Trial Outcomes & Findings for Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis (NCT NCT00962741)
NCT ID: NCT00962741
Last Updated: 2014-06-10
Results Overview
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.
COMPLETED
PHASE3
127 participants
Week 12
2014-06-10
Participant Flow
Participant milestones
| Measure |
Etanercept
Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Overall Study
STARTED
|
127
|
|
Overall Study
COMPLETED
|
119
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Etanercept
Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Overall Study
Failed to return
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
drug ineffective+prohibited drug taken
|
1
|
Baseline Characteristics
Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Baseline characteristics by cohort
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Age, Continuous
|
11.70 Years
STANDARD_DEVIATION 4.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: 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.
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.
Outcome measures
| Measure |
Etanercept
n=123 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
|
88.6 Percentage of participants
Interval 81.6 to 93.6
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 72 (N = 114)
|
96.5 Percentage of participants
Interval 91.3 to 99.0
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 84 (N = 113)
|
93.8 Percentage of participants
Interval 87.7 to 97.5
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 4 (N = 126)
|
71.4 Percentage of participants
Interval 62.7 to 79.1
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 8 (N = 121)
|
88.4 Percentage of participants
Interval 81.3 to 93.5
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 12 (N = 123)
|
88.6 Percentage of participants
Interval 81.6 to 93.6
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 24 (N = 122)
|
94.3 Percentage of participants
Interval 88.5 to 97.7
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 36 (N = 120)
|
95.8 Percentage of participants
Interval 90.5 to 98.6
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 48 (N = 119)
|
94.1 Percentage of participants
Interval 88.3 to 97.6
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 60 (N = 116)
|
95.7 Percentage of participants
Interval 90.2 to 98.6
|
|
Percentage of Participants With an ACR Pedi 30 Response
Week 96 (N = 108)
|
99.1 Percentage of participants
Interval 94.9 to 100.0
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
Interval 54.4 to 79.4
|
|
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
Interval 75.9 to 94.8
|
|
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
Interval 78.8 to 96.1
|
|
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
Interval 85.6 to 98.9
|
|
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
Interval 85.4 to 98.9
|
|
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
Interval 87.9 to 99.6
|
|
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
Interval 90.4 to 100.0
|
|
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
Interval 90.3 to 100.0
|
|
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
Interval 90.3 to 100.0
|
|
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
Interval 93.3 to 100.0
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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.
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).
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 96 (N = 30)
|
100 Percentage of participants
Interval 88.4 to 100.0
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 4 (N = 38)
|
84.2 Percentage of participants
Interval 68.7 to 94.0
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 8 (N = 36)
|
91.7 Percentage of participants
Interval 77.5 to 98.2
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 12 (N = 36)
|
83.3 Percentage of participants
Interval 67.2 to 93.6
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 24 (N = 36)
|
91.7 Percentage of participants
Interval 77.5 to 98.2
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 36 (N = 35)
|
97.1 Percentage of participants
Interval 85.1 to 99.9
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 48 (N = 34)
|
91.2 Percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 60 (N = 33)
|
90.9 Percentage of participants
Interval 75.7 to 98.1
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 72 (N = 32)
|
93.8 Percentage of participants
Interval 79.2 to 99.2
|
|
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
Week 84 (N = 31)
|
90.3 Percentage of participants
Interval 74.2 to 98.0
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 4 (N = 29)
|
62.1 Percentage of participants
Interval 42.3 to 79.3
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 48 (N = 28)
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 60 (N = 27)
|
96.3 Percentage of participants
Interval 81.0 to 99.9
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 8 (N = 29)
|
86.2 Percentage of participants
Interval 68.3 to 96.1
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 12 (N = 29)
|
93.1 Percentage of participants
Interval 77.2 to 99.2
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 24 (N = 28)
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 36 (N = 28)
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 72 (N = 27)
|
96.3 Percentage of participants
Interval 81.0 to 99.9
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 84 (N = 27)
|
88.9 Percentage of participants
Interval 70.8 to 97.6
|
|
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
Week 96 (N = 25)
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 60 (N = 116)
|
92.2 Percentage of participants
Interval 85.8 to 96.4
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 72 (N = 114)
|
93.9 Percentage of participants
Interval 87.8 to 97.5
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 84 (N = 113)
|
91.2 Percentage of participants
Interval 84.3 to 95.7
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 4 (N = 125)
|
51.2 Percentage of participants
Interval 42.1 to 60.2
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 8 (N = 121)
|
76.9 Percentage of participants
Interval 68.3 to 84.0
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 12 (N = 122)
|
81.1 Percentage of participants
Interval 73.1 to 87.7
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 24 (N = 122)
|
88.5 Percentage of participants
Interval 81.5 to 93.6
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 36 (N = 120)
|
88.3 Percentage of participants
Interval 81.2 to 93.5
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 48 (N = 119)
|
93.3 Percentage of participants
Interval 87.2 to 97.1
|
|
Percentage of Participants With an ACR Pedi 50 Response
Week 96 (N = 108)
|
98.1 Percentage of participants
Interval 93.5 to 99.8
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 12 (N = 58)
|
79.3 Percentage of participants
Interval 66.6 to 88.8
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 24 (N = 58)
|
86.2 Percentage of participants
Interval 74.6 to 93.9
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 84 (N = 55)
|
96.4 Percentage of participants
Interval 87.5 to 99.6
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 96 (N = 53)
|
100 Percentage of participants
Interval 93.3 to 100.0
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 4 (N = 58)
|
51.7 Percentage of participants
Interval 38.2 to 65.0
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 8 (N = 56)
|
75.0 Percentage of participants
Interval 61.6 to 85.6
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 36 (N = 57)
|
91.2 Percentage of participants
Interval 80.7 to 97.1
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 48 (N = 57)
|
94.7 Percentage of participants
Interval 85.4 to 98.9
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 60 (N = 56)
|
92.9 Percentage of participants
Interval 82.7 to 98.0
|
|
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
Week 72 (N = 55)
|
96.4 Percentage of participants
Interval 87.5 to 99.6
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 12 (N = 35)
|
80.0 Percentage of participants
Interval 63.1 to 91.6
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 84 (N = 31)
|
83.9 Percentage of participants
Interval 66.3 to 94.5
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 96 (N = 30)
|
96.7 Percentage of participants
Interval 82.8 to 99.9
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 48 (N = 34)
|
91.2 Percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 60 (N = 33)
|
87.9 Percentage of participants
Interval 71.8 to 96.6
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 72 (N = 32)
|
90.6 Percentage of participants
Interval 75.0 to 98.0
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 4 (N = 38)
|
63.2 Percentage of participants
Interval 46.0 to 78.2
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 8 (N = 36)
|
86.1 Percentage of participants
Interval 70.5 to 95.3
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 24 (N = 36)
|
86.1 Percentage of participants
Interval 70.5 to 95.3
|
|
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
Week 36 (N = 35)
|
82.9 Percentage of participants
Interval 66.4 to 93.4
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 4 (N = 29)
|
34.5 Percentage of participants
Interval 17.9 to 54.3
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 8 (N = 29)
|
69.0 Percentage of participants
Interval 49.2 to 84.7
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 12 (N = 29)
|
86.2 Percentage of participants
Interval 68.3 to 96.1
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 24 (N = 28)
|
96.4 Percentage of participants
Interval 81.7 to 99.9
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 36 (N = 28)
|
89.3 Percentage of participants
Interval 71.8 to 97.7
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 48 (N = 28)
|
92.9 Percentage of participants
Interval 76.5 to 99.1
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 60 (N = 27)
|
96.3 Percentage of participants
Interval 81.0 to 99.9
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 72 (N = 27)
|
