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Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

A 2-Part Open-Label Study to Assess the Clinical Benefit and Long-Term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00962741
Acronym
CLIPPER
Enrollment
127
Registered
2009-08-20
Start date
2009-09-30
Completion date
2013-01-31
Last updated
2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Juvenile Idiopathic

Brief summary

This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

Interventions

DRUGEtanercept

Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years. * \>= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

Exclusion criteria

* Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria. * Other rheumatic diseases. * Active uveitis within 6 months of the baseline visit. * Any other significant health problem.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12Week 12ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

Secondary

MeasureTime frameDescription
Duration of Morning Stiffness: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Patient/Parent Global AssessmentBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Patient/Parent Global Assessment: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Patient/Parent Global Assessment: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Patient/Parent Global Assessment: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Number of Active JointsBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Number of Active Joints: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Number of Active Joints: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Number of Active Joints: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Number of Joints With Limitation of MotionBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Pain Assessment: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Pain Assessment: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Number of Joints With Limitation of Motion: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Number of Joints With Limitation of Motion: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Number of Joints With Limitation of Motion: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
C-reactive Protein (CRP)Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
C-reactive Protein (CRP): eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
C-reactive Protein (CRP): ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
C-reactive Protein (CRP): PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Pain AssessmentBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Pain Assessment: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Duration of Morning StiffnessBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Duration of Morning Stiffness: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Duration of Morning Stiffness: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Percentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Childhood Health Assessment Questionnaire (CHAQ) ScoreBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Percentage of Participants With an ACR Pedi 30 ResponseWeek 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Percentage of Participants With an ACR Pedi 50 ResponseWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 70 ResponseWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 90 ResponseWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 100 ResponseWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Physician's Global Assessment (PGA) of Disease ActivityBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.

Other

MeasureTime frameDescription
Nocturnal Back Pain Score for ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.
Modified Schober's Test for ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.
Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.
Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and Almost clear' includes all participants who were scored as a 0 or 1.
Number of Participants With Adverse Events (AEs)Week 12, Week 96An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Number of Participants With Adverse Events (AEs): eoJIA SubpopulationWeek 12, Week 96An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Number of Participants With Adverse Events (AEs): ERA Sub-populationWeek 12, Week 96An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Number of Participants With Adverse Events (AEs): PsA Sub-populationWeek 12, Week 96An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.
Tanner Assessment Score by Age GroupBaseline, Week 12, Week 48, Week 96Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Tanner Assessment Score by Age Group for eoJIA Sub-populationBaseline, Week 12, Week 48, Week 96Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Tanner Assessment Score by Age Group for ERA Sub-populationBaseline, Week 12, Week 48, Week 96Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Tanner Assessment Score by Age Group for PsA Sub-populationBaseline, Week 12, Week 48, Week 96Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).
Height z-Score by Age GroupBaseline, Week 12, Week 48, Week 72, Week 96Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Height z-Score by Age Group for eoJIA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Height z-Score by Age Group for ERA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Height z-Score by Age Group for PsA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Weight z-Scores by Age GroupBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Weight z-Scores by Age Group for eoJIA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Weight z-Scores by Age Group for ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Weight z-Scores by Age Group for PsA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Body Mass Index (BMI) z-Score by Age GroupBaseline, Week 12, Week 48, Week 72, Week 96BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Body Mass Index (BMI) z-Score by Age Group for ERA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Body Mass Index (BMI) z-Score by Age Group for PsA Sub-populationBaseline, Week 12, Week 48, Week 72, Week 96BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.
Number of Participants With Anti-etanercept AntibodiesBaseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-populationBaseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: ERA Sub-populationBaseline up to Week 12, Week 48, Week 96
Number of Participants With Anti-etanercept Antibodies: PsA Sub-populationBaseline up to Week 12, Week 48, Week 96
Number of Participants With Neutralizing Anti-etanercept AntibodiesBaseline up to Week 12, Week 48, Week 96
Overall Back Pain Score for ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.
Tender Entheseal Assessment for ERA Sub-populationBaseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66\*(total number of tender entheses with counts \> 0)/number of non-missing tender entheses. If \> 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

Countries

Australia, Belgium, Colombia, Czechia, France, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Russia, Serbia, Slovakia, Slovenia, Spain

Participant flow

Participants by arm

ArmCount
Etanercept
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
127
Total127

Withdrawals & dropouts

PeriodReasonFG000
Overall Studydrug ineffective+prohibited drug taken1
Overall StudyFailed to return3
Overall StudyLack of Efficacy1
Overall StudyLost to Follow-up2
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicEtanercept
Age, Continuous11.70 Years
STANDARD_DEVIATION 4.51
Sex: Female, Male
Female
72 Participants
Sex: Female, Male
Male
55 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
106 / 127
serious
Total, serious adverse events
24 / 127

Outcome results

Primary

Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12

ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

Time frame: Week 12

Population: Modified Intent-to-Treat (mITT) population included all participants who received at least 1 dose of the study medication. Here 'N' (Number of participants analyzed) signified those participants who were evaluable for this measure at week 12.

ArmMeasureValue (NUMBER)
EtanerceptPercentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 1288.6 Percentage of participants
Secondary

Childhood Health Assessment Questionnaire (CHAQ) Score

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 12 (N = 123)0.32 Units on a scaleStandard Deviation 0.4
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 24 (N = 122)0.28 Units on a scaleStandard Deviation 0.39
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 36 (N = 120)0.23 Units on a scaleStandard Deviation 0.39
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 48 (N = 119)0.24 Units on a scaleStandard Deviation 0.41
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 60 (N = 116)0.20 Units on a scaleStandard Deviation 0.37
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 72 (N = 114)0.17 Units on a scaleStandard Deviation 0.32
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 84 (N = 113)0.17 Units on a scaleStandard Deviation 0.35
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 96 (N = 109)0.16 Units on a scaleStandard Deviation 0.35
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreBaseline (N = 127)0.80 Units on a scaleStandard Deviation 0.63
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 4 (N = 126)0.54 Units on a scaleStandard Deviation 0.55
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) ScoreWeek 8 (N = 121)0.42 Units on a scaleStandard Deviation 0.45
Secondary

Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 12 (N = 58)0.40 Units on a scaleStandard Deviation 0.48
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 36 (N = 57)0.26 Units on a scaleStandard Deviation 0.46
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 48 (N = 57)0.27 Units on a scaleStandard Deviation 0.48
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 60 (N = 56)0.25 Units on a scaleStandard Deviation 0.45
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 72 (N = 55)0.21 Units on a scaleStandard Deviation 0.37
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 84 (N = 55)0.21 Units on a scaleStandard Deviation 0.41
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 96 (N = 54)0.20 Units on a scaleStandard Deviation 0.4
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationBaseline (N = 60)0.90 Units on a scaleStandard Deviation 0.68
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 4 (N = 59)0.64 Units on a scaleStandard Deviation 0.6
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 8 (N = 56)0.50 Units on a scaleStandard Deviation 0.54
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-populationWeek 24 (N = 58)0.31 Units on a scaleStandard Deviation 0.43
Secondary

Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar /enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationBaseline (N = 38)0.72 Units on a scaleStandard Deviation 0.51
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 4 (N = 38)0.48 Units on a scaleStandard Deviation 0.56
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 12 (N = 36)0.23 Units on a scaleStandard Deviation 0.27
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 24 (N = 36)0.27 Units on a scaleStandard Deviation 0.38
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 48 (N = 34)0.18 Units on a scaleStandard Deviation 0.28
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 60 (N = 33)0.17 Units on a scaleStandard Deviation 0.29
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 72 (N = 32)0.13 Units on a scaleStandard Deviation 0.27
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 84 (N = 31)0.10 Units on a scaleStandard Deviation 0.22
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 96 (N = 30)0.08 Units on a scaleStandard Deviation 0.21
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 8 (N = 36)0.40 Units on a scaleStandard Deviation 0.34
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-populationWeek 36 (N = 35)0.20 Units on a scaleStandard Deviation 0.32
Secondary

Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population

CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationBaseline (N = 29)0.68 Units on a scaleStandard Deviation 0.63
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 4 (N = 29)0.42 Units on a scaleStandard Deviation 0.41
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 8 (N = 29)0.30 Units on a scaleStandard Deviation 0.34
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 12 (N = 29)0.29 Units on a scaleStandard Deviation 0.35
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 24 (N = 28)0.26 Units on a scaleStandard Deviation 0.32
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 48 (N = 28)0.24 Units on a scaleStandard Deviation 0.38
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 60 (N = 27)0.13 Units on a scaleStandard Deviation 0.25
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 72 (N = 27)0.15 Units on a scaleStandard Deviation 0.29
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 84 (N = 27)0.18 Units on a scaleStandard Deviation 0.35
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 96 (N = 25)0.18 Units on a scaleStandard Deviation 0.36
EtanerceptChildhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-populationWeek 36 (N = 28)0.21 Units on a scaleStandard Deviation 0.32
Secondary

C-reactive Protein (CRP)

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptC-reactive Protein (CRP)Baseline (N = 127)8.26 mg/Liter (mg/L)Standard Deviation 14.7
EtanerceptC-reactive Protein (CRP)Week 4 (N = 125)3.29 mg/Liter (mg/L)Standard Deviation 7.85
EtanerceptC-reactive Protein (CRP)Week 8 (N = 121)2.32 mg/Liter (mg/L)Standard Deviation 3.92
EtanerceptC-reactive Protein (CRP)Week 12 (N = 120)2.47 mg/Liter (mg/L)Standard Deviation 7.19
EtanerceptC-reactive Protein (CRP)Week 24 (N = 120)3.54 mg/Liter (mg/L)Standard Deviation 10.72
EtanerceptC-reactive Protein (CRP)Week 36 (N = 119)2.81 mg/Liter (mg/L)Standard Deviation 5.75
EtanerceptC-reactive Protein (CRP)Week 48 (N = 117)2.04 mg/Liter (mg/L)Standard Deviation 3.94
EtanerceptC-reactive Protein (CRP)Week 60 (N = 110)2.16 mg/Liter (mg/L)Standard Deviation 4.87
EtanerceptC-reactive Protein (CRP)Week 72 (N = 111)2.26 mg/Liter (mg/L)Standard Deviation 4.01
EtanerceptC-reactive Protein (CRP)Week 84 (N = 109)3.98 mg/Liter (mg/L)Standard Deviation 12.51
EtanerceptC-reactive Protein (CRP)Week 96 (N = 103)2.76 mg/Liter (mg/L)Standard Deviation 5.27
Secondary

