Phase 3
N=127
Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Juvenile Idiopahtic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01421069 ↗Enrolled (actual)
127
Serious AEs
20.2%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants With Malignancy: All Periods of Parent and Extension Study — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- etanercept (Drug)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Malignancy: All Periods of Parent and Extension Study |
1 | — |
| SECONDARY Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study |
45 | — |
| SECONDARY Number of Participants With Serious Infections: All Periods of Parent and Extension Study |
14 | — |
| SECONDARY Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study |
12 | — |
| SECONDARY Number of Participants With Infections: All Periods of Parent and Extension Study |
111 | — |
| SECONDARY Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study |
67; 6 | — |
| SECONDARY Number of Participants With Infections: Extension Study: Withdrawal Period |
8; 1 | — |
| SECONDARY Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study |
3; 14 | — |
| SECONDARY Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period |
— | — |
| SECONDARY Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study |
2; 0 | — |
| SECONDARY Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period |
0.22; 0.17; 0.21; 0.19; 0.25; 0.30 | — |
| SECONDARY Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period |
-0.10; -0.13; 0.03; 0.26; 0.41; 0.52 | — |
| SECONDARY Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period |
-0.21; -0.19; -0.19; 0.07; -0.08; 0.08 | — |
| SECONDARY Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period |
0.78; 1.02; 1.35; 1.69; 1.70; 2.25 | — |
| SECONDARY Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period |
0.08; 0.38; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period |
0.04; 0.52; 1.52; 1.27; 1.67 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period |
95.7; 98.4; 96.7; 100; 100; 100 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period |
95.7; 100; 100; 88.9; 88.9; 100 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period: |
100; 100; 91.7; 90.9; 100; 100 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
95.7; 98.3; 96.7; 98.2; 98.1; 100 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period |
87.0; 100; 90.9; 88.9; 88.9; 87.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period |
100; 100; 91.7; 90.9; 100; 87.5 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
95.7; 87.1; 88.7; 89.3; 88.5; 89.4 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period |
77.3; 93.3; 90.9; 88.9; 88.9; 85.7 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period |
91.7; 83.3; 81.8; 81.8; 80.0; 75.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
64.0; 70.2; 72.6; 64.8; 63.5; 71.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period |
66.7; 71.4; 70.0; 75.0; 87.5; 75.0 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period |
63.6; 66.7; 66.7; 70.0; 75.0; 57.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
44.0; 51.9; 55.0; 45.5; 40.4; 52.8 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
61.9; 64.3; 63.6; 66.7; 77.8; 66.7 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
54.5; 50.0; 63.6; 62.5; 75.0; 57.1 | — |
| SECONDARY Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period |
-4.51; -4.66; -4.71; -4.67; -4.69; -4.75 | — |
| SECONDARY Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-4.92; -4.70; -5.50; -5.09; -5.30; -5.15 | — |
| SECONDARY Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-3.73; -4.19; -4.13; -3.82; -3.85; -3.81 | — |
| SECONDARY Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-3.93; -3.79; -4.13; -4.18; -4.38; -4.20 | — |
| SECONDARY Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-4.38; -3.97; -5.04; -4.65; -4.60; -4.50 | — |
| SECONDARY Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-2.81; -2.73; -2.83; -2.86; -2.65; -2.81 | — |
| SECONDARY Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-0.66; -0.71; -0.72; -0.81; -0.82; -0.86 | — |
| SECONDARY Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-0.81; -0.90; -1.04; -1.04; -1.15; -1.15 | — |
| SECONDARY Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-0.65; -0.66; -0.78; -0.80; -0.78; -0.75 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
0.09; 0.10; 0.09; 0.13; 0.15; 0.17 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