92.6 Percentage of participants
Interval 75.7 to 99.1
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 84 (N = 27)
|
88.9 Percentage of participants
Interval 70.8 to 97.6
|
|
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
Week 96 (N = 25)
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 4 (N = 126)
|
26.2 Percentage of participants
Interval 18.8 to 34.8
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 8 (N = 121)
|
47.1 Percentage of participants
Interval 38.0 to 56.4
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 60 (N = 115)
|
81.7 Percentage of participants
Interval 73.5 to 88.3
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 12 (N = 122)
|
61.5 Percentage of participants
Interval 52.2 to 70.1
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 24 (N = 122)
|
71.3 Percentage of participants
Interval 62.4 to 79.1
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 36 (N = 120)
|
73.3 Percentage of participants
Interval 64.5 to 81.0
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 48 (N = 119)
|
79.8 Percentage of participants
Interval 71.5 to 86.6
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 72 (N = 114)
|
84.2 Percentage of participants
Interval 76.2 to 90.4
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 84 (N = 113)
|
87.6 Percentage of participants
Interval 80.1 to 93.1
|
|
Percentage of Participants With an ACR Pedi 70 Response
Week 96 (N = 108)
|
92.6 Percentage of participants
Interval 85.9 to 96.7
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 4 (N = 59)
|
28.8 Percentage of participants
Interval 17.8 to 42.1
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 8 (N = 56)
|
51.8 Percentage of participants
Interval 38.0 to 65.3
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 12 (N = 58)
|
63.8 Percentage of participants
Interval 50.1 to 76.0
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 24 (N = 58)
|
70.7 Percentage of participants
Interval 57.3 to 81.9
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 36 (N = 57)
|
75.4 Percentage of participants
Interval 62.2 to 85.9
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 48 (N = 57)
|
77.2 Percentage of participants
Interval 64.2 to 87.3
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 60 (N = 55)
|
80.0 Percentage of participants
Interval 67.0 to 89.6
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 72 (N = 55)
|
85.5 Percentage of participants
Interval 73.3 to 93.5
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 84 (N = 55)
|
90.9 Percentage of participants
Interval 80.0 to 97.0
|
|
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
Week 96 (N = 53)
|
94.3 Percentage of participants
Interval 84.3 to 98.8
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 48 (N = 34)
|
85.3 Percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 60 (N = 33)
|
81.8 Percentage of participants
Interval 64.5 to 93.0
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 72 (N = 32)
|
81.3 Percentage of participants
Interval 63.6 to 92.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 4 (N = 38)
|
28.9 Percentage of participants
Interval 15.4 to 45.9
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 8 (N = 36)
|
52.8 Percentage of participants
Interval 35.5 to 69.6
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 12 (N = 35)
|
71.4 Percentage of participants
Interval 53.7 to 85.4
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 24 (N = 36)
|
80.6 Percentage of participants
Interval 64.0 to 91.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 36 (N = 35)
|
77.1 Percentage of participants
Interval 59.9 to 89.6
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 84 (N = 31)
|
80.6 Percentage of participants
Interval 62.5 to 92.5
|
|
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
Week 96 (N = 30)
|
86.7 Percentage of participants
Interval 69.3 to 96.2
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 12 (N = 29)
|
44.8 Percentage of participants
Interval 26.4 to 64.3
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 24 (N = 28)
|
60.7 Percentage of participants
Interval 40.6 to 78.5
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 48 (N = 28)
|
78.6 Percentage of participants
Interval 59.0 to 91.7
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 60 (N = 27)
|
85.2 Percentage of participants
Interval 66.3 to 95.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 72 (N = 27)
|
85.2 Percentage of participants
Interval 66.3 to 95.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 84 (N = 27)
|
88.9 Percentage of participants
Interval 70.8 to 97.6
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 96 (N = 25)
|
96.0 Percentage of participants
Interval 79.6 to 99.9
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 4 (N = 29)
|
17.2 Percentage of participants
Interval 5.8 to 35.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 8 (N = 29)
|
31.0 Percentage of participants
Interval 15.3 to 50.8
|
|
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
Week 36 (N = 28)
|
64.3 Percentage of participants
Interval 44.1 to 81.4
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 96 (N = 107)
|
65.4 Percentage of participants
Interval 55.6 to 74.4
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 4 (N = 126)
|
6.3 Percentage of participants
Interval 2.8 to 12.1
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 8 (N = 121)
|
14.9 Percentage of participants
Interval 9.1 to 22.5
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 12 (N = 121)
|
29.8 Percentage of participants
Interval 21.8 to 38.7
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 24 (N = 122)
|
43.4 Percentage of participants
Interval 34.5 to 52.7
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 36 (N = 120)
|
47.5 Percentage of participants
Interval 38.3 to 56.8
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 48 (N = 119)
|
50.4 Percentage of participants
Interval 41.1 to 59.7
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 60 (N = 115)
|
53.0 Percentage of participants
Interval 43.5 to 62.4
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 72 (N = 113)
|
60.2 Percentage of participants
Interval 50.5 to 69.3
|
|
Percentage of Participants With an ACR Pedi 90 Response
Week 84 (N = 113)
|
64.6 Percentage of participants
Interval 55.0 to 73.4
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 24 (N = 58)
|
53.4 Percentage of participants
Interval 39.9 to 66.7
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 48 (N = 57)
|
52.6 Percentage of participants
Interval 39.0 to 66.0
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 60 (N = 55)
|
52.7 Percentage of participants
Interval 38.8 to 66.3
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 4 (N = 59)
|
6.8 Percentage of participants
Interval 1.9 to 16.5
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 8 (N = 56)
|
16.1 Percentage of participants
Interval 7.6 to 28.3
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 12 (N = 58)
|
27.6 Percentage of participants
Interval 16.7 to 40.9
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 36 (N = 57)
|
49.1 Percentage of participants
Interval 35.6 to 62.7
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 72 (N = 54)
|
61.1 Percentage of participants
Interval 46.9 to 74.1
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 84 (N = 55)
|
67.3 Percentage of participants
Interval 53.3 to 79.3
|
|
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
Week 96 (N = 53)
|
62.3 Percentage of participants
Interval 47.9 to 75.2
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 12 (N = 35)
|
45.7 Percentage of participants
Interval 28.8 to 63.4
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 24 (N = 36)
|
41.7 Percentage of participants
Interval 25.5 to 59.2
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 48 (N = 34)
|
50.0 Percentage of participants
Interval 32.4 to 67.6
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 60 (N = 33)
|
57.6 Percentage of participants
Interval 39.2 to 74.5
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 96 (N = 30)
|
66.7 Percentage of participants
Interval 47.2 to 82.7
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 4 (N = 38)
|
10.5 Percentage of participants
Interval 2.9 to 24.8
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 8 (N = 36)
|
22.2 Percentage of participants
Interval 10.1 to 39.2
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 36 (N = 35)
|
48.6 Percentage of participants
Interval 31.4 to 66.0
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 72 (N = 32)
|
71.9 Percentage of participants
Interval 53.3 to 86.3
|
|
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
Week 84 (N = 31)
|
64.5 Percentage of participants
Interval 45.4 to 80.8
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 4 (N = 29)
|
0.0 Percentage of participants
Interval 0.0 to 11.9
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 8 (N = 29)
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 48 (N = 28)
|
46.4 Percentage of participants
Interval 27.5 to 66.1
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 12 (N = 28)
|
14.3 Percentage of participants
Interval 4.0 to 32.7
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 24 (N = 28)
|
25.0 Percentage of participants
Interval 10.7 to 44.9
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 36 (N = 28)
|
42.9 Percentage of participants
Interval 24.5 to 62.8
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 60 (N = 27)
|
48.1 Percentage of participants
Interval 28.7 to 68.1
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 72 (N = 27)
|
44.4 Percentage of participants
Interval 25.5 to 64.7
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 84 (N = 27)
|
59.3 Percentage of participants
Interval 38.8 to 77.6
|
|
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
Week 96 (N = 24)
|
70.8 Percentage of participants
Interval 48.3 to 87.4
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 36 (N = 120)
|
36.7 Percentage of participants
Interval 28.1 to 45.9
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 48 (N = 119)
|
40.3 Percentage of participants