C-reactive Protein (CRP): eoJIA Sub-population

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 72 (N = 55)2.42 mg/LStandard Deviation 4.28
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 84 (N = 54)3.94 mg/LStandard Deviation 9.13
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationBaseline (N = 60)6.27 mg/LStandard Deviation 10.59
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 4 (N = 58)3.45 mg/LStandard Deviation 7.79
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 8 (N = 56)2.66 mg/LStandard Deviation 5.05
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 12 (N = 58)3.36 mg/LStandard Deviation 10.07
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 24 (N = 56)5.26 mg/LStandard Deviation 15.34
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 36 (N = 57)3.25 mg/LStandard Deviation 6.56
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 48 (N = 55)1.93 mg/LStandard Deviation 4.2
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 60 (N = 55)2.76 mg/LStandard Deviation 6.52
EtanerceptC-reactive Protein (CRP): eoJIA Sub-populationWeek 96 (N = 52)3.34 mg/LStandard Deviation 6.62
Secondary

C-reactive Protein (CRP): ERA Sub-population

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptC-reactive Protein (CRP): ERA Sub-populationBaseline (N = 38)15.27 mg/LStandard Deviation 21.52
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 4 (N = 38)4.37 mg/LStandard Deviation 10.36
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 8 (N = 36)2.53 mg/LStandard Deviation 3.3
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 12 (N = 34)1.87 mg/LStandard Deviation 2.84
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 24 (N = 36)1.96 mg/LStandard Deviation 2.04
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 36 (N = 35)3.24 mg/LStandard Deviation 6.41
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 48 (N = 34)2.79 mg/LStandard Deviation 4.89
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 60 (N = 30)1.99 mg/LStandard Deviation 2.84
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 72 (N = 30)2.12 mg/LStandard Deviation 4.03
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 84 (N = 29)6.36 mg/LStandard Deviation 20.81
EtanerceptC-reactive Protein (CRP): ERA Sub-populationWeek 96 (N = 27)2.68 mg/LStandard Deviation 4.1
Secondary

C-reactive Protein (CRP): PsA Sub-population

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 4 (N = 29)1.58 mg/LStandard Deviation 1.73
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 8 (N = 29)1.41 mg/LStandard Deviation 0.98
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 12 (N = 28)1.36 mg/LStandard Deviation 0.75
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 24 (N = 28)2.11 mg/LStandard Deviation 3.16
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 36 (N = 27)1.31 mg/LStandard Deviation 0.81
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 48 (N = 28)1.35 mg/LStandard Deviation 0.97
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 60 (N = 25)1.04 mg/LStandard Deviation 0.12
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 72 (N = 26)2.08 mg/LStandard Deviation 3.51
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 84 (N = 26)1.44 mg/LStandard Deviation 0.97
EtanerceptC-reactive Protein (CRP): PsA Sub-populationWeek 96 (N = 24)1.58 mg/LStandard Deviation 2.18
EtanerceptC-reactive Protein (CRP): PsA Sub-populationBaseline (N = 29)3.19 mg/LStandard Deviation 4.71
Secondary

Duration of Morning Stiffness

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDuration of Morning StiffnessWeek 48 (N = 119)6.01 MinutesStandard Deviation 23.94
EtanerceptDuration of Morning StiffnessWeek 60 (N = 116)7.28 MinutesStandard Deviation 30.28
EtanerceptDuration of Morning StiffnessBaseline (N = 127)73.50 MinutesStandard Deviation 100.61
EtanerceptDuration of Morning StiffnessWeek 4 (N = 126)29.86 MinutesStandard Deviation 60
EtanerceptDuration of Morning StiffnessWeek 8 (N = 121)25.02 MinutesStandard Deviation 75.32
EtanerceptDuration of Morning StiffnessWeek 12 (N = 123)13.29 MinutesStandard Deviation 41.2
EtanerceptDuration of Morning StiffnessWeek 24 (N = 122)8.83 MinutesStandard Deviation 23.41
EtanerceptDuration of Morning StiffnessWeek 36 (N = 120)6.76 MinutesStandard Deviation 24.41
EtanerceptDuration of Morning StiffnessWeek 72 (N = 113)8.98 MinutesStandard Deviation 30.67
EtanerceptDuration of Morning StiffnessWeek 84 (N = 112)8.40 MinutesStandard Deviation 32.38
EtanerceptDuration of Morning StiffnessWeek 96 (N = 109)5.76 MinutesStandard Deviation 21.7
Secondary

Duration of Morning Stiffness: eoJIA Sub-population

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationBaseline (N = 60)72.78 MinutesStandard Deviation 97.24
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 4 (N = 59)20.46 MinutesStandard Deviation 47.37
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 8 (N = 56)20.18 MinutesStandard Deviation 70.7
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 12 (N = 58)9.05 MinutesStandard Deviation 24.52
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 24 (N = 58)5.72 MinutesStandard Deviation 18.85
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 36 (N = 57)2.49 MinutesStandard Deviation 9.35
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 48 (N = 57)2.19 MinutesStandard Deviation 6.61
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 60 (N = 56)2.41 MinutesStandard Deviation 7.32
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 72 (N = 54)3.89 MinutesStandard Deviation 15.16
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 84 (N = 55)2.64 MinutesStandard Deviation 8.97
EtanerceptDuration of Morning Stiffness: eoJIA Sub-populationWeek 96 (N = 54)2.37 MinutesStandard Deviation 12.42
Secondary

Duration of Morning Stiffness: ERA Sub-population

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 96 (N = 30)10.67 MinutesStandard Deviation 28.31
EtanerceptDuration of Morning Stiffness: ERA Sub-populationBaseline (N = 38)89.29 MinutesStandard Deviation 128.94
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 4 (N = 38)49.34 MinutesStandard Deviation 78.73
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 8 (N = 36)44.03 MinutesStandard Deviation 102.65
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 12 (N = 36)25.69 MinutesStandard Deviation 67.57
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 24 (N = 36)15.69 MinutesStandard Deviation 28.87
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 36 (N = 35)17.17 MinutesStandard Deviation 41.01
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 48 (N = 34)13.38 MinutesStandard Deviation 36.88
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 60 (N = 33)14.09 MinutesStandard Deviation 42.21
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 72 (N = 32)16.25 MinutesStandard Deviation 42.12
EtanerceptDuration of Morning Stiffness: ERA Sub-populationWeek 84 (N = 30)12.70 MinutesStandard Deviation 36.16
Secondary

Duration of Morning Stiffness: PsA Sub-population

Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptDuration of Morning Stiffness: PsA Sub-populationBaseline (N = 29)54.31 MinutesStandard Deviation 54.16
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 4 (N = 29)23.45 MinutesStandard Deviation 49.86
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 8 (N = 29)10.79 MinutesStandard Deviation 24.55
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 12 (N = 29)6.38 MinutesStandard Deviation 13.42
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 24 (N = 28)6.43 MinutesStandard Deviation 23.17
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 36 (N = 28)2.43 MinutesStandard Deviation 11.33
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 48 (N = 28)4.82 MinutesStandard Deviation 25.51
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 60 (N = 27)9.07 MinutesStandard Deviation 40.43
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 72 (N = 27)10.56 MinutesStandard Deviation 36.7
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 84 (N = 27)15.37 MinutesStandard Deviation 52.05
EtanerceptDuration of Morning Stiffness: PsA Sub-populationWeek 96 (N = 25)7.20 MinutesStandard Deviation 27.43
Secondary

Number of Active Joints

Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Active JointsWeek 48 (N = 119)0.88 JointsStandard Deviation 1.92
EtanerceptNumber of Active JointsWeek 60 (N = 116)0.87 JointsStandard Deviation 1.94
EtanerceptNumber of Active JointsWeek 72 (N = 114)0.77 JointsStandard Deviation 1.97
EtanerceptNumber of Active JointsWeek 84 (N = 113)0.81 JointsStandard Deviation 2.2
EtanerceptNumber of Active JointsBaseline (N = 127)6.74 JointsStandard Deviation 4.59
EtanerceptNumber of Active JointsWeek 4 (N = 126)3.17 JointsStandard Deviation 3.32
EtanerceptNumber of Active JointsWeek 8 (N = 121)2.07 JointsStandard Deviation 2.67
EtanerceptNumber of Active JointsWeek 12 (N = 123)1.72 JointsStandard Deviation 2.52
EtanerceptNumber of Active JointsWeek 24 (N = 122)1.16 JointsStandard Deviation 2.06
EtanerceptNumber of Active JointsWeek 36 (N = 120)0.99 JointsStandard Deviation 1.86
EtanerceptNumber of Active JointsWeek 96 (N = 109)0.61 JointsStandard Deviation 2.06
Secondary

Number of Active Joints: eoJIA Sub-population

Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 12 (N = 58)2.07 JointsStandard Deviation 2.77
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 72 (N = 55)0.73 JointsStandard Deviation 1.21
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 84 (N = 55)0.65 JointsStandard Deviation 1.16
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 96 (N = 54)0.50 JointsStandard Deviation 0.89
EtanerceptNumber of Active Joints: eoJIA Sub-populationBaseline (N = 60)7.58 JointsStandard Deviation 5.09
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 4 (N = 59)3.95 JointsStandard Deviation 3.75
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 8 (N = 56)2.46 JointsStandard Deviation 2.7
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 24 (N = 58)1.34 JointsStandard Deviation 2.29
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 36 (N = 57)1.14 JointsStandard Deviation 1.97
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 48 (N = 57)1.00 JointsStandard Deviation 1.6
EtanerceptNumber of Active Joints: eoJIA Sub-populationWeek 60 (N = 56)0.98 JointsStandard Deviation 1.63
Secondary

Number of Active Joints: ERA Sub-population

Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Active Joints: ERA Sub-populationBaseline (N = 38)5.21 JointsStandard Deviation 3.57
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 8 (N = 36)1.47 JointsStandard Deviation 2.25
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 84 (N = 31)0.68 JointsStandard Deviation 1.19
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 96 (N = 30)0.50 JointsStandard Deviation 0.94
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 4 (N = 38)2.40 JointsStandard Deviation 2.62
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 12 (N = 36)1.08 JointsStandard Deviation 1.57
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 24 (N = 36)0.78 JointsStandard Deviation 1.07
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 36 (N = 35)0.74 JointsStandard Deviation 1.29
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 48 (N = 34)0.68 JointsStandard Deviation 1.09
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 60 (N = 33)0.48 JointsStandard Deviation 0.94
EtanerceptNumber of Active Joints: ERA Sub-populationWeek 72 (N = 32)0.59 JointsStandard Deviation 1.21
Secondary

