Evaluation of a therapeutic de-eScalation strategy based on therapeutic drug MOnitOring in chronic non-infectious uveitis Treated witH adalimumab

Conditions

noninfectious uveitis

Brief summary

The primary endpoint is a composite of : - Maintenance of complete ophthalmological response at W48 Complete ophthalmological response being defined as the combination, in both eyes, of: absence of inflammatory lesions AND a cellular grade of the anterior chamber and vitreous ≤ 0.5+. - The absence of infection during follow-up for up to 48 weeks.

Detailed description

Maintenance of complete ophthalmological response and absence of infection as defined in the primary endpoint section at W12, W24 and W36., Occurrence of a relapse, defined by the presence of any inflammatory lesion and a cellular grade of the anterior chamber and vitreous >0.5+ and/or the occurrence of an infection up to 48 weeks, collected on dedicated forms, notified and validated by the adjudication committee., Anti-ADA antibody positivity and titers at W0, W12, W24, W36 and W48 using a "drug-sensitive" test (i-Tracker anti-ADA) and a "drug-tolerant" test (allowing the absence of false negatives due to the formation of ADA-anti-ADA complexes)., Measurement of quality of life using the National Eye Institute Visual Functioning Questionaire-25 (NEI VFQ-25) composite score at W0, W12, W24, W36 and W48., Incremental cost-effectiveness ratio (ICER)

Related papers

No related papers found yet.

Interventions

DRUGHumira 40 mg solution for injection in pre-filled pen

DRUGHumira 40 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is a composite of : - Maintenance of complete ophthalmological response at W48 Complete ophthalmological response being defined as the combination, in both eyes, of: absence of inflammatory lesions AND a cellular grade of the anterior chamber and vitreous ≤ 0.5+. - The absence of infection during follow-up for up to 48 weeks.	—

Secondary

Measure	Time frame
Maintenance of complete ophthalmological response and absence of infection as defined in the primary endpoint section at W12, W24 and W36., Occurrence of a relapse, defined by the presence of any inflammatory lesion and a cellular grade of the anterior chamber and vitreous >0.5+ and/or the occurrence of an infection up to 48 weeks, collected on dedicated forms, notified and validated by the adjudication committee., Anti-ADA antibody positivity and titers at W0, W12, W24, W36 and W48 using a "drug-sensitive" test (i-Tracker anti-ADA) and a "drug-tolerant" test (allowing the absence of false negatives due to the formation of ADA-anti-ADA complexes)., Measurement of quality of life using the National Eye Institute Visual Functioning Questionaire-25 (NEI VFQ-25) composite score at W0, W12, W24, W36 and W48., Incremental cost-effectiveness ratio (ICER)	—

Measure

Time frame

Maintenance of complete ophthalmological response and absence of infection as defined in the primary endpoint section at W12, W24 and W36., Occurrence of a relapse, defined by the presence of any inflammatory lesion and a cellular grade of the anterior chamber and vitreous >0.5+ and/or the occurrence of an infection up to 48 weeks, collected on dedicated forms, notified and validated by the adjudication committee., Anti-ADA antibody positivity and titers at W0, W12, W24, W36 and W48 using a "drug-sensitive" test (i-Tracker anti-ADA) and a "drug-tolerant" test (allowing the absence of false negatives due to the formation of ADA-anti-ADA complexes)., Measurement of quality of life using the National Eye Institute Visual Functioning Questionaire-25 (NEI VFQ-25) composite score at W0, W12, W24, W36 and W48., Incremental cost-effectiveness ratio (ICER)

—

Countries

France

Outcome results

None listed