| Primary | Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 | ACR Pedi 30 response: greater than or equal to (>=) 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| | | Title | Denominators | Categories |
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| | |
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| Secondary | Percentage of Participants With an ACR Pedi 30 Response | ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population | ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population | ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population | ACR Pedi 30 response: >= 30% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response | ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population | ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population | ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population | ACR Pedi 50 response: >= 50% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 70 Response | ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population | ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population | ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population | ACR Pedi 70 response: >= 70% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 90 Response | ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population | ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population | ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population | ACR Pedi 90 response: >= 90% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 100 Response | ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population | ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population | ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population | ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening > 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit. | 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). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Physician's Global Assessment (PGA) of Disease Activity | PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population | PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population | PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population | PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Patient/Parent Global Assessment | Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Patient/Parent Global Assessment: eoJIA Sub-population | Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Patient/Parent Global Assessment: ERA Sub-population | Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Patient/Parent Global Assessment: PsA Sub-population | Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Active Joints | Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Active Joints: eoJIA Sub-population | Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Active Joints: ERA Sub-population | Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Active Joints: PsA Sub-population | Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73*(total number of active joints with counts > 0)/number of non-missing active joints. JR and NE were treated as missing. If > 36 active joint counts were missing, total number of active joints was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Joints With Limitation of Motion | The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Joints With Limitation of Motion: eoJIA Sub-population | The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Joints With Limitation of Motion: ERA Sub-population | The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Number of Joints With Limitation of Motion: PsA Sub-population | The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69*(total number of joints with counts of limitation of motion > 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If > 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Joints | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | C-reactive Protein (CRP) | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | 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). | Posted | | Mean | Standard Deviation | mg/Liter (mg/L) | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | C-reactive Protein (CRP): eoJIA Sub-population | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | 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). | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | C-reactive Protein (CRP): ERA Sub-population | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | 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). | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | C-reactive Protein (CRP): PsA Sub-population | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. | 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). | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Pain Assessment | Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Pain Assessment: eoJIA Sub-population | Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Pain Assessment: ERA Sub-population | Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Pain Assessment: PsA Sub-population | Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Duration of Morning Stiffness | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). | 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). | Posted | | Mean | Standard Deviation | Minutes | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Duration of Morning Stiffness: eoJIA Sub-population | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). | 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). | Posted | | Mean | Standard Deviation | Minutes | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Duration of Morning Stiffness: ERA Sub-population | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). | 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). | Posted | | Mean | Standard Deviation | Minutes | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Duration of Morning Stiffness: PsA Sub-population | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded). | 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). | Posted | | Mean | Standard Deviation | Minutes | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition | Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. | 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). | Posted | | Number | | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population | Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. | 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). | Posted | | Number | | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population | Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. | 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). | Posted | | Number | | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population | Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS. | 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). | Posted | | Number | | Percentage of participants | | Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Childhood Health Assessment Questionnaire (CHAQ) Score | CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population | CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population | CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Secondary | Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population | CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Tender Entheseal Assessment for ERA Sub-population | Tender entheseal assessment: Entheses were assessed and coded as: 1= any tenderness, 0= no tenderness, NE= not evaluable. Total number of tender entheses: 66*(total number of tender entheses with counts > 0)/number of non-missing tender entheses. If > 33 tender entheseal counts were missing, total number of tender entheses was defined as missing. | 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). | Posted | | Mean | Standard Deviation | Tender entheses | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Overall Back Pain Score for ERA Sub-population | Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain. | 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). | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Nocturnal Back Pain Score for ERA Sub-population | Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain. | 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). | Posted | | Mean | Standard Deviation | mm | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Modified Schober's Test for ERA Sub-population | Modified Schober's Test: A mark was placed in the midpoint of a line that joined the posterior superior iliac spines. Another mark was placed 10 centimeter (cm) above the first. The participant then bent maximally forward with the knees fully extended. The distance between the two marks was then re-measured. The full measurement between the two lines was recorded to the nearest tenth of a centimeter. | 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). | Posted | | Mean | Standard Deviation | cm | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population | Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1 percent (%) of BSA. Regions of the body were assigned specific number of palms with percentage [Head and neck= 10% (10 palms), upper extremities= 20% (20 palms), Trunk (axillae and groin)= 30% (30 palms), lower extremities (buttocks)= 40% (40 palms)]. The total BSA affected was the summation of individual regions affected. | 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). | Posted | | Mean | Standard Deviation | Percentage of BSA | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population | PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5. 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1. | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections. | 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). | Posted | | Number | | Participants | | Week 12, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Adverse Events (AEs): eoJIA Subpopulation | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections. | 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). | Posted | | Number | | Participants | | Week 12, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Adverse Events (AEs): ERA Sub-population | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections. | 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). | Posted | | Number | | Participants | | Week 12, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Adverse Events (AEs): PsA Sub-population | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Number of participants reporting adverse events included medically important infections, infections considered preventable by vaccination, injection site reactions (ISRS), malignancies, adverse events, excluding infections and injection site reactions, infections and serious adverse events including infections. | 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). | Posted | | Number | | Participants | | Week 12, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Tanner Assessment Score by Age Group | Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Tanner Assessment Score by Age Group for eoJIA Sub-population | Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Tanner Assessment Score by Age Group for ERA Sub-population | Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Tanner Assessment Score by Age Group for PsA Sub-population | Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size). | 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). | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Height z-Score by Age Group | Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Height z-Score by Age Group for eoJIA Sub-population | Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Height z-Score by Age Group for ERA Sub-population | Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Height z-Score by Age Group for PsA Sub-population | Standing height was taken as a mean of 3 consecutive measurements using a wall mounted stadiometer. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Weight z-Scores by Age Group | Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Weight z-Scores by Age Group for eoJIA Sub-population | Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Weight z-Scores by Age Group for ERA Sub-population | Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Weight z-Scores by Age Group for PsA Sub-population | Weight was taken as a mean of 3 consecutive measurements using a medical electronic scale. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Body Mass Index (BMI) z-Score by Age Group | BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Body Mass Index (BMI) z-Score by Age Group for eoJIA Sub-population | BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Body Mass Index (BMI) z-Score by Age Group for ERA Sub-population | BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Body Mass Index (BMI) z-Score by Age Group for PsA Sub-population | BMI was used to measure body fat based on height and weight. It was calculated by body weight (kg)/height (m) squared. Z-Score was a statistical measure to evaluate how a single data point compares to a standard. It described whether a mean was above or below the standard and how unusual the measurement is with range from -3 to +3; 0 =same mean, >0 a greater mean, and <0 a lesser mean than the standard. Growth parameters were compared to a standard defined by Centers for Disease Control's growth charts. | 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). | Posted | | Mean | Standard Deviation | z-score | | Baseline, Week 12, Week 48, Week 72, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Anti-etanercept Antibodies | | 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). | Posted | | Number | | Participants | | Baseline up to Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| | |
| Other Pre-specified | Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-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). | Posted | | Number | | Participants | | Baseline up to Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Anti-etanercept Antibodies: ERA Sub-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). | Posted | | Number | | Participants | | Baseline up to Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Anti-etanercept Antibodies: PsA Sub-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). | Posted | | Number | | Participants | | Baseline up to Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| |
| Other Pre-specified | Number of Participants With Neutralizing Anti-etanercept Antibodies | | Safety population included all participants who received at least 1 dose of the study medication. | Posted | | Number | | Participants | | Baseline up to Week 12, Week 48, Week 96 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept | Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks. |
| | |