Number of Active Joints: PsA Sub-population

Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 4 (N = 29)2.59 JointsStandard Deviation 2.92
EtanerceptNumber of Active Joints: PsA Sub-populationBaseline (N = 29)7.00 JointsStandard Deviation 4.33
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 8 (N = 29)2.07 JointsStandard Deviation 3.05
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 12 (N = 29)1.79 JointsStandard Deviation 2.86
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 24 (N = 28)1.25 JointsStandard Deviation 2.47
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 36 (N = 28)1.00 JointsStandard Deviation 2.21
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 48 (N = 28)0.89 JointsStandard Deviation 3.03
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 60 (N = 27)1.11 JointsStandard Deviation 3.11
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 72 (N = 27)1.08 JointsStandard Deviation 3.45
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 84 (N = 27)1.30 JointsStandard Deviation 4.02
EtanerceptNumber of Active Joints: PsA Sub-populationWeek 96 (N = 25)0.96 JointsStandard Deviation 4
Secondary

Number of Joints With Limitation of Motion

The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Joints With Limitation of MotionBaseline (N = 127)5.72 JointsStandard Deviation 4.22
EtanerceptNumber of Joints With Limitation of MotionWeek 4 (N = 126)3.20 JointsStandard Deviation 3.27
EtanerceptNumber of Joints With Limitation of MotionWeek 8 (N = 121)2.26 JointsStandard Deviation 3.41
EtanerceptNumber of Joints With Limitation of MotionWeek 12 (N = 123)1.62 JointsStandard Deviation 2.31
EtanerceptNumber of Joints With Limitation of MotionWeek 24 (N = 122)1.43 JointsStandard Deviation 2.03
EtanerceptNumber of Joints With Limitation of MotionWeek 36 (N = 120)1.39 JointsStandard Deviation 2.13
EtanerceptNumber of Joints With Limitation of MotionWeek 48 (N = 119)1.26 JointsStandard Deviation 2.51
EtanerceptNumber of Joints With Limitation of MotionWeek 60 (N = 116)1.41 JointsStandard Deviation 2.98
EtanerceptNumber of Joints With Limitation of MotionWeek 72 (N = 114)1.13 JointsStandard Deviation 2.36
EtanerceptNumber of Joints With Limitation of MotionWeek 84 (N = 113)1.41 JointsStandard Deviation 3.05
EtanerceptNumber of Joints With Limitation of MotionWeek 96 (N = 109)1.06 JointsStandard Deviation 2.71
Secondary

Number of Joints With Limitation of Motion: eoJIA Sub-population

The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationBaseline (N = 60)6.33 JointsStandard Deviation 4.37
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 4 (N = 59)3.12 JointsStandard Deviation 2.74
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 8 (N = 56)2.23 JointsStandard Deviation 3.47
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 12 (N = 58)1.78 JointsStandard Deviation 2.25
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 24 (N = 58)1.40 JointsStandard Deviation 1.77
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 36 (N = 57)1.16 JointsStandard Deviation 1.54
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 48 (N = 57)1.05 JointsStandard Deviation 1.63
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 60 (N = 56)1.36 JointsStandard Deviation 2.56
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 72 (N = 55)0.89 JointsStandard Deviation 1.58
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 84 (N = 55)0.98 JointsStandard Deviation 2.08
EtanerceptNumber of Joints With Limitation of Motion: eoJIA Sub-populationWeek 96 (N = 54)0.74 JointsStandard Deviation 1.22
Secondary

Number of Joints With Limitation of Motion: ERA Sub-population

The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationBaseline (N = 38)4.84 JointsStandard Deviation 4
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 4 (N = 38)2.98 JointsStandard Deviation 3.73
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 8 (N = 36)2.28 JointsStandard Deviation 3.59
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 12 (N = 36)1.58 JointsStandard Deviation 2.94
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 24 (N = 36)1.53 JointsStandard Deviation 2.8
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 36 (N = 35)1.55 JointsStandard Deviation 2.69
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 48 (N = 34)1.53 JointsStandard Deviation 2.88
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 60 (N = 33)1.36 JointsStandard Deviation 3.26
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 72 (N = 32)1.19 JointsStandard Deviation 2.09
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 84 (N = 31)1.68 JointsStandard Deviation 3.17
EtanerceptNumber of Joints With Limitation of Motion: ERA Sub-populationWeek 96 (N = 30)1.33 JointsStandard Deviation 2.89
Secondary

Number of Joints With Limitation of Motion: PsA Sub-population

The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationBaseline (N = 29)5.62 JointsStandard Deviation 4.1
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 4 (N = 29)3.66 JointsStandard Deviation 3.66
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 8 (N = 29)2.28 JointsStandard Deviation 3.15
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 12 (N = 29)1.34 JointsStandard Deviation 1.4
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 24 (N = 28)1.36 JointsStandard Deviation 1.31
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 36 (N = 28)1.64 JointsStandard Deviation 2.39
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 48 (N = 28)1.36 JointsStandard Deviation 3.42
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 60 (N = 27)1.56 JointsStandard Deviation 3.51
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 72 (N = 27)1.56 JointsStandard Deviation 3.68
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 84 (N = 27)1.96 JointsStandard Deviation 4.34
EtanerceptNumber of Joints With Limitation of Motion: PsA Sub-populationWeek 96 (N = 25)1.40 JointsStandard Deviation 4.39
Secondary

Pain Assessment

Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPain AssessmentBaseline (N = 127)5.06 Units on a scaleStandard Deviation 2.52
EtanerceptPain AssessmentWeek 4 (N = 126)3.12 Units on a scaleStandard Deviation 2.25
EtanerceptPain AssessmentWeek 8 (N = 121)2.58 Units on a scaleStandard Deviation 2.1
EtanerceptPain AssessmentWeek 12 (N = 123)2.02 Units on a scaleStandard Deviation 1.89
EtanerceptPain AssessmentWeek 24 (N = 122)1.64 Units on a scaleStandard Deviation 1.74
EtanerceptPain AssessmentWeek 36 (N = 120)1.63 Units on a scaleStandard Deviation 1.94
EtanerceptPain AssessmentWeek 48 (N = 119)1.51 Units on a scaleStandard Deviation 1.81
EtanerceptPain AssessmentWeek 60 (N = 116)1.18 Units on a scaleStandard Deviation 1.46
EtanerceptPain AssessmentWeek 72 (N = 114)1.14 Units on a scaleStandard Deviation 1.62
EtanerceptPain AssessmentWeek 84 (N = 112)1.13 Units on a scaleStandard Deviation 1.67
EtanerceptPain AssessmentWeek 96 (N = 108)0.91 Units on a scaleStandard Deviation 1.42
Secondary

Pain Assessment: eoJIA Sub-population

Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPain Assessment: eoJIA Sub-populationBaseline (N = 60)4.81 Units on a scaleStandard Deviation 2.56
EtanerceptPain Assessment: eoJIA Sub-populationWeek 4 (N = 59)2.64 Units on a scaleStandard Deviation 2.09
EtanerceptPain Assessment: eoJIA Sub-populationWeek 8 (N = 56)2.12 Units on a scaleStandard Deviation 1.97
EtanerceptPain Assessment: eoJIA Sub-populationWeek 12 (N = 58)1.69 Units on a scaleStandard Deviation 1.77
EtanerceptPain Assessment: eoJIA Sub-populationWeek 24 (N = 58)1.27 Units on a scaleStandard Deviation 1.66
EtanerceptPain Assessment: eoJIA Sub-populationWeek 36 (N = 57)1.43 Units on a scaleStandard Deviation 1.98
EtanerceptPain Assessment: eoJIA Sub-populationWeek 48 (N = 57)1.19 Units on a scaleStandard Deviation 1.77
EtanerceptPain Assessment: eoJIA Sub-populationWeek 60 (N = 56)1.19 Units on a scaleStandard Deviation 1.38
EtanerceptPain Assessment: eoJIA Sub-populationWeek 72 (N = 55)1.01 Units on a scaleStandard Deviation 1.52
EtanerceptPain Assessment: eoJIA Sub-populationWeek 84 (N = 54)0.91 Units on a scaleStandard Deviation 1.5
EtanerceptPain Assessment: eoJIA Sub-populationWeek 96 (N = 53)0.97 Units on a scaleStandard Deviation 1.52
Secondary

Pain Assessment: ERA Sub-population

Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPain Assessment: ERA Sub-populationBaseline (N = 38)5.76 Units on a scaleStandard Deviation 2.51
EtanerceptPain Assessment: ERA Sub-populationWeek 4 (N = 38)3.82 Units on a scaleStandard Deviation 2.59
EtanerceptPain Assessment: ERA Sub-populationWeek 8 (N = 36)3.13 Units on a scaleStandard Deviation 2.42
EtanerceptPain Assessment: ERA Sub-populationWeek 12 (N = 36)2.54 Units on a scaleStandard Deviation 2.18
EtanerceptPain Assessment: ERA Sub-populationWeek 24 (N = 36)2.28 Units on a scaleStandard Deviation 1.89
EtanerceptPain Assessment: ERA Sub-populationWeek 36 (N = 35)1.87 Units on a scaleStandard Deviation 2.07
EtanerceptPain Assessment: ERA Sub-populationWeek 48 (N = 34)1.78 Units on a scaleStandard Deviation 1.72
EtanerceptPain Assessment: ERA Sub-populationWeek 60 (N = 33)1.17 Units on a scaleStandard Deviation 1.69
EtanerceptPain Assessment: ERA Sub-populationWeek 72 (N = 32)1.17 Units on a scaleStandard Deviation 1.69
EtanerceptPain Assessment: ERA Sub-populationWeek 84 (N = 31)1.08 Units on a scaleStandard Deviation 1.34
EtanerceptPain Assessment: ERA Sub-populationWeek 96 (N = 30)0.87 Units on a scaleStandard Deviation 1.21
Secondary

