Efficacy, Safety and Costs of Methotrexate, Adalimumab, or Their Combination in Non-infectious No… (NCT04798755) | Clinical Trial Compass
UnknownPhase 3
Efficacy, Safety and Costs of Methotrexate, Adalimumab, or Their Combination in Non-infectious Non-anterior Uveitis
Spain192 participantsStarted 2022-01-12
Plain-language summary
Introduction: Non-infectious uveitis (NIUs) include a heterogeneous group of sight-threatening conditions. NIUs can be highly disabling and be associated with a profound impact in the quality-of-life (QoL) and wellbeing. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), which can be prescribed in monotherapy or in combination. Several observational studies have provided evidence that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet.
Methods and analysis: The Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicenter, prospective, randomized, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate (MTX), adalimumab (ADA), or their combination in non-infectious non-anterior uveitis. The duration of the treatment and follow-up will last up to 52 weeks. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secundray measures of efficacy (QoL, visual acuity, costs) and safety, we will identify subjects' subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects diagnosed with non-infectious intermediate-, posterior-, or pan-uveitis in at least one eye;
✓. Adult patients (≥18 years);
✓. Subjects with at least one flare of active eye inflammation in the previous 180 days before Baseline visit, defined by the presence of at least 1 of the following parameters in either eye:
✓. Active chorioretinal or retinal vascular lesion, AND/OR
✓. Presence of macular edema by optical coherence tomography (OCT:thickness \>350 μm AND cysts or intraretinal fluid), AND/OR
✕. Subjects with previous intolerability, safety issues according to investigator criteria, AND/OR previous failure to control ocular or other inflammation with MTX
✕. Subjects with previous exposure to any biological therapy at any time (excluding intravitreal anti-vascular endothelial growth factor \[anti-VEGF\] therapy and denosumab), including those with that have a potential or known association with progressive multifocal leukoencephalopathy (i.e. natalizumab, rituximab or efalizumab);
✕. Subjects with previous exposure to synthetic immunosuppressive therapy (such as mycophenolate or cyclosporine) other than corticosteroids in the past 6 months before Baseline;
✕. Subjects with chronic structural eye damage considered by the Site's