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Treatment Tapering in JIA With Inactive Disease

NCT02840175 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-03-23

No results posted yet for this study

Summary

As biologic treatments are expensive and associated with some concerns regarding long-term safety, investigator hypothesize that early tapering and then withdrawal of biological agent, in an homogenous group of children with juvenile idiopathic arthritis achieving inactive disease, is safe and not inferior to the maintenance of stable treatment intensity over 24 weeks. In addition, investigator also hypothesize that an earlier tapering of treatment is associated with a better quality-of-life and a general cost saving effect. MRP8/14 will be studied as a potential biomarker for the risk of relapse. A study for biologic agent, anti-biologic agent antibodies and a pharmacogenomic approach will complete the research, as pharmacokinetic study during withdrawal of biologic treatment are rare in children.

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

etanercept

will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks

DRUG

adalimumab

will be tapered from every 2 weeks to every 3 weeks for 12 weeks and to every 4 weeks for 12 weeks

DRUG

Abatacept

will be tapered from every 4 weeks to every 6 weeks for 24 weeks

DRUG

Tocilizumab

will be tapered from every 4 weeks to every 6 weeks for 24 weeks

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Florence UETTWILLER, PhD · Necker Children's Hospital, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2019-10-29
Completion
2020-10-01

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT02840175 on ClinicalTrials.gov