Interval 31.4 to 49.7
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 4 (N = 126)
|
3.2 Percentage of participants
Interval 0.9 to 7.9
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 8 (N = 121)
|
6.6 Percentage of participants
Interval 2.9 to 12.6
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 12 (N = 122)
|
23.0 Percentage of participants
Interval 15.8 to 31.4
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 24 (N = 122)
|
33.6 Percentage of participants
Interval 25.3 to 42.7
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 60 (N = 114)
|
42.1 Percentage of participants
Interval 32.9 to 51.7
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 72 (N = 113)
|
49.6 Percentage of participants
Interval 40.0 to 59.1
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 84 (N = 112)
|
55.4 Percentage of participants
Interval 45.7 to 64.8
|
|
Percentage of Participants With an ACR Pedi 100 Response
Week 96 (N = 107)
|
54.2 Percentage of participants
Interval 44.3 to 63.9
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 96 (N = 53)
|
54.7 Percentage of participants
Interval 40.4 to 68.4
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 4 (N = 59)
|
6.8 Percentage of participants
Interval 1.9 to 16.5
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 8 (N = 56)
|
8.9 Percentage of participants
Interval 3.0 to 19.6
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 12 (N = 58)
|
20.7 Percentage of participants
Interval 11.2 to 33.4
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 24 (N = 58)
|
39.7 Percentage of participants
Interval 27.0 to 53.4
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 36 (N = 57)
|
42.1 Percentage of participants
Interval 29.1 to 55.9
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 48 (N = 57)
|
47.4 Percentage of participants
Interval 34.0 to 61.0
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 60 (N = 55)
|
47.3 Percentage of participants
Interval 33.7 to 61.2
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 72 (N = 54)
|
51.9 Percentage of participants
Interval 37.8 to 65.7
|
|
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
Week 84 (N = 55)
|
60.0 Percentage of participants
Interval 45.9 to 73.0
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 4 (N = 38)
|
0.0 Percentage of participants
Interval 0.0 to 9.3
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 12 (N = 35)
|
34.3 Percentage of participants
Interval 19.1 to 52.2
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 24 (N = 36)
|
36.1 Percentage of participants
Interval 20.8 to 53.8
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 72 (N = 32)
|
59.4 Percentage of participants
Interval 40.6 to 76.3
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 84 (N = 31)
|
54.8 Percentage of participants
Interval 36.0 to 72.7
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 8 (N = 36)
|
5.6 Percentage of participants
Interval 0.7 to 18.7
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 36 (N = 35)
|
34.3 Percentage of participants
Interval 19.1 to 52.2
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 48 (N = 34)
|
32.4 Percentage of participants
Interval 17.4 to 50.5
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 60 (N = 33)
|
42.4 Percentage of participants
Interval 25.5 to 60.8
|
|
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
Week 96 (N = 30)
|
50.0 Percentage of participants
Interval 31.3 to 68.7
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 4 (N = 29)
|
0.0 Percentage of participants
Interval 0.0 to 11.9
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 8 (N = 29)
|
3.4 Percentage of participants
Interval 0.1 to 17.8
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 12 (N = 29)
|
13.8 Percentage of participants
Interval 3.9 to 31.7
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 60 (N = 26)
|
30.8 Percentage of participants
Interval 14.3 to 51.8
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 24 (N = 28)
|
17.9 Percentage of participants
Interval 6.1 to 36.9
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 36 (N = 28)
|
28.6 Percentage of participants
Interval 13.2 to 48.7
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 48 (N = 28)
|
35.7 Percentage of participants
Interval 18.6 to 55.9
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 72 (N = 27)
|
33.3 Percentage of participants
Interval 16.5 to 54.0
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 84 (N = 26)
|
46.2 Percentage of participants
Interval 36.6 to 66.6
|
|
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
Week 96 (N = 24)
|
58.3 Percentage of participants
Interval 36.6 to 77.9
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 12 (N = 123)
|
1.50 Units on a scale
Standard Deviation 1.30
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 24 (N = 122)
|
1.15 Units on a scale
Standard Deviation 1.22
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 48 (N = 119)
|
1.03 Units on a scale
Standard Deviation 1.19
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 60 (N = 116)
|
0.88 Units on a scale
Standard Deviation 0.99
|
|
Physician's Global Assessment (PGA) of Disease Activity
Baseline (N = 127)
|
5.02 Units on a scale
Standard Deviation 1.75
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 4 (N = 126)
|
2.78 Units on a scale
Standard Deviation 1.78
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 8 (N = 121)
|
2.00 Units on a scale
Standard Deviation 1.55
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 36 (N = 120)
|
1.05 Units on a scale
Standard Deviation 1.17
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 72 (N = 113)
|
0.78 Units on a scale
Standard Deviation 0.97
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 84 (N = 113)
|
0.78 Units on a scale
Standard Deviation 1.04
|
|
Physician's Global Assessment (PGA) of Disease Activity
Week 96 (N = 108)
|
0.62 Units on a scale
Standard Deviation 0.79
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
Week 48 (N = 57)
|
0.88 Units on a scale
Standard Deviation 1.20
|
|
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
|
|
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
|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
Baseline (N = 60)
|
4.96 Units on a scale
Standard Deviation 1.76
|
|
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
Week 4 (N = 59)
|
2.73 Units on a scale
Standard Deviation 1.80
|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
Week 12 (N = 58)
|
1.40 Units on a scale
Standard Deviation 1.30
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
Week 8 (N = 36)
|
2.19 Units on a scale
Standard Deviation 1.50
|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
Baseline (N = 38)
|
5.39 Units on a scale
Standard Deviation 1.94
|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
Week 36 (N = 35)
|
1.21 Units on a scale
Standard Deviation 1.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
Baseline (N = 29)
|
4.66 Units on a scale
Standard Deviation 1.42
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
Week 96 (N = 25)
|
0.66 Units on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Patient/Parent Global Assessment
Baseline (N = 127)
|
4.96 Units on a scale
Standard Deviation 2.33
|
|
Patient/Parent Global Assessment
Week 4 (N = 126)
|
3.22 Units on a scale
Standard Deviation 2.23
|
|
Patient/Parent Global Assessment
Week 8 (N = 121)
|
2.79 Units on a scale
Standard Deviation 2.10
|
|
Patient/Parent Global Assessment
Week 12 (N = 123)
|
2.21 Units on a scale
Standard Deviation 1.84
|
|
Patient/Parent Global Assessment
Week 24 (N = 122)
|
1.79 Units on a scale
Standard Deviation 1.75
|
|
Patient/Parent Global Assessment
Week 36 (N = 120)
|
1.74 Units on a scale
Standard Deviation 1.97
|
|
Patient/Parent Global Assessment
Week 48 (N = 119)
|
1.65 Units on a scale
Standard Deviation 1.88
|
|
Patient/Parent Global Assessment
Week 60 (N = 116)
|
1.33 Units on a scale
Standard Deviation 1.56
|
|
Patient/Parent Global Assessment
Week 72 (N = 114)
|
1.29 Units on a scale
Standard Deviation 1.63
|
|
Patient/Parent Global Assessment
Week 84 (N = 113)
|
1.17 Units on a scale
Standard Deviation 1.56
|
|
Patient/Parent Global Assessment
Week 96 (N = 109)
|
0.97 Units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Baseline (N = 60)
|
4.82 Units on a scale
Standard Deviation 2.44
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 4 (N = 59)
|
2.82 Units on a scale
Standard Deviation 2.11
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 8 (N = 56)
|
2.38 Units on a scale
Standard Deviation 2.02
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 12 (N = 58)
|
1.97 Units on a scale
Standard Deviation 1.81
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 24 (N = 58)
|
1.51 Units on a scale
Standard Deviation 1.69
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 36 (N = 57)
|
1.56 Units on a scale
Standard Deviation 2.07
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 48 (N = 57)
|
1.32 Units on a scale
Standard Deviation 1.82
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 60 (N = 56)
|
1.29 Units on a scale
Standard Deviation 1.54
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 72 (N = 55)
|
1.17 Units on a scale
Standard Deviation 1.55
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 84 (N = 55)
|
0.90 Units on a scale
Standard Deviation 1.21
|
|
Patient/Parent Global Assessment: eoJIA Sub-population
Week 96 (N = 54)
|
1.00 Units on a scale
Standard Deviation 1.43
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 60 (N = 33)
|
1.39 Units on a scale
Standard Deviation 1.74
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 72 (N = 32)
|
1.39 Units on a scale
Standard Deviation 1.80
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 84 (N = 31)
|
1.29 Units on a scale
Standard Deviation 1.60
|
|
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: ERA Sub-population
Baseline (N = 38)
|
5.43 Units on a scale
Standard Deviation 2.26
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 4 (N = 38)
|
3.62 Units on a scale
Standard Deviation 2.43
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 8 (N = 36)
|