Pain Assessment: PsA Sub-population

Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPain Assessment: PsA Sub-populationWeek 48 (N = 28)1.82 Units on a scaleStandard Deviation 1.95
EtanerceptPain Assessment: PsA Sub-populationWeek 60 (N = 27)1.19 Units on a scaleStandard Deviation 1.35
EtanerceptPain Assessment: PsA Sub-populationWeek 12 (N = 29)2.03 Units on a scaleStandard Deviation 1.65
EtanerceptPain Assessment: PsA Sub-populationWeek 24 (N = 28)1.61 Units on a scaleStandard Deviation 1.51
EtanerceptPain Assessment: PsA Sub-populationWeek 36 (N = 28)1.71 Units on a scaleStandard Deviation 1.67
EtanerceptPain Assessment: PsA Sub-populationWeek 72 (N = 27)1.37 Units on a scaleStandard Deviation 1.74
EtanerceptPain Assessment: PsA Sub-populationWeek 84 (N = 27)1.61 Units on a scaleStandard Deviation 2.2
EtanerceptPain Assessment: PsA Sub-populationBaseline (N = 29)4.64 Units on a scaleStandard Deviation 2.31
EtanerceptPain Assessment: PsA Sub-populationWeek 4 (N = 29)3.19 Units on a scaleStandard Deviation 1.91
EtanerceptPain Assessment: PsA Sub-populationWeek 8 (N = 29)2.81 Units on a scaleStandard Deviation 1.74
EtanerceptPain Assessment: PsA Sub-populationWeek 96 (N = 25)0.84 Units on a scaleStandard Deviation 1.48
Secondary

Patient/Parent Global Assessment

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPatient/Parent Global AssessmentBaseline (N = 127)4.96 Units on a scaleStandard Deviation 2.33
EtanerceptPatient/Parent Global AssessmentWeek 4 (N = 126)3.22 Units on a scaleStandard Deviation 2.23
EtanerceptPatient/Parent Global AssessmentWeek 8 (N = 121)2.79 Units on a scaleStandard Deviation 2.1
EtanerceptPatient/Parent Global AssessmentWeek 12 (N = 123)2.21 Units on a scaleStandard Deviation 1.84
EtanerceptPatient/Parent Global AssessmentWeek 24 (N = 122)1.79 Units on a scaleStandard Deviation 1.75
EtanerceptPatient/Parent Global AssessmentWeek 36 (N = 120)1.74 Units on a scaleStandard Deviation 1.97
EtanerceptPatient/Parent Global AssessmentWeek 48 (N = 119)1.65 Units on a scaleStandard Deviation 1.88
EtanerceptPatient/Parent Global AssessmentWeek 60 (N = 116)1.33 Units on a scaleStandard Deviation 1.56
EtanerceptPatient/Parent Global AssessmentWeek 72 (N = 114)1.29 Units on a scaleStandard Deviation 1.63
EtanerceptPatient/Parent Global AssessmentWeek 84 (N = 113)1.17 Units on a scaleStandard Deviation 1.56
EtanerceptPatient/Parent Global AssessmentWeek 96 (N = 109)0.97 Units on a scaleStandard Deviation 1.31
Secondary

Patient/Parent Global Assessment: eoJIA Sub-population

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 60 (N = 56)1.29 Units on a scaleStandard Deviation 1.54
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationBaseline (N = 60)4.82 Units on a scaleStandard Deviation 2.44
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 4 (N = 59)2.82 Units on a scaleStandard Deviation 2.11
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 8 (N = 56)2.38 Units on a scaleStandard Deviation 2.02
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 12 (N = 58)1.97 Units on a scaleStandard Deviation 1.81
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 24 (N = 58)1.51 Units on a scaleStandard Deviation 1.69
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 36 (N = 57)1.56 Units on a scaleStandard Deviation 2.07
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 48 (N = 57)1.32 Units on a scaleStandard Deviation 1.82
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 72 (N = 55)1.17 Units on a scaleStandard Deviation 1.55
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 84 (N = 55)0.90 Units on a scaleStandard Deviation 1.21
EtanerceptPatient/Parent Global Assessment: eoJIA Sub-populationWeek 96 (N = 54)1.00 Units on a scaleStandard Deviation 1.43
Secondary

Patient/Parent Global Assessment: ERA Sub-population

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 8 (N = 36)3.19 Units on a scaleStandard Deviation 2.26
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 12 (N = 36)2.56 Units on a scaleStandard Deviation 2.13
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 24 (N = 36)2.26 Units on a scaleStandard Deviation 2.03
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationBaseline (N = 38)5.43 Units on a scaleStandard Deviation 2.26
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 4 (N = 38)3.62 Units on a scaleStandard Deviation 2.43
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 36 (N = 35)2.04 Units on a scaleStandard Deviation 2.05
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 48 (N = 34)2.07 Units on a scaleStandard Deviation 2.14
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 60 (N = 33)1.39 Units on a scaleStandard Deviation 1.74
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 72 (N = 32)1.39 Units on a scaleStandard Deviation 1.8
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 84 (N = 31)1.29 Units on a scaleStandard Deviation 1.6
EtanerceptPatient/Parent Global Assessment: ERA Sub-populationWeek 96 (N = 30)0.93 Units on a scaleStandard Deviation 1.19
Secondary

Patient/Parent Global Assessment: PsA Sub-population

Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 72 (N = 27)1.39 Units on a scaleStandard Deviation 1.64
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationBaseline (N = 29)4.62 Units on a scaleStandard Deviation 2.17
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 4 (N = 29)3.50 Units on a scaleStandard Deviation 2.14
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 8 (N = 29)3.10 Units on a scaleStandard Deviation 1.97
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 12 (N = 29)2.26 Units on a scaleStandard Deviation 1.46
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 24 (N = 28)1.75 Units on a scaleStandard Deviation 1.38
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 36 (N = 28)1.73 Units on a scaleStandard Deviation 1.64
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 48 (N = 28)1.82 Units on a scaleStandard Deviation 1.61
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 60 (N = 27)1.33 Units on a scaleStandard Deviation 1.42
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 84 (N = 27)1.59 Units on a scaleStandard Deviation 2.05
EtanerceptPatient/Parent Global Assessment: PsA Sub-populationWeek 96 (N = 25)0.96 Units on a scaleStandard Deviation 1.22
Secondary

Percentage of Participants With an ACR Pedi 100 Response

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 4 (N = 126)3.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 8 (N = 121)6.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 12 (N = 122)23.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 24 (N = 122)33.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 36 (N = 120)36.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 48 (N = 119)40.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 60 (N = 114)42.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 72 (N = 113)49.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 84 (N = 112)55.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 ResponseWeek 96 (N = 107)54.2 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 4 (N = 59)6.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 8 (N = 56)8.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 12 (N = 58)20.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 24 (N = 58)39.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 36 (N = 57)42.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 48 (N = 57)47.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 60 (N = 55)47.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 72 (N = 54)51.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 84 (N = 55)60.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-populationWeek 96 (N = 53)54.7 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 4 (N = 38)0.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 8 (N = 36)5.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 12 (N = 35)34.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 24 (N = 36)36.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 36 (N = 35)34.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 48 (N = 34)32.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 60 (N = 33)42.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 72 (N = 32)59.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 84 (N = 31)54.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: ERA Sub-populationWeek 96 (N = 30)50.0 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population

ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 48 (N = 28)35.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 60 (N = 26)30.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 4 (N = 29)0.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 8 (N = 29)3.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 12 (N = 29)13.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 24 (N = 28)17.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 36 (N = 28)28.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 72 (N = 27)33.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 84 (N = 26)46.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 100 Response: PsA Sub-populationWeek 96 (N = 24)58.3 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 30 Response

ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

Time frame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 4 (N = 126)71.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 8 (N = 121)88.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 12 (N = 123)88.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 24 (N = 122)94.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 36 (N = 120)95.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 48 (N = 119)94.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 60 (N = 116)95.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 72 (N = 114)96.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 84 (N = 113)93.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 ResponseWeek 96 (N = 108)99.1 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population

ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA:participants with arthritis(Ar) or(/)enthesitis,any 2:sacroiliac joint tenderness/inflammatory(Ifm)lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;acute anterior uveitis(AAU)/AAU first-degree relative.

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 4 (N = 38)84.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 8 (N = 36)91.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 12 (N = 36)83.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 24 (N = 36)91.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 48 (N = 34)91.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 84 (N = 31)90.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 36 (N = 35)97.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 60 (N = 33)90.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 72 (N = 32)93.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-populationWeek 96 (N = 30)100 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population

ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 4 (N = 59)67.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 8 (N = 56)87.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 12 (N = 58)89.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 24 (N = 58)94.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 36 (N = 57)94.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 48 (N = 57)96.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 60 (N = 56)98.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 72 (N = 55)98.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 84 (N = 55)98.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-populationWeek 96 (N = 53)100 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population

ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 4 (N = 29)62.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 8 (N = 29)86.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 12 (N = 29)93.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 24 (N = 28)96.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 36 (N = 28)96.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 48 (N = 28)92.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 60 (N = 27)96.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 72 (N = 27)96.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 84 (N = 27)88.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-populationWeek 96 (N = 25)96.0 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 50 Response

ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 12 (N = 122)81.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 24 (N = 122)88.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 36 (N = 120)88.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 72 (N = 114)93.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 84 (N = 113)91.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 96 (N = 108)98.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 4 (N = 125)51.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 8 (N = 121)76.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 48 (N = 119)93.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 ResponseWeek 60 (N = 116)92.2 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population

ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 4 (N = 58)51.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 96 (N = 53)100 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 8 (N = 56)75.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 12 (N = 58)79.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 24 (N = 58)86.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 36 (N = 57)91.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 48 (N = 57)94.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 60 (N = 56)92.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 72 (N = 55)96.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-populationWeek 84 (N = 55)96.4 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population

ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 4 (N = 38)63.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 8 (N = 36)86.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 12 (N = 35)80.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 24 (N = 36)86.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 36 (N = 35)82.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 48 (N = 34)91.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 60 (N = 33)87.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 72 (N = 32)90.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 84 (N = 31)83.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: ERA Sub-populationWeek 96 (N = 30)96.7 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population

ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 60 (N = 27)96.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 72 (N = 27)92.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 4 (N = 29)34.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 8 (N = 29)69.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 12 (N = 29)86.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 24 (N = 28)96.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 36 (N = 28)89.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 48 (N = 28)92.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 84 (N = 27)88.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 50 Response: PsA Sub-populationWeek 96 (N = 25)96.0 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 70 Response

ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 84 (N = 113)87.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 4 (N = 126)26.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 8 (N = 121)47.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 12 (N = 122)61.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 24 (N = 122)71.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 36 (N = 120)73.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 48 (N = 119)79.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 60 (N = 115)81.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 72 (N = 114)84.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 ResponseWeek 96 (N = 108)92.6 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population

ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 36 (N = 57)75.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 48 (N = 57)77.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 60 (N = 55)80.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 96 (N = 53)94.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 4 (N = 59)28.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 8 (N = 56)51.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 12 (N = 58)63.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 24 (N = 58)70.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 72 (N = 55)85.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-populationWeek 84 (N = 55)90.9 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population

ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 4 (N = 38)28.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 8 (N = 36)52.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 12 (N = 35)71.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 24 (N = 36)80.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 36 (N = 35)77.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 48 (N = 34)85.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 60 (N = 33)81.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 72 (N = 32)81.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 84 (N = 31)80.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: ERA Sub-populationWeek 96 (N = 30)86.7 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population

ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 48 (N = 28)78.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 4 (N = 29)17.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 8 (N = 29)31.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 12 (N = 29)44.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 24 (N = 28)60.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 36 (N = 28)64.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 60 (N = 27)85.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 72 (N = 27)85.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 84 (N = 27)88.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 70 Response: PsA Sub-populationWeek 96 (N = 25)96.0 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 90 Response

ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 4 (N = 126)6.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 8 (N = 121)14.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 12 (N = 121)29.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 24 (N = 122)43.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 36 (N = 120)47.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 48 (N = 119)50.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 60 (N = 115)53.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 72 (N = 113)60.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 84 (N = 113)64.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 ResponseWeek 96 (N = 107)65.4 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population

ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 4 (N = 59)6.8 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 8 (N = 56)16.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 12 (N = 58)27.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 24 (N = 58)53.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 36 (N = 57)49.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 48 (N = 57)52.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 60 (N = 55)52.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 72 (N = 54)61.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 84 (N = 55)67.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-populationWeek 96 (N = 53)62.3 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population

ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 48 (N = 34)50.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 4 (N = 38)10.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 8 (N = 36)22.2 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 12 (N = 35)45.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 24 (N = 36)41.7 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 36 (N = 35)48.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 60 (N = 33)57.6 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 72 (N = 32)71.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 84 (N = 31)64.5 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: ERA Sub-populationWeek 96 (N = 30)66.7 Percentage of participants
Secondary

Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population

ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 4 (N = 29)0.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 8 (N = 29)3.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 12 (N = 28)14.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 24 (N = 28)25.0 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 36 (N = 28)42.9 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 48 (N = 28)46.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 60 (N = 27)48.1 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 72 (N = 27)44.4 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 84 (N = 27)59.3 Percentage of participants
EtanerceptPercentage of Participants With an ACR Pedi 90 Response: PsA Sub-populationWeek 96 (N = 24)70.8 Percentage of participants
Secondary

Percentage of Participants With Inactive Disease Per Wallace 2004 Definition

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 4 (N = 126)2.4 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 8 (N = 121)2.5 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 12 (N = 123)12.2 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 24 (N = 121)24.8 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 36 (N = 120)25.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 48 (N = 118)29.7 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 60 (N = 113)33.6 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 72 (N = 111)36.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 84 (N = 110)34.5 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 DefinitionWeek 96 (N = 106)34.0 Percentage of participants
Secondary

Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 4 (N = 59)5.1 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 8 (N = 56)3.6 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 12 (N = 58)12.1 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 24 (N = 57)29.8 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 36 (N = 57)35.1 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 48 (N = 56)37.5 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 60 (N = 56)48.2 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 72 (N = 54)46.3 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 84 (N = 54)44.4 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-populationWeek 96 (N = 53)37.7 Percentage of participants
Secondary

Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA:participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history;ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;humanleukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 4 (N = 38)0.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 8 (N = 36)2.8 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 12 (N = 36)16.7 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 24 (N = 36)25.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 36 (N = 35)14.3 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 48 (N = 34)23.5 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 60 (N = 30)23.3 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 72 (N = 30)33.3 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 84 (N = 29)27.6 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-populationWeek 96 (N = 28)28.6 Percentage of participants
Secondary

Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population

Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.

Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 4 (N = 29)0.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 8 (N = 29)0.0 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 12 (N = 29)6.9 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 24 (N = 28)14.3 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 36 (N = 28)17.9 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 48 (N = 28)21.4 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 60 (N = 27)14.8 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 72 (N=27)18.5 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 84 (N = 27)22.2 Percentage of participants
EtanerceptPercentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-populationWeek 96 (N = 25)32.0 Percentage of participants
Secondary

Physician's Global Assessment (PGA) of Disease Activity

PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: mITT population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityBaseline (N = 127)5.02 Units on a scaleStandard Deviation 1.75
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 4 (N = 126)2.78 Units on a scaleStandard Deviation 1.78
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 8 (N = 121)2.00 Units on a scaleStandard Deviation 1.55
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 12 (N = 123)1.50 Units on a scaleStandard Deviation 1.3
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 24 (N = 122)1.15 Units on a scaleStandard Deviation 1.22
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 36 (N = 120)1.05 Units on a scaleStandard Deviation 1.17
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 48 (N = 119)1.03 Units on a scaleStandard Deviation 1.19
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 60 (N = 116)0.88 Units on a scaleStandard Deviation 0.99
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 72 (N = 113)0.78 Units on a scaleStandard Deviation 0.97
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 84 (N = 113)0.78 Units on a scaleStandard Deviation 1.04
EtanerceptPhysician's Global Assessment (PGA) of Disease ActivityWeek 96 (N = 108)0.62 Units on a scaleStandard Deviation 0.79
Secondary

Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population

PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationBaseline (N = 60)4.96 Units on a scaleStandard Deviation 1.76
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 4 (N = 59)2.73 Units on a scaleStandard Deviation 1.8
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 8 (N = 56)1.80 Units on a scaleStandard Deviation 1.62
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 12 (N = 58)1.40 Units on a scaleStandard Deviation 1.3
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 24 (N = 58)1.03 Units on a scaleStandard Deviation 1.34
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 36 (N = 57)0.89 Units on a scaleStandard Deviation 1.25
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 48 (N = 57)0.88 Units on a scaleStandard Deviation 1.2
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 60 (N = 56)0.83 Units on a scaleStandard Deviation 1.06
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 72 (N = 54)0.72 Units on a scaleStandard Deviation 0.99
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 84 (N = 55)0.60 Units on a scaleStandard Deviation 0.86
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-populationWeek 96 (N = 53)0.59 Units on a scaleStandard Deviation 0.81
Secondary

Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population

PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 12 (N = 36)1.53 Units on a scaleStandard Deviation 1.34
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 24 (N = 36)1.32 Units on a scaleStandard Deviation 1.12
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 36 (N = 35)1.21 Units on a scaleStandard Deviation 1.1
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 48 (N = 34)1.16 Units on a scaleStandard Deviation 1.14
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 60 (N = 33)0.80 Units on a scaleStandard Deviation 0.87
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationBaseline (N = 38)5.39 Units on a scaleStandard Deviation 1.94
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 4 (N = 38)2.71 Units on a scaleStandard Deviation 1.94
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 8 (N = 36)2.19 Units on a scaleStandard Deviation 1.5
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 72 (N = 32)0.78 Units on a scaleStandard Deviation 0.98
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 84 (N = 31)0.84 Units on a scaleStandard Deviation 1.09
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: ERA Sub-populationWeek 96 (N = 30)0.62 Units on a scaleStandard Deviation 0.67
Secondary

Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population

PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 48 (N = 28)1.18 Units on a scaleStandard Deviation 1.22
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 60 (N = 27)1.06 Units on a scaleStandard Deviation 0.99
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationBaseline (N = 29)4.66 Units on a scaleStandard Deviation 1.42
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 4 (N = 29)2.98 Units on a scaleStandard Deviation 1.56
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 8 (N = 29)2.14 Units on a scaleStandard Deviation 1.49
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 12 (N = 29)1.69 Units on a scaleStandard Deviation 1.28
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 24 (N = 28)1.18 Units on a scaleStandard Deviation 1.06
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 36 (N = 28)1.20 Units on a scaleStandard Deviation 1.09
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 72 (N = 27)0.89 Units on a scaleStandard Deviation 0.93
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 84 (N = 27)1.07 Units on a scaleStandard Deviation 1.25
EtanerceptPhysician's Global Assessment (PGA) of Disease Activity: PsA Sub-populationWeek 96 (N = 25)0.66 Units on a scaleStandard Deviation 0.9
Other Pre-specified

Body Mass Index (BMI) z-Score by Age Group

BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptBody Mass Index (BMI) z-Score by Age GroupWeek 12: 2 to 17 years (N = 123)0.03 z-scoreStandard Deviation 1.15
EtanerceptBody Mass Index (BMI) z-Score by Age GroupBaseline: 2 to 17 years (N = 125)0.03 z-scoreStandard Deviation 1.17
EtanerceptBody Mass Index (BMI) z-Score by Age GroupWeek 48: 2 to 17 years (N = 118)0.05 z-scoreStandard Deviation 1.11
EtanerceptBody Mass Index (BMI) z-Score by Age GroupWeek 72: 2 to 17 years (N = 114)0.07 z-scoreStandard Deviation 1.03
EtanerceptBody Mass Index (BMI) z-Score by Age GroupWeek 96: 2 to 17 years (N = 109)0.04 z-scoreStandard Deviation 1.06
Other Pre-specified

Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population

BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationBaseline: 2 to 4 years (N=15)-0.60 z-scoreStandard Deviation 1.7
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationBaseline: 5 to 11 years (N=22)0.03 z-scoreStandard Deviation 1.28
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationBaseline: 12 to 17 years (N=21)0.40 z-scoreStandard Deviation 0.72
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationBaseline: 2 to 17 years (N=58)0.00 z-scoreStandard Deviation 1.28
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 4 years (N=15)-0.78 z-scoreStandard Deviation 1.64
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 12: 5 to 11 years (N=22)0.21 z-scoreStandard Deviation 1.13
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 12: 12 to 17 years (N=21)0.38 z-scoreStandard Deviation 0.73
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 17 years (N=58)0.01 z-scoreStandard Deviation 1.25
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 4 years (N=14)-0.85 z-scoreStandard Deviation 1.69
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 48: 5 to 11 years (N=21)0.18 z-scoreStandard Deviation 0.96
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 48: 12 to 17 years (N=21)0.34 z-scoreStandard Deviation 0.68
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 17 years (N=56)-0.02 z-scoreStandard Deviation 1.19
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 72: 2 to 4 years (N=14)-0.48 z-scoreStandard Deviation 1.46
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 72: 5 to 11 years (N=21)0.37 z-scoreStandard Deviation 0.97
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 72: 12 to 17 years (N=20)0.20 z-scoreStandard Deviation 0.73
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 72: 2 to 17 years (N=55)0.09 z-scoreStandard Deviation 1.08
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 4 years (N=14)-0.50 z-scoreStandard Deviation 1.55
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 96: 5 to 11 years (N=20)0.44 z-scoreStandard Deviation 0.9
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 96: 12 to 17 years (N=20)0.05 z-scoreStandard Deviation 0.83
EtanerceptBody Mass Index (BMI) z-Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 17 years (N=54)0.05 z-scoreStandard Deviation 1.13
Other Pre-specified

Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population

BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptBody Mass Index (BMI) z-Score by Age Group for ERA Sub-populationBaseline: 12 to 17 years (N = 38)-0.29 z-scoreStandard Deviation 0.87
EtanerceptBody Mass Index (BMI) z-Score by Age Group for ERA Sub-populationWeek 12: 12 to 17 years (N = 36)-0.31 z-scoreStandard Deviation 0.86
EtanerceptBody Mass Index (BMI) z-Score by Age Group for ERA Sub-populationWeek 48: 12 to 17 years (N = 34)-0.27 z-scoreStandard Deviation 0.91
EtanerceptBody Mass Index (BMI) z-Score by Age Group for ERA Sub-populationWeek 72: 12 to 17 years (N = 32)-0.23 z-scoreStandard Deviation 0.87
EtanerceptBody Mass Index (BMI) z-Score by Age Group for ERA Sub-populationWeek 96: 12 to 17 years (N = 30)-0.29 z-scoreStandard Deviation 0.84
Other Pre-specified

Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population

BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptBody Mass Index (BMI) z-Score by Age Group for PsA Sub-populationBaseline: 12 to 17 years (N = 29)0.51 z-scoreStandard Deviation 1.17
EtanerceptBody Mass Index (BMI) z-Score by Age Group for PsA Sub-populationWeek 12: 12 to 17 years (N = 29)0.49 z-scoreStandard Deviation 1.14
EtanerceptBody Mass Index (BMI) z-Score by Age Group for PsA Sub-populationWeek 48: 12 to 17 years (N = 28)0.55 z-scoreStandard Deviation 1.01
EtanerceptBody Mass Index (BMI) z-Score by Age Group for PsA Sub-populationWeek 72: 12 to 17 years (N = 27)0.37 z-scoreStandard Deviation 1.04
EtanerceptBody Mass Index (BMI) z-Score by Age Group for PsA Sub-populationWeek 96: 12 to 17 years (N = 25)0.40 z-scoreStandard Deviation 1.06
Other Pre-specified

Height z-Score by Age Group

Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptHeight z-Score by Age GroupBaseline: 2 to 17 years (N = 125)0.19 z-scoreStandard Deviation 1.07
EtanerceptHeight z-Score by Age GroupWeek 12: 2 to 17 years (N = 123)0.31 z-scoreStandard Deviation 0.98
EtanerceptHeight z-Score by Age GroupWeek 48: 2 to 17 years (N = 118)0.34 z-scoreStandard Deviation 1.02
EtanerceptHeight z-Score by Age GroupWeek 72: 2 to 17 years (N = 114)0.41 z-scoreStandard Deviation 0.97
EtanerceptHeight z-Score by Age GroupWeek 96: 2 to 17 years (N = 109)0.39 z-scoreStandard Deviation 0.99
Other Pre-specified

Height z-Score by Age Group for eoJIA Sub-population

Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: eoJIA sub-population: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationBaseline: 2 to 17 years (N=58)0.06 z-scoreStandard Deviation 1.17
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 4 years (N=15)0.17 z-scoreStandard Deviation 0.97
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 12: 5 to 11 years (N=22)0.28 z-scoreStandard Deviation 1.23
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 12: 12 to 17 years (N=21)0.16 z-scoreStandard Deviation 0.83
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 17 years (N=58)0.21 z-scoreStandard Deviation 1.02
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 4 years (N=14)0.37 z-scoreStandard Deviation 1.06
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 48: 5 to 11 years (N=21)0.30 z-scoreStandard Deviation 1.3
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 48: 12 to 17 years (N=21)0.18 z-scoreStandard Deviation 0.87
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 17 years (N=56)0.27 z-scoreStandard Deviation 1.08
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 72: 2 to 4 years (N=14)0.39 z-scoreStandard Deviation 0.99
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 72: 5 to 11 years (N=21)0.43 z-scoreStandard Deviation 1.11
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 72: 12 to 17 years (N=20)0.20 z-scoreStandard Deviation 0.87
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 72: 2 to 17 years (N=55)0.34 z-scoreStandard Deviation 0.98
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 4 years (N=14)0.34 z-scoreStandard Deviation 0.99
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 96: 5 to 11 years (N=20)0.46 z-scoreStandard Deviation 1.15
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 96: 12 to 17 years (N=20)0.17 z-scoreStandard Deviation 0.89
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 17 years (N=54)0.32 z-scoreStandard Deviation 1.01
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationBaseline: 2 to 4 years (N=15)-0.24 z-scoreStandard Deviation 1.32
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationBaseline: 5 to 11 years (N=22)0.20 z-scoreStandard Deviation 1.35
EtanerceptHeight z-Score by Age Group for eoJIA Sub-populationBaseline: 12 to 17 years (N=21)0.13 z-scoreStandard Deviation 0.84
Other Pre-specified

Height z-Score by Age Group for ERA Sub-population

Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptHeight z-Score by Age Group for ERA Sub-populationBaseline: 12 to 17 years (N = 38)0.24 z-scoreStandard Deviation 0.89
EtanerceptHeight z-Score by Age Group for ERA Sub-populationWeek 72: 12 to 17 years (N = 32)0.46 z-scoreStandard Deviation 0.84
EtanerceptHeight z-Score by Age Group for ERA Sub-populationWeek 96: 12 to 17 years (N = 30)0.43 z-scoreStandard Deviation 0.86
EtanerceptHeight z-Score by Age Group for ERA Sub-populationWeek 12: 12 to 17 years (N = 36)0.35 z-scoreStandard Deviation 0.86
EtanerceptHeight z-Score by Age Group for ERA Sub-populationWeek 48: 12 to 17 years (N = 34)0.36 z-scoreStandard Deviation 0.85
Other Pre-specified

Height z-Score by Age Group for PsA Sub-population

Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 12, Week 48, Week 72, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptHeight z-Score by Age Group for PsA Sub-populationBaseline: 12 to 17 years (N = 29)0.41 z-scoreStandard Deviation 1.06
EtanerceptHeight z-Score by Age Group for PsA Sub-populationWeek 12: 12 to 17 years (N = 29)0.46 z-scoreStandard Deviation 1.05
EtanerceptHeight z-Score by Age Group for PsA Sub-populationWeek 48: 12 to 17 years (N = 28)0.47 z-scoreStandard Deviation 1.11
EtanerceptHeight z-Score by Age Group for PsA Sub-populationWeek 72: 12 to 17 years (N = 27)0.51 z-scoreStandard Deviation 1.1
EtanerceptHeight z-Score by Age Group for PsA Sub-populationWeek 96: 12 to 17 years (N = 25)0.48 z-scoreStandard Deviation 1.11
Other Pre-specified

Modified Schober's Test for ERA Sub-population

Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptModified Schober's Test for ERA Sub-populationWeek 24 (N = 36)5.35 cmStandard Deviation 2.1
EtanerceptModified Schober's Test for ERA Sub-populationWeek 36 (N = 35)5.49 cmStandard Deviation 2.1
EtanerceptModified Schober's Test for ERA Sub-populationWeek 48 (N = 34)5.38 cmStandard Deviation 1.59
EtanerceptModified Schober's Test for ERA Sub-populationWeek 84 (N = 30)5.47 cmStandard Deviation 1.68
EtanerceptModified Schober's Test for ERA Sub-populationWeek 96 (N = 30)5.33 cmStandard Deviation 1.65
EtanerceptModified Schober's Test for ERA Sub-populationBaseline (N = 37)5.03 cmStandard Deviation 1.94
EtanerceptModified Schober's Test for ERA Sub-populationWeek 4 (N = 38)5.24 cmStandard Deviation 1.94
EtanerceptModified Schober's Test for ERA Sub-populationWeek 8 (N = 36)5.12 cmStandard Deviation 2.36
EtanerceptModified Schober's Test for ERA Sub-populationWeek 12 (N = 36)5.45 cmStandard Deviation 1.98
EtanerceptModified Schober's Test for ERA Sub-populationWeek 60 (N = 33)5.33 cmStandard Deviation 1.71
EtanerceptModified Schober's Test for ERA Sub-populationWeek 72 (N = 32)5.27 cmStandard Deviation 1.59
Other Pre-specified

Nocturnal Back Pain Score for ERA Sub-population

Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 60 (N = 32)3.34 mmStandard Deviation 13.36
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 72 (N = 32)6.47 mmStandard Deviation 19.64
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 84 (N = 31)2.66 mmStandard Deviation 6.86
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 96 (N = 30)2.17 mmStandard Deviation 3.5
EtanerceptNocturnal Back Pain Score for ERA Sub-populationBaseline (N = 38)16.37 mmStandard Deviation 27.76
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 4 (N = 38)8.58 mmStandard Deviation 19.31
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 8 (N = 36)7.82 mmStandard Deviation 18.34
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 12 (N = 36)5.81 mmStandard Deviation 11.74
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 24 (N = 36)5.31 mmStandard Deviation 15.17
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 36 (N = 35)7.54 mmStandard Deviation 17.66
EtanerceptNocturnal Back Pain Score for ERA Sub-populationWeek 48 (N = 34)5.85 mmStandard Deviation 13.82
Other Pre-specified

Number of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

Time frame: Week 12, Week 96

Population: Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Adverse Events (AEs)Vaccine preventable infections8 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)ISRs16 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)Malignancies0 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)Infections96 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)Medically important infections11 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)Infection and ISRs excluded93 Participants
EtanerceptNumber of Participants With Adverse Events (AEs)Serious AE: Infection11 Participants
Other Pre-specified

Number of Participants With Adverse Events (AEs): eoJIA Subpopulation

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

Time frame: Week 12, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationMedically important infections4 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationVaccine preventable infections6 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationISRs8 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationMalignancies0 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationInfections48 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationInfection and ISRs excluded44 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): eoJIA SubpopulationSerious AE: Infection4 Participants
Other Pre-specified

Number of Participants With Adverse Events (AEs): ERA Sub-population

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

Time frame: Week 12, Week 96

Population: ERA:participants with Ar/enthesitis, any 2: sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis, ERA, sacroiliitis with Ifm bowel disease, Reiter's syndrome history; human leukocyte antigen-B27;Ar in male\>6yrs; AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationInfections28 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationMedically important infections4 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationVaccine preventable infections1 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationISRs6 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationMalignancies0 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationInfection and ISRs excluded30 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): ERA Sub-populationSerious AE: Infection4 Participants
Other Pre-specified

Number of Participants With Adverse Events (AEs): PsA Sub-population

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections.

