Last updated: March 31, 2021
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed
Phase
3
Condition
Musculoskeletal Diseases
Joint Injuries
Collagen Vascular Diseases
Treatment
N/AClinical Study ID
NCT02840175
P 150902
2016-000312-15
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 themarketing authorization.
- Patient who achieved inactive disease within two years of treatment with the lastbiologic agent administered, according to Wallace criteria : no joints with activearthritis, no active uveitis (as defined by the SUN Working Group), ESR or CRP levelwithin normal limits in the laboratory where tested (or, if elevated, not attributableto JIA), physician's global assessment of disease activity score (< 10/100 visualanalogue scale), and duration of morning stiffness < ou = 15 minutes (within 7 daysbefore 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 beforeinclusion
- Patient without steroids or joint injection or live vaccines injection for at leastone month.
- Signed informed consent by both parents (or legal guardian) and patient's agreement.
- Patient affiliated to the National Health Assurance system.
Exclusion
Exclusion Criteria:
- Patient with systemic form, rheumatoid factor positive, psoriatic or associated withenthesitis related JIA.
- Patient undergoing biologic therapy due to JIA-associated uveitis or with activeuveitis at time of randomization.
- Patient with any contraindication to continue ongoing biologic treatment, notablyongoing uncontrolled infection, suspicion or evidence of demyelinating disease of thecentral nervous system.
- Patient previously treated with the same biotherapy for which dose decreasing orbiotherapy withdrawal was already tested in the past for inactive disease and thenreintroduced.
- Pregnancy or absence of effective contraception (including abstinence) in a pubertalpatient.
- Patient suffering from tuberculosis.
- Patient with moderate to severe cardiac failure (NYHA class III / IV).
Study Design
Total Participants: 62
Study Start date:
May 18, 2017
Estimated Completion Date:
October 01, 2020
Study Description
Connect with a study center
Necker Children's Hospital
Paris, 75015
FranceSite Not Available

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