Arthritis, Juvenile Idiopathic
Conditions
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
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Morning Stiffness: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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). |
| Patient/Parent Global Assessment | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Patient/Parent Global Assessment: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Patient/Parent Global Assessment: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Patient/Parent Global Assessment: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Active Joints | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Active Joints: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Active Joints: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Active Joints: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Joints With Limitation of Motion | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Pain Assessment: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Pain Assessment: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Joints With Limitation of Motion: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Joints With Limitation of Motion: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Joints With Limitation of Motion: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| C-reactive Protein (CRP) | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| C-reactive Protein (CRP): eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| C-reactive Protein (CRP): ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| C-reactive Protein (CRP): PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Pain Assessment | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Pain Assessment: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Duration of Morning Stiffness | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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). |
| Duration of Morning Stiffness: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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). |
| Duration of Morning Stiffness: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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). |
| Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Childhood Health Assessment Questionnaire (CHAQ) Score | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 30 Response | Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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). |
| Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 50 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 70 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 90 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 100 Response | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Physician's Global Assessment (PGA) of Disease Activity | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Back Pain Score for ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | Nocturnal 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-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Number of Participants With Adverse Events (AEs) | Week 12, Week 96 | 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. |
| Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Week 12, Week 96 | 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. |
| Number of Participants With Adverse Events (AEs): ERA Sub-population | Week 12, Week 96 | 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. |
| Number of Participants With Adverse Events (AEs): PsA Sub-population | Week 12, Week 96 | 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. |
| Tanner Assessment Score by Age Group | Baseline, Week 12, Week 48, Week 96 | 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). |
| Tanner Assessment Score by Age Group for eoJIA Sub-population | Baseline, Week 12, Week 48, Week 96 | 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). |
| Tanner Assessment Score by Age Group for ERA Sub-population | Baseline, Week 12, Week 48, Week 96 | 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). |
| Tanner Assessment Score by Age Group for PsA Sub-population | Baseline, Week 12, Week 48, Week 96 | 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). |
| Height z-Score by Age Group | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Height z-Score by Age Group for eoJIA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Height z-Score by Age Group for ERA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Height z-Score by Age Group for PsA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Weight z-Scores by Age Group | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Weight z-Scores by Age Group for eoJIA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Weight z-Scores by Age Group for ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Weight z-Scores by Age Group for PsA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Body Mass Index (BMI) z-Score by Age Group | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Baseline, Week 12, Week 48, Week 72, Week 96 | 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. |
| Number of Participants With Anti-etanercept Antibodies | Baseline up to Week 12, Week 48, Week 96 | — |
| Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population | Baseline up to Week 12, Week 48, Week 96 | — |
| Number of Participants With Anti-etanercept Antibodies: ERA Sub-population | Baseline up to Week 12, Week 48, Week 96 | — |
| Number of Participants With Anti-etanercept Antibodies: PsA Sub-population | Baseline up to Week 12, Week 48, Week 96 | — |
| Number of Participants With Neutralizing Anti-etanercept Antibodies | Baseline up to Week 12, Week 48, Week 96 | — |
| Overall Back Pain Score for ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
| Tender Entheseal Assessment for ERA Sub-population | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | 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. |
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
| Arm | Count |
|---|---|
| Etanercept Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | drug ineffective+prohibited drug taken | 1 |
| Overall Study | Failed to return | 3 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Etanercept |
|---|---|
| Age, Continuous | 11.70 Years STANDARD_DEVIATION 4.51 |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 127 |
| serious Total, serious adverse events | 24 / 127 |
Outcome results
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | 88.6 Percentage of participants |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 12 (N = 123) | 0.32 Units on a scale | Standard Deviation 0.4 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 24 (N = 122) | 0.28 Units on a scale | Standard Deviation 0.39 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 36 (N = 120) | 0.23 Units on a scale | Standard Deviation 0.39 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 48 (N = 119) | 0.24 Units on a scale | Standard Deviation 0.41 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 60 (N = 116) | 0.20 Units on a scale | Standard Deviation 0.37 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 72 (N = 114) | 0.17 Units on a scale | Standard Deviation 0.32 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 84 (N = 113) | 0.17 Units on a scale | Standard Deviation 0.35 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 96 (N = 109) | 0.16 Units on a scale | Standard Deviation 0.35 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Baseline (N = 127) | 0.80 Units on a scale | Standard Deviation 0.63 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 4 (N = 126) | 0.54 Units on a scale | Standard Deviation 0.55 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score | Week 8 (N = 121) | 0.42 Units on a scale | Standard Deviation 0.45 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 12 (N = 58) | 0.40 Units on a scale | Standard Deviation 0.48 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 36 (N = 57) | 0.26 Units on a scale | Standard Deviation 0.46 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 48 (N = 57) | 0.27 Units on a scale | Standard Deviation 0.48 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 60 (N = 56) | 0.25 Units on a scale | Standard Deviation 0.45 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 72 (N = 55) | 0.21 Units on a scale | Standard Deviation 0.37 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 84 (N = 55) | 0.21 Units on a scale | Standard Deviation 0.41 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 96 (N = 54) | 0.20 Units on a scale | Standard Deviation 0.4 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Baseline (N = 60) | 0.90 Units on a scale | Standard Deviation 0.68 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 4 (N = 59) | 0.64 Units on a scale | Standard Deviation 0.6 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 8 (N = 56) | 0.50 Units on a scale | Standard Deviation 0.54 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | Week 24 (N = 58) | 0.31 Units on a scale | Standard Deviation 0.43 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Baseline (N = 38) | 0.72 Units on a scale | Standard Deviation 0.51 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 4 (N = 38) | 0.48 Units on a scale | Standard Deviation 0.56 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 12 (N = 36) | 0.23 Units on a scale | Standard Deviation 0.27 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 24 (N = 36) | 0.27 Units on a scale | Standard Deviation 0.38 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 48 (N = 34) | 0.18 Units on a scale | Standard Deviation 0.28 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 60 (N = 33) | 0.17 Units on a scale | Standard Deviation 0.29 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 72 (N = 32) | 0.13 Units on a scale | Standard Deviation 0.27 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 84 (N = 31) | 0.10 Units on a scale | Standard Deviation 0.22 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 96 (N = 30) | 0.08 Units on a scale | Standard Deviation 0.21 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 8 (N = 36) | 0.40 Units on a scale | Standard Deviation 0.34 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | Week 36 (N = 35) | 0.20 Units on a scale | Standard Deviation 0.32 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Baseline (N = 29) | 0.68 Units on a scale | Standard Deviation 0.63 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 4 (N = 29) | 0.42 Units on a scale | Standard Deviation 0.41 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 8 (N = 29) | 0.30 Units on a scale | Standard Deviation 0.34 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 12 (N = 29) | 0.29 Units on a scale | Standard Deviation 0.35 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 24 (N = 28) | 0.26 Units on a scale | Standard Deviation 0.32 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 48 (N = 28) | 0.24 Units on a scale | Standard Deviation 0.38 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 60 (N = 27) | 0.13 Units on a scale | Standard Deviation 0.25 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 72 (N = 27) | 0.15 Units on a scale | Standard Deviation 0.29 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 84 (N = 27) | 0.18 Units on a scale | Standard Deviation 0.35 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 96 (N = 25) | 0.18 Units on a scale | Standard Deviation 0.36 |
| Etanercept | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | Week 36 (N = 28) | 0.21 Units on a scale | Standard Deviation 0.32 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | C-reactive Protein (CRP) | Baseline (N = 127) | 8.26 mg/Liter (mg/L) | Standard Deviation 14.7 |
| Etanercept | C-reactive Protein (CRP) | Week 4 (N = 125) | 3.29 mg/Liter (mg/L) | Standard Deviation 7.85 |
| Etanercept | C-reactive Protein (CRP) | Week 8 (N = 121) | 2.32 mg/Liter (mg/L) | Standard Deviation 3.92 |
| Etanercept | C-reactive Protein (CRP) | Week 12 (N = 120) | 2.47 mg/Liter (mg/L) | Standard Deviation 7.19 |
