Details

Autor(en) / Beteiligte

• 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
• Fort, Mara Albert
• Gutierrez, Mayte Ariño
• Villalobos, Pedro Arriola
• Beobide, Joseba Artaraz
• Sandoval, Antonio Atanes
• Sanchez, Jose Manuel
• Blázquez, Francisco
• Deniz, Pablo Borges
• Sanz, Lara Borrego
• Sanchez-Arnedo, Gabriela Bustamante
• Silva, Bruno Casco
• Sardiña, Ricardo Cuiña
• Cabrera, Almudena De Pablo
• Ortega, Maria Del Mar Esteban
• Puente, Patricia Fernandez
• Nuñez, Dalifer Dayanira
• Bella, Javier Garcia
• Carazo, Sara Garcia
• Onrubia, Luis Garcia
• Morales, Jose Maria
• Fernandez, Jose Antonio
• Hernandez, Vanesa Hernandez
• Rodriguez, Inés Hernanz
• Cantalapiedra, Jose Maria
• Barrero, Ventura Hidalgo
• Casano, Maria De Jovani
• Rodriguez, Maria Isabel
• Sierra, Sara López
• Lopez, Virginia Lozano
• Garcia, Alfredo Madrid
• Fernandez, Rosalia Mendez
• Aranda, Pilar Nozal
• Blazquez, Eugenio Perez
• Rodriguez, Chamaida Plasencia
• Diaz, Sheila Recuero
• Barrena, Ignacio Robles
• Almaraz, Esther Rodriguez
• Gonzalez, Fayna Maria
• Martinez, Guadalupe Rodriguez
• Bueno, Fredeswinda Isabel
• Arruza, Ioana Ruiz
• Marugan, Beatriz Sanchez
• Pernaute, Olga Sanchez
• Giraud, Armelle Schlinker
• Lopez, Alvaro Seijas
• Alonso, Patricia Simon
• Santana, Marta Tejera
• Pascual, Elia Valls

Titel

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

Ist Teil von

• BMJ open, 2022-03, Vol.12 (3), p.e051378-e051378

Ort / Verlag

England: British Medical Journal Publishing Group

Erscheinungsjahr

2022

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• IntroductionNon-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 analysisThe 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 disseminationThe 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 number2020-000130-18; NCT04798755.