3.19 Units on a scale
Standard Deviation 2.26
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 12 (N = 36)
|
2.56 Units on a scale
Standard Deviation 2.13
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 24 (N = 36)
|
2.26 Units on a scale
Standard Deviation 2.03
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 36 (N = 35)
|
2.04 Units on a scale
Standard Deviation 2.05
|
|
Patient/Parent Global Assessment: ERA Sub-population
Week 48 (N = 34)
|
2.07 Units on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Patient/Parent Global Assessment: PsA Sub-population
Baseline (N = 29)
|
4.62 Units on a scale
Standard Deviation 2.17
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 4 (N = 29)
|
3.50 Units on a scale
Standard Deviation 2.14
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 8 (N = 29)
|
3.10 Units on a scale
Standard Deviation 1.97
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 12 (N = 29)
|
2.26 Units on a scale
Standard Deviation 1.46
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 24 (N = 28)
|
1.75 Units on a scale
Standard Deviation 1.38
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 36 (N = 28)
|
1.73 Units on a scale
Standard Deviation 1.64
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 48 (N = 28)
|
1.82 Units on a scale
Standard Deviation 1.61
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 60 (N = 27)
|
1.33 Units on a scale
Standard Deviation 1.42
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 72 (N = 27)
|
1.39 Units on a scale
Standard Deviation 1.64
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 84 (N = 27)
|
1.59 Units on a scale
Standard Deviation 2.05
|
|
Patient/Parent Global Assessment: PsA Sub-population
Week 96 (N = 25)
|
0.96 Units on a scale
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Active Joints
Week 36 (N = 120)
|
0.99 Joints
Standard Deviation 1.86
|
|
Number of Active Joints
Week 48 (N = 119)
|
0.88 Joints
Standard Deviation 1.92
|
|
Number of Active Joints
Week 60 (N = 116)
|
0.87 Joints
Standard Deviation 1.94
|
|
Number of Active Joints
Baseline (N = 127)
|
6.74 Joints
Standard Deviation 4.59
|
|
Number of Active Joints
Week 4 (N = 126)
|
3.17 Joints
Standard Deviation 3.32
|
|
Number of Active Joints
Week 8 (N = 121)
|
2.07 Joints
Standard Deviation 2.67
|
|
Number of Active Joints
Week 12 (N = 123)
|
1.72 Joints
Standard Deviation 2.52
|
|
Number of Active Joints
Week 24 (N = 122)
|
1.16 Joints
Standard Deviation 2.06
|
|
Number of Active Joints
Week 72 (N = 114)
|
0.77 Joints
Standard Deviation 1.97
|
|
Number of Active Joints
Week 84 (N = 113)
|
0.81 Joints
Standard Deviation 2.20
|
|
Number of Active Joints
Week 96 (N = 109)
|
0.61 Joints
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Active Joints: eoJIA Sub-population
Week 48 (N = 57)
|
1.00 Joints
Standard Deviation 1.60
|
|
Number of Active Joints: eoJIA Sub-population
Week 60 (N = 56)
|
0.98 Joints
Standard Deviation 1.63
|
|
Number of Active Joints: eoJIA Sub-population
Week 72 (N = 55)
|
0.73 Joints
Standard Deviation 1.21
|
|
Number of Active Joints: eoJIA Sub-population
Week 84 (N = 55)
|
0.65 Joints
Standard Deviation 1.16
|
|
Number of Active Joints: eoJIA Sub-population
Week 96 (N = 54)
|
0.50 Joints
Standard Deviation 0.89
|
|
Number of Active Joints: eoJIA Sub-population
Baseline (N = 60)
|
7.58 Joints
Standard Deviation 5.09
|
|
Number of Active Joints: eoJIA Sub-population
Week 4 (N = 59)
|
3.95 Joints
Standard Deviation 3.75
|
|
Number of Active Joints: eoJIA Sub-population
Week 8 (N = 56)
|
2.46 Joints
Standard Deviation 2.70
|
|
Number of Active Joints: eoJIA Sub-population
Week 12 (N = 58)
|
2.07 Joints
Standard Deviation 2.77
|
|
Number of Active Joints: eoJIA Sub-population
Week 24 (N = 58)
|
1.34 Joints
Standard Deviation 2.29
|
|
Number of Active Joints: eoJIA Sub-population
Week 36 (N = 57)
|
1.14 Joints
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Active Joints: ERA Sub-population
Baseline (N = 38)
|
5.21 Joints
Standard Deviation 3.57
|
|
Number of Active Joints: ERA Sub-population
Week 4 (N = 38)
|
2.40 Joints
Standard Deviation 2.62
|
|
Number of Active Joints: ERA Sub-population
Week 8 (N = 36)
|
1.47 Joints
Standard Deviation 2.25
|
|
Number of Active Joints: ERA Sub-population
Week 12 (N = 36)
|
1.08 Joints
Standard Deviation 1.57
|
|
Number of Active Joints: ERA Sub-population
Week 24 (N = 36)
|
0.78 Joints
Standard Deviation 1.07
|
|
Number of Active Joints: ERA Sub-population
Week 36 (N = 35)
|
0.74 Joints
Standard Deviation 1.29
|
|
Number of Active Joints: ERA Sub-population
Week 48 (N = 34)
|
0.68 Joints
Standard Deviation 1.09
|
|
Number of Active Joints: ERA Sub-population
Week 60 (N = 33)
|
0.48 Joints
Standard Deviation 0.94
|
|
Number of Active Joints: ERA Sub-population
Week 72 (N = 32)
|
0.59 Joints
Standard Deviation 1.21
|
|
Number of Active Joints: ERA Sub-population
Week 84 (N = 31)
|
0.68 Joints
Standard Deviation 1.19
|
|
Number of Active Joints: ERA Sub-population
Week 96 (N = 30)
|
0.50 Joints
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Active Joints: PsA Sub-population
Week 8 (N = 29)
|
2.07 Joints
Standard Deviation 3.05
|
|
Number of Active Joints: PsA Sub-population
Week 12 (N = 29)
|
1.79 Joints
Standard Deviation 2.86
|
|
Number of Active Joints: PsA Sub-population
Week 24 (N = 28)
|
1.25 Joints
Standard Deviation 2.47
|
|
Number of Active Joints: PsA Sub-population
Week 36 (N = 28)
|
1.00 Joints
Standard Deviation 2.21
|
|
Number of Active Joints: PsA Sub-population
Week 48 (N = 28)
|
0.89 Joints
Standard Deviation 3.03
|
|
Number of Active Joints: PsA Sub-population
Week 60 (N = 27)
|
1.11 Joints
Standard Deviation 3.11
|
|
Number of Active Joints: PsA Sub-population
Week 72 (N = 27)
|
1.08 Joints
Standard Deviation 3.45
|
|
Number of Active Joints: PsA Sub-population
Week 84 (N = 27)
|
1.30 Joints
Standard Deviation 4.02
|
|
Number of Active Joints: PsA Sub-population
Week 96 (N = 25)
|
0.96 Joints
Standard Deviation 4.00
|
|
Number of Active Joints: PsA Sub-population
Baseline (N = 29)
|
7.00 Joints
Standard Deviation 4.33
|
|
Number of Active Joints: PsA Sub-population
Week 4 (N = 29)
|
2.59 Joints
Standard Deviation 2.92
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Joints With Limitation of Motion
Baseline (N = 127)
|
5.72 Joints
Standard Deviation 4.22
|
|
Number of Joints With Limitation of Motion
Week 12 (N = 123)
|
1.62 Joints
Standard Deviation 2.31
|
|
Number of Joints With Limitation of Motion
Week 36 (N = 120)
|
1.39 Joints
Standard Deviation 2.13
|
|
Number of Joints With Limitation of Motion
Week 48 (N = 119)
|
1.26 Joints
Standard Deviation 2.51
|
|
Number of Joints With Limitation of Motion
Week 4 (N = 126)
|
3.20 Joints
Standard Deviation 3.27
|
|
Number of Joints With Limitation of Motion
Week 8 (N = 121)
|
2.26 Joints
Standard Deviation 3.41
|
|
Number of Joints With Limitation of Motion
Week 24 (N = 122)
|
1.43 Joints
Standard Deviation 2.03
|
|
Number of Joints With Limitation of Motion
Week 60 (N = 116)
|
1.41 Joints
Standard Deviation 2.98
|
|
Number of Joints With Limitation of Motion
Week 72 (N = 114)
|
1.13 Joints
Standard Deviation 2.36
|
|
Number of Joints With Limitation of Motion
Week 84 (N = 113)
|
1.41 Joints
Standard Deviation 3.05
|
|
Number of Joints With Limitation of Motion
Week 96 (N = 109)
|
1.06 Joints
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 48 (N = 57)
|
1.05 Joints
Standard Deviation 1.63
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 60 (N = 56)
|
1.36 Joints
Standard Deviation 2.56
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 72 (N = 55)
|
0.89 Joints
Standard Deviation 1.58
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 84 (N = 55)
|
0.98 Joints
Standard Deviation 2.08
|
|
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: eoJIA Sub-population
Baseline (N = 60)
|
6.33 Joints
Standard Deviation 4.37
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 4 (N = 59)
|
3.12 Joints
Standard Deviation 2.74
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 8 (N = 56)
|
2.23 Joints
Standard Deviation 3.47
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 12 (N = 58)
|
1.78 Joints
Standard Deviation 2.25
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 24 (N = 58)
|
1.40 Joints
Standard Deviation 1.77
|
|
Number of Joints With Limitation of Motion: eoJIA Sub-population
Week 36 (N = 57)
|
1.16 Joints
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Baseline (N = 38)
|
4.84 Joints
Standard Deviation 4.00
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 4 (N = 38)
|
2.98 Joints
Standard Deviation 3.73
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 8 (N = 36)
|
2.28 Joints
Standard Deviation 3.59
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 12 (N = 36)
|
1.58 Joints
Standard Deviation 2.94
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 24 (N = 36)
|
1.53 Joints
Standard Deviation 2.80
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 36 (N = 35)
|
1.55 Joints
Standard Deviation 2.69
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 48 (N = 34)
|
1.53 Joints
Standard Deviation 2.88
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 60 (N = 33)
|
1.36 Joints
Standard Deviation 3.26
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 72 (N = 32)
|
1.19 Joints
Standard Deviation 2.09
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 84 (N = 31)
|
1.68 Joints
Standard Deviation 3.17
|
|
Number of Joints With Limitation of Motion: ERA Sub-population
Week 96 (N = 30)
|
1.33 Joints
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Baseline (N = 29)
|
5.62 Joints
Standard Deviation 4.10
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 4 (N = 29)
|
3.66 Joints
Standard Deviation 3.66
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 8 (N = 29)
|
2.28 Joints
Standard Deviation 3.15
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 12 (N = 29)
|
1.34 Joints
Standard Deviation 1.40
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 24 (N = 28)
|
1.36 Joints
Standard Deviation 1.31
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 36 (N = 28)
|
1.64 Joints
Standard Deviation 2.39