| Etanercept | C-reactive Protein (CRP) | Week 24 (N = 120) | 3.54 mg/Liter (mg/L) | Standard Deviation 10.72 |
| Etanercept | C-reactive Protein (CRP) | Week 36 (N = 119) | 2.81 mg/Liter (mg/L) | Standard Deviation 5.75 |
| Etanercept | C-reactive Protein (CRP) | Week 48 (N = 117) | 2.04 mg/Liter (mg/L) | Standard Deviation 3.94 |
| Etanercept | C-reactive Protein (CRP) | Week 60 (N = 110) | 2.16 mg/Liter (mg/L) | Standard Deviation 4.87 |
| Etanercept | C-reactive Protein (CRP) | Week 72 (N = 111) | 2.26 mg/Liter (mg/L) | Standard Deviation 4.01 |
| Etanercept | C-reactive Protein (CRP) | Week 84 (N = 109) | 3.98 mg/Liter (mg/L) | Standard Deviation 12.51 |
| Etanercept | C-reactive Protein (CRP) | Week 96 (N = 103) | 2.76 mg/Liter (mg/L) | Standard Deviation 5.27 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 72 (N = 55) | 2.42 mg/L | Standard Deviation 4.28 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 84 (N = 54) | 3.94 mg/L | Standard Deviation 9.13 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Baseline (N = 60) | 6.27 mg/L | Standard Deviation 10.59 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 4 (N = 58) | 3.45 mg/L | Standard Deviation 7.79 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 8 (N = 56) | 2.66 mg/L | Standard Deviation 5.05 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 12 (N = 58) | 3.36 mg/L | Standard Deviation 10.07 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 24 (N = 56) | 5.26 mg/L | Standard Deviation 15.34 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 36 (N = 57) | 3.25 mg/L | Standard Deviation 6.56 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 48 (N = 55) | 1.93 mg/L | Standard Deviation 4.2 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 60 (N = 55) | 2.76 mg/L | Standard Deviation 6.52 |
| Etanercept | C-reactive Protein (CRP): eoJIA Sub-population | Week 96 (N = 52) | 3.34 mg/L | Standard Deviation 6.62 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Baseline (N = 38) | 15.27 mg/L | Standard Deviation 21.52 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 4 (N = 38) | 4.37 mg/L | Standard Deviation 10.36 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 8 (N = 36) | 2.53 mg/L | Standard Deviation 3.3 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 12 (N = 34) | 1.87 mg/L | Standard Deviation 2.84 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 24 (N = 36) | 1.96 mg/L | Standard Deviation 2.04 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 36 (N = 35) | 3.24 mg/L | Standard Deviation 6.41 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 48 (N = 34) | 2.79 mg/L | Standard Deviation 4.89 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 60 (N = 30) | 1.99 mg/L | Standard Deviation 2.84 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 72 (N = 30) | 2.12 mg/L | Standard Deviation 4.03 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 84 (N = 29) | 6.36 mg/L | Standard Deviation 20.81 |
| Etanercept | C-reactive Protein (CRP): ERA Sub-population | Week 96 (N = 27) | 2.68 mg/L | Standard Deviation 4.1 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 4 (N = 29) | 1.58 mg/L | Standard Deviation 1.73 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 8 (N = 29) | 1.41 mg/L | Standard Deviation 0.98 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 12 (N = 28) | 1.36 mg/L | Standard Deviation 0.75 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 24 (N = 28) | 2.11 mg/L | Standard Deviation 3.16 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 36 (N = 27) | 1.31 mg/L | Standard Deviation 0.81 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 48 (N = 28) | 1.35 mg/L | Standard Deviation 0.97 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 60 (N = 25) | 1.04 mg/L | Standard Deviation 0.12 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 72 (N = 26) | 2.08 mg/L | Standard Deviation 3.51 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 84 (N = 26) | 1.44 mg/L | Standard Deviation 0.97 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Week 96 (N = 24) | 1.58 mg/L | Standard Deviation 2.18 |
| Etanercept | C-reactive Protein (CRP): PsA Sub-population | Baseline (N = 29) | 3.19 mg/L | Standard Deviation 4.71 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Duration of Morning Stiffness | Week 48 (N = 119) | 6.01 Minutes | Standard Deviation 23.94 |
| Etanercept | Duration of Morning Stiffness | Week 60 (N = 116) | 7.28 Minutes | Standard Deviation 30.28 |
| Etanercept | Duration of Morning Stiffness | Baseline (N = 127) | 73.50 Minutes | Standard Deviation 100.61 |
| Etanercept | Duration of Morning Stiffness | Week 4 (N = 126) | 29.86 Minutes | Standard Deviation 60 |
| Etanercept | Duration of Morning Stiffness | Week 8 (N = 121) | 25.02 Minutes | Standard Deviation 75.32 |
| Etanercept | Duration of Morning Stiffness | Week 12 (N = 123) | 13.29 Minutes | Standard Deviation 41.2 |
| Etanercept | Duration of Morning Stiffness | Week 24 (N = 122) | 8.83 Minutes | Standard Deviation 23.41 |
| Etanercept | Duration of Morning Stiffness | Week 36 (N = 120) | 6.76 Minutes | Standard Deviation 24.41 |
| Etanercept | Duration of Morning Stiffness | Week 72 (N = 113) | 8.98 Minutes | Standard Deviation 30.67 |
| Etanercept | Duration of Morning Stiffness | Week 84 (N = 112) | 8.40 Minutes | Standard Deviation 32.38 |
| Etanercept | Duration of Morning Stiffness | Week 96 (N = 109) | 5.76 Minutes | Standard Deviation 21.7 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Baseline (N = 60) | 72.78 Minutes | Standard Deviation 97.24 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 4 (N = 59) | 20.46 Minutes | Standard Deviation 47.37 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 8 (N = 56) | 20.18 Minutes | Standard Deviation 70.7 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 12 (N = 58) | 9.05 Minutes | Standard Deviation 24.52 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 24 (N = 58) | 5.72 Minutes | Standard Deviation 18.85 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 36 (N = 57) | 2.49 Minutes | Standard Deviation 9.35 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 48 (N = 57) | 2.19 Minutes | Standard Deviation 6.61 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 60 (N = 56) | 2.41 Minutes | Standard Deviation 7.32 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 72 (N = 54) | 3.89 Minutes | Standard Deviation 15.16 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 84 (N = 55) | 2.64 Minutes | Standard Deviation 8.97 |
| Etanercept | Duration of Morning Stiffness: eoJIA Sub-population | Week 96 (N = 54) | 2.37 Minutes | Standard Deviation 12.42 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 96 (N = 30) | 10.67 Minutes | Standard Deviation 28.31 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Baseline (N = 38) | 89.29 Minutes | Standard Deviation 128.94 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 4 (N = 38) | 49.34 Minutes | Standard Deviation 78.73 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 8 (N = 36) | 44.03 Minutes | Standard Deviation 102.65 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 12 (N = 36) | 25.69 Minutes | Standard Deviation 67.57 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 24 (N = 36) | 15.69 Minutes | Standard Deviation 28.87 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 36 (N = 35) | 17.17 Minutes | Standard Deviation 41.01 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 48 (N = 34) | 13.38 Minutes | Standard Deviation 36.88 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 60 (N = 33) | 14.09 Minutes | Standard Deviation 42.21 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 72 (N = 32) | 16.25 Minutes | Standard Deviation 42.12 |
| Etanercept | Duration of Morning Stiffness: ERA Sub-population | Week 84 (N = 30) | 12.70 Minutes | Standard Deviation 36.16 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Baseline (N = 29) | 54.31 Minutes | Standard Deviation 54.16 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 4 (N = 29) | 23.45 Minutes | Standard Deviation 49.86 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 8 (N = 29) | 10.79 Minutes | Standard Deviation 24.55 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 12 (N = 29) | 6.38 Minutes | Standard Deviation 13.42 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 24 (N = 28) | 6.43 Minutes | Standard Deviation 23.17 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 36 (N = 28) | 2.43 Minutes | Standard Deviation 11.33 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 48 (N = 28) | 4.82 Minutes | Standard Deviation 25.51 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 60 (N = 27) | 9.07 Minutes | Standard Deviation 40.43 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 72 (N = 27) | 10.56 Minutes | Standard Deviation 36.7 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 84 (N = 27) | 15.37 Minutes | Standard Deviation 52.05 |
| Etanercept | Duration of Morning Stiffness: PsA Sub-population | Week 96 (N = 25) | 7.20 Minutes | Standard Deviation 27.43 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Active Joints | Week 48 (N = 119) | 0.88 Joints | Standard Deviation 1.92 |
| Etanercept | Number of Active Joints | Week 60 (N = 116) | 0.87 Joints | Standard Deviation 1.94 |
| Etanercept | Number of Active Joints | Week 72 (N = 114) | 0.77 Joints | Standard Deviation 1.97 |
| Etanercept | Number of Active Joints | Week 84 (N = 113) | 0.81 Joints | Standard Deviation 2.2 |
| Etanercept | Number of Active Joints | Baseline (N = 127) | 6.74 Joints | Standard Deviation 4.59 |
| Etanercept | Number of Active Joints | Week 4 (N = 126) | 3.17 Joints | Standard Deviation 3.32 |
| Etanercept | Number of Active Joints | Week 8 (N = 121) | 2.07 Joints | Standard Deviation 2.67 |
| Etanercept | Number of Active Joints | Week 12 (N = 123) | 1.72 Joints | Standard Deviation 2.52 |
| Etanercept | Number of Active Joints | Week 24 (N = 122) | 1.16 Joints | Standard Deviation 2.06 |
| Etanercept | Number of Active Joints | Week 36 (N = 120) | 0.99 Joints | Standard Deviation 1.86 |
| Etanercept | Number of Active Joints | Week 96 (N = 109) | 0.61 Joints | Standard Deviation 2.06 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 12 (N = 58) | 2.07 Joints | Standard Deviation 2.77 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 72 (N = 55) | 0.73 Joints | Standard Deviation 1.21 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 84 (N = 55) | 0.65 Joints | Standard Deviation 1.16 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 96 (N = 54) | 0.50 Joints | Standard Deviation 0.89 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Baseline (N = 60) | 7.58 Joints | Standard Deviation 5.09 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 4 (N = 59) | 3.95 Joints | Standard Deviation 3.75 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 8 (N = 56) | 2.46 Joints | Standard Deviation 2.7 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 24 (N = 58) | 1.34 Joints | Standard Deviation 2.29 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 36 (N = 57) | 1.14 Joints | Standard Deviation 1.97 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 48 (N = 57) | 1.00 Joints | Standard Deviation 1.6 |
| Etanercept | Number of Active Joints: eoJIA Sub-population | Week 60 (N = 56) | 0.98 Joints | Standard Deviation 1.63 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Active Joints: ERA Sub-population | Baseline (N = 38) | 5.21 Joints | Standard Deviation 3.57 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 8 (N = 36) | 1.47 Joints | Standard Deviation 2.25 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 84 (N = 31) | 0.68 Joints | Standard Deviation 1.19 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 96 (N = 30) | 0.50 Joints | Standard Deviation 0.94 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 4 (N = 38) | 2.40 Joints | Standard Deviation 2.62 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 12 (N = 36) | 1.08 Joints | Standard Deviation 1.57 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 24 (N = 36) | 0.78 Joints | Standard Deviation 1.07 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 36 (N = 35) | 0.74 Joints | Standard Deviation 1.29 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 48 (N = 34) | 0.68 Joints | Standard Deviation 1.09 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 60 (N = 33) | 0.48 Joints | Standard Deviation 0.94 |
| Etanercept | Number of Active Joints: ERA Sub-population | Week 72 (N = 32) | 0.59 Joints | Standard Deviation 1.21 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Active Joints: PsA Sub-population | Week 4 (N = 29) | 2.59 Joints | Standard Deviation 2.92 |
| Etanercept | Number of Active Joints: PsA Sub-population | Baseline (N = 29) | 7.00 Joints | Standard Deviation 4.33 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 8 (N = 29) | 2.07 Joints | Standard Deviation 3.05 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 12 (N = 29) | 1.79 Joints | Standard Deviation 2.86 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 24 (N = 28) | 1.25 Joints | Standard Deviation 2.47 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 36 (N = 28) | 1.00 Joints | Standard Deviation 2.21 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 48 (N = 28) | 0.89 Joints | Standard Deviation 3.03 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 60 (N = 27) | 1.11 Joints | Standard Deviation 3.11 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 72 (N = 27) | 1.08 Joints | Standard Deviation 3.45 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 84 (N = 27) | 1.30 Joints | Standard Deviation 4.02 |
| Etanercept | Number of Active Joints: PsA Sub-population | Week 96 (N = 25) | 0.96 Joints | Standard Deviation 4 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Joints With Limitation of Motion | Baseline (N = 127) | 5.72 Joints | Standard Deviation 4.22 |
| Etanercept | Number of Joints With Limitation of Motion | Week 4 (N = 126) | 3.20 Joints | Standard Deviation 3.27 |
| Etanercept | Number of Joints With Limitation of Motion | Week 8 (N = 121) | 2.26 Joints | Standard Deviation 3.41 |
| Etanercept | Number of Joints With Limitation of Motion | Week 12 (N = 123) | 1.62 Joints | Standard Deviation 2.31 |
| Etanercept | Number of Joints With Limitation of Motion | Week 24 (N = 122) | 1.43 Joints | Standard Deviation 2.03 |
| Etanercept | Number of Joints With Limitation of Motion | Week 36 (N = 120) | 1.39 Joints | Standard Deviation 2.13 |
| Etanercept | Number of Joints With Limitation of Motion | Week 48 (N = 119) | 1.26 Joints | Standard Deviation 2.51 |
| Etanercept | Number of Joints With Limitation of Motion | Week 60 (N = 116) | 1.41 Joints | Standard Deviation 2.98 |
| Etanercept | Number of Joints With Limitation of Motion | Week 72 (N = 114) | 1.13 Joints | Standard Deviation 2.36 |
| Etanercept | Number of Joints With Limitation of Motion | Week 84 (N = 113) | 1.41 Joints | Standard Deviation 3.05 |
| Etanercept | Number of Joints With Limitation of Motion | Week 96 (N = 109) | 1.06 Joints | Standard Deviation 2.71 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Baseline (N = 60) | 6.33 Joints | Standard Deviation 4.37 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 4 (N = 59) | 3.12 Joints | Standard Deviation 2.74 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 8 (N = 56) | 2.23 Joints | Standard Deviation 3.47 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 12 (N = 58) | 1.78 Joints | Standard Deviation 2.25 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 24 (N = 58) | 1.40 Joints | Standard Deviation 1.77 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 36 (N = 57) | 1.16 Joints | Standard Deviation 1.54 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 48 (N = 57) | 1.05 Joints | Standard Deviation 1.63 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 60 (N = 56) | 1.36 Joints | Standard Deviation 2.56 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 72 (N = 55) | 0.89 Joints | Standard Deviation 1.58 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 84 (N = 55) | 0.98 Joints | Standard Deviation 2.08 |
| Etanercept | Number of Joints With Limitation of Motion: eoJIA Sub-population | Week 96 (N = 54) | 0.74 Joints | Standard Deviation 1.22 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Baseline (N = 38) | 4.84 Joints | Standard Deviation 4 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 4 (N = 38) | 2.98 Joints | Standard Deviation 3.73 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 8 (N = 36) | 2.28 Joints | Standard Deviation 3.59 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 12 (N = 36) | 1.58 Joints | Standard Deviation 2.94 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 24 (N = 36) | 1.53 Joints | Standard Deviation 2.8 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 36 (N = 35) | 1.55 Joints | Standard Deviation 2.69 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 48 (N = 34) | 1.53 Joints | Standard Deviation 2.88 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 60 (N = 33) | 1.36 Joints | Standard Deviation 3.26 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 72 (N = 32) | 1.19 Joints | Standard Deviation 2.09 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 84 (N = 31) | 1.68 Joints | Standard Deviation 3.17 |
| Etanercept | Number of Joints With Limitation of Motion: ERA Sub-population | Week 96 (N = 30) | 1.33 Joints | Standard Deviation 2.89 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Baseline (N = 29) | 5.62 Joints | Standard Deviation 4.1 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 4 (N = 29) | 3.66 Joints | Standard Deviation 3.66 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 8 (N = 29) | 2.28 Joints | Standard Deviation 3.15 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 12 (N = 29) | 1.34 Joints | Standard Deviation 1.4 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 24 (N = 28) | 1.36 Joints | Standard Deviation 1.31 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 36 (N = 28) | 1.64 Joints | Standard Deviation 2.39 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 48 (N = 28) | 1.36 Joints | Standard Deviation 3.42 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 60 (N = 27) | 1.56 Joints | Standard Deviation 3.51 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 72 (N = 27) | 1.56 Joints | Standard Deviation 3.68 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 84 (N = 27) | 1.96 Joints | Standard Deviation 4.34 |
| Etanercept | Number of Joints With Limitation of Motion: PsA Sub-population | Week 96 (N = 25) | 1.40 Joints | Standard Deviation 4.39 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Pain Assessment | Baseline (N = 127) | 5.06 Units on a scale | Standard Deviation 2.52 |
| Etanercept | Pain Assessment | Week 4 (N = 126) | 3.12 Units on a scale | Standard Deviation 2.25 |
| Etanercept | Pain Assessment | Week 8 (N = 121) | 2.58 Units on a scale | Standard Deviation 2.1 |
| Etanercept | Pain Assessment | Week 12 (N = 123) | 2.02 Units on a scale | Standard Deviation 1.89 |
| Etanercept | Pain Assessment | Week 24 (N = 122) | 1.64 Units on a scale | Standard Deviation 1.74 |
| Etanercept | Pain Assessment | Week 36 (N = 120) | 1.63 Units on a scale | Standard Deviation 1.94 |
| Etanercept | Pain Assessment | Week 48 (N = 119) | 1.51 Units on a scale | Standard Deviation 1.81 |
| Etanercept | Pain Assessment | Week 60 (N = 116) | 1.18 Units on a scale | Standard Deviation 1.46 |
| Etanercept | Pain Assessment | Week 72 (N = 114) | 1.14 Units on a scale | Standard Deviation 1.62 |
| Etanercept | Pain Assessment | Week 84 (N = 112) | 1.13 Units on a scale | Standard Deviation 1.67 |
| Etanercept | Pain Assessment | Week 96 (N = 108) | 0.91 Units on a scale | Standard Deviation 1.42 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Pain Assessment: eoJIA Sub-population | Baseline (N = 60) | 4.81 Units on a scale | Standard Deviation 2.56 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 4 (N = 59) | 2.64 Units on a scale | Standard Deviation 2.09 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 8 (N = 56) | 2.12 Units on a scale | Standard Deviation 1.97 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 12 (N = 58) | 1.69 Units on a scale | Standard Deviation 1.77 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 24 (N = 58) | 1.27 Units on a scale | Standard Deviation 1.66 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 36 (N = 57) | 1.43 Units on a scale | Standard Deviation 1.98 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 48 (N = 57) | 1.19 Units on a scale | Standard Deviation 1.77 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 60 (N = 56) | 1.19 Units on a scale | Standard Deviation 1.38 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 72 (N = 55) | 1.01 Units on a scale | Standard Deviation 1.52 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 84 (N = 54) | 0.91 Units on a scale | Standard Deviation 1.5 |
| Etanercept | Pain Assessment: eoJIA Sub-population | Week 96 (N = 53) | 0.97 Units on a scale | Standard Deviation 1.52 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Pain Assessment: ERA Sub-population | Baseline (N = 38) | 5.76 Units on a scale | Standard Deviation 2.51 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 4 (N = 38) | 3.82 Units on a scale | Standard Deviation 2.59 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 8 (N = 36) | 3.13 Units on a scale | Standard Deviation 2.42 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 12 (N = 36) | 2.54 Units on a scale | Standard Deviation 2.18 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 24 (N = 36) | 2.28 Units on a scale | Standard Deviation 1.89 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 36 (N = 35) | 1.87 Units on a scale | Standard Deviation 2.07 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 48 (N = 34) | 1.78 Units on a scale | Standard Deviation 1.72 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 60 (N = 33) | 1.17 Units on a scale | Standard Deviation 1.69 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 72 (N = 32) | 1.17 Units on a scale | Standard Deviation 1.69 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 84 (N = 31) | 1.08 Units on a scale | Standard Deviation 1.34 |
| Etanercept | Pain Assessment: ERA Sub-population | Week 96 (N = 30) | 0.87 Units on a scale | Standard Deviation 1.21 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Pain Assessment: PsA Sub-population | Week 48 (N = 28) | 1.82 Units on a scale | Standard Deviation 1.95 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 60 (N = 27) | 1.19 Units on a scale | Standard Deviation 1.35 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 12 (N = 29) | 2.03 Units on a scale | Standard Deviation 1.65 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 24 (N = 28) | 1.61 Units on a scale | Standard Deviation 1.51 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 36 (N = 28) | 1.71 Units on a scale | Standard Deviation 1.67 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 72 (N = 27) | 1.37 Units on a scale | Standard Deviation 1.74 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 84 (N = 27) | 1.61 Units on a scale | Standard Deviation 2.2 |
| Etanercept | Pain Assessment: PsA Sub-population | Baseline (N = 29) | 4.64 Units on a scale | Standard Deviation 2.31 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 4 (N = 29) | 3.19 Units on a scale | Standard Deviation 1.91 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 8 (N = 29) | 2.81 Units on a scale | Standard Deviation 1.74 |
| Etanercept | Pain Assessment: PsA Sub-population | Week 96 (N = 25) | 0.84 Units on a scale | Standard Deviation 1.48 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient/Parent Global Assessment | Baseline (N = 127) | 4.96 Units on a scale | Standard Deviation 2.33 |
| Etanercept | Patient/Parent Global Assessment | Week 4 (N = 126) | 3.22 Units on a scale | Standard Deviation 2.23 |
| Etanercept | Patient/Parent Global Assessment | Week 8 (N = 121) | 2.79 Units on a scale | Standard Deviation 2.1 |
| Etanercept | Patient/Parent Global Assessment | Week 12 (N = 123) | 2.21 Units on a scale | Standard Deviation 1.84 |
