Therapeutic Drug Monitoring-baSed adalimuMab De-escalatiOn in nOn-infecTious cHronic Uveitis

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with long-lasting uveitis (eye inflammation) not caused by infection. Their uveitis must be fully controlled while they take adalimumab (ADA).

Életkor

18 years or older

Nem

All sexes

A betegség stádiuma

Chronic non-infectious uveitis by the SUN criteria. The eye must have responded fully for at least 48 weeks (96 weeks for uveitis linked to Behçet's disease).

Korábbi kezelés

Must be on ADA 40mg every 14 days for at least 24 weeks. Must not have had corticosteroids by mouth or injection (systemic) for at least 12 weeks.

A részvétel fő kizáró okai

• Uveitis that is suspected or proven to come from an infection
• A change to other immune treatments taken with ADA (such as methotrexate, hydroxychloroquine, mycophenolate) in the 12 weeks before joining
• Planned surgery or other expected medical event that would need ADA to stop during the study
• Unable or unwilling to do the follow-up visits
• Unable or unwilling to understand or sign the consent form

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

Uveitis and its complications are thought to account for 10 to 15% of preventable blindness in Western countries. The diagnosis of chronic non-infectious uveitis (CNUI) can be made after exclusion of pseudo uveitis or infectious uveitis, in the case of any persistent uveitis or uveitis with frequent relapses occurring less than 3 months after cessation of treatment. Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids. The use of ADA has been optimized, in particular through Therapeutic Drug Monitoring (TDM), based on the determination of serum ADA levels and anti-ADA antibodies. Recently, an article showed that a strategy of spacing ADA administrations in RA patients with concentrations >8 μg/mL was not inferior to standard.

A vizsgálat 2 csoportja

• Control arm : conventional strategyMár használt kezelés, összehasonlításként

  At W0, ADA administration will be continued every 14 days. At W24, the control arm will continue to receive ADA every 14 days regardless of serum ADA concentration.

  Kezelés: Blood sample és Adalimumab Injection

• Arm 2: Interventional arm : adalimumab dose spacing strategyA vizsgált kezelés

  At W0, if the serum ADA concentration is ≥ 8 μg/mL, ADA administration will be spaced every 21 days. At W24, if the ADA concentration is \< 3.3 μg/mL (having a serum ADA concentration above this threshold was associated with a complete therapeutic response according to one study), administrations will be repeated every 14 days. If the ADA concentration is ≥ 3.3 and \< 8μg/mL, administrations will be left every 21 days. If ADA concentration is still ≥8μg/mL, ADA administrations will be spaced every 28 days.

  Kezelés: Blood sample és Adalimumab Injection