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 48 (N = 28)
|
1.36 Joints
Standard Deviation 3.42
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 60 (N = 27)
|
1.56 Joints
Standard Deviation 3.51
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 72 (N = 27)
|
1.56 Joints
Standard Deviation 3.68
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 84 (N = 27)
|
1.96 Joints
Standard Deviation 4.34
|
|
Number of Joints With Limitation of Motion: PsA Sub-population
Week 96 (N = 25)
|
1.40 Joints
Standard Deviation 4.39
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
C-reactive Protein (CRP)
Week 24 (N = 120)
|
3.54 mg/Liter (mg/L)
Standard Deviation 10.72
|
|
C-reactive Protein (CRP)
Week 36 (N = 119)
|
2.81 mg/Liter (mg/L)
Standard Deviation 5.75
|
|
C-reactive Protein (CRP)
Week 48 (N = 117)
|
2.04 mg/Liter (mg/L)
Standard Deviation 3.94
|
|
C-reactive Protein (CRP)
Week 60 (N = 110)
|
2.16 mg/Liter (mg/L)
Standard Deviation 4.87
|
|
C-reactive Protein (CRP)
Week 72 (N = 111)
|
2.26 mg/Liter (mg/L)
Standard Deviation 4.01
|
|
C-reactive Protein (CRP)
Week 84 (N = 109)
|
3.98 mg/Liter (mg/L)
Standard Deviation 12.51
|
|
C-reactive Protein (CRP)
Week 96 (N = 103)
|
2.76 mg/Liter (mg/L)
Standard Deviation 5.27
|
|
C-reactive Protein (CRP)
Baseline (N = 127)
|
8.26 mg/Liter (mg/L)
Standard Deviation 14.70
|
|
C-reactive Protein (CRP)
Week 4 (N = 125)
|
3.29 mg/Liter (mg/L)
Standard Deviation 7.85
|
|
C-reactive Protein (CRP)
Week 8 (N = 121)
|
2.32 mg/Liter (mg/L)
Standard Deviation 3.92
|
|
C-reactive Protein (CRP)
Week 12 (N = 120)
|
2.47 mg/Liter (mg/L)
Standard Deviation 7.19
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
C-reactive Protein (CRP): eoJIA Sub-population
Baseline (N = 60)
|
6.27 mg/L
Standard Deviation 10.59
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 8 (N = 56)
|
2.66 mg/L
Standard Deviation 5.05
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 12 (N = 58)
|
3.36 mg/L
Standard Deviation 10.07
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 24 (N = 56)
|
5.26 mg/L
Standard Deviation 15.34
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 36 (N = 57)
|
3.25 mg/L
Standard Deviation 6.56
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 48 (N = 55)
|
1.93 mg/L
Standard Deviation 4.20
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 60 (N = 55)
|
2.76 mg/L
Standard Deviation 6.52
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 72 (N = 55)
|
2.42 mg/L
Standard Deviation 4.28
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 84 (N = 54)
|
3.94 mg/L
Standard Deviation 9.13
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 96 (N = 52)
|
3.34 mg/L
Standard Deviation 6.62
|
|
C-reactive Protein (CRP): eoJIA Sub-population
Week 4 (N = 58)
|
3.45 mg/L
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
C-reactive Protein (CRP): ERA Sub-population
Baseline (N = 38)
|
15.27 mg/L
Standard Deviation 21.52
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 4 (N = 38)
|
4.37 mg/L
Standard Deviation 10.36
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 8 (N = 36)
|
2.53 mg/L
Standard Deviation 3.30
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 12 (N = 34)
|
1.87 mg/L
Standard Deviation 2.84
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 24 (N = 36)
|
1.96 mg/L
Standard Deviation 2.04
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 36 (N = 35)
|
3.24 mg/L
Standard Deviation 6.41
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 48 (N = 34)
|
2.79 mg/L
Standard Deviation 4.89
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 60 (N = 30)
|
1.99 mg/L
Standard Deviation 2.84
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 72 (N = 30)
|
2.12 mg/L
Standard Deviation 4.03
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 84 (N = 29)
|
6.36 mg/L
Standard Deviation 20.81
|
|
C-reactive Protein (CRP): ERA Sub-population
Week 96 (N = 27)
|
2.68 mg/L
Standard Deviation 4.10
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
C-reactive Protein (CRP): PsA Sub-population
Baseline (N = 29)
|
3.19 mg/L
Standard Deviation 4.71
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 4 (N = 29)
|
1.58 mg/L
Standard Deviation 1.73
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 8 (N = 29)
|
1.41 mg/L
Standard Deviation 0.98
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 12 (N = 28)
|
1.36 mg/L
Standard Deviation 0.75
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 24 (N = 28)
|
2.11 mg/L
Standard Deviation 3.16
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 36 (N = 27)
|
1.31 mg/L
Standard Deviation 0.81
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 48 (N = 28)
|
1.35 mg/L
Standard Deviation 0.97
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 84 (N = 26)
|
1.44 mg/L
Standard Deviation 0.97
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 96 (N = 24)
|
1.58 mg/L
Standard Deviation 2.18
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 60 (N = 25)
|
1.04 mg/L
Standard Deviation 0.12
|
|
C-reactive Protein (CRP): PsA Sub-population
Week 72 (N = 26)
|
2.08 mg/L
Standard Deviation 3.51
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Pain Assessment
Baseline (N = 127)
|
5.06 Units on a scale
Standard Deviation 2.52
|
|
Pain Assessment
Week 4 (N = 126)
|
3.12 Units on a scale
Standard Deviation 2.25
|
|
Pain Assessment
Week 8 (N = 121)
|
2.58 Units on a scale
Standard Deviation 2.10
|
|
Pain Assessment
Week 12 (N = 123)
|
2.02 Units on a scale
Standard Deviation 1.89
|
|
Pain Assessment
Week 24 (N = 122)
|
1.64 Units on a scale
Standard Deviation 1.74
|
|
Pain Assessment
Week 36 (N = 120)
|
1.63 Units on a scale
Standard Deviation 1.94
|
|
Pain Assessment
Week 48 (N = 119)
|
1.51 Units on a scale
Standard Deviation 1.81
|
|
Pain Assessment
Week 60 (N = 116)
|
1.18 Units on a scale
Standard Deviation 1.46
|
|
Pain Assessment
Week 72 (N = 114)
|
1.14 Units on a scale
Standard Deviation 1.62
|
|
Pain Assessment
Week 84 (N = 112)
|
1.13 Units on a scale
Standard Deviation 1.67
|
|
Pain Assessment
Week 96 (N = 108)
|
0.91 Units on a scale
Standard Deviation 1.42
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Pain Assessment: eoJIA Sub-population
Week 72 (N = 55)
|
1.01 Units on a scale
Standard Deviation 1.52
|
|
Pain Assessment: eoJIA Sub-population
Week 84 (N = 54)
|
0.91 Units on a scale
Standard Deviation 1.50
|
|
Pain Assessment: eoJIA Sub-population
Baseline (N = 60)
|
4.81 Units on a scale
Standard Deviation 2.56
|
|
Pain Assessment: eoJIA Sub-population
Week 4 (N = 59)
|
2.64 Units on a scale
Standard Deviation 2.09
|
|
Pain Assessment: eoJIA Sub-population
Week 8 (N = 56)
|
2.12 Units on a scale
Standard Deviation 1.97
|
|
Pain Assessment: eoJIA Sub-population
Week 12 (N = 58)
|
1.69 Units on a scale
Standard Deviation 1.77
|
|
Pain Assessment: eoJIA Sub-population
Week 24 (N = 58)
|
1.27 Units on a scale
Standard Deviation 1.66
|
|
Pain Assessment: eoJIA Sub-population
Week 36 (N = 57)
|
1.43 Units on a scale
Standard Deviation 1.98
|
|
Pain Assessment: eoJIA Sub-population
Week 48 (N = 57)
|
1.19 Units on a scale
Standard Deviation 1.77
|
|
Pain Assessment: eoJIA Sub-population
Week 60 (N = 56)
|
1.19 Units on a scale
Standard Deviation 1.38
|
|
Pain Assessment: eoJIA Sub-population
Week 96 (N = 53)
|
0.97 Units on a scale
Standard Deviation 1.52
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Pain Assessment: ERA Sub-population
Baseline (N = 38)
|
5.76 Units on a scale
Standard Deviation 2.51
|
|
Pain Assessment: ERA Sub-population
Week 4 (N = 38)
|
3.82 Units on a scale
Standard Deviation 2.59
|
|
Pain Assessment: ERA Sub-population
Week 8 (N = 36)
|
3.13 Units on a scale
Standard Deviation 2.42
|
|
Pain Assessment: ERA Sub-population
Week 12 (N = 36)
|
2.54 Units on a scale
Standard Deviation 2.18
|
|
Pain Assessment: ERA Sub-population
Week 24 (N = 36)
|
2.28 Units on a scale
Standard Deviation 1.89
|
|
Pain Assessment: ERA Sub-population
Week 36 (N = 35)
|
1.87 Units on a scale
Standard Deviation 2.07
|
|
Pain Assessment: ERA Sub-population
Week 48 (N = 34)
|
1.78 Units on a scale
Standard Deviation 1.72
|
|
Pain Assessment: ERA Sub-population
Week 60 (N = 33)
|
1.17 Units on a scale
Standard Deviation 1.69
|
|
Pain Assessment: ERA Sub-population
Week 72 (N = 32)
|
1.17 Units on a scale
Standard Deviation 1.69
|
|
Pain Assessment: ERA Sub-population
Week 84 (N = 31)
|
1.08 Units on a scale
Standard Deviation 1.34
|
|
Pain Assessment: ERA Sub-population
Week 96 (N = 30)
|
0.87 Units on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Pain Assessment: PsA Sub-population
Week 84 (N = 27)
|
1.61 Units on a scale
Standard Deviation 2.20
|
|
Pain Assessment: PsA Sub-population
Baseline (N = 29)
|
4.64 Units on a scale
Standard Deviation 2.31
|
|
Pain Assessment: PsA Sub-population
Week 4 (N = 29)
|
3.19 Units on a scale
Standard Deviation 1.91
|
|
Pain Assessment: PsA Sub-population
Week 8 (N = 29)
|
2.81 Units on a scale
Standard Deviation 1.74
|
|
Pain Assessment: PsA Sub-population
Week 12 (N = 29)
|
2.03 Units on a scale
Standard Deviation 1.65
|
|
Pain Assessment: PsA Sub-population
Week 24 (N = 28)
|
1.61 Units on a scale
Standard Deviation 1.51
|
|
Pain Assessment: PsA Sub-population
Week 36 (N = 28)
|
1.71 Units on a scale
Standard Deviation 1.67
|
|
Pain Assessment: PsA Sub-population
Week 48 (N = 28)
|
1.82 Units on a scale
Standard Deviation 1.95
|
|
Pain Assessment: PsA Sub-population
Week 60 (N = 27)
|
1.19 Units on a scale
Standard Deviation 1.35
|
|
Pain Assessment: PsA Sub-population
Week 72 (N = 27)
|
1.37 Units on a scale
Standard Deviation 1.74
|
|
Pain Assessment: PsA Sub-population
Week 96 (N = 25)
|
0.84 Units on a scale
Standard Deviation 1.48
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Duration of Morning Stiffness
Week 12 (N = 123)
|
13.29 Minutes
Standard Deviation 41.20
|
|
Duration of Morning Stiffness
Week 36 (N = 120)
|
6.76 Minutes
Standard Deviation 24.41
|
|
Duration of Morning Stiffness
Week 48 (N = 119)
|
6.01 Minutes
Standard Deviation 23.94
|
|
Duration of Morning Stiffness
Baseline (N = 127)
|
73.50 Minutes
Standard Deviation 100.61
|
|
Duration of Morning Stiffness
Week 4 (N = 126)
|
29.86 Minutes
Standard Deviation 60.00
