value:** 11.958
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 312.758
- **Upper Limit:** 
- **Value:** -21.565
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 122.88
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 293.156
- **Upper Limit:** 
- **Value:** -16.408
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 20.762
- **Upper Limit:** 
- **Value:** 14.206
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 303.851
- **Upper Limit:** 
- **Value:** -38.921
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.814
- **Upper Limit:** 
- **Value:** 13.273
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 16
- **Group ID:** OG001
- **Value:** 16
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.458
- **Upper Limit:** 
- **Value:** 14.765
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 289.698
- **Upper Limit:** 
- **Value:** -44.611
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18.455
- **Upper Limit:** 
- **Value:** 10.401
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 20
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 225.72
- **Upper Limit:** 
- **Value:** 140.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 241.69
- **Upper Limit:** 
- **Value:** 206.7
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 41.14
- **Upper Limit:** 
- **Value:** -4.04
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 29.68
- **Upper Limit:** 
- **Value:** 1.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 53.39
- **Upper Limit:** 
- **Value:** -1.45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 51.71
- **Upper Limit:** 
- **Value:** 4.58
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 16
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 75.29
- **Upper Limit:** 
- **Value:** 89.72
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 66.75
- **Upper Limit:** 
- **Value:** 68.90
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** The data was not available as single participant was evaluated.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** 323.4
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 1
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 143.28
- **Upper Limit:** 
- **Value:** 194.46
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 100.58
- **Upper Limit:** 
- **Value:** 124.65
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 158.69
- **Upper Limit:** 
- **Value:** 193.25
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 237.02
- **Upper Limit:** 
- **Value:** 418.54
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 194.47
- **Upper Limit:** 
- **Value:** 239.86
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 344.44
- **Upper Limit:** 
- **Value:** 407.36
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 234.92
- **Upper Limit:** 
- **Value:** 233.82
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 317.77
- **Upper Limit:** 
- **Value:** 464.77
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 260.33
- **Upper Limit:** 
- **Value:** 286.06
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 280.99
- **Upper Limit:** 
- **Value:** 461.85
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 253.45
- **Upper Limit:** 
- **Value:** 245.05
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 299.43
- **Upper Limit:** 
- **Value:** 482.55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 230.86
- **Upper Limit:** 
- **Value:** 274.85
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 17
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 254.46
- **Upper Limit:** 
- **Value:** 268.72
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 345.97
- **Upper Limit:** 
- **Value:** 461.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 257.08
- **Upper Limit:** 
- **Value:** 244.53
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 303.29
- **Upper Limit:** 
- **Value:** 514.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 234.7
- **Upper Limit:** 
- **Value:** 256.47
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 276.35
- **Upper Limit:** 
- **Value:** 494.05
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 229.2
- **Upper Limit:** 
- **Value:** 292.29
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 19
- **Group ID:** OG001
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 241.9
- **Upper Limit:** 
- **Value:** 272.93
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 295.29
- **Upper Limit:** 
- **Value:** 497.21
- **Comment:** The data was not available as single participant was evaluated.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** 200
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 1
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 270.07
- **Upper Limit:** 
- **Value:** 532.81
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 286.78
- **Upper Limit:** 
- **Value:** 295.28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 305.07
- **Upper Limit:** 
- **Value:** 416.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 276.03
- **Upper Limit:** 
- **Value:** 269.32
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 18
- **Group ID:** OG001
- **Value:** 18
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 299.72
- **Upper Limit:** 
- **Value:** 243.93
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 263.38
- **Upper Limit:** 
- **Value:** 470.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 318.38
- **Upper Limit:** 
- **Value:** 209.51
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.27
- **Upper Limit:** 
- **Value:** 3.391
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.908
- **Upper Limit:** 
- **Value:** 3.356
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.270
- **Upper Limit:** 
- **Value:** -2.187
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.21
- **Upper Limit:** 
- **Value:** -3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.735
- **Upper Limit:** 
- **Value:** -2.368
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.346
- **Upper Limit:** 
- **Value:** -3.069
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.285
- **Upper Limit:** 
- **Value:** -3.16
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.559
- **Upper Limit:** 
- **Value:** -1.783
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 24
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.377
- **Upper Limit:** 
- **Value:** -3.213
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.158
- **Upper Limit:** 
- **Value:** -1.336
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.279
- **Upper Limit:** 
- **Value:** -3.122
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.455
- **Upper Limit:** 
- **Value:** -2.467
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.492
- **Upper Limit:** 
- **Value:** -3.254
