1. 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
- Author
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José Antonio Pinto, Alex Fonollosa, Ester Carreño, Maria Isabel Rodriguez, David Diaz-Valle, Diana Peiteado, Luis Rodriguez-Rodriguez, Miguel Cordero-Coma, Marta Tejera Santana, Lidia Cocho, Ana Belen Rivas, Amanda Lopez-Picado, Valentina Calamia, Felix M Francisco Hernandez, Angel Garcia-Aparicio, Javier Garcia-Gonzalez, Jose Juan Mondejar, Leticia Lojo-Oliveira, Llucí Martínez-Costa, Santiago Munoz, Beatriz Rodriguez-Lozano, Esperanza Pato, Elena Molina, Luis Alberto Tebar, Mara Albert Fort, Mayte Ariño Gutierrez, Pedro Arriola Villalobos, Joseba Artaraz Beobide, Antonio Atanes Sandoval, Jose Manuel Sanchez, Francisco Blázquez, Pablo Borges Deniz, Lara Borrego Sanz, Gabriela Bustamante Sanchez-Arnedo, Bruno Casco Silva, Ricardo Cuiña Sardiña, Almudena De Pablo Cabrera, Maria Del Mar Esteban Ortega, Patricia Fernandez Puente, Dalifer Dayanira Nuñez, Javier Garcia Bella, Sara Garcia Carazo, Luis Garcia Onrubia, Jose Maria Morales, Jose Antonio Fernandez, Vanesa Hernandez Hernandez, Inés Hernanz Rodriguez, Jose Maria Cantalapiedra, Ventura Hidalgo Barrero, Maria De Jovani Casano, Sara López Sierra, Virginia Lozano Lopez, Alfredo Madrid Garcia, Rosalia Mendez Fernandez, Pilar Nozal Aranda, Eugenio Perez Blazquez, Chamaida Plasencia Rodriguez, Sheila Recuero Diaz, Ignacio Robles Barrena, Esther Rodriguez Almaraz, Fayna Maria Gonzalez, Guadalupe Rodriguez Martinez, Fredeswinda Isabel Bueno, Ioana Ruiz Arruza, Beatriz Sanchez Marugan, Olga Sanchez Pernaute, Armelle Schlinker Giraud, Alvaro Seijas Lopez, Patricia Simon Alonso, and Elia Valls Pascual
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Medicine - 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.
- Published
- 2022
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