HAVEN

• Research type

  Research Study

• Full title

  HAVEN: Hydroxychloroquine in ANCA Vasculitis Evaluation- A Multicentre, Randomised, Double-blind, Placebo-controlled Trial

• IRAS ID

  251987

• Contact name

  David D'Cruz

• Contact email

  david.d'cruz@kcl.ac.uk

• Sponsor organisation

  Guy's and St. Thomas' NHS Foundation Trust

• Eudract number

  2018-001268-40

• Duration of Study in the UK

  3 years, 0 months, 31 days

• Research summary

  The purpose of this study is to find out whether hydroxychloroquine, in addition to background treatments, reduces disease activity in patients with anti-neutrophil cytoplasmic antibody (ANCA) Vasculitis, a group of autoimmune diseases.

  Hydroxychloroquine 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. 1 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 over 2 years.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  20/LO/0028

• Date of REC Opinion

  23 Jan 2020

• REC opinion

  Favourable Opinion