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STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS

NCT03728478 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-10-15

No results posted yet for this study

Summary

This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).

Conditions

  • Oligoarthritis, Juvenile
  • Polyarthritis, Juvenile, Rheumatoid Factor Negative

Interventions

DRUG

Etanercept

Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).

DRUG

Methotrexate

Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).

DRUG

Intra-articular corticosteroid injections

Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.

Sponsors & Collaborators

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Compagnia di San Paolo

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Istituto Giannina Gaslini

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-29
Primary Completion
2025-02-28
Completion
2025-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728478 on ClinicalTrials.gov