| Etanercept | Patient/Parent Global Assessment | Week 24 (N = 122) | 1.79 Units on a scale | Standard Deviation 1.75 |
| Etanercept | Patient/Parent Global Assessment | Week 36 (N = 120) | 1.74 Units on a scale | Standard Deviation 1.97 |
| Etanercept | Patient/Parent Global Assessment | Week 48 (N = 119) | 1.65 Units on a scale | Standard Deviation 1.88 |
| Etanercept | Patient/Parent Global Assessment | Week 60 (N = 116) | 1.33 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Patient/Parent Global Assessment | Week 72 (N = 114) | 1.29 Units on a scale | Standard Deviation 1.63 |
| Etanercept | Patient/Parent Global Assessment | Week 84 (N = 113) | 1.17 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Patient/Parent Global Assessment | Week 96 (N = 109) | 0.97 Units on a scale | Standard Deviation 1.31 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 60 (N = 56) | 1.29 Units on a scale | Standard Deviation 1.54 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Baseline (N = 60) | 4.82 Units on a scale | Standard Deviation 2.44 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 4 (N = 59) | 2.82 Units on a scale | Standard Deviation 2.11 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 8 (N = 56) | 2.38 Units on a scale | Standard Deviation 2.02 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 12 (N = 58) | 1.97 Units on a scale | Standard Deviation 1.81 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 24 (N = 58) | 1.51 Units on a scale | Standard Deviation 1.69 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 36 (N = 57) | 1.56 Units on a scale | Standard Deviation 2.07 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 48 (N = 57) | 1.32 Units on a scale | Standard Deviation 1.82 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 72 (N = 55) | 1.17 Units on a scale | Standard Deviation 1.55 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 84 (N = 55) | 0.90 Units on a scale | Standard Deviation 1.21 |
| Etanercept | Patient/Parent Global Assessment: eoJIA Sub-population | Week 96 (N = 54) | 1.00 Units on a scale | Standard Deviation 1.43 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 8 (N = 36) | 3.19 Units on a scale | Standard Deviation 2.26 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 12 (N = 36) | 2.56 Units on a scale | Standard Deviation 2.13 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 24 (N = 36) | 2.26 Units on a scale | Standard Deviation 2.03 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Baseline (N = 38) | 5.43 Units on a scale | Standard Deviation 2.26 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 4 (N = 38) | 3.62 Units on a scale | Standard Deviation 2.43 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 36 (N = 35) | 2.04 Units on a scale | Standard Deviation 2.05 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 48 (N = 34) | 2.07 Units on a scale | Standard Deviation 2.14 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 60 (N = 33) | 1.39 Units on a scale | Standard Deviation 1.74 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 72 (N = 32) | 1.39 Units on a scale | Standard Deviation 1.8 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 84 (N = 31) | 1.29 Units on a scale | Standard Deviation 1.6 |
| Etanercept | Patient/Parent Global Assessment: ERA Sub-population | Week 96 (N = 30) | 0.93 Units on a scale | Standard Deviation 1.19 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 72 (N = 27) | 1.39 Units on a scale | Standard Deviation 1.64 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Baseline (N = 29) | 4.62 Units on a scale | Standard Deviation 2.17 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 4 (N = 29) | 3.50 Units on a scale | Standard Deviation 2.14 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 8 (N = 29) | 3.10 Units on a scale | Standard Deviation 1.97 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 12 (N = 29) | 2.26 Units on a scale | Standard Deviation 1.46 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 24 (N = 28) | 1.75 Units on a scale | Standard Deviation 1.38 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 36 (N = 28) | 1.73 Units on a scale | Standard Deviation 1.64 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 48 (N = 28) | 1.82 Units on a scale | Standard Deviation 1.61 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 60 (N = 27) | 1.33 Units on a scale | Standard Deviation 1.42 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 84 (N = 27) | 1.59 Units on a scale | Standard Deviation 2.05 |
| Etanercept | Patient/Parent Global Assessment: PsA Sub-population | Week 96 (N = 25) | 0.96 Units on a scale | Standard Deviation 1.22 |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 4 (N = 126) | 3.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 8 (N = 121) | 6.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 12 (N = 122) | 23.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 24 (N = 122) | 33.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 36 (N = 120) | 36.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 48 (N = 119) | 40.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 60 (N = 114) | 42.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 72 (N = 113) | 49.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 84 (N = 112) | 55.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response | Week 96 (N = 107) | 54.2 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 4 (N = 59) | 6.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 8 (N = 56) | 8.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 12 (N = 58) | 20.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 24 (N = 58) | 39.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 36 (N = 57) | 42.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 48 (N = 57) | 47.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 60 (N = 55) | 47.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 72 (N = 54) | 51.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 84 (N = 55) | 60.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | Week 96 (N = 53) | 54.7 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 4 (N = 38) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 8 (N = 36) | 5.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 12 (N = 35) | 34.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 24 (N = 36) | 36.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 36 (N = 35) | 34.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 48 (N = 34) | 32.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 60 (N = 33) | 42.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 72 (N = 32) | 59.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 84 (N = 31) | 54.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | Week 96 (N = 30) | 50.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 48 (N = 28) | 35.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 60 (N = 26) | 30.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 4 (N = 29) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 8 (N = 29) | 3.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 12 (N = 29) | 13.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 24 (N = 28) | 17.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 36 (N = 28) | 28.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 72 (N = 27) | 33.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 84 (N = 26) | 46.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | Week 96 (N = 24) | 58.3 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 4 (N = 126) | 71.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 8 (N = 121) | 88.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 12 (N = 123) | 88.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 24 (N = 122) | 94.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 36 (N = 120) | 95.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 48 (N = 119) | 94.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 60 (N = 116) | 95.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 72 (N = 114) | 96.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 84 (N = 113) | 93.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response | Week 96 (N = 108) | 99.1 Percentage of participants |
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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 4 (N = 38) | 84.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 8 (N = 36) | 91.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 12 (N = 36) | 83.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 24 (N = 36) | 91.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 48 (N = 34) | 91.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 84 (N = 31) | 90.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 36 (N = 35) | 97.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 60 (N = 33) | 90.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 72 (N = 32) | 93.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | Week 96 (N = 30) | 100 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 4 (N = 59) | 67.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 8 (N = 56) | 87.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 12 (N = 58) | 89.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 24 (N = 58) | 94.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 36 (N = 57) | 94.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 48 (N = 57) | 96.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 60 (N = 56) | 98.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 72 (N = 55) | 98.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 84 (N = 55) | 98.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | Week 96 (N = 53) | 100 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 4 (N = 29) | 62.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 8 (N = 29) | 86.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 12 (N = 29) | 93.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 24 (N = 28) | 96.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 36 (N = 28) | 96.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 48 (N = 28) | 92.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 60 (N = 27) | 96.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 72 (N = 27) | 96.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 84 (N = 27) | 88.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | Week 96 (N = 25) | 96.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 12 (N = 122) | 81.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 24 (N = 122) | 88.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 36 (N = 120) | 88.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 72 (N = 114) | 93.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 84 (N = 113) | 91.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 96 (N = 108) | 98.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 4 (N = 125) | 51.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 8 (N = 121) | 76.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 48 (N = 119) | 93.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response | Week 60 (N = 116) | 92.2 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 4 (N = 58) | 51.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 96 (N = 53) | 100 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 8 (N = 56) | 75.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 12 (N = 58) | 79.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 24 (N = 58) | 86.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 36 (N = 57) | 91.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 48 (N = 57) | 94.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 60 (N = 56) | 92.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 72 (N = 55) | 96.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | Week 84 (N = 55) | 96.4 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 4 (N = 38) | 63.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 8 (N = 36) | 86.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 12 (N = 35) | 80.