Time frame: Week 12, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationMedically important infections3 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationVaccine preventable infections1 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationISRs2 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationMalignancies0 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationInfections20 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationInfection and ISRs excluded19 Participants
EtanerceptNumber of Participants With Adverse Events (AEs): PsA Sub-populationSerious AE: Infection3 Participants
Other Pre-specified

Number of Participants With Anti-etanercept Antibodies

Time frame: Baseline up to Week 12, Week 48, Week 96

Population: Safety population included all participants who received at least 1 dose of the study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Anti-etanercept AntibodiesWeek 96 (N=105)14 Participants
EtanerceptNumber of Participants With Anti-etanercept AntibodiesOverall (N=127)26 Participants
EtanerceptNumber of Participants With Anti-etanercept AntibodiesWeek 12 (N=120)6 Participants
EtanerceptNumber of Participants With Anti-etanercept AntibodiesWeek 48 (N=116)14 Participants
Other Pre-specified

Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population

Time frame: Baseline up to Week 12, Week 48, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Anti-etanercept Antibodies: eoJIA Sub-populationOverall (N=60)11 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: eoJIA Sub-populationWeek 12 (N=56)0 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: eoJIA Sub-populationWeek 48 (N=55)7 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: eoJIA Sub-populationWeek 96 (N=52)7 Participants
Other Pre-specified

Number of Participants With Anti-etanercept Antibodies: ERA Sub-population

Time frame: Baseline up to Week 12, Week 48, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Anti-etanercept Antibodies: ERA Sub-populationOverall (N=38)9 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: ERA Sub-populationWeek 12 (N=36)4 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: ERA Sub-populationWeek 48 (N=34)4 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: ERA Sub-populationWeek 96 (N=29)3 Participants
Other Pre-specified

Number of Participants With Anti-etanercept Antibodies: PsA Sub-population

Time frame: Baseline up to Week 12, Week 48, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a firstdegree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (NUMBER)
EtanerceptNumber of Participants With Anti-etanercept Antibodies: PsA Sub-populationOverall (N=29)6 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: PsA Sub-populationWeek 12 (N=28)2 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: PsA Sub-populationWeek 48 (N=27)3 Participants
EtanerceptNumber of Participants With Anti-etanercept Antibodies: PsA Sub-populationWeek 96 (N=24)4 Participants
Other Pre-specified

Number of Participants With Neutralizing Anti-etanercept Antibodies

Time frame: Baseline up to Week 12, Week 48, Week 96

Population: Safety population included all participants who received at least 1 dose of the study medication.

ArmMeasureValue (NUMBER)
EtanerceptNumber of Participants With Neutralizing Anti-etanercept Antibodies0 Participants
Other Pre-specified

Overall Back Pain Score for ERA Sub-population

Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 36 (N = 35)10.16 mmStandard Deviation 19.2
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 24 (N = 36)9.81 mmStandard Deviation 17.23
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 12 (N = 36)11.83 mmStandard Deviation 18.22
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 48 (N = 34)8.62 mmStandard Deviation 15.76
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 60 (N = 32)5.13 mmStandard Deviation 12.28
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 72 (N = 32)6.03 mmStandard Deviation 14.67
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 84 (N = 31)5.03 mmStandard Deviation 8.4
EtanerceptOverall Back Pain Score for ERA Sub-populationBaseline (N = 37)25.94 mmStandard Deviation 28
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 4 (N = 38)14.24 mmStandard Deviation 19.87
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 8 (N = 36)12.94 mmStandard Deviation 22.6
EtanerceptOverall Back Pain Score for ERA Sub-populationWeek 96 (N = 30)2.37 mmStandard Deviation 4.51
Other Pre-specified

Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population

Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage \[Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)\]. The total BSA affected was the summation of individual regions affected.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationBaseline (N = 29)9.83 Percentage of BSAStandard Deviation 13.61
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 4 (N = 29)6.81 Percentage of BSAStandard Deviation 9.02
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 8 (N = 29)4.67 Percentage of BSAStandard Deviation 7.68
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 12 (N = 29)3.49 Percentage of BSAStandard Deviation 5.66
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 24 (N = 28)2.36 Percentage of BSAStandard Deviation 4.24
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 36 (N = 28)2.91 Percentage of BSAStandard Deviation 8.7
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 60 (N = 27)1.48 Percentage of BSAStandard Deviation 2.38
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 72 (N = 27)1.53 Percentage of BSAStandard Deviation 2.17
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 84 (N = 27)1.56 Percentage of BSAStandard Deviation 2.27
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 96 (N = 25)1.14 Percentage of BSAStandard Deviation 2.12
EtanerceptPercentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-populationWeek 48 (N = 28)3.12 Percentage of BSAStandard Deviation 8.13
Other Pre-specified

Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population

PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and Almost clear' includes all participants who were scored as a 0 or 1.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationBaseline (N = 29)1.76 Units on a scaleStandard Deviation 1.46
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 4 (N = 29)1.41 Units on a scaleStandard Deviation 1.18
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 8 (N = 29)1.07 Units on a scaleStandard Deviation 1.03
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 12 (N = 28)0.82 Units on a scaleStandard Deviation 0.72
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 24 (N = 28)0.61 Units on a scaleStandard Deviation 0.69
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 36 (N = 28)0.61 Units on a scaleStandard Deviation 0.88
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 48 (N = 28)0.75 Units on a scaleStandard Deviation 0.89
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 60 (N = 27)0.78 Units on a scaleStandard Deviation 0.97
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 72 (N = 26)0.65 Units on a scaleStandard Deviation 0.94
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 84 (N = 27)0.56 Units on a scaleStandard Deviation 0.85
EtanerceptPhysician's Global Assessment (PGA) of Psoriasis for PsA Sub-populationWeek 96 (N = 25)0.48 Units on a scaleStandard Deviation 0.82
Other Pre-specified

Tanner Assessment Score by Age Group

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

Time frame: Baseline, Week 12, Week 48, Week 96

Population: Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptTanner Assessment Score by Age GroupBaseline: 2 to 17 years (N = 126)3.08 Units on a scaleStandard Deviation 1.59
EtanerceptTanner Assessment Score by Age GroupWeek 12: 2 to 17 years (N = 122)3.18 Units on a scaleStandard Deviation 1.63
EtanerceptTanner Assessment Score by Age GroupWeek 48: 2 to 17 years (N = 118)3.34 Units on a scaleStandard Deviation 1.61
EtanerceptTanner Assessment Score by Age GroupWeek 96: 2 to 17 years (N = 106)3.57 Units on a scaleStandard Deviation 1.61
Other Pre-specified

Tanner Assessment Score by Age Group for eoJIA Sub-population

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

Time frame: Baseline, Week 12, Week 48, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease that progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationBaseline: 2 to 4 years (N=14)1.00 Units on a scaleStandard Deviation 0
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationBaseline: 5 to 11 years (N=23)1.16 Units on a scaleStandard Deviation 0.44
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationBaseline: 12 to 17 years (N=22)3.94 Units on a scaleStandard Deviation 0.97
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationBaseline: 2 to 17 years (N=59)2.16 Units on a scaleStandard Deviation 1.53
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 4 years (N=14)1.00 Units on a scaleStandard Deviation 0
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 12: 5 to 11 years (N=22)1.17 Units on a scaleStandard Deviation 0.45
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 12: 12 to 17 years (N=21)4.02 Units on a scaleStandard Deviation 0.95
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 12: 2 to 17 years (N=57)2.18 Units on a scaleStandard Deviation 1.56
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 4 years (n=13)1.00 Units on a scaleStandard Deviation 0
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 48: 5 to 11 years (N=22)1.30 Units on a scaleStandard Deviation 0.63
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 48: 12 to 17 years (N=21)4.35 Units on a scaleStandard Deviation 0.83
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 48: 2 to 17 years (N=56)2.37 Units on a scaleStandard Deviation 1.67
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 4 years (N=13)1.00 Units on a scaleStandard Deviation 0
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 96: 5 to 11 years (N=19)1.67 Units on a scaleStandard Deviation 1.08
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 96: 12 to 17 years (N=20)4.53 Units on a scaleStandard Deviation 0.62
EtanerceptTanner Assessment Score by Age Group for eoJIA Sub-populationWeek 96: 2 to 17 years (N=52)2.60 Units on a scaleStandard Deviation 1.73
Other Pre-specified

Tanner Assessment Score by Age Group for ERA Sub-population

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

Time frame: Baseline, Week 12, Week 48, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptTanner Assessment Score by Age Group for ERA Sub-populationBaseline: 12 to 17 years (N = 38)3.87 Units on a scaleStandard Deviation 1.07
EtanerceptTanner Assessment Score by Age Group for ERA Sub-populationWeek 12: 12 to 17 years (N = 36)4.09 Units on a scaleStandard Deviation 1.04
EtanerceptTanner Assessment Score by Age Group for ERA Sub-populationWeek 48: 12 to 17 years (N = 34)4.24 Units on a scaleStandard Deviation 0.84
EtanerceptTanner Assessment Score by Age Group for ERA Sub-populationWeek 96: 12 to 17 years (N = 30)4.51 Units on a scaleStandard Deviation 0.66
Other Pre-specified

Tanner Assessment Score by Age Group for PsA Sub-population

Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).

