Evaluation of a therapeutic de-eScalation strategy based on therapeutic drug MOnitOring in chronic non-infectious uveitis Treated witH adalimumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 9
- 主要终点
- 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.
研究概览
简要总结
To demonstrate the superiority of ADA spacing based on TDM, compared to a conventional ADA-based therapeutic strategy in patients with NICU who have achieved complete response, in terms of net clinical benefit (maintenance of complete ophthalmological response and absence of infection) at 48 weeks (W48).
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Is a member or beneficiary of a social security scheme
- •Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
- •Adult (age ≥ 18 years)
- •Patient with a diagnosis of chronic non-infectious uveitis in at least one eye and meeting the Standardization of Uveitis Nomenclature (SUN) criteria
- •Patient with a complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
- •Patient on ADA 40mg / 14 days for ≥ 24 weeks (allowing steady state)
- •Patient not having received systemic corticosteroid therapy for ≥ 12 weeks
排除标准
- •Inability or refusal to understand and/or sign the informed consent to participate in the study.
- •Inability and/or refusal to carry out the follow-up examinations required for the study
- •Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion
- •Uveitis suspected or proven to be of infectious origin
- •Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study
结局指标
主要结局
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.
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.
次要结局
- 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)
研究者
Projet manager
Scientific
Centre Hospitalier Universitaire De Saint Etienne