|
|
Duration of Morning Stiffness
Week 8 (N = 121)
|
25.02 Minutes
Standard Deviation 75.32
|
|
Duration of Morning Stiffness
Week 24 (N = 122)
|
8.83 Minutes
Standard Deviation 23.41
|
|
Duration of Morning Stiffness
Week 60 (N = 116)
|
7.28 Minutes
Standard Deviation 30.28
|
|
Duration of Morning Stiffness
Week 72 (N = 113)
|
8.98 Minutes
Standard Deviation 30.67
|
|
Duration of Morning Stiffness
Week 84 (N = 112)
|
8.40 Minutes
Standard Deviation 32.38
|
|
Duration of Morning Stiffness
Week 96 (N = 109)
|
5.76 Minutes
Standard Deviation 21.70
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 96 (N = 54)
|
2.37 Minutes
Standard Deviation 12.42
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Baseline (N = 60)
|
72.78 Minutes
Standard Deviation 97.24
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 4 (N = 59)
|
20.46 Minutes
Standard Deviation 47.37
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 8 (N = 56)
|
20.18 Minutes
Standard Deviation 70.70
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 12 (N = 58)
|
9.05 Minutes
Standard Deviation 24.52
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 24 (N = 58)
|
5.72 Minutes
Standard Deviation 18.85
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 36 (N = 57)
|
2.49 Minutes
Standard Deviation 9.35
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 48 (N = 57)
|
2.19 Minutes
Standard Deviation 6.61
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 60 (N = 56)
|
2.41 Minutes
Standard Deviation 7.32
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 72 (N = 54)
|
3.89 Minutes
Standard Deviation 15.16
|
|
Duration of Morning Stiffness: eoJIA Sub-population
Week 84 (N = 55)
|
2.64 Minutes
Standard Deviation 8.97
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Duration of Morning Stiffness: ERA Sub-population
Week 36 (N = 35)
|
17.17 Minutes
Standard Deviation 41.01
|
|
Duration of Morning Stiffness: ERA Sub-population
Baseline (N = 38)
|
89.29 Minutes
Standard Deviation 128.94
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 4 (N = 38)
|
49.34 Minutes
Standard Deviation 78.73
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 8 (N = 36)
|
44.03 Minutes
Standard Deviation 102.65
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 12 (N = 36)
|
25.69 Minutes
Standard Deviation 67.57
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 24 (N = 36)
|
15.69 Minutes
Standard Deviation 28.87
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 48 (N = 34)
|
13.38 Minutes
Standard Deviation 36.88
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 60 (N = 33)
|
14.09 Minutes
Standard Deviation 42.21
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 72 (N = 32)
|
16.25 Minutes
Standard Deviation 42.12
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 84 (N = 30)
|
12.70 Minutes
Standard Deviation 36.16
|
|
Duration of Morning Stiffness: ERA Sub-population
Week 96 (N = 30)
|
10.67 Minutes
Standard Deviation 28.31
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Duration of Morning Stiffness: PsA Sub-population
Week 48 (N = 28)
|
4.82 Minutes
Standard Deviation 25.51
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 60 (N = 27)
|
9.07 Minutes
Standard Deviation 40.43
|
|
Duration of Morning Stiffness: PsA Sub-population
Baseline (N = 29)
|
54.31 Minutes
Standard Deviation 54.16
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 4 (N = 29)
|
23.45 Minutes
Standard Deviation 49.86
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 8 (N = 29)
|
10.79 Minutes
Standard Deviation 24.55
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 12 (N = 29)
|
6.38 Minutes
Standard Deviation 13.42
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 24 (N = 28)
|
6.43 Minutes
Standard Deviation 23.17
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 36 (N = 28)
|
2.43 Minutes
Standard Deviation 11.33
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 72 (N = 27)
|
10.56 Minutes
Standard Deviation 36.70
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 84 (N = 27)
|
15.37 Minutes
Standard Deviation 52.05
|
|
Duration of Morning Stiffness: PsA Sub-population
Week 96 (N = 25)
|
7.20 Minutes
Standard Deviation 27.43
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 4 (N = 126)
|
2.4 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 8 (N = 121)
|
2.5 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 24 (N = 121)
|
24.8 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 36 (N = 120)
|
25.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 48 (N = 118)
|
29.7 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 12 (N = 123)
|
12.2 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 60 (N = 113)
|
33.6 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 72 (N = 111)
|
36.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 84 (N = 110)
|
34.5 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Week 96 (N = 106)
|
34.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 4 (N = 59)
|
5.1 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 8 (N = 56)
|
3.6 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 12 (N = 58)
|
12.1 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 24 (N = 57)
|
29.8 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 36 (N = 57)
|
35.1 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 48 (N = 56)
|
37.5 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 60 (N = 56)
|
48.2 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 72 (N = 54)
|
46.3 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 84 (N = 54)
|
44.4 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Week 96 (N = 53)
|
37.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 4 (N = 38)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 8 (N = 36)
|
2.8 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 12 (N = 36)
|
16.7 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 24 (N = 36)
|
25.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 36 (N = 35)
|
14.3 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 48 (N = 34)
|
23.5 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 60 (N = 30)
|
23.3 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 72 (N = 30)
|
33.3 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 84 (N = 29)
|
27.6 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Week 96 (N = 28)
|
28.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 36 (N = 28)
|
17.9 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 48 (N = 28)
|
21.4 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 60 (N = 27)
|
14.8 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 72 (N=27)
|
18.5 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 84 (N = 27)
|
22.2 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 4 (N = 29)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 8 (N = 29)
|
0.0 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 12 (N = 29)
|
6.9 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 24 (N = 28)
|
14.3 Percentage of participants
|
|
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Week 96 (N = 25)
|
32.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 4 (N = 126)
|
0.54 Units on a scale
Standard Deviation 0.55
|
|
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
Week 24 (N = 122)
|
0.28 Units on a scale
Standard Deviation 0.39
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 36 (N = 120)
|
0.23 Units on a scale
Standard Deviation 0.39
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 48 (N = 119)
|
0.24 Units on a scale
Standard Deviation 0.41
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 60 (N = 116)
|
0.20 Units on a scale
Standard Deviation 0.37
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 84 (N = 113)
|
0.17 Units on a scale
Standard Deviation 0.35
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 96 (N = 109)
|
0.16 Units on a scale
Standard Deviation 0.35
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Baseline (N = 127)
|
0.80 Units on a scale
Standard Deviation 0.63
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 12 (N = 123)
|
0.32 Units on a scale
Standard Deviation 0.40
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score
Week 72 (N = 114)
|
0.17 Units on a scale
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Baseline (N = 60)
|
0.90 Units on a scale
Standard Deviation 0.68
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 4 (N = 59)
|
0.64 Units on a scale
Standard Deviation 0.60
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 12 (N = 58)
|
0.40 Units on a scale
Standard Deviation 0.48
|
|
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: eoJIA Sub-population
Week 36 (N = 57)
|
0.26 Units on a scale
Standard Deviation 0.46
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 48 (N = 57)
|
0.27 Units on a scale
Standard Deviation 0.48
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 60 (N = 56)
|
0.25 Units on a scale
Standard Deviation 0.45
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 72 (N = 55)
|
0.21 Units on a scale
Standard Deviation 0.37
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 84 (N = 55)
|
0.21 Units on a scale
Standard Deviation 0.41
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 8 (N = 56)
|
0.50 Units on a scale
Standard Deviation 0.54
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
Week 96 (N = 54)
|
0.20 Units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 4 (N = 38)
|
0.48 Units on a scale
Standard Deviation 0.56
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 8 (N = 36)
|
0.40 Units on a scale
Standard Deviation 0.34
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 24 (N = 36)
|
0.27 Units on a scale
Standard Deviation 0.38
|
|
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: ERA Sub-population
Week 48 (N = 34)
|
0.18 Units on a scale
Standard Deviation 0.28
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 60 (N = 33)
|
0.17 Units on a scale
Standard Deviation 0.29
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 72 (N = 32)
|
0.13 Units on a scale
Standard Deviation 0.27
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 96 (N = 30)