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 24 (N = 36) | 86.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 36 (N = 35) | 82.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 48 (N = 34) | 91.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 60 (N = 33) | 87.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 72 (N = 32) | 90.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 84 (N = 31) | 83.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | Week 96 (N = 30) | 96.7 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 60 (N = 27) | 96.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 72 (N = 27) | 92.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 4 (N = 29) | 34.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 8 (N = 29) | 69.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 12 (N = 29) | 86.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 24 (N = 28) | 96.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 36 (N = 28) | 89.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 48 (N = 28) | 92.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 84 (N = 27) | 88.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | Week 96 (N = 25) | 96.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 84 (N = 113) | 87.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 4 (N = 126) | 26.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 8 (N = 121) | 47.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 12 (N = 122) | 61.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 24 (N = 122) | 71.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 36 (N = 120) | 73.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 48 (N = 119) | 79.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 60 (N = 115) | 81.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 72 (N = 114) | 84.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response | Week 96 (N = 108) | 92.6 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 36 (N = 57) | 75.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 48 (N = 57) | 77.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 60 (N = 55) | 80.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 96 (N = 53) | 94.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 4 (N = 59) | 28.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 8 (N = 56) | 51.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 12 (N = 58) | 63.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 24 (N = 58) | 70.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 72 (N = 55) | 85.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | Week 84 (N = 55) | 90.9 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 4 (N = 38) | 28.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 8 (N = 36) | 52.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 12 (N = 35) | 71.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 24 (N = 36) | 80.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 36 (N = 35) | 77.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 48 (N = 34) | 85.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 60 (N = 33) | 81.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 72 (N = 32) | 81.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 84 (N = 31) | 80.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | Week 96 (N = 30) | 86.7 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 48 (N = 28) | 78.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 4 (N = 29) | 17.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 8 (N = 29) | 31.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 12 (N = 29) | 44.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 24 (N = 28) | 60.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 36 (N = 28) | 64.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 60 (N = 27) | 85.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 72 (N = 27) | 85.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 84 (N = 27) | 88.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | Week 96 (N = 25) | 96.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 4 (N = 126) | 6.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 8 (N = 121) | 14.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 12 (N = 121) | 29.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 24 (N = 122) | 43.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 36 (N = 120) | 47.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 48 (N = 119) | 50.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 60 (N = 115) | 53.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 72 (N = 113) | 60.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 84 (N = 113) | 64.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response | Week 96 (N = 107) | 65.4 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 4 (N = 59) | 6.8 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 8 (N = 56) | 16.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 12 (N = 58) | 27.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 24 (N = 58) | 53.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 36 (N = 57) | 49.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 48 (N = 57) | 52.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 60 (N = 55) | 52.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 72 (N = 54) | 61.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 84 (N = 55) | 67.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | Week 96 (N = 53) | 62.3 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 48 (N = 34) | 50.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 4 (N = 38) | 10.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 8 (N = 36) | 22.2 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 12 (N = 35) | 45.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 24 (N = 36) | 41.7 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 36 (N = 35) | 48.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 60 (N = 33) | 57.6 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 72 (N = 32) | 71.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 84 (N = 31) | 64.5 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | Week 96 (N = 30) | 66.7 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 4 (N = 29) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 8 (N = 29) | 3.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 12 (N = 28) | 14.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 24 (N = 28) | 25.0 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 36 (N = 28) | 42.9 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 48 (N = 28) | 46.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 60 (N = 27) | 48.1 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 72 (N = 27) | 44.4 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 84 (N = 27) | 59.3 Percentage of participants |
| Etanercept | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | Week 96 (N = 24) | 70.8 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 4 (N = 126) | 2.4 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 8 (N = 121) | 2.5 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 12 (N = 123) | 12.2 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 24 (N = 121) | 24.8 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 36 (N = 120) | 25.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 48 (N = 118) | 29.7 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 60 (N = 113) | 33.6 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 72 (N = 111) | 36.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 84 (N = 110) | 34.5 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Week 96 (N = 106) | 34.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 4 (N = 59) | 5.1 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 8 (N = 56) | 3.6 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 12 (N = 58) | 12.1 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 24 (N = 57) | 29.8 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 36 (N = 57) | 35.1 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 48 (N = 56) | 37.5 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 60 (N = 56) | 48.2 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 72 (N = 54) | 46.3 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 84 (N = 54) | 44.4 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Week 96 (N = 53) | 37.7 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 4 (N = 38) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 8 (N = 36) | 2.8 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 12 (N = 36) | 16.7 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 24 (N = 36) | 25.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 36 (N = 35) | 14.3 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 48 (N = 34) | 23.5 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 60 (N = 30) | 23.3 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 72 (N = 30) | 33.3 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 84 (N = 29) | 27.6 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Week 96 (N = 28) | 28.6 Percentage of participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 4 (N = 29) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 8 (N = 29) | 0.0 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 12 (N = 29) | 6.9 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 24 (N = 28) | 14.3 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 36 (N = 28) | 17.9 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 48 (N = 28) | 21.4 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 60 (N = 27) | 14.8 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 72 (N=27) | 18.5 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 84 (N = 27) | 22.2 Percentage of participants |
| Etanercept | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Week 96 (N = 25) | 32.0 Percentage of participants |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Baseline (N = 127) | 5.02 Units on a scale | Standard Deviation 1.75 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 4 (N = 126) | 2.78 Units on a scale | Standard Deviation 1.78 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 8 (N = 121) | 2.00 Units on a scale | Standard Deviation 1.55 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 12 (N = 123) | 1.50 Units on a scale | Standard Deviation 1.3 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 24 (N = 122) | 1.15 Units on a scale | Standard Deviation 1.22 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 36 (N = 120) | 1.05 Units on a scale | Standard Deviation 1.17 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 48 (N = 119) | 1.03 Units on a scale | Standard Deviation 1.19 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 60 (N = 116) | 0.88 Units on a scale | Standard Deviation 0.99 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 72 (N = 113) | 0.78 Units on a scale | Standard Deviation 0.97 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 84 (N = 113) | 0.78 Units on a scale | Standard Deviation 1.04 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity | Week 96 (N = 108) | 0.62 Units on a scale | Standard Deviation 0.79 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Baseline (N = 60) | 4.96 Units on a scale | Standard Deviation 1.76 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 4 (N = 59) | 2.73 Units on a scale | Standard Deviation 1.8 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 8 (N = 56) | 1.80 Units on a scale | Standard Deviation 1.62 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 12 (N = 58) | 1.40 Units on a scale | Standard Deviation 1.3 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 24 (N = 58) | 1.03 Units on a scale | Standard Deviation 1.34 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 36 (N = 57) | 0.89 Units on a scale | Standard Deviation 1.25 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 48 (N = 57) | 0.88 Units on a scale | Standard Deviation 1.2 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 60 (N = 56) | 0.83 Units on a scale | Standard Deviation 1.06 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 