0.00; 0.02; 0.03; 0.00; 0.00; 0.00 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-0.81; -0.81; -0.42; -0.81; -0.75; -0.75 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-7.00; -6.94; -6.82; -6.48; -6.43; -6.82 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-6.96; -8.53; -8.50; -8.73; -8.70; -8.40 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-6.31; -6.46; -6.17; -6.18; -6.60; -5.63 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-4.80; -5.51; -5.32; -5.12; -5.03; -5.23 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-5.38; -5.60; -5.67; -5.36; -5.40; -5.10 | — |
| SECONDARY Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-5.15; -5.46; -4.75; -5.45; -5.60; -3.88 | — |
| SECONDARY Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-3.71; -3.37; -3.82; -4.00; -3.89; -3.52 | — |
| SECONDARY Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-0.99; -2.47; -3.01; -0.27; -0.25; 0.07 | — |
| SECONDARY Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period |
-5.50; -5.99; -6.42; -6.91; -6.68; -7.79 | — |
| SECONDARY Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-3.43; -4.02; -4.24; -4.40; -4.26; -4.03 | — |
| SECONDARY Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-4.75; -4.03; -5.00; -4.36; -4.70; -4.50 | — |
| SECONDARY Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-2.64; -2.65; -2.68; -3.05; -2.25; -2.25 | — |
| SECONDARY Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-52.11; -73.33; -80.24; -72.19; -66.36; -75.04 | — |
| SECONDARY Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-83.96; -71.43; -56.67; -29.09; -32.00; -32.00 | — |
| SECONDARY Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-116.15; -107.69; -126.67; -130.00; -111.00; -85.63 | — |
| SECONDARY Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
11.8; 25.7; 36.2; 24.2; 30.5; 32.1 | — |
| SECONDARY Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
54.5; 66.7; 66.7; 81.8; 80.0; 80.0 | — |
| SECONDARY Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
23.1; 46.2; 33.3; 45.5; 50.0; 62.5 | — |
| SECONDARY Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
-15.00; -15.09; -15.83; -15.73; -15.54; -15.89 | — |
| SECONDARY Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period |
-16.66; -17.90; -20.41; -20.25; -20.19; -19.44 | — |
| SECONDARY Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period |
-13.59; -13.80; -14.39; -13.26; -13.51; -12.68 | — |
| SECONDARY Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA) |
-19.88; -21.66; -20.34; -20.08; -21.50; -21.69 | — |
| SECONDARY Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA) |
-18.13; -27.48; -35.21; -30.50; -32.00; -33.50 | — |
| SECONDARY Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA) |
-21.00; -29.00; -24.50; -23.50; -31.00; -13.00 | — |
| SECONDARY Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA) |
-17.41; -14.99; -16.90; -18.09; -17.31; -19.23 | — |
| SECONDARY Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA) |
-1.28; 0.02; 0.04; 0.50; -0.50; 0.00 | — |
| SECONDARY Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA) |
-3.00; -6.00; -0.50; 0.00; 4.00; 14.00 | — |
| SECONDARY Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA) |
0.39; 0.21; 0.23; 0.40; 0.30; 0.17 | — |
| SECONDARY Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA) |
-5.45; -10.07; -9.82; -11.85; -10.95; -10.38 | — |
| SECONDARY Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA) |
-1.33; -1.33; -1.20; -1.54; -1.07; -1.21 | — |
| SECONDARY All Cause Mortality: All Periods of Extension Study |
— | — |
| SECONDARY Number of Participants With Prior Non-study Medication: All Periods of Extension Study |
2; 5; 5; 0; 57; 13 | — |
| SECONDARY Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study |
62; 29; 16; 12; 64; 51 | — |
| SECONDARY Number of Participants With After Non-study Medication: All Periods of Extension Study |
7; 6; 3; 1; 48; 16 | — |
| SECONDARY Exposure Time: Extension Study: Active Treatment Period |
244.79 | — |
| SECONDARY Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period |
68.8; 73.0; 79.0; 78.3; 86.5; 90.6 | — |
| SECONDARY Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period |
1; 14; 4; 2; 0 | — |
Summary
This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) [extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).
Eligibility Criteria
Inclusion Criteria
Receipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)
Personally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.
Exclusion Criteria
Exclusion criteria for subject planning to continue investigational product:
withdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).
History of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.
Data sourced from ClinicalTrials.gov (NCT01421069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.