Time frame: Baseline, Week 12, Week 48, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptTanner Assessment Score by Age Group for PsA Sub-populationBaseline: 12 to 17 years (N = 29)3.93 Units on a scaleStandard Deviation 1.22
EtanerceptTanner Assessment Score by Age Group for PsA Sub-populationWeek 12: 12 to 17 years (N = 29)4.02 Units on a scaleStandard Deviation 1.19
EtanerceptTanner Assessment Score by Age Group for PsA Sub-populationWeek 48: 12 to 17 years (N = 28)4.20 Units on a scaleStandard Deviation 0.95
EtanerceptTanner Assessment Score by Age Group for PsA Sub-populationWeek 96: 12 to 17 years (N = 24)4.51 Units on a scaleStandard Deviation 0.69
Other Pre-specified

Tender Entheseal Assessment for ERA Sub-population

Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66\*(total number of tender entheses with counts \> 0)/number of non-missing tender entheses. If \> 33 tender entheseal counts were missing, total number of tender entheses was defined as missing.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptTender Entheseal Assessment for ERA Sub-populationBaseline (N = 38)5.87 Tender enthesesStandard Deviation 9.42
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 4 (N = 38)4.68 Tender enthesesStandard Deviation 11.81
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 8 (N = 36)2.06 Tender enthesesStandard Deviation 5.79
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 12 (N = 36)1.81 Tender enthesesStandard Deviation 6.15
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 24 (N = 36)1.89 Tender enthesesStandard Deviation 6.89
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 60 (N = 33)0.97 Tender enthesesStandard Deviation 2.98
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 36 (N = 35)2.03 Tender enthesesStandard Deviation 5.7
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 48 (N = 34)1.32 Tender enthesesStandard Deviation 3.76
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 72 (N = 32)0.56 Tender enthesesStandard Deviation 1.29
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 84 (N = 31)0.77 Tender enthesesStandard Deviation 2
EtanerceptTender Entheseal Assessment for ERA Sub-populationWeek 96 (N = 30)0.33 Tender enthesesStandard Deviation 1.03
Other Pre-specified

Weight z-Scores by Age Group

Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: Safety population: participants who received at least 1 dose of study medication. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptWeight z-Scores by Age GroupBaseline: 2 to 17 years (N = 127)0.17 z-scoreStandard Deviation 1.02
EtanerceptWeight z-Scores by Age GroupWeek 4: 2 to 17 years (N = 126)0.18 z-scoreStandard Deviation 1.02
EtanerceptWeight z-Scores by Age GroupWeek 8: 2 to 17 years (N = 121)0.23 z-scoreStandard Deviation 1.02
EtanerceptWeight z-Scores by Age GroupWeek 12: 2 to 17 years (N = 123)0.22 z-scoreStandard Deviation 1
EtanerceptWeight z-Scores by Age GroupWeek 24: 2 to 17 years (N = 122)0.25 z-scoreStandard Deviation 0.99
EtanerceptWeight z-Scores by Age GroupWeek 36: 2 to 17 years (N = 120)0.26 z-scoreStandard Deviation 0.97
EtanerceptWeight z-Scores by Age GroupWeek 48: 2 to 17 years (N = 118)0.25 z-scoreStandard Deviation 0.97
EtanerceptWeight z-Scores by Age GroupWeek 60: 2 to 17 years (N = 116)0.24 z-scoreStandard Deviation 0.95
EtanerceptWeight z-Scores by Age GroupWeek 72: 2 to 17 years (N = 114)0.29 z-scoreStandard Deviation 0.91
EtanerceptWeight z-Scores by Age GroupWeek 84: 2 to 17 years (N = 113)0.27 z-scoreStandard Deviation 0.93
EtanerceptWeight z-Scores by Age GroupWeek 96: 2 to 17 years (N = 109)0.25 z-scoreStandard Deviation 0.93
Other Pre-specified

Weight z-Scores by Age Group for eoJIA Sub-population

Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: eoJIA: participants with arthritis affecting 1 to 4 joints during the first 6 months of the disease and had progressed to affect more than 4 joints after the first 6 months of disease. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationBaseline: 2 to 4 years (N=15)-0.50 z-scoreStandard Deviation 0.98
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationBaseline: 5 to 11 years (N=23)0.15 z-scoreStandard Deviation 1.33
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationBaseline: 12 to 17 years (N=22)0.40 z-scoreStandard Deviation 0.72
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationBaseline: 2 to 17 years (N=60)0.08 z-scoreStandard Deviation 1.1
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 4: 2 to 4 years (N=15)-0.54 z-scoreStandard Deviation 1.13
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 4: 5 to 11 years (N=23)0.17 z-scoreStandard Deviation 1.34
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 4: 12 to 17 years (N=21)0.38 z-scoreStandard Deviation 0.69
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 4: 2 to 17 years (N=59)0.06 z-scoreStandard Deviation 1.13
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 8: 2 to 4 years (N=14)-0.48 z-scoreStandard Deviation 1.25
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 8: 5 to 11 years (N=21)0.30 z-scoreStandard Deviation 1.3
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 8: 12 to 17 years (N=21)0.40 z-scoreStandard Deviation 0.72
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 8: 2 to 17 years (N=56)0.14 z-scoreStandard Deviation 1.14
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 12: 2 to 4 years (n=15)-0.35 z-scoreStandard Deviation 1.09
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 12: 5 to 11 years (N=22)0.22 z-scoreStandard Deviation 1.35
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 12: 12 to 17 years (N=21)0.41 z-scoreStandard Deviation 0.72
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 12: 2 to 17 years (N=58)0.14 z-scoreStandard Deviation 1.11
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 24: 2 to 4 years (N=15)-0.21 z-scoreStandard Deviation 1.1
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 24: 5 to 11 years (N=22)0.21 z-scoreStandard Deviation 1.32
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 24: 12 to 17 years (N=21)0.46 z-scoreStandard Deviation 0.69
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 24: 2 to 17 years (N=58)0.19 z-scoreStandard Deviation 1.08
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 36: 2 to 4 years (N=14)-0.25 z-scoreStandard Deviation 1.14
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 36: 5 to 11 years (N=22)0.27 z-scoreStandard Deviation 1.25
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 36: 12 to 17 years (N=21)0.39 z-scoreStandard Deviation 0.7
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 36: 2 to 17 years (N=57)0.18 z-scoreStandard Deviation 1.06
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 48: 2 to 4 years (N=14)-0.28 z-scoreStandard Deviation 1.15
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 48: 5 to 11 years (N=21)0.21 z-scoreStandard Deviation 1.24
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 48: 12 to 17 years (N=21)0.40 z-scoreStandard Deviation 0.65
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 48: 2 to 17 years (N=56)0.16 z-scoreStandard Deviation 1.05
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 60: 2 to 4 years (N=14)-0.18 z-scoreStandard Deviation 1.15
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 60: 5 to 11 years (N=22)0.23 z-scoreStandard Deviation 1.24
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 60: 12 to 17 years (N=20)0.31 z-scoreStandard Deviation 0.62
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 60: 2 to 17 years (N=56)0.16 z-scoreStandard Deviation 1.04
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 72: 2 to 4 years (N=14)-0.09 z-scoreStandard Deviation 1.12
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 72: 5 to 11 years (N=21)0.43 z-scoreStandard Deviation 1.13
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 72: 12 to 17 years (N=20)0.29 z-scoreStandard Deviation 0.67
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 72: 2 to 17 years (N=55)0.25 z-scoreStandard Deviation 0.99
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 84: 2 to 4 years (N=14)-0.10 z-scoreStandard Deviation 1.13
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 84: 5 to 11 years (N=21)0.42 z-scoreStandard Deviation 1.15
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 84: 12 to 17 years (N=20)0.23 z-scoreStandard Deviation 0.74
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 84: 2 to 17 years (N=55)0.22 z-scoreStandard Deviation 1.02
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 96: 2 to 4 years (N=14)-0.14 z-scoreStandard Deviation 1.18
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 96: 5 to 11 years (N=20)0.49 z-scoreStandard Deviation 1.11
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 96: 12 to 17 years (N=20)0.16 z-scoreStandard Deviation 0.76
EtanerceptWeight z-Scores by Age Group for eoJIA Sub-populationWeek 96: 2 to 17 years (N=54)0.20 z-scoreStandard Deviation 1.03
Other Pre-specified

Weight z-Scores by Age Group for ERA Sub-population

Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: ERA: participants with Ar/enthesitis,any 2:sacroiliac joint tenderness/Ifm lumbosacral pain history; ankylosing spondylitis,ERA,sacroiliitis with Ifm bowel disease,Reiter's syndrome history;human leukocyte antigen;Ar in male\>6years;AAU/AAU in first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationBaseline: 12 to 17 years (N = 38)-0.05 z-scoreStandard Deviation 0.74
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 4: 12 to 17 years (N = 38)-0.00 z-scoreStandard Deviation 0.72
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 8: 12 to 17 years (N = 36)0.04 z-scoreStandard Deviation 0.68
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 12: 12 to 17 years (N = 36)-0.00 z-scoreStandard Deviation 0.65
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 24: 12 to 17 years (N = 36)0.01 z-scoreStandard Deviation 0.68
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 36: 12 to 17 years (N = 35)0.03 z-scoreStandard Deviation 0.68
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 48: 12 to 17 years (N = 34)0.04 z-scoreStandard Deviation 0.7
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 60: 12 to 17 years (N = 33)0.08 z-scoreStandard Deviation 0.67
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 72: 12 to 17 years (N = 32)0.12 z-scoreStandard Deviation 0.65
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 84: 12 to 17 years (N = 31)0.07 z-scoreStandard Deviation 0.67
EtanerceptWeight z-Scores by Age Group for ERA Sub-populationWeek 96: 12 to 17 years (N = 30)0.06 z-scoreStandard Deviation 0.63
Other Pre-specified

Weight z-Scores by Age Group for PsA Sub-population

Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, \>0 a greater mean, and \<0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96

Population: PsA: participants with arthritis and psoriasis, or arthritis plus at least 2 of the following: 1) dactylitis; 2) nail pitting or onycholysis; 3) psoriasis in a first-degree relative. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).

ArmMeasureGroupValue (MEAN)Dispersion
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationBaseline: 12 to 17 years (N = 29)0.63 z-scoreStandard Deviation 1.05
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 4: 12 to 17 years (N = 29)0.66 z-scoreStandard Deviation 1.01
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 8: 12 to 17 years (N = 29)0.64 z-scoreStandard Deviation 1.04
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 12: 12 to 17 years (N = 29)0.63 z-scoreStandard Deviation 1.04
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 24: 12 to 17 years (N = 28)0.66 z-scoreStandard Deviation 1.04
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 36: 12 to 17 years (N = 28)0.69 z-scoreStandard Deviation 0.97
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 48: 12 to 17 years (N = 28)0.70 z-scoreStandard Deviation 0.96
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 60: 12 to 17 years (N = 27)0.61 z-scoreStandard Deviation 1
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 72: 12 to 17 years (N = 27)0.57 z-scoreStandard Deviation 0.97
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 84: 12 to 17 years (N = 27)0.59 z-scoreStandard Deviation 0.94
EtanerceptWeight z-Scores by Age Group for PsA Sub-populationWeek 96: 12 to 17 years (N = 25)0.59 z-scoreStandard Deviation 0.96

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026