Phase 3 N=127 Treatment

Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Arthritis, Juvenile Idiopathic

Bottom Line

View on ClinicalTrials.gov: NCT00962741 ↗

Enrolled (actual)

127

Serious AEs

18.9%

Results posted

Jul 2012

Primary outcome: Primary: Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12 — 88.6 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Etanercept (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jun 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With an American College of Rheumatology Pediatric 30 (ACR Pedi 30) Response at Week 12	88.6	—
SECONDARY Percentage of Participants With an ACR Pedi 30 Response	71.4; 88.4; 88.6; 94.3; 95.8; 94.1	—
SECONDARY Percentage of Participants With an ACR Pedi 30 Response: Extended Oligoarticular Juvenile Idiopathic Arthritis (eoJIA) Sub-population	67.8; 87.5; 89.7; 94.8; 94.7; 96.5	—
SECONDARY Percentage of Participants With an ACR Pedi 30 Response: Enthesitis-Related Arthritis (ERA) Sub-population	84.2; 91.7; 83.3; 91.7; 97.1; 91.2	—
SECONDARY Percentage of Participants With an ACR Pedi 30 Response: Psoriatic Arthritis (PsA) Sub-population	62.1; 86.2; 93.1; 96.4; 96.4; 92.9	—
SECONDARY Percentage of Participants With an ACR Pedi 50 Response	51.2; 76.9; 81.1; 88.5; 88.3; 93.3	—
SECONDARY Percentage of Participants With an ACR Pedi 50 Response: eoJIA Sub-population	51.7; 75.0; 79.3; 86.2; 91.2; 94.7	—
SECONDARY Percentage of Participants With an ACR Pedi 50 Response: ERA Sub-population	63.2; 86.1; 80.0; 86.1; 82.9; 91.2	—
SECONDARY Percentage of Participants With an ACR Pedi 50 Response: PsA Sub-population	34.5; 69.0; 86.2; 96.4; 89.3; 92.9	—
SECONDARY Percentage of Participants With an ACR Pedi 70 Response	26.2; 47.1; 61.5; 71.3; 73.3; 79.8	—
SECONDARY Percentage of Participants With an ACR Pedi 70 Response: eoJIA Sub-population	28.8; 51.8; 63.8; 70.7; 75.4; 77.2	—
SECONDARY Percentage of Participants With an ACR Pedi 70 Response: ERA Sub-population	28.9; 52.8; 71.4; 80.6; 77.1; 85.3	—
SECONDARY Percentage of Participants With an ACR Pedi 70 Response: PsA Sub-population	17.2; 31.0; 44.8; 60.7; 64.3; 78.6	—
SECONDARY Percentage of Participants With an ACR Pedi 90 Response	6.3; 14.9; 29.8; 43.4; 47.5; 50.4	—
SECONDARY Percentage of Participants With an ACR Pedi 90 Response:eoJIA Sub-population	6.8; 16.1; 27.6; 53.4; 49.1; 52.6	—
SECONDARY Percentage of Participants With an ACR Pedi 90 Response: ERA Sub-population	10.5; 22.2; 45.7; 41.7; 48.6; 50.0	—
SECONDARY Percentage of Participants With an ACR Pedi 90 Response: PsA Sub-population	0.0; 3.4; 14.3; 25.0; 42.9; 46.4	—
SECONDARY Percentage of Participants With an ACR Pedi 100 Response	3.2; 6.6; 23.0; 33.6; 36.7; 40.3	—
SECONDARY Percentage of Participants With an ACR Pedi 100 Response: eoJIA Sub-population	6.8; 8.9; 20.7; 39.7; 42.1; 47.4	—
SECONDARY Percentage of Participants With an ACR Pedi 100 Response: ERA Sub-population	0.0; 5.6; 34.3; 36.1; 34.3; 32.4	—
SECONDARY Percentage of Participants With an ACR Pedi 100 Response: PsA Sub-population	0.0; 3.4; 13.8; 17.9; 28.6; 35.7	—
SECONDARY Physician's Global Assessment (PGA) of Disease Activity	5.02; 2.78; 2.00; 1.50; 1.15; 1.05	—
SECONDARY Physician's Global Assessment (PGA) of Disease Activity: eoJIA Sub-population	4.96; 2.73; 1.80; 1.40; 1.03; 0.89	—
SECONDARY Physician's Global Assessment (PGA) of Disease Activity: ERA Sub-population	5.39; 2.71; 2.19; 1.53; 1.32; 1.21	—
SECONDARY Physician's Global Assessment (PGA) of Disease Activity: PsA Sub-population	4.66; 2.98; 2.14; 1.69; 1.18; 1.20	—
SECONDARY Patient/Parent Global Assessment	4.96; 3.22; 2.79; 2.21; 1.79; 1.74	—
SECONDARY Patient/Parent Global Assessment: eoJIA Sub-population	4.82; 2.82; 2.38; 1.97; 1.51; 1.56	—
SECONDARY Patient/Parent Global Assessment: ERA Sub-population	5.43; 3.62; 3.19; 2.56; 2.26; 2.04	—
SECONDARY Patient/Parent Global Assessment: PsA Sub-population	4.62; 3.50; 3.10; 2.26; 1.75; 1.73	—
SECONDARY Number of Active Joints	6.74; 3.17; 2.07; 1.72; 1.16; 0.99	—
