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The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Learoyd, Annastazia E  ORCID logo  https://orcid.org/0000-0001-6964-9041
Arnold, Lauren 
Reid, Fiona 
Beckley-Hoelscher, Nicholas 
Casian, Alina 

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 1:1 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.

Description

Keywords

AAV, ANCA, Auto-immune conditions, Hydroxychloroquine, Prednisolone, Vasculitis, Humans, COVID-19, SARS-CoV-2, Hydroxychloroquine, Antibodies, Antineutrophil Cytoplasmic, Quality of Life, Double-Blind Method, Prednisolone, Immunosuppressive Agents, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Treatment Outcome, Randomized Controlled Trials as Topic, Multicenter Studies as Topic

Journal Title

Trials

Conference Name

Journal ISSN

1745-6215
1745-6215

Volume Title

24

Publisher

Springer Science and Business Media LLC
Sponsorship
Medical Research Council (MR/R006253/1)