72 (N = 54) | 0.72 Units on a scale | Standard Deviation 0.99 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 84 (N = 55) | 0.60 Units on a scale | Standard Deviation 0.86 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | Week 96 (N = 53) | 0.59 Units on a scale | Standard Deviation 0.81 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 12 (N = 36) | 1.53 Units on a scale | Standard Deviation 1.34 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 24 (N = 36) | 1.32 Units on a scale | Standard Deviation 1.12 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 36 (N = 35) | 1.21 Units on a scale | Standard Deviation 1.1 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 48 (N = 34) | 1.16 Units on a scale | Standard Deviation 1.14 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 60 (N = 33) | 0.80 Units on a scale | Standard Deviation 0.87 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Baseline (N = 38) | 5.39 Units on a scale | Standard Deviation 1.94 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 4 (N = 38) | 2.71 Units on a scale | Standard Deviation 1.94 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 8 (N = 36) | 2.19 Units on a scale | Standard Deviation 1.5 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 72 (N = 32) | 0.78 Units on a scale | Standard Deviation 0.98 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 84 (N = 31) | 0.84 Units on a scale | Standard Deviation 1.09 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | Week 96 (N = 30) | 0.62 Units on a scale | Standard Deviation 0.67 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 48 (N = 28) | 1.18 Units on a scale | Standard Deviation 1.22 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 60 (N = 27) | 1.06 Units on a scale | Standard Deviation 0.99 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Baseline (N = 29) | 4.66 Units on a scale | Standard Deviation 1.42 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 4 (N = 29) | 2.98 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 8 (N = 29) | 2.14 Units on a scale | Standard Deviation 1.49 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 12 (N = 29) | 1.69 Units on a scale | Standard Deviation 1.28 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 24 (N = 28) | 1.18 Units on a scale | Standard Deviation 1.06 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 36 (N = 28) | 1.20 Units on a scale | Standard Deviation 1.09 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 72 (N = 27) | 0.89 Units on a scale | Standard Deviation 0.93 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 84 (N = 27) | 1.07 Units on a scale | Standard Deviation 1.25 |
| Etanercept | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | Week 96 (N = 25) | 0.66 Units on a scale | Standard Deviation 0.9 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Body Mass Index (BMI) z-Score by Age Group | Week 12: 2 to 17 years (N = 123) | 0.03 z-score | Standard Deviation 1.15 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group | Baseline: 2 to 17 years (N = 125) | 0.03 z-score | Standard Deviation 1.17 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group | Week 48: 2 to 17 years (N = 118) | 0.05 z-score | Standard Deviation 1.11 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group | Week 72: 2 to 17 years (N = 114) | 0.07 z-score | Standard Deviation 1.03 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group | Week 96: 2 to 17 years (N = 109) | 0.04 z-score | Standard Deviation 1.06 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Baseline: 2 to 4 years (N=15) | -0.60 z-score | Standard Deviation 1.7 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Baseline: 5 to 11 years (N=22) | 0.03 z-score | Standard Deviation 1.28 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Baseline: 12 to 17 years (N=21) | 0.40 z-score | Standard Deviation 0.72 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Baseline: 2 to 17 years (N=58) | 0.00 z-score | Standard Deviation 1.28 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 12: 2 to 4 years (N=15) | -0.78 z-score | Standard Deviation 1.64 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 12: 5 to 11 years (N=22) | 0.21 z-score | Standard Deviation 1.13 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 12: 12 to 17 years (N=21) | 0.38 z-score | Standard Deviation 0.73 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 12: 2 to 17 years (N=58) | 0.01 z-score | Standard Deviation 1.25 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 48: 2 to 4 years (N=14) | -0.85 z-score | Standard Deviation 1.69 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 48: 5 to 11 years (N=21) | 0.18 z-score | Standard Deviation 0.96 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 48: 12 to 17 years (N=21) | 0.34 z-score | Standard Deviation 0.68 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 48: 2 to 17 years (N=56) | -0.02 z-score | Standard Deviation 1.19 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 72: 2 to 4 years (N=14) | -0.48 z-score | Standard Deviation 1.46 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 72: 5 to 11 years (N=21) | 0.37 z-score | Standard Deviation 0.97 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 72: 12 to 17 years (N=20) | 0.20 z-score | Standard Deviation 0.73 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 72: 2 to 17 years (N=55) | 0.09 z-score | Standard Deviation 1.08 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 96: 2 to 4 years (N=14) | -0.50 z-score | Standard Deviation 1.55 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 96: 5 to 11 years (N=20) | 0.44 z-score | Standard Deviation 0.9 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 96: 12 to 17 years (N=20) | 0.05 z-score | Standard Deviation 0.83 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | Week 96: 2 to 17 years (N=54) | 0.05 z-score | Standard Deviation 1.13 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Baseline: 12 to 17 years (N = 38) | -0.29 z-score | Standard Deviation 0.87 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Week 12: 12 to 17 years (N = 36) | -0.31 z-score | Standard Deviation 0.86 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Week 48: 12 to 17 years (N = 34) | -0.27 z-score | Standard Deviation 0.91 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Week 72: 12 to 17 years (N = 32) | -0.23 z-score | Standard Deviation 0.87 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | Week 96: 12 to 17 years (N = 30) | -0.29 z-score | Standard Deviation 0.84 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Baseline: 12 to 17 years (N = 29) | 0.51 z-score | Standard Deviation 1.17 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Week 12: 12 to 17 years (N = 29) | 0.49 z-score | Standard Deviation 1.14 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Week 48: 12 to 17 years (N = 28) | 0.55 z-score | Standard Deviation 1.01 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Week 72: 12 to 17 years (N = 27) | 0.37 z-score | Standard Deviation 1.04 |
| Etanercept | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | Week 96: 12 to 17 years (N = 25) | 0.40 z-score | Standard Deviation 1.06 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Height z-Score by Age Group | Baseline: 2 to 17 years (N = 125) | 0.19 z-score | Standard Deviation 1.07 |
| Etanercept | Height z-Score by Age Group | Week 12: 2 to 17 years (N = 123) | 0.31 z-score | Standard Deviation 0.98 |
| Etanercept | Height z-Score by Age Group | Week 48: 2 to 17 years (N = 118) | 0.34 z-score | Standard Deviation 1.02 |
| Etanercept | Height z-Score by Age Group | Week 72: 2 to 17 years (N = 114) | 0.41 z-score | Standard Deviation 0.97 |
| Etanercept | Height z-Score by Age Group | Week 96: 2 to 17 years (N = 109) | 0.39 z-score | Standard Deviation 0.99 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Baseline: 2 to 17 years (N=58) | 0.06 z-score | Standard Deviation 1.17 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 12: 2 to 4 years (N=15) | 0.17 z-score | Standard Deviation 0.97 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 12: 5 to 11 years (N=22) | 0.28 z-score | Standard Deviation 1.23 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 12: 12 to 17 years (N=21) | 0.16 z-score | Standard Deviation 0.83 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 12: 2 to 17 years (N=58) | 0.21 z-score | Standard Deviation 1.02 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 48: 2 to 4 years (N=14) | 0.37 z-score | Standard Deviation 1.06 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 48: 5 to 11 years (N=21) | 0.30 z-score | Standard Deviation 1.3 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 48: 12 to 17 years (N=21) | 0.18 z-score | Standard Deviation 0.87 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 48: 2 to 17 years (N=56) | 0.27 z-score | Standard Deviation 1.08 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 72: 2 to 4 years (N=14) | 0.39 z-score | Standard Deviation 0.99 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 72: 5 to 11 years (N=21) | 0.43 z-score | Standard Deviation 1.11 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 72: 12 to 17 years (N=20) | 0.20 z-score | Standard Deviation 0.87 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 72: 2 to 17 years (N=55) | 0.34 z-score | Standard Deviation 0.98 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 96: 2 to 4 years (N=14) | 0.34 z-score | Standard Deviation 0.99 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 96: 5 to 11 years (N=20) | 0.46 z-score | Standard Deviation 1.15 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 96: 12 to 17 years (N=20) | 0.17 z-score | Standard Deviation 0.89 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Week 96: 2 to 17 years (N=54) | 0.32 z-score | Standard Deviation 1.01 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Baseline: 2 to 4 years (N=15) | -0.24 z-score | Standard Deviation 1.32 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Baseline: 5 to 11 years (N=22) | 0.20 z-score | Standard Deviation 1.35 |
| Etanercept | Height z-Score by Age Group for eoJIA Sub-population | Baseline: 12 to 17 years (N=21) | 0.13 z-score | Standard Deviation 0.84 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Height z-Score by Age Group for ERA Sub-population | Baseline: 12 to 17 years (N = 38) | 0.24 z-score | Standard Deviation 0.89 |
| Etanercept | Height z-Score by Age Group for ERA Sub-population | Week 72: 12 to 17 years (N = 32) | 0.46 z-score | Standard Deviation 0.84 |
| Etanercept | Height z-Score by Age Group for ERA Sub-population | Week 96: 12 to 17 years (N = 30) | 0.43 z-score | Standard Deviation 0.86 |
| Etanercept | Height z-Score by Age Group for ERA Sub-population | Week 12: 12 to 17 years (N = 36) | 0.35 z-score | Standard Deviation 0.86 |
| Etanercept | Height z-Score by Age Group for ERA Sub-population | Week 48: 12 to 17 years (N = 34) | 0.36 z-score | Standard Deviation 0.85 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Height z-Score by Age Group for PsA Sub-population | Baseline: 12 to 17 years (N = 29) | 0.41 z-score | Standard Deviation 1.06 |
| Etanercept | Height z-Score by Age Group for PsA Sub-population | Week 12: 12 to 17 years (N = 29) | 0.46 z-score | Standard Deviation 1.05 |
| Etanercept | Height z-Score by Age Group for PsA Sub-population | Week 48: 12 to 17 years (N = 28) | 0.47 z-score | Standard Deviation 1.11 |
| Etanercept | Height z-Score by Age Group for PsA Sub-population | Week 72: 12 to 17 years (N = 27) | 0.51 z-score | Standard Deviation 1.1 |