|
0.08 Units on a scale
Standard Deviation 0.21
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Baseline (N = 38)
|
0.72 Units on a scale
Standard Deviation 0.51
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 12 (N = 36)
|
0.23 Units on a scale
Standard Deviation 0.27
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
Week 84 (N = 31)
|
0.10 Units on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Baseline (N = 29)
|
0.68 Units on a scale
Standard Deviation 0.63
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 4 (N = 29)
|
0.42 Units on a scale
Standard Deviation 0.41
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 8 (N = 29)
|
0.30 Units on a scale
Standard Deviation 0.34
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 12 (N = 29)
|
0.29 Units on a scale
Standard Deviation 0.35
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 24 (N = 28)
|
0.26 Units on a scale
Standard Deviation 0.32
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 36 (N = 28)
|
0.21 Units on a scale
Standard Deviation 0.32
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 48 (N = 28)
|
0.24 Units on a scale
Standard Deviation 0.38
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 60 (N = 27)
|
0.13 Units on a scale
Standard Deviation 0.25
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 72 (N = 27)
|
0.15 Units on a scale
Standard Deviation 0.29
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 84 (N = 27)
|
0.18 Units on a scale
Standard Deviation 0.35
|
|
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
Week 96 (N = 25)
|
0.18 Units on a scale
Standard Deviation 0.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Tender Entheseal Assessment for ERA Sub-population
Baseline (N = 38)
|
5.87 Tender entheses
Standard Deviation 9.42
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 4 (N = 38)
|
4.68 Tender entheses
Standard Deviation 11.81
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 8 (N = 36)
|
2.06 Tender entheses
Standard Deviation 5.79
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 12 (N = 36)
|
1.81 Tender entheses
Standard Deviation 6.15
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 24 (N = 36)
|
1.89 Tender entheses
Standard Deviation 6.89
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 36 (N = 35)
|
2.03 Tender entheses
Standard Deviation 5.70
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 48 (N = 34)
|
1.32 Tender entheses
Standard Deviation 3.76
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 60 (N = 33)
|
0.97 Tender entheses
Standard Deviation 2.98
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 72 (N = 32)
|
0.56 Tender entheses
Standard Deviation 1.29
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 84 (N = 31)
|
0.77 Tender entheses
Standard Deviation 2.00
|
|
Tender Entheseal Assessment for ERA Sub-population
Week 96 (N = 30)
|
0.33 Tender entheses
Standard Deviation 1.03
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Overall Back Pain Score for ERA Sub-population
Week 72 (N = 32)
|
6.03 mm
Standard Deviation 14.67
|
|
Overall Back Pain Score for ERA Sub-population
Week 84 (N = 31)
|
5.03 mm
Standard Deviation 8.40
|
|
Overall Back Pain Score for ERA Sub-population
Week 96 (N = 30)
|
2.37 mm
Standard Deviation 4.51
|
|
Overall Back Pain Score for ERA Sub-population
Baseline (N = 37)
|
25.94 mm
Standard Deviation 28.00
|
|
Overall Back Pain Score for ERA Sub-population
Week 4 (N = 38)
|
14.24 mm
Standard Deviation 19.87
|
|
Overall Back Pain Score for ERA Sub-population
Week 8 (N = 36)
|
12.94 mm
Standard Deviation 22.60
|
|
Overall Back Pain Score for ERA Sub-population
Week 12 (N = 36)
|
11.83 mm
Standard Deviation 18.22
|
|
Overall Back Pain Score for ERA Sub-population
Week 24 (N = 36)
|
9.81 mm
Standard Deviation 17.23
|
|
Overall Back Pain Score for ERA Sub-population
Week 36 (N = 35)
|
10.16 mm
Standard Deviation 19.20
|
|
Overall Back Pain Score for ERA Sub-population
Week 48 (N = 34)
|
8.62 mm
Standard Deviation 15.76
|
|
Overall Back Pain Score for ERA Sub-population
Week 60 (N = 32)
|
5.13 mm
Standard Deviation 12.28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 4 (N = 38)
|
8.58 mm
Standard Deviation 19.31
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 8 (N = 36)
|
7.82 mm
Standard Deviation 18.34
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 48 (N = 34)
|
5.85 mm
Standard Deviation 13.82
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 60 (N = 32)
|
3.34 mm
Standard Deviation 13.36
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 72 (N = 32)
|
6.47 mm
Standard Deviation 19.64
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 96 (N = 30)
|
2.17 mm
Standard Deviation 3.50
|
|
Nocturnal Back Pain Score for ERA Sub-population
Baseline (N = 38)
|
16.37 mm
Standard Deviation 27.76
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 12 (N = 36)
|
5.81 mm
Standard Deviation 11.74
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 24 (N = 36)
|
5.31 mm
Standard Deviation 15.17
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 36 (N = 35)
|
7.54 mm
Standard Deviation 17.66
|
|
Nocturnal Back Pain Score for ERA Sub-population
Week 84 (N = 31)
|
2.66 mm
Standard Deviation 6.86
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Modified Schober's Test for ERA Sub-population
Baseline (N = 37)
|
5.03 cm
Standard Deviation 1.94
|
|
Modified Schober's Test for ERA Sub-population
Week 4 (N = 38)
|
5.24 cm
Standard Deviation 1.94
|
|
Modified Schober's Test for ERA Sub-population
Week 12 (N = 36)
|
5.45 cm
Standard Deviation 1.98
|
|
Modified Schober's Test for ERA Sub-population
Week 24 (N = 36)
|
5.35 cm
Standard Deviation 2.10
|
|
Modified Schober's Test for ERA Sub-population
Week 36 (N = 35)
|
5.49 cm
Standard Deviation 2.10
|
|
Modified Schober's Test for ERA Sub-population
Week 48 (N = 34)
|
5.38 cm
Standard Deviation 1.59
|
|
Modified Schober's Test for ERA Sub-population
Week 60 (N = 33)
|
5.33 cm
Standard Deviation 1.71
|
|
Modified Schober's Test for ERA Sub-population
Week 72 (N = 32)
|
5.27 cm
Standard Deviation 1.59
|
|
Modified Schober's Test for ERA Sub-population
Week 84 (N = 30)
|
5.47 cm
Standard Deviation 1.68
|
|
Modified Schober's Test for ERA Sub-population
Week 96 (N = 30)
|
5.33 cm
Standard Deviation 1.65
|
|
Modified Schober's Test for ERA Sub-population
Week 8 (N = 36)
|
5.12 cm
Standard Deviation 2.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Percentage of Body Surface Area (BSA) Affected by Psoriasis for PsA Sub-population
Week 36 (N = 28)
|
2.91 Percentage of BSA
Standard Deviation 8.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Physician's Global Assessment (PGA) of Psoriasis for PsA Sub-population
Baseline (N = 29)
|
1.76 Units on a scale
Standard Deviation 1.46
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
Medically important infections
|
11 Participants
|
|
Number of Participants With Adverse Events (AEs)
Vaccine preventable infections
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs)
ISRs
|
16 Participants
|
|
Number of Participants With Adverse Events (AEs)
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Infections
|
96 Participants
|
|
Number of Participants With Adverse Events (AEs)
Infection and ISRs excluded
|
93 Participants
|
|
Number of Participants With Adverse Events (AEs)
Serious AE: Infection
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Medically important infections
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Vaccine preventable infections
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Infections
|
48 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Infection and ISRs excluded
|
44 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
ISRs
|
8 Participants
|
|
Number of Participants With Adverse Events (AEs): eoJIA Subpopulation
Serious AE: Infection
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Vaccine preventable infections
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
ISRs
|
6 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Infections
|
28 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Infection and ISRs excluded
|
30 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Serious AE: Infection
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs): ERA Sub-population
Medically important infections
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 12, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Medically important infections
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Vaccine preventable infections
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Serious AE: Infection
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
ISRs
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Malignancies
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Infections
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs): PsA Sub-population
Infection and ISRs excluded
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Tanner Assessment Score by Age Group
Baseline: 2 to 17 years (N = 126)
|
3.08 Units on a scale
Standard Deviation 1.59
|
|
Tanner Assessment Score by Age Group
Week 12: 2 to 17 years (N = 122)
|
3.18 Units on a scale
Standard Deviation 1.63
|
|
Tanner Assessment Score by Age Group
Week 48: 2 to 17 years (N = 118)
|
3.34 Units on a scale
Standard Deviation 1.61
|
|
Tanner Assessment Score by Age Group
Week 96: 2 to 17 years (N = 106)
|
3.57 Units on a scale
Standard Deviation 1.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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 0.00
|
|
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
|
|
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
|
|
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 0.00
|
|
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
|
|
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
|
|
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
|
|
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 0.00
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.00
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 96Population: 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).
