Eligibility, any sex, with Juvenile Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With a JRA Response at Month 6Primary· Baseline and month 6
Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 30% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:
* Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
* Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
* Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive
Group
Value
95% CI
Methotrexate + Placebo
33
Methotrexate + Etanercept
38
Percentage of Participants With a 50% Improvement in JRA DOI at Month 6Secondary· Baseline and month 6
Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 50% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:
* Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
* Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
* Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive
Group
Value
95% CI
Methotrexate + Placebo
25
Methotrexate + Etanercept
38
Percentage of Participants With a 70% Improvement in JRA DOI at Month 6Secondary· Baseline and month 6
Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 70% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:
* Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
* Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
* Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive
Group
Value
95% CI
Methotrexate + Placebo
8
Methotrexate + Etanercept
38
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 12 months on-study evaluations plus 1 month follow-up.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Methotrexate + Placebo (Blinded Phase)
Serious: 1/12 (8%)
Deaths: —
Methotrexate + Etanercept (Blinded Phase)
Serious: 1/13 (8%)
Deaths: —
Methotrexate + Etanercept (Open Label Phase)
Serious: 0/19 (0%)
Deaths: —
Serious adverse events (2 terms)
Reaction
System
Methotrexate + Placebo (Bl…
Methotrexate + Etanercept …
Methotrexate + Etanercept …
Appendicitis
Infections and infestations
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
Other adverse events (103 terms — click to expand)
The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis
· not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
· Phase 4
· not yet recruiting
NCT06707194 — Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis
· Phase 4
· recruiting
NCT06011889 — Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
· Phase 2, PHASE3
· recruiting
NCT05281614 — Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D
· EARLY_PHASE1
· completed
Other recruiting trials for Juvenile Rheumatoid Arthritis
Currently open trials in the same condition.
NCT05715463 — Rheumatology-based Adaptive Intervention for Social Determinants and Health Equity
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 2 August 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03781375.