| Etanercept | Height z-Score by Age Group for PsA Sub-population | Week 96: 12 to 17 years (N = 25) | 0.48 z-score | Standard Deviation 1.11 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 24 (N = 36) | 5.35 cm | Standard Deviation 2.1 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 36 (N = 35) | 5.49 cm | Standard Deviation 2.1 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 48 (N = 34) | 5.38 cm | Standard Deviation 1.59 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 84 (N = 30) | 5.47 cm | Standard Deviation 1.68 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 96 (N = 30) | 5.33 cm | Standard Deviation 1.65 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Baseline (N = 37) | 5.03 cm | Standard Deviation 1.94 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 4 (N = 38) | 5.24 cm | Standard Deviation 1.94 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 8 (N = 36) | 5.12 cm | Standard Deviation 2.36 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 12 (N = 36) | 5.45 cm | Standard Deviation 1.98 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 60 (N = 33) | 5.33 cm | Standard Deviation 1.71 |
| Etanercept | Modified Schober's Test for ERA Sub-population | Week 72 (N = 32) | 5.27 cm | Standard Deviation 1.59 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 60 (N = 32) | 3.34 mm | Standard Deviation 13.36 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 72 (N = 32) | 6.47 mm | Standard Deviation 19.64 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 84 (N = 31) | 2.66 mm | Standard Deviation 6.86 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 96 (N = 30) | 2.17 mm | Standard Deviation 3.5 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Baseline (N = 38) | 16.37 mm | Standard Deviation 27.76 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 4 (N = 38) | 8.58 mm | Standard Deviation 19.31 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 8 (N = 36) | 7.82 mm | Standard Deviation 18.34 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 12 (N = 36) | 5.81 mm | Standard Deviation 11.74 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 24 (N = 36) | 5.31 mm | Standard Deviation 15.17 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 36 (N = 35) | 7.54 mm | Standard Deviation 17.66 |
| Etanercept | Nocturnal Back Pain Score for ERA Sub-population | Week 48 (N = 34) | 5.85 mm | Standard Deviation 13.82 |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs) | Vaccine preventable infections | 8 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | ISRs | 16 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Malignancies | 0 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Infections | 96 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Medically important infections | 11 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Infection and ISRs excluded | 93 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs) | Serious AE: Infection | 11 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Medically important infections | 4 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Vaccine preventable infections | 6 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | ISRs | 8 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Malignancies | 0 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Infections | 48 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Infection and ISRs excluded | 44 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | Serious AE: Infection | 4 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Infections | 28 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Medically important infections | 4 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Vaccine preventable infections | 1 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | ISRs | 6 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Malignancies | 0 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Infection and ISRs excluded | 30 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): ERA Sub-population | Serious AE: Infection | 4 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Medically important infections | 3 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Vaccine preventable infections | 1 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | ISRs | 2 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Malignancies | 0 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Infections | 20 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Infection and ISRs excluded | 19 Participants |
| Etanercept | Number of Participants With Adverse Events (AEs): PsA Sub-population | Serious AE: Infection | 3 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Anti-etanercept Antibodies | Week 96 (N=105) | 14 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies | Overall (N=127) | 26 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies | Week 12 (N=120) | 6 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies | Week 48 (N=116) | 14 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population | Overall (N=60) | 11 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population | Week 12 (N=56) | 0 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population | Week 48 (N=55) | 7 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population | Week 96 (N=52) | 7 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Anti-etanercept Antibodies: ERA Sub-population | Overall (N=38) | 9 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: ERA Sub-population | Week 12 (N=36) | 4 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: ERA Sub-population | Week 48 (N=34) | 4 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: ERA Sub-population | Week 96 (N=29) | 3 Participants |
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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Number of Participants With Anti-etanercept Antibodies: PsA Sub-population | Overall (N=29) | 6 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: PsA Sub-population | Week 12 (N=28) | 2 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: PsA Sub-population | Week 48 (N=27) | 3 Participants |
| Etanercept | Number of Participants With Anti-etanercept Antibodies: PsA Sub-population | Week 96 (N=24) | 4 Participants |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Number of Participants With Neutralizing Anti-etanercept Antibodies | 0 Participants |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 36 (N = 35) | 10.16 mm | Standard Deviation 19.2 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 24 (N = 36) | 9.81 mm | Standard Deviation 17.23 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 12 (N = 36) | 11.83 mm | Standard Deviation 18.22 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 48 (N = 34) | 8.62 mm | Standard Deviation 15.76 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 60 (N = 32) | 5.13 mm | Standard Deviation 12.28 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 72 (N = 32) | 6.03 mm | Standard Deviation 14.67 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 84 (N = 31) | 5.03 mm | Standard Deviation 8.4 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Baseline (N = 37) | 25.94 mm | Standard Deviation 28 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 4 (N = 38) | 14.24 mm | Standard Deviation 19.87 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 8 (N = 36) | 12.94 mm | Standard Deviation 22.6 |
| Etanercept | Overall Back Pain Score for ERA Sub-population | Week 96 (N = 30) | 2.37 mm | Standard Deviation 4.51 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Baseline (N = 29) | 9.83 Percentage of BSA | Standard Deviation 13.61 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 4 (N = 29) | 6.81 Percentage of BSA | Standard Deviation 9.02 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 8 (N = 29) | 4.67 Percentage of BSA | Standard Deviation 7.68 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 12 (N = 29) | 3.49 Percentage of BSA | Standard Deviation 5.66 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 24 (N = 28) | 2.36 Percentage of BSA | Standard Deviation 4.24 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 36 (N = 28) | 2.91 Percentage of BSA | Standard Deviation 8.7 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 60 (N = 27) | 1.48 Percentage of BSA | Standard Deviation 2.38 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 72 (N = 27) | 1.53 Percentage of BSA | Standard Deviation 2.17 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 84 (N = 27) | 1.56 Percentage of BSA | Standard Deviation 2.27 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 96 (N = 25) | 1.14 Percentage of BSA | Standard Deviation 2.12 |
| Etanercept | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Week 48 (N = 28) | 3.12 Percentage of BSA | Standard Deviation 8.13 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Baseline (N = 29) | 1.76 Units on a scale | Standard Deviation 1.46 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 4 (N = 29) | 1.41 Units on a scale | Standard Deviation 1.18 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 8 (N = 29) | 1.07 Units on a scale | Standard Deviation 1.03 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 12 (N = 28) | 0.82 Units on a scale | Standard Deviation 0.72 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 24 (N = 28) | 0.61 Units on a scale | Standard Deviation 0.69 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 36 (N = 28) | 0.61 Units on a scale | Standard Deviation 0.88 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 48 (N = 28) | 0.75 Units on a scale | Standard Deviation 0.89 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 60 (N = 27) | 0.78 Units on a scale | Standard Deviation 0.97 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 72 (N = 26) | 0.65 Units on a scale | Standard Deviation 0.94 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 84 (N = 27) | 0.56 Units on a scale | Standard Deviation 0.85 |
| Etanercept | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | Week 96 (N = 25) | 0.48 Units on a scale | Standard Deviation 0.82 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Tanner Assessment Score by Age Group | Baseline: 2 to 17 years (N = 126) | 3.08 Units on a scale | Standard Deviation 1.59 |
| Etanercept | Tanner Assessment Score by Age Group | Week 12: 2 to 17 years (N = 122) | 3.18 Units on a scale | Standard Deviation 1.63 |
| Etanercept | Tanner Assessment Score by Age Group | Week 48: 2 to 17 years (N = 118) | 3.34 Units on a scale | Standard Deviation 1.61 |
| Etanercept | Tanner Assessment Score by Age Group | Week 96: 2 to 17 years (N = 106) | 3.57 Units on a scale | Standard Deviation 1.61 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Baseline: 2 to 4 years (N=14) | 1.00 Units on a scale | Standard Deviation 0 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Baseline: 5 to 11 years (N=23) | 1.16 Units on a scale | Standard Deviation 0.44 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Baseline: 12 to 17 years (N=22) | 3.94 Units on a scale | Standard Deviation 0.97 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Baseline: 2 to 17 years (N=59) | 2.16 Units on a scale | Standard Deviation 1.53 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 12: 2 to 4 years (N=14) | 1.00 Units on a scale | Standard Deviation 0 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 12: 5 to 11 years (N=22) | 1.17 Units on a scale | Standard Deviation 0.45 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 12: 12 to 17 years (N=21) | 4.02 Units on a scale | Standard Deviation 0.95 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 12: 2 to 17 years (N=57) | 2.18 Units on a scale | Standard Deviation 1.56 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 48: 2 to 4 years (n=13) | 1.00 Units on a scale | Standard Deviation 0 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 48: 5 to 11 years (N=22) | 1.30 Units on a scale | Standard Deviation 0.63 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 48: 12 to 17 years (N=21) | 4.35 Units on a scale | Standard Deviation 0.83 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 48: 2 to 17 years (N=56) | 2.37 Units on a scale | Standard Deviation 1.67 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 96: 2 to 4 years (N=13) | 1.00 Units on a scale | Standard Deviation 0 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 96: 5 to 11 years (N=19) | 1.67 Units on a scale | Standard Deviation 1.08 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 96: 12 to 17 years (N=20) | 4.53 Units on a scale | Standard Deviation 0.62 |
