Phase 3 Completed N=127 Treatment

Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis

Arthritis, Juvenile Idiopathic

Source: ClinicalTrials.gov NCT00962741 ↗

Enrolled (actual)

127

Serious AEs

18.9%

Results posted

Jul 2012

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

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.

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	—

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. Informational only — not medical advice.