drugset / Trial / NCT02840175

Treatment Tapering in JIA With Inactive Disease

NCT02840175

RandomizedFactorialOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified
Subject Adalimumab Monoclonal antibody
Subject Etanercept Protein / enzyme biologic
Subject Tocilizumab Monoclonal antibody