| Etanercept | Tanner Assessment Score by Age Group for eoJIA Sub-population | Week 96: 2 to 17 years (N=52) | 2.60 Units on a scale | Standard Deviation 1.73 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Tanner Assessment Score by Age Group for ERA Sub-population | Baseline: 12 to 17 years (N = 38) | 3.87 Units on a scale | Standard Deviation 1.07 |
| Etanercept | Tanner Assessment Score by Age Group for ERA Sub-population | Week 12: 12 to 17 years (N = 36) | 4.09 Units on a scale | Standard Deviation 1.04 |
| Etanercept | Tanner Assessment Score by Age Group for ERA Sub-population | Week 48: 12 to 17 years (N = 34) | 4.24 Units on a scale | Standard Deviation 0.84 |
| Etanercept | Tanner Assessment Score by Age Group for ERA Sub-population | Week 96: 12 to 17 years (N = 30) | 4.51 Units on a scale | Standard Deviation 0.66 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Tanner Assessment Score by Age Group for PsA Sub-population | Baseline: 12 to 17 years (N = 29) | 3.93 Units on a scale | Standard Deviation 1.22 |
| Etanercept | Tanner Assessment Score by Age Group for PsA Sub-population | Week 12: 12 to 17 years (N = 29) | 4.02 Units on a scale | Standard Deviation 1.19 |
| Etanercept | Tanner Assessment Score by Age Group for PsA Sub-population | Week 48: 12 to 17 years (N = 28) | 4.20 Units on a scale | Standard Deviation 0.95 |
| Etanercept | Tanner Assessment Score by Age Group for PsA Sub-population | Week 96: 12 to 17 years (N = 24) | 4.51 Units on a scale | Standard Deviation 0.69 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Baseline (N = 38) | 5.87 Tender entheses | Standard Deviation 9.42 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 4 (N = 38) | 4.68 Tender entheses | Standard Deviation 11.81 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 8 (N = 36) | 2.06 Tender entheses | Standard Deviation 5.79 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 12 (N = 36) | 1.81 Tender entheses | Standard Deviation 6.15 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 24 (N = 36) | 1.89 Tender entheses | Standard Deviation 6.89 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 60 (N = 33) | 0.97 Tender entheses | Standard Deviation 2.98 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 36 (N = 35) | 2.03 Tender entheses | Standard Deviation 5.7 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 48 (N = 34) | 1.32 Tender entheses | Standard Deviation 3.76 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 72 (N = 32) | 0.56 Tender entheses | Standard Deviation 1.29 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 84 (N = 31) | 0.77 Tender entheses | Standard Deviation 2 |
| Etanercept | Tender Entheseal Assessment for ERA Sub-population | Week 96 (N = 30) | 0.33 Tender entheses | Standard Deviation 1.03 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Weight z-Scores by Age Group | Baseline: 2 to 17 years (N = 127) | 0.17 z-score | Standard Deviation 1.02 |
| Etanercept | Weight z-Scores by Age Group | Week 4: 2 to 17 years (N = 126) | 0.18 z-score | Standard Deviation 1.02 |
| Etanercept | Weight z-Scores by Age Group | Week 8: 2 to 17 years (N = 121) | 0.23 z-score | Standard Deviation 1.02 |
| Etanercept | Weight z-Scores by Age Group | Week 12: 2 to 17 years (N = 123) | 0.22 z-score | Standard Deviation 1 |
| Etanercept | Weight z-Scores by Age Group | Week 24: 2 to 17 years (N = 122) | 0.25 z-score | Standard Deviation 0.99 |
| Etanercept | Weight z-Scores by Age Group | Week 36: 2 to 17 years (N = 120) | 0.26 z-score | Standard Deviation 0.97 |
| Etanercept | Weight z-Scores by Age Group | Week 48: 2 to 17 years (N = 118) | 0.25 z-score | Standard Deviation 0.97 |
| Etanercept | Weight z-Scores by Age Group | Week 60: 2 to 17 years (N = 116) | 0.24 z-score | Standard Deviation 0.95 |
| Etanercept | Weight z-Scores by Age Group | Week 72: 2 to 17 years (N = 114) | 0.29 z-score | Standard Deviation 0.91 |
| Etanercept | Weight z-Scores by Age Group | Week 84: 2 to 17 years (N = 113) | 0.27 z-score | Standard Deviation 0.93 |
| Etanercept | Weight z-Scores by Age Group | Week 96: 2 to 17 years (N = 109) | 0.25 z-score | Standard Deviation 0.93 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Baseline: 2 to 4 years (N=15) | -0.50 z-score | Standard Deviation 0.98 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Baseline: 5 to 11 years (N=23) | 0.15 z-score | Standard Deviation 1.33 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Baseline: 12 to 17 years (N=22) | 0.40 z-score | Standard Deviation 0.72 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Baseline: 2 to 17 years (N=60) | 0.08 z-score | Standard Deviation 1.1 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 4: 2 to 4 years (N=15) | -0.54 z-score | Standard Deviation 1.13 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 4: 5 to 11 years (N=23) | 0.17 z-score | Standard Deviation 1.34 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 4: 12 to 17 years (N=21) | 0.38 z-score | Standard Deviation 0.69 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 4: 2 to 17 years (N=59) | 0.06 z-score | Standard Deviation 1.13 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 8: 2 to 4 years (N=14) | -0.48 z-score | Standard Deviation 1.25 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 8: 5 to 11 years (N=21) | 0.30 z-score | Standard Deviation 1.3 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 8: 12 to 17 years (N=21) | 0.40 z-score | Standard Deviation 0.72 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 8: 2 to 17 years (N=56) | 0.14 z-score | Standard Deviation 1.14 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 12: 2 to 4 years (n=15) | -0.35 z-score | Standard Deviation 1.09 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 12: 5 to 11 years (N=22) | 0.22 z-score | Standard Deviation 1.35 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 12: 12 to 17 years (N=21) | 0.41 z-score | Standard Deviation 0.72 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 12: 2 to 17 years (N=58) | 0.14 z-score | Standard Deviation 1.11 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 24: 2 to 4 years (N=15) | -0.21 z-score | Standard Deviation 1.1 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 24: 5 to 11 years (N=22) | 0.21 z-score | Standard Deviation 1.32 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 24: 12 to 17 years (N=21) | 0.46 z-score | Standard Deviation 0.69 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 24: 2 to 17 years (N=58) | 0.19 z-score | Standard Deviation 1.08 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 36: 2 to 4 years (N=14) | -0.25 z-score | Standard Deviation 1.14 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 36: 5 to 11 years (N=22) | 0.27 z-score | Standard Deviation 1.25 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 36: 12 to 17 years (N=21) | 0.39 z-score | Standard Deviation 0.7 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 36: 2 to 17 years (N=57) | 0.18 z-score | Standard Deviation 1.06 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 48: 2 to 4 years (N=14) | -0.28 z-score | Standard Deviation 1.15 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 48: 5 to 11 years (N=21) | 0.21 z-score | Standard Deviation 1.24 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 48: 12 to 17 years (N=21) | 0.40 z-score | Standard Deviation 0.65 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 48: 2 to 17 years (N=56) | 0.16 z-score | Standard Deviation 1.05 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 60: 2 to 4 years (N=14) | -0.18 z-score | Standard Deviation 1.15 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 60: 5 to 11 years (N=22) | 0.23 z-score | Standard Deviation 1.24 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 60: 12 to 17 years (N=20) | 0.31 z-score | Standard Deviation 0.62 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 60: 2 to 17 years (N=56) | 0.16 z-score | Standard Deviation 1.04 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 72: 2 to 4 years (N=14) | -0.09 z-score | Standard Deviation 1.12 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 72: 5 to 11 years (N=21) | 0.43 z-score | Standard Deviation 1.13 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 72: 12 to 17 years (N=20) | 0.29 z-score | Standard Deviation 0.67 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 72: 2 to 17 years (N=55) | 0.25 z-score | Standard Deviation 0.99 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 84: 2 to 4 years (N=14) | -0.10 z-score | Standard Deviation 1.13 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 84: 5 to 11 years (N=21) | 0.42 z-score | Standard Deviation 1.15 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 84: 12 to 17 years (N=20) | 0.23 z-score | Standard Deviation 0.74 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 84: 2 to 17 years (N=55) | 0.22 z-score | Standard Deviation 1.02 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 96: 2 to 4 years (N=14) | -0.14 z-score | Standard Deviation 1.18 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 96: 5 to 11 years (N=20) | 0.49 z-score | Standard Deviation 1.11 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 96: 12 to 17 years (N=20) | 0.16 z-score | Standard Deviation 0.76 |
| Etanercept | Weight z-Scores by Age Group for eoJIA Sub-population | Week 96: 2 to 17 years (N=54) | 0.20 z-score | Standard Deviation 1.03 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Baseline: 12 to 17 years (N = 38) | -0.05 z-score | Standard Deviation 0.74 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 4: 12 to 17 years (N = 38) | -0.00 z-score | Standard Deviation 0.72 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 8: 12 to 17 years (N = 36) | 0.04 z-score | Standard Deviation 0.68 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 12: 12 to 17 years (N = 36) | -0.00 z-score | Standard Deviation 0.65 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 24: 12 to 17 years (N = 36) | 0.01 z-score | Standard Deviation 0.68 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 36: 12 to 17 years (N = 35) | 0.03 z-score | Standard Deviation 0.68 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 48: 12 to 17 years (N = 34) | 0.04 z-score | Standard Deviation 0.7 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 60: 12 to 17 years (N = 33) | 0.08 z-score | Standard Deviation 0.67 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 72: 12 to 17 years (N = 32) | 0.12 z-score | Standard Deviation 0.65 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 84: 12 to 17 years (N = 31) | 0.07 z-score | Standard Deviation 0.67 |
| Etanercept | Weight z-Scores by Age Group for ERA Sub-population | Week 96: 12 to 17 years (N = 30) | 0.06 z-score | Standard Deviation 0.63 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Baseline: 12 to 17 years (N = 29) | 0.63 z-score | Standard Deviation 1.05 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 4: 12 to 17 years (N = 29) | 0.66 z-score | Standard Deviation 1.01 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 8: 12 to 17 years (N = 29) | 0.64 z-score | Standard Deviation 1.04 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 12: 12 to 17 years (N = 29) | 0.63 z-score | Standard Deviation 1.04 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 24: 12 to 17 years (N = 28) | 0.66 z-score | Standard Deviation 1.04 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 36: 12 to 17 years (N = 28) | 0.69 z-score | Standard Deviation 0.97 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 48: 12 to 17 years (N = 28) | 0.70 z-score | Standard Deviation 0.96 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 60: 12 to 17 years (N = 27) | 0.61 z-score | Standard Deviation 1 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 72: 12 to 17 years (N = 27) | 0.57 z-score | Standard Deviation 0.97 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 84: 12 to 17 years (N = 27) | 0.59 z-score | Standard Deviation 0.94 |
| Etanercept | Weight z-Scores by Age Group for PsA Sub-population | Week 96: 12 to 17 years (N = 25) | 0.59 z-score | Standard Deviation 0.96 |