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.316
- **Upper Limit:** 
- **Value:** -2.209
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 25
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.47
- **Upper Limit:** 
- **Value:** -2.039
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.385
- **Upper Limit:** 
- **Value:** -3.153
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.453
- **Upper Limit:** 
- **Value:** -3.344
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 25
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.285
- **Upper Limit:** 
- **Value:** -2.225
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.2
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.1
- **Upper Limit:** 
- **Value:** 13
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9
- **Upper Limit:** 
- **Value:** -7.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.8
- **Upper Limit:** 
- **Value:** -10.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.5
- **Upper Limit:** 
- **Value:** -7.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.9
- **Upper Limit:** 
- **Value:** -9.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 25
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.4
- **Upper Limit:** 
- **Value:** -9.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** -6.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.3
- **Upper Limit:** 
- **Value:** -11.8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.2
- **Upper Limit:** 
- **Value:** -7.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 25
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.2
- **Upper Limit:** 
- **Value:** -11.9
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 27
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.2
- **Upper Limit:** 
- **Value:** -8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 23
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.8
- **Upper Limit:** 
- **Value:** -11.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.1
- **Upper Limit:** 
- **Value:** -8
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** -10.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 21
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.2
- **Upper Limit:** 
- **Value:** -12
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 26
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 13
- **Upper Limit:** 
- **Value:** -12.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 25
- **Group ID:** OG001
- **Value:** 0
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.2
- **Upper Limit:** 
- **Value:** -8.5
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 0
- **Group ID:** OG001
- **Value:** 22
**Units:** Participants
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.0
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic population included all enrolled participants who were adherent to the protocol.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
**Title:** Minimum Serum Concentration (Cmin) of TCZ at Steady State
**Type:** PRIMARY
**Unit of Measure:** Micrograms/milliliter (mcg/mL)
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 2
**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
**Dispersion Type:** Full Range
**Parameter Type:** MEAN
**Population Description:** Pharmacokinetic population.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
**Title:** Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
**Type:** PRIMARY
**Unit of Measure:** mcg*day/mL
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 3
**Description:** Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants \>/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Pharmacokinetic population
**Reporting Status:** POSTED
**Time Frame:** Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
**Title:** Maximum Serum Concentration (Cmax) of TCZ at Steady State
**Type:** PRIMARY
**Unit of Measure:** mcg/mL
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 4
**Description:** IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
**Title:** Change From Baseline in Serum Interleukin-6 (IL-6) Levels
**Type:** SECONDARY
**Unit of Measure:** picograms/milliliter (pg/mL)
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 5
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety population. Here Number of participants analyzed represents participants evaluable for this outcome measure. Number Analyzed represents participants evaluable for the specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
**Title:** Change From Baseline in Soluble IL-6 Receptor Levels
**Type:** SECONDARY
**Unit of Measure:** nanograms per milliliter (ng/mL)
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 6
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety population. Number Analyzed represents participants evaluable for the specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
**Title:** Change From Baseline in C-Reactive Protein (CRP) Levels
**Type:** SECONDARY
**Unit of Measure:** mg/L
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 7
**Description:** The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Safety population. Number Analyzed represents participants evaluable for the specified category.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
**Title:** Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
**Type:** SECONDARY
**Unit of Measure:** millimeters per hour (mm/h)
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
#### Outcome Measure 8
**Parameter Type:** NUMBER
**Population Description:** Safety population.
**Reporting Status:** POSTED
**Time Frame:** Baseline up to Week 52
**Title:** Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants with body weight \< 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
**ID:** OG000
**Title:** TCZ SC 162 mg Q3W
##### Group
**Description:** Participants with body weight \>/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
**ID:** OG001
**Title:** TCZ SC 162 mg Q2W
### Participant Flow Module
#### Group
**Description:** Participants with body weight less than (\<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
**ID:** FG000
**Title:** TCZ SC 162 mg Q3W
#### Group
**Description:** Participants with body weight greater than or equal to (\>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
**ID:** FG001
**Title:** TCZ SC 162 mg Q2W
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 27
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 25
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 24
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 22
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
**Recruitment Details:** A total of 52 participants were enrolled in the study. Study included a 21-day screening period.
**Has Results:** True