The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.
Trials
; 24(1): 261, 2023 Apr 06.
Artículo
en Inglés
| MEDLINE | ID: covidwho-2298532
ABSTRACT
BACKGROUND:
Patients with non-severe ANCA-associated vasculitis (AAV) are often prescribed immunosuppressive medications that are associated with severe side effects and a reduced quality of life. There is an unmet need for safer effective treatments for these patients. Hydroxychloroquine is being explored due to its effect in similar autoimmune conditions such as systemic lupus erythematosus.METHODS:
Double-blind, placebo-controlled multicentre trial recruiting 76 patients across 20 sites. Participants will be randomised 11 to hydroxychloroquine or placebo in addition to standard of care immunosuppressive therapies over the course of 52 weeks. A phase II selection design will be used to determine hdroxychloroquine's efficacy, using prednisolone dosage and Birmingham Vasculitis Activity Score as a measure of disease activity. Secondary outcomes will explore other elements of AAV progression, including disease flares and time to remission.DISCUSSION:
This trial aims to explore Hydroxychloroquine as a treatment for patients with AAV. If effective, the need for immunosuppressive treatments such as prednisolone could be reduced. Hydroxychloroquine is safer, cheaper and has fewer adverse effects than conventional immunosuppressive treatments. This could improve patient outcomes while saving money for the NHS. TRIAL REGISTRATION ISRCTN ISRCTN79334891. Registered 07 June 2021. EudraCT 2018-001268-40. Registered 13 September 2019. CLINICALTRIALS gov NCT04316494. Registered 20 March 2020.Palabras clave
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Vasculitis Asociada a Anticuerpos Citoplasmáticos Antineutrófilos
/
COVID-19
Tipo de estudio:
Estudios diagnósticos
/
Estudio experimental
/
Estudio pronóstico
/
Ensayo controlado aleatorizado
Límite:
Humanos
Idioma:
Inglés
Revista:
Trials
Asunto de la revista:
Medicina
/
Terapeutica
Año:
2023
Tipo del documento:
Artículo
País de afiliación:
S13063-023-07108-3
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