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).
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Height z-Score by Age Group
Week 48: 2 to 17 years (N = 118)
|
0.34 z-score
Standard Deviation 1.02
|
|
Height z-Score by Age Group
Baseline: 2 to 17 years (N = 125)
|
0.19 z-score
Standard Deviation 1.07
|
|
Height z-Score by Age Group
Week 12: 2 to 17 years (N = 123)
|
0.31 z-score
Standard Deviation 0.98
|
|
Height z-Score by Age Group
Week 72: 2 to 17 years (N = 114)
|
0.41 z-score
Standard Deviation 0.97
|
|
Height z-Score by Age Group
Week 96: 2 to 17 years (N = 109)
|
0.39 z-score
Standard Deviation 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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 eoJIA Sub-population
Baseline: 2 to 17 years (N=58)
|
0.06 z-score
Standard Deviation 1.17
|
|
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
|
|
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
|
|
Height z-Score by Age Group for eoJIA Sub-population
Week 48: 5 to 11 years (N=21)
|
0.30 z-score
Standard Deviation 1.30
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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 ERA Sub-population
Week 72: 12 to 17 years (N = 32)
|
0.46 z-score
Standard Deviation 0.84
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Height z-Score by Age Group for PsA Sub-population
Week 72: 12 to 17 years (N = 27)
|
0.51 z-score
Standard Deviation 1.10
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Weight z-Scores by Age Group
Baseline: 2 to 17 years (N = 127)
|
0.17 z-score
Standard Deviation 1.02
|
|
Weight z-Scores by Age Group
Week 4: 2 to 17 years (N = 126)
|
0.18 z-score
Standard Deviation 1.02
|
|
Weight z-Scores by Age Group
Week 8: 2 to 17 years (N = 121)
|
0.23 z-score
Standard Deviation 1.02
|
|
Weight z-Scores by Age Group
Week 12: 2 to 17 years (N = 123)
|
0.22 z-score
Standard Deviation 1.00
|
|
Weight z-Scores by Age Group
Week 24: 2 to 17 years (N = 122)
|
0.25 z-score
Standard Deviation 0.99
|
|
Weight z-Scores by Age Group
Week 36: 2 to 17 years (N = 120)
|
0.26 z-score
Standard Deviation 0.97
|
|
Weight z-Scores by Age Group
Week 48: 2 to 17 years (N = 118)
|
0.25 z-score
Standard Deviation 0.97
|
|
Weight z-Scores by Age Group
Week 60: 2 to 17 years (N = 116)
|
0.24 z-score
Standard Deviation 0.95
|
|
Weight z-Scores by Age Group
Week 72: 2 to 17 years (N = 114)
|
0.29 z-score
Standard Deviation 0.91
|
|
Weight z-Scores by Age Group
Week 84: 2 to 17 years (N = 113)
|
0.27 z-score
Standard Deviation 0.93
|
|
Weight z-Scores by Age Group
Week 96: 2 to 17 years (N = 109)
|
0.25 z-score
Standard Deviation 0.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Weight z-Scores by Age Group for eoJIA Sub-population
Baseline: 2 to 17 years (N=60)
|
0.08 z-score
Standard Deviation 1.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Weight z-Scores by Age Group for eoJIA Sub-population
Week 8: 5 to 11 years (N=21)
|
0.30 z-score
Standard Deviation 1.30
|
|
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
|
|
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
|
|
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
|
|
Weight z-Scores by Age Group for eoJIA Sub-population
Week 24: 2 to 4 years (N=15)
|
-0.21 z-score
Standard Deviation 1.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Weight z-Scores by Age Group for eoJIA Sub-population
Week 36: 12 to 17 years (N=21)
|
0.39 z-score
Standard Deviation 0.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Weight z-Scores by Age Group for ERA Sub-population
Week 48: 12 to 17 years (N = 34)
|
0.04 z-score
Standard Deviation 0.70
|
|
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
|
|
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 ERA Sub-population
Week 12: 12 to 17 years (N = 36)
|
-0.00 z-score
Standard Deviation 0.65
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Weight z-Scores by Age Group for PsA Sub-population
Week 60: 12 to 17 years (N = 27)
|
0.61 z-score
Standard Deviation 1.00
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
Body Mass Index (BMI) z-Score by Age Group
Baseline: 2 to 17 years (N = 125)
|
0.03 z-score
Standard Deviation 1.17
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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 1.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.90
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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 ERA Sub-population
Baseline: 12 to 17 years (N = 38)
|
-0.29 z-score
Standard Deviation 0.87
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 12, Week 48, Week 72, Week 96Population: 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).
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.
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 12, Week 48, Week 96Population: 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).
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Anti-etanercept Antibodies
Overall (N=127)
|
26 Participants
|
|
Number of Participants With Anti-etanercept Antibodies
Week 96 (N=105)
|
14 Participants
|
|
Number of Participants With Anti-etanercept Antibodies
Week 12 (N=120)
|
6 Participants
|
|
Number of Participants With Anti-etanercept Antibodies
Week 48 (N=116)
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 12, Week 48, Week 96Population: 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).
Outcome measures
| Measure |
Etanercept
n=60 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population
Overall (N=60)
|
11 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population
Week 12 (N=56)
|
0 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population
Week 48 (N=55)
|
7 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: eoJIA Sub-population
Week 96 (N=52)
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 12, Week 48, Week 96Population: 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).
Outcome measures
| Measure |
Etanercept
n=38 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Anti-etanercept Antibodies: ERA Sub-population
Overall (N=38)
|
9 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: ERA Sub-population
Week 12 (N=36)
|
4 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: ERA Sub-population
Week 48 (N=34)
|
4 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: ERA Sub-population
Week 96 (N=29)
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 12, Week 48, Week 96Population: 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).
Outcome measures
| Measure |
Etanercept
n=29 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Anti-etanercept Antibodies: PsA Sub-population
Overall (N=29)
|
6 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: PsA Sub-population
Week 12 (N=28)
|
2 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: PsA Sub-population
Week 48 (N=27)
|
3 Participants
|
|
Number of Participants With Anti-etanercept Antibodies: PsA Sub-population
Week 96 (N=24)
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 12, Week 48, Week 96Population: Safety population included all participants who received at least 1 dose of the study medication.
Outcome measures
| Measure |
Etanercept
n=127 Participants
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Number of Participants With Neutralizing Anti-etanercept Antibodies
|
0 Participants
|
Adverse Events
Etanercept
Serious adverse events
| Measure |
Etanercept
n=127 participants at risk
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchopneumonia
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
1.6%
2/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pyelocystitis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Acute tonsillitis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Helicobacter gastritis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Peritonitis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Cartilage injury
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Juvenile arthritis
|
1.6%
2/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Syncope
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Adenoidectomy
|
0.79%
1/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Etanercept
n=127 participants at risk
Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.7%
6/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.9%
10/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
7.1%
9/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
10.2%
13/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
14.2%
18/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
12.6%
16/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
25.2%
32/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
8.7%
11/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.1%
42/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
13.4%
17/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
4/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.5%
7/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
4/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
3.9%
5/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
3.9%
5/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
5/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
5/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
8.7%
11/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
7.1%
9/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
4.7%
6/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tonsillitis
|
7.1%
9/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
4.7%
6/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
6/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Hepatic enzyme increased
|
3.9%
5/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
6/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
3.1%
4/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.5%
7/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
4/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
3.1%
4/127 • Screening up to Week 96
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER