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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Kim Mynard
+44 (0)1223 768317
kim.mynard@nhs.net


Dr Rachel Jones
+44 (0)1223 254637
rachel.jones154@nhs.net


Dr Yangfan Gao
+44 (0)1223 761886
yangfan.gao@nhs.net


Study Location:

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Be Part of Research - Trial Details - Obinutuzumab compared with rituximab for treating ANCA-associated vasculitis
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Obinutuzumab compared with rituximab for treating ANCA-associated vasculitis

Recruiting

Open to: All Genders

Age: Adult

Cambridge

Medical Conditions

ANCA-associated vasculitis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 a treatment for certain types of blood cancer) is better than rituximab at removing B cells.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

09 Jan 2023 14 Jun 2026

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39019638/ (added 19/07/2024)

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 nor 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.


Adults with ANCA-associated vasculitis

You can take part if:



You may not be able to take part if:


1. Women who are pregnant, plan to become pregnant or breast feed during the trial.2. Current participation in any other interventional treatment trials.3. Compliance: is unlikely to comply with trial visits based on investigator judgment. 4. MPO ANCA or anti–GBM antibody positivity by ELISA during screening. 5. Presence of pulmonary haemorrhage with hypoxia.6. Estimated glomerular filtration rate (eGFR) <15 ml/min/1.73m2.7. Symptomatic herpes zoster within 3 months of screening.8. Evidence of active or latent tuberculosis (TB) determined by a positive (not indeterminate) QuantiFERON®-TB Gold test (or equivalent).9. Known hypersensitivity or significant allergies to monoclonal antibodies.10. Malignant neoplasm within 5 years (from screening) excluding basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and without metastatic disease for 3 years. 11. A history of a primary immunodeficiency.12. IgA deficiency (IgA < 10 mg/dL).13. IgG deficiency (IgG < 400 mg/dL).14. Neutrophils < 1.5 x 109 cells/L.15. B cell lymphopenia at screening (total CD19+ count <0.1x109/L).16. Alanine transferase (ALT) >2.5x upper limit of normal (ULN). 17. Active bleeding disorders, and/or inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.18. Severe nasal deformity precluding endoscopic assessment/biopsy of postnasal space 19. Severe heart failure (New York Heart Association Class IV) or other severe, uncontrolled cardiac disease.20. Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.21. Have an acute or chronic infection requiring management as follows: 21.1. Currently on any treatment for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria21.2. Hospitalisation solely for treatment of proven infection requiring parenteral (IV or IM) antibiotics (antibacterials, antivirals, antifungals, or anti-parasitic agents) within 60 days of Day 1. NB Hospitalisation for a participant with active vasculitis with co-existent infection requiring IV or IM antibiotics is permitted. 21.3. Proven severe infection requiring outpatient treatment with parenteral (IV or IM) antibiotics (antibacterials, antivirals, antifungals, or anti-parasitic agents) within 60 days of Day 1. Prophylactic anti-infective treatment is allowed. Precautionary PO/IV antibiotics in a participant with active vasculitis is permitted. 22. Positive human immunodeficiency virus (HIV) antibody test.23. Positive serology for Hepatitis B (HB), defined as: (i) HB surface antigen positive (HBsAg+) OR (ii) HB core antibody positive (HBcAb+).24. Positive Hepatitis C (HCV) antibody test.25. Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to vasculitis which, in the opinion of the principal investigator, could confound the results of the trial or put the participant at undue risk.26. Have a planned surgical procedure, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the participant unsuitable for the trial.

Prior/Concomitant Therapy:27. Live vaccine(s) within 30 days prior to Day 1, or plans to receive live vaccines during the trial.28. Have received any anti-CD20 (or any other B cell depleting therapies including alemtuzumab) within 12 months of Day 1.29. Have received any of the following within 180 days of Day 1: 29.1. Cyclophosphamide29.2. Belimumab 30. Have received any of the following within 90 days of Day 1: 30.1. Anti-TNF or anti-IL-6 therapy (e.g., adalimumab, etanercept, infliximab, tocilizumab),30.2. Abatacept,30.3. Interleukin-1 receptor antagonist (e.g., anakinra), 30.4. Intravenous immunoglobulin (IVIG), 30.5. Plasmapheresis, leukapheresis. 31. Have received any investigational agent (that is not approved for use in the UK) within 60 days of Day 1. 32. Have received emergency IV steroid >3g methylprednisolone between 30 days prior to Screening Visit and up to Day 1 (including Day 1).


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Addenbrookes Hospital
    Hills Road
    Cambridge
    CB2 0QQ

The benefits of participating in the trial are that the new drug obinutuzumab might work better and prevent relapses more than rituximab which is currently given as the standard of care.
A full medical history will be taken to exclude participants who might be at additional risk. The stringent exclusion criteria will mitigate significant risk. There is the risk of a reaction to the test and control IMPs (obinutuzumab and rituximab) but pre-medication therapy (IV corticosteroids, paracetamol, antihistamine) is given to prevent this. The most common side-effects of both IMPs are bacterial or viral infections; lower white blood cells; lower immunity during the infusions; nausea; chills; and headache. Very rarely, potentially fatal side effects such as reactivation of viruses including hepatitis B causing liver failure and reactivation of JC virus causing progressive multifocal leucoencephalopathy can occur. All the common and important side effects will be clearly described in the Patient Information Sheet and discussed with the potential participant prior to signature. Patients will be excluded based on significant infection history, HBV or Hepatitis C virus (HCV) infection and immunoglobulin deficiency. There are small risks with taking blood such as possible fainting, bruising/bleeding, mild pain or irritation and rarely infection. Participants will be closely monitored for signs of infection. In addition to routine clinical tests, participants will have two nasal biopsies and give blood a little more often than if they were not in a trial. There are small risks associated with having a local anaesthetic nasal biopsy such as minor bleeding or infection. Any bleeding is easily stopped using packing gauze. Infection risks are minimised by using sterile equipment. The most common risk of local anaesthetic is minor discomfort when injecting the inside of the nose. There is a small risk of an allergic response to the local anaesthetic. Other possible side effects include dizziness, nausea, vomiting, accelerated heart rate, slow heart rate and prolonged numbness.
Participants should also consider the burden of having to attend hospital visits more regularly than if they were not taking part in a trial. Wherever possible, we will try to arrange study visits to coincide with routine standard-of-care appointments. Some appointments will be quite lengthy, especially on the days of the two infusions and two biopsies. If the patient works full-time, some time off will be required. Reasonable travel costs will be offered for additional trial appointments. There is a risk associated with the participant completing the prednisolone taper schedule daily at home, i.e. a small risk of the participant taking too much or too little of their scheduled dose. To mitigate this a taper schedule is provided to the participant with clear instructions on how much to take each day (with dates added). The trial nurse will spend time with each participant explaining how to complete this schedule and will be encouraged to contact the trial team with any queries.

Dr Yangfan Gao
+44 (0)1223 761886
yangfan.gao@nhs.net


Dr Rachel Jones
+44 (0)1223 254637
rachel.jones154@nhs.net


Ms Kim Mynard
+44 (0)1223 768317
kim.mynard@nhs.net



The study is sponsored by Cambridge Clinical Trials Unit and funded by Medical Research Council.



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Read full details for Trial ID: ISRCTN13069630

Or CPMS 51946

Last updated 20 November 2024

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