Adalimumab for Non-infectious uveitis

Inclusion criteria

• {"criterion_text":"- Is a member or beneficiary of a social security scheme\n- Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study\n- Adult (age ≥ 18 years)\n- Patient with a diagnosis of chronic non-infectious uveitis in at least one eye and meeting the Standardization of Uveitis Nomenclature (SUN) criteria\n- Patient with a complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined\n- Patient on ADA 40mg / 14 days for ≥ 24 weeks (allowing steady state)\n- Patient not having received systemic corticosteroid therapy for ≥ 12 weeks"}

Exclusion criteria

• {"criterion_text":"- Inability or refusal to understand and/or sign the informed consent to participate in the study.\n- Inability and/or refusal to carry out the follow-up examinations required for the study\n- Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion\n- Uveitis suspected or proven to be of infectious origin\n- Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite endpoint measured at Week 48: maintenance of complete ophthalmological response defined as, in both eyes, absence of inflammatory lesions AND anterior chamber and vitreous cellular grade ≤ 0.5+; plus absence of infection during follow-up up to 48 weeks."}

Secondary endpoints

• {"endpoint_text":"- Maintenance of complete ophthalmological response and absence of infection as defined in the primary endpoint section at W12, W24 and W36.","definition_or_measurement_approach":"Measured at Weeks 12, 24 and 36 using the same composite definition as primary endpoint (complete ophthalmological response and absence of infection)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Relapse defined as presence of any inflammatory lesion and/or anterior chamber/vitreous cellular grade >0.5+, and/or occurrence of infection; events collected on dedicated forms and adjudicated by committee up to 48 weeks."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Immunogenicity measured at specified visits (W0, W12, W24, W36, W48) using both a drug-sensitive assay (i-Tracker anti-ADA) and a drug-tolerant assay to assess anti-ADA antibodies and titers."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Patient-reported quality of life assessed with NEI VFQ-25 composite score at baseline and Weeks 12, 24, 36 and 48."}
• {"endpoint_text":"- Incremental cost-effectiveness ratio (ICER)","definition_or_measurement_approach":"Health economic outcome measuring incremental cost-effectiveness (ICER) as defined in the protocol (details not provided in the CTIS extract)."}

France

Earliest CTIS Part Ii Submission Date

19-12-2024

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

130

Number Of Sites

10

Number Of Participants

320

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Saint Etienne

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"French Ministry of health","duties_or_roles":"Source of monetary support","organisation_type":""}