Treatment Tapering in JIA With Inactive Disease

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT02840175
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • etanercept — DRUG
    will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks
  • adalimumab — DRUG
    will be tapered from every 2 weeks to every 3 weeks for 12 weeks and to every 4 weeks for 12 weeks
  • Abatacept — DRUG
    will be tapered from every 4 weeks to every 6 weeks for 24 weeks
  • Tocilizumab — DRUG
    will be tapered from every 4 weeks to every 6 weeks for 24 weeks

Study Details

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.

Key Dates

Start date
May 18, 2017
Status verified
Mar 2026
Primary completion
Oct 29, 2019
Completion
Oct 1, 2020

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    * Day 0 at Weeks 24 : Increase the interval between 2 doses of the biological agent (etanercept, adalimumab, tocilizumab, abatacept) * Weeks 24 at Weeks 72: Stop the biological agent if inactive disease is maintained.
  • Active Comparator: Control
    * Day 0 at Weeks 24: Maintain the biological agent (etanercept, adalimumab, tocilizumab, abatacept) at the same dose. * Weeks 24 at Weeks 48 : Increase the interval between 2 doses of the biological agent. * Weeks 48 at Weeks 72: Stop the biological agent if inactive disease is maintained.

Primary Outcome Measure

Persistence of inactive disease [ Time Frame: 24 weeks ]

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