Efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis: a protocol for a multicentre, randomised, parallel three arms, active-controlled, phase III open label with blinded outcome assessment study. Issue 3 (22nd March 2022)

• Record Type: Journal Article
• Authors: Rivas, Ana Belen; Lopez-Picado, Amanda; Calamia, Valentina; Carreño, Ester; Cocho, Lidia; Cordero-Coma, Miguel; Fonollosa, Alex; Francisco Hernandez, Felix M; Garcia-Aparicio, Angel; Garcia-Gonzalez, Javier; Mondejar, Jose Juan; Lojo-Oliveira, Leticia; Martínez-Costa, Llucí; Munoz, Santiago; Peiteado, Diana; Pinto, Jose Antonio; Rodriguez-Lozano, Beatriz; Pato, Esperanza; Diaz-Valle, David; Molina, Elena; Tebar, Luis Alberto; Rodriguez-Rodriguez, Luis
• Other Names: author non-byline.; Fort Mara Albert author non-byline.; Gutierrez Mayte Ariño author non-byline.; Villalobos Pedro Arriola author non-byline.; Beobide Joseba Artaraz author non-byline.; Sandoval Antonio Atanes author non-byline.; Sanchez Jose Manuel author non-byline.; Blázquez Francisco author non-byline.; Deniz Pablo Borges author non-byline.; Sanz Lara Borrego author non-byline.; Sanchez-Arnedo Gabriela Bustamante author non-byline.; Silva Bruno Casco author non-byline.; Sardiña Ricardo Cuiña author non-byline.; Cabrera Almudena De Pablo author non-byline.; Ortega Maria Del Mar Esteban author non-byline.; Puente Patricia Fernandez author non-byline.; Nuñez Dalifer Dayanira author non-byline.; Bella Javier Garcia author non-byline.; Carazo Sara Garcia author non-byline.; Onrubia Luis Garcia author non-byline.; Morales Jose Maria author non-byline.; Fernandez Jose Antonio author non-byline.; Hernandez Vanesa Hernandez author non-byline.; Rodriguez Inés Hernanz author non-byline.; Cantalapiedra Jose Maria author non-byline.; Barrero Ventura Hidalgo author non-byline.; Casano Maria De Jovani author non-byline.; Rodriguez Maria Isabel author non-byline.; Sierra Sara López author non-byline.; Lopez Virginia Lozano author non-byline.; Garcia Alfredo Madrid author non-byline.; Fernandez Rosalia Mendez author non-byline.; Aranda Pilar Nozal author non-byline.; Blazquez Eugenio Perez author non-byline.; Rodriguez Chamaida Plasencia author non-byline.; Diaz Sheila Recuero author non-byline.; Barrena Ignacio Robles author non-byline.; Almaraz Esther Rodriguez author non-byline.; Gonzalez Fayna Maria author non-byline.; Martinez Guadalupe Rodriguez author non-byline.; Bueno Fredeswinda Isabel author non-byline.; Arruza Ioana Ruiz author non-byline.; Marugan Beatriz Sanchez author non-byline.; Pernaute Olga Sanchez author non-byline.; Giraud Armelle Schlinker author non-byline.; Lopez Alvaro Seijas author non-byline.; Alonso Patricia Simon author non-byline.; Santana Marta Tejera author non-byline.; Pascual Elia Valls author non-byline.;
• Is Part Of: BMJ open. Volume 12:Issue 3(2022)
• Publication Date: 2022-03-22
• Subjects: clinical trials -- ophthalmology -- rheumatology; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-051378
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Non-infectious uveitis include a heterogeneous group of sight-threatening and incapacitating conditions. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), prescribed in monotherapy or in combination. Several observational studies showed 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, multicentre, prospective, randomised, 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, adalimumab or their combination in non-infectious non-anterior uveitis. We aim to recruit 192 subjects. The duration of the treatment and follow-up will last up to 52 weeks, plus 70 days follow-up with no treatment. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secondary measurements of efficacy (quality of life, visual acuity and 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. Ethics and dissemination: The protocol, annexes and informed consent forms were approved by the Reference Clinical Research Ethic Committee at the Hospital Clínico San Carlos (Madrid, Spain) and the Spanish Agency for Medicines and Health Products. We will elaborate a dissemination plan including production of materials adapted to several formats to communicate the clinical trial progress and findings to a broad group of stakeholders. The promoter will be the only access to the participant-level data, although it can be shared within the legal situation. Trial registration number: 2020-000130-18; NCT04798755 .