The HAVEN study-hydroxychloroquine in ANCA vasculitis evaluation-a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan.
Humans
COVID-19
SARS-CoV-2
Hydroxychloroquine
/ adverse effects
Antibodies, Antineutrophil Cytoplasmic
Quality of Life
Double-Blind Method
Prednisolone
Immunosuppressive Agents
/ adverse effects
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
/ diagnosis
Treatment Outcome
Randomized Controlled Trials as Topic
Multicenter Studies as Topic
AAV
ANCA
Auto-immune conditions
Hydroxychloroquine
Prednisolone
Vasculitis
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Apr 2023
06 Apr 2023
Historique:
received:
03
11
2022
accepted:
20
01
2023
medline:
10
4
2023
entrez:
6
4
2023
pubmed:
7
4
2023
Statut:
epublish
Résumé
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. 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. 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. ISRCTN: ISRCTN79334891. Registered 07 June 2021. EudraCT: 2018-001268-40. Registered 13 September 2019. gov: NCT04316494. Registered 20 March 2020.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
ISRCTN: ISRCTN79334891. Registered 07 June 2021. EudraCT: 2018-001268-40. Registered 13 September 2019.
CLINICALTRIALS
RESULTS
gov: NCT04316494. Registered 20 March 2020.
Identifiants
pubmed: 37024906
doi: 10.1186/s13063-023-07108-3
pii: 10.1186/s13063-023-07108-3
pmc: PMC10077754
doi:
Substances chimiques
Hydroxychloroquine
4QWG6N8QKH
Antibodies, Antineutrophil Cytoplasmic
0
Prednisolone
9PHQ9Y1OLM
Immunosuppressive Agents
0
Banques de données
ClinicalTrials.gov
['NCT04316494']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
261Subventions
Organisme : Medical Research Council
ID : MR/R006253/1
Pays : United Kingdom
Informations de copyright
© 2023. The Author(s).
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