A randomized, two-armed, single-blind, parallel, active controlled, and non-inferiority clinical trial to Compare Efficacy and Safety of anti TNF-alfa biosimilar molecules to the originators in children with active Juvenile Idiopathic Arthritis

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515557-22-00

Enrollment

290

Registered

2024-08-19

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Juvenile Idiopathic Arthritis

Brief summary

Clinical remission. Efficacy of therapeutic strategies will be compared by assessing the frequency of clinical remission (CR) at 18 months (6 months after randomization for entrance in Phase B). CR is defined as the persistence of the Juvenile Arthritis Disease Activity Score (JADAS) state of inactive disease (ID) for at least 6 months. Assessment of efficacy of the switch will be determined comparing the proportion of patients in CR at 18 months in the switched vs the non switched cohort

Interventions

DRUGEnbrel 25 mg powder and solvent for solution for injection

DRUGADALIMUMAB

DRUGETANERCEPT

DRUGHumira 20 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Clinical remission. Efficacy of therapeutic strategies will be compared by assessing the frequency of clinical remission (CR) at 18 months (6 months after randomization for entrance in Phase B). CR is defined as the persistence of the Juvenile Arthritis Disease Activity Score (JADAS) state of inactive disease (ID) for at least 6 months. Assessment of efficacy of the switch will be determined comparing the proportion of patients in CR at 18 months in the switched vs the non switched cohort	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026