TerminatedPhase 4

Hydroxychloroquine in ANCA Vasculitis Evaluation

Stopped: Recruitment was terminated early by the funder due to study sites' inability to recruit sufficient number of participants.

United Kingdom43 participantsStarted 2020-12-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Are at least 18 years of age at screening.
✓. Have a clinical diagnosis of Granulomatosis Polyangiitis (GPA) or a diagnosis of Microscopic Polyangiitis (MPA) or a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) according to the Chapel Hill criteria.
✓. Have a Birmingham Vasculitis Activity Score \>3 BVAS v.3 (Appendix 2) with minor BVAS items only (no major BVAS items).BVAS should be \>3 at screening and at randomisation.
✓. Patients should be receiving maintenance therapy at a stable dose for 4 weeks prior to randomisation. Maintenance therapy is defined as prednisolone and/or azathioprine, methotrexate, mycophenolate, co-trimoxazole or maintenance rituximab therapy.
✓. Patients receiving corticosteroids for reasons other than vasculitis must be on a stable regimen for four weeks prior to randomisation.
✓. A female patient is eligible to enter the study if she is:
✓. No contraindications to hydroxychloroquine therapy.
✓. Willing and able to give written informed consent to participate in the trial.

Exclusion criteria

What they're measuring

The percentage of patients with • uncontrolled AAV disease activity OR • controlled AAV disease activity but prednisolone dose >7.5mg daily OR • controlled AAV disease activity but any corticosteroid use >7.5mg daily for any reason

Timeframe: BVAS will be assessed during the final 12 (±7 days) weeks that the patient is on the study drug in the trial.

Trial details

NCT IDNCT04316494

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-15

View on ClinicalTrials.gov More ANCA Associated Vasculitis trials