This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
Etanercept 0.8 mg/kg QW up to a maximum dose of 50 mg
Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12
ACR Pedi 30 response: greater than or equal to (\>=) 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) childhood health assessment questionnaire (CHAQ) 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 12
Percentage of Participants With an ACR Pedi 30 Response
ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population
ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population
ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein. Data are presented for Part 1 (up to 12 weeks) and Part 2 (up to 96 weeks).
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Pfizer Investigational Site
Westmead, Sydney, New South Wales, Australia
Pfizer Investigational Site
Parkville, Melbourne, Victoria, Australia
Pfizer Investigational Site
Ghent, Belgium, Belgium
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Leuven, Belgium
Pfizer Investigational Site
Barranquilla, Atlántico, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bucaramanga, Santander Department, Colombia
Pfizer Investigational Site
Brno, Czechia
Pfizer Investigational Site
Prague, Czechia
...and 32 more locations
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population
ACR Pedi 30 response: \>= 30% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of arthritis pain, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 50 Response
ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population
ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population
ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population
ACR Pedi 50 response: \>= 50% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 70 Response
ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population
ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population
ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population
ACR Pedi 70 response: \>= 70% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 90 Response
ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population
ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population
ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population
ACR Pedi 90 response: \>= 90% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 100 Response
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population
ACR Pedi 100 response: 100% improvement from baseline in 3 of 6 criteria with worsening \> 30% in no more than 1 of 6 criteria: 1) physician's global assessment of disease activity, 2) parent/patient global assessment of disease activity, 3) CHAQ 4) number of active joints 5) number of joints with limited range of motion and 6) C-reactive protein at each visit.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Physician's Global Assessment (PGA) of Disease Activity
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population
PGA of Disease Activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= Maximum disease activity.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment: eoJIA Sub-population
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment: ERA Sub-population
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Patient/Parent Global Assessment: PsA Sub-population
Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Active Joints
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Active Joints: eoJIA Sub-population
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Active Joints: ERA Sub-population
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Active Joints: PsA Sub-population
Active joints: Joints that were swollen or, in absence of swelling, joints with limited motion with pain and/or tenderness. Joints were coded as: 0= no swelling, limitation of motion, or pain and/or tenderness on motion; 1= any swelling, limitation of motion, or pain and/or tenderness on motion; JR= joint replacement; NE= not evaluable. Total number of active joints= 73\*(total number of active joints with counts \> 0)/number of non-missing active joints. JR and NE were treated as missing. If \> 36 active joint counts were missing, total number of active joints was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Joints With Limitation of Motion
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Joints With Limitation of Motion: eoJIA Sub-population
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Joints With Limitation of Motion: ERA Sub-population
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Number of Joints With Limitation of Motion: PsA Sub-population
The joints were assessed and coded as: 0= no limitation of motion; 1= any limitation of motion; JR= joint replacement; NE= not evaluable. Total number of joints with limitation of motion: 69\*(total number of joints with counts of limitation of motion \> 0)/number of non-missing limitation of motions. JR and NE were treated as missing. If \> 34 counts of limitation of motion were missing, total number of joints with limitation of motion was defined as missing.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
C-reactive Protein (CRP)
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
C-reactive Protein (CRP): eoJIA Sub-population
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
C-reactive Protein (CRP): ERA Sub-population
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
C-reactive Protein (CRP): PsA Sub-population
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment: eoJIA Sub-population
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment: ERA Sub-population
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Pain Assessment: PsA Sub-population
Pain Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = no pain and 10 = very severe pain.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of Morning Stiffness
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of Morning Stiffness: eoJIA Sub-population
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of Morning Stiffness: ERA Sub-population
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Duration of Morning Stiffness: PsA Sub-population
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (If none was present = 0; If morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported; If stiffness persisted the entire day, 1440 minutes was recorded).
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population
Inactive disease was defined as no joints with active arthritis, a normal CRP, and a PGA of Disease Activity of 0 on a 21-circle VAS.
Time frame: Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Childhood Health Assessment Questionnaire (CHAQ) Score
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96
Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population
CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participants's ability to perform activities in 8 domains: dressing, arising, eating, walking,hygiene, each,grip,common activities distributed in total of 30 items.Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for domain is score for that domain.Overall score = sum of domain scores divided by number of domains answered. Total score: 0=no difficulty to 3=extreme difficulty.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96