ObiVas

• Research type

  Research Study

• Full title

  A randomised, phase II, double blind, controlled mechanistic study of obinutuzumab versus rituximab in ANCA-associated vasculitis (ObiVas)

• IRAS ID

  1004254

• Contact name

  Rachel Jones

• Contact email

  rachel.jones@addenbrookes.nhs.uk

• Sponsor organisation

  Cambridge Clinical Trials Unit

• Eudract number

  2021-005218-32

• ISRCTN Number

  ISRCTN13069630

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This trial will test if a drug called obinutuzumab works better than rituximab in treating ANCA (Anti-neutrophil cytoplasmic antibody) associated vasculitis, a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation of the blood vessels. The drugs being tested, remove a type of white blood cell called 'B cells' which make the antibodies that are associated with the disease being active. Only rituximab is currently approved to treat vasculitis patients but data suggests that obinutuzumab (approved as treatment for certain types blood cancer) is better than rituximab at removing B cells.
  Following consent, screening assessments will be performed such as taking blood, to check the participant is eligible for the trial. The trial will last for just over 18 months. Participants will receive 2 infusions of one of the medicines, 2 weeks apart at the very beginning of the trial. Which medicine a patient received will be determined randomly i.e. by chance using a computer and neither the participant or trial doctors will know which drug has been assigned. On Day 1 and then again after 12 weeks, a nasal biopsy will be performed. This involves taking some tissue from inside the nose using a local anaesthetic. These small samples from the lining of the nose will be used to assess how well B cells are removed from tissues by obinutuzumab compared to rituximab. There will be 11 visits in total to the hospital, plus four telephone visits, where assessments e.g. blood and urine tests will be performed. Tests on these samples will help to understand how well the two treatments are working.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  22/WM/0174

• Date of REC Opinion

  29 Sep 2022

• REC opinion

  Further Information Favourable Opinion