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Hydroxychloroquine in ANCA Vasculitis Evaluation
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Summary
The purpose of this study is to find out whether hydroxychloroquine, in addition to background treatments, reduces disease activity in patients with Anti-Neutrophilic Cytoplasmic Autoantibodies (ANCA) Vasculitis, a group of autoimmune diseases. Hydroxychloroquine and is an established, effective, safe and inexpensive therapy, widely used in other autoimmune diseases such as lupus and rheumatoid arthritis. The study is open to adults diagnosed with certain types of vasculitis, called Granulomatosis Polyangiitis (GPA), Microscopic Polyangiitis (MPA) or Eosinophilic Granulomatosis with Polyangiitis (EGPA). Participants will be eligible if they are treated with background medication to control their vasculitis disease and have a low level of disease activity as defined by a Birmingham Vasculitis Activity Score (BVAS) of greater than 3. Participants will be randomly placed in 1 of 2 groups. Both groups will be given background medication. One group will receive hydroxychloroquine and the other will receive placebo. Participants will be on treatment for 1 year. 76 ANCA Vasculitis participants will be recruited (38 in each treatment arm) from UK vasculitis specialist centres.
Official title: Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2020-12-17
Completion Date
2025-05-15
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
Hydroxychloroquine
White, round, film-coated tablets marked 'HCQ' on one side and 200' on the other side. Excipients: Lactose monohydrate Maize Starch Magnesium Stearate Polyvidone Opadry OY-L-28900
Placebo
Placebo to match Hydroxychloroquine. Excipients: Microcrystalline cellulose Lactose Magnesium Stearate
Locations (18)
Royal Berkshire NHS Foundation Trust
Reading, Berkshire, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, United Kingdom
NHS Highland
Inverness, Inverness-shire, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Royal United Hospitals Bath NHS Foundation Trust
Bath, Somerset, United Kingdom
Surrey and Sussex Healthcare NHS Trust
Redhill, Surrey, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Brighton, Sussex, United Kingdom
Cardiff & Vale University Health Board
Cardiff, United Kingdom
Epsom and St Helier University Hospitals NHS Trust
Epsom, United Kingdom
Cwm Taf Morgannwg University Health Board
Llantrisant, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Sunderland, United Kingdom
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom