Treatment Tapering in JIA With Inactive Disease
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Juvenile idiopathic arthritis (JIA) is characterized by chronic arthritis of unknown etiology
      starting before the age of 16. There are four to five thousand paediatric patients with JIA
      in France. Most of these patients are diagnosed with oligoarticular or rheumatoid factor
      negative polyarticular JIA. The prognosis of the disease has dramatically improved thanks to
      the introduction of biologic agents in patients with an extended oligoarticular or rheumatoid
      factor negative polyarticular JIA and inadequate response to methotrexate. Inactive disease
      and long-lasting clinical remission are achieved in most cases. "Treat to target" approaches
      are increasingly recommended, with earlier introduction of biologics, however the way to
      taper or withdraw treatment in patients achieving inactive disease is not codified. As
      biologic treatments are expensive and associated with some concerns regarding long-term
      safety, this study aim to test, in a randomized fashion, the hypothesis that early tapering
      of biologic agents (i.e. increasing the intervals between injections as soon as inactive
      disease is documented) is safe and non-inferior to the maintenance of stable treatment
      intensity over 24 weeks, and therefore test the possibility of early biologic agent
      withdrawal. It will also study concentrations of different biological agent, the occurrence
      of anti-drugs antibodies while tapering and then withdrawing biologics, and their possible
      association with a higher risk of relapse. In addition, investigators will test if the serum
      level of proteins 100 (MRP8/14) could be predictive of flares. Finally, pharmaco-economic
      analyses and quality of life studies will be conducted.
    

Intervention name(s): etanercept; adalimumab; Abatacept; Tocilizumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks; will be tapered from every 2 weeks to every 3 weeks for 12 weeks and to every 4 weeks for 12 weeks; will be tapered from every 4 weeks to every 6 weeks for 24 weeks; will be tapered from every 4 weeks to every 6 weeks for 24 weeks
Other intervention name(s): Enbrel®; Humira®; Orencia®; RoActemra®
Intervention MeSH terms: Adalimumab; Etanercept; Abatacept
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment tapering; Oligoarticular; Juvenile Idiopathic Arthritis; Inactive disease; Biologic therapy