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TERMINATED
NCT04316494
PHASE4

Hydroxychloroquine in ANCA Vasculitis Evaluation

Sponsor: Guy's and St Thomas' NHS Foundation Trust

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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