SECONDARY Number of Active Joints: eoJIA Sub-population	7.58; 3.95; 2.46; 2.07; 1.34; 1.14	—
SECONDARY Number of Active Joints: ERA Sub-population	5.21; 2.40; 1.47; 1.08; 0.78; 0.74	—
SECONDARY Number of Active Joints: PsA Sub-population	7.00; 2.59; 2.07; 1.79; 1.25; 1.00	—
SECONDARY Number of Joints With Limitation of Motion	5.72; 3.20; 2.26; 1.62; 1.43; 1.39	—
SECONDARY Number of Joints With Limitation of Motion: eoJIA Sub-population	6.33; 3.12; 2.23; 1.78; 1.40; 1.16	—
SECONDARY Number of Joints With Limitation of Motion: ERA Sub-population	4.84; 2.98; 2.28; 1.58; 1.53; 1.55	—
SECONDARY Number of Joints With Limitation of Motion: PsA Sub-population	5.62; 3.66; 2.28; 1.34; 1.36; 1.64	—
SECONDARY C-reactive Protein (CRP)	8.26; 3.29; 2.32; 2.47; 3.54; 2.81	—
SECONDARY C-reactive Protein (CRP): eoJIA Sub-population	6.27; 3.45; 2.66; 3.36; 5.26; 3.25	—
SECONDARY C-reactive Protein (CRP): ERA Sub-population	15.27; 4.37; 2.53; 1.87; 1.96; 3.24	—
SECONDARY C-reactive Protein (CRP): PsA Sub-population	3.19; 1.58; 1.41; 1.36; 2.11; 1.31	—
SECONDARY Pain Assessment	5.06; 3.12; 2.58; 2.02; 1.64; 1.63	—
SECONDARY Pain Assessment: eoJIA Sub-population	4.81; 2.64; 2.12; 1.69; 1.27; 1.43	—
SECONDARY Pain Assessment: ERA Sub-population	5.76; 3.82; 3.13; 2.54; 2.28; 1.87	—
SECONDARY Pain Assessment: PsA Sub-population	4.64; 3.19; 2.81; 2.03; 1.61; 1.71	—
SECONDARY Duration of Morning Stiffness	73.50; 29.86; 25.02; 13.29; 8.83; 6.76	—
SECONDARY Duration of Morning Stiffness: eoJIA Sub-population	72.78; 20.46; 20.18; 9.05; 5.72; 2.49	—
SECONDARY Duration of Morning Stiffness: ERA Sub-population	89.29; 49.34; 44.03; 25.69; 15.69; 17.17	—
SECONDARY Duration of Morning Stiffness: PsA Sub-population	54.31; 23.45; 10.79; 6.38; 6.43; 2.43	—
SECONDARY Percentage of Participants With Inactive Disease Per Wallace 2004 Definition	2.4; 2.5; 12.2; 24.8; 25.0; 29.7	—
SECONDARY Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: eoJIA Sub-population	5.1; 3.6; 12.1; 29.8; 35.1; 37.5	—
SECONDARY Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: ERA Sub-population	0.0; 2.8; 16.7; 25.0; 14.3; 23.5	—
SECONDARY Percentage of Participants With Inactive Disease Per Wallace 2004 Definition: PsA Sub-population	0.0; 0.0; 6.9; 14.3; 17.9; 21.4	—
SECONDARY Childhood Health Assessment Questionnaire (CHAQ) Score	0.80; 0.54; 0.42; 0.32; 0.28; 0.23	—
SECONDARY Childhood Health Assessment Questionnaire (CHAQ) Score: eoJIA Sub-population	0.90; 0.64; 0.50; 0.40; 0.31; 0.26	—
SECONDARY Childhood Health Assessment Questionnaire (CHAQ) Score: ERA Sub-population	0.72; 0.48; 0.40; 0.23; 0.27; 0.20	—
SECONDARY Childhood Health Assessment Questionnaire (CHAQ) Score: PsA Sub-population	0.68; 0.42; 0.30; 0.29; 0.26; 0.21	—

Summary

This study will evaluate the effect of etanercept on the clinical benefit, safety, and physical functioning (ability to function in daily life) in children and adolescent subjects with 3 subtypes of childhood arthritis.

Eligibility Criteria

Inclusion Criteria

Male and female subjects with a diagnosis per International League of Associations for Rheumatology (ILAR) criteria of extended oligoarticular juvenile idiopathic arthritis (JIA) between the ages of 2 and 17 years; enthesitis-related arthritis (ERA) between the ages of 12 and 17 years; or psoriatic arthritis (PsA) between the ages of 12 and 17 years.
>= 2 active joints and the following for the relevant JIA subtype: extended oligoarticular JIA or PsA with a history of intolerance or an unsatisfactory response to a disease modifying antirheumatic drug (DMARD); or ERA with a history of intolerance or an unsatisfactory response to a nonsteroidal anti-inflammatory drug (NSAID) or a DMARD.

Exclusion Criteria

Systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria.
Other rheumatic diseases.
Active uveitis within 6 months of the baseline visit.
Any other significant health problem.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00962741). 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.