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Treatment Tapering in JIA With Inactive Disease

CompletedPhase 3

Sponsor: Assistance Publique - Hôpitaux de Paris

Conditions: Juvenile Idiopathic Arthritis

Interventions: etanercept, adalimumab, Abatacept, Tocilizumab

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 2 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patient aged 2 to 17 years and treated with etanercept or tocilizumab or adalimumab, or patient aged 6 to 17 years and treated with abatacept.
* Patient with an oligoarticular or polyarticular rheumatoid factor negative JIA
* Patient treated with biologic treatment for persistent arthritis according to the marketing authorization.
* Patient who achieved inactive disease within two years of treatment with the last biologic agent administered, according to Wallace criteria : no joints with active arthritis, no active uveitis (as defined by the SUN Working Group), ESR or CRP level within normal limits in the laboratory where tested (or, if elevated, not attributable to JIA), physician's global assessment of disease activity score (\< 10/100 visual analogue scale), and duration of morning stiffness \< ou = 15 minutes (within 7 days before the visit).
* Patient with inactive disease achieved for less than 12 months.
* Patient with stable doses of non-steroidal anti-inflammatory drugs, Methotrexate (maximum 20 mg/m2/week), and other non biologic DMARD for at least one month before inclusion
* Patient without steroids or joint injection or live vaccines injection for at least one month.
* Signed informed consent by both parents (or legal guardian) and patient's agreement.
* Patient affiliated to the National Health Assurance system.

Exclusion Criteria:

* Patient with systemic form, rheumatoid factor positive, psoriatic or associated with enthesitis related JIA.
* Patient undergoing biologic therapy due to JIA-associated uveitis or with active uveitis at time of randomization.
* Patient with any contraindication to continue ongoing biologic treatment, notably ongoing uncontrolled infection, suspicion or evidence of demyelinating disease of the central nervous system.
* Patient previously treated with the same biotherapy for which dose decreasing or biotherapy withdrawal was already tested in the past for inactive disease and then reintroduced.
* Pregnancy or absence of effective contraception (including abstinence) in a pubertal patient.
* Patient suffering from tuberculosis.
* Patient with moderate to severe cardiac failure (NYHA class III / IV).

Locations (1)

Paris, Paris, France