Rituximab and Belimumab Combination Therapy in PR3 Vasculitis (COMBIVAS)

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    30
  • sponsor
    Rachel Jones
Updated on 9 February 2022
rituximab
prednisolone
vasculitis
belimumab
microscopic polyangiitis
anca
anti-neutrophil cytoplasmic antibody

Summary

Mechanistic study to assess whether dual B-cell immunotherapy by co-administration of rituximab and belimumab will result in improvements in biological endpoints, functional outcomes and clinical status compared to rituximab with placebo.

Details
Condition ANCA Associated Vasculitis, Granulomatosis With Polyangiitis
Treatment Rituximab, Prednisolone, belimumab
Clinical Study IdentifierNCT03967925
SponsorRachel Jones
Last Modified on9 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must be 18 of age
Have a diagnosis of AAV (granulomatosis with polyangiitis or microscopic polyangiitis)
Have PR3 ANCA positivity by ELISA at screening
Have active disease defined by one major or three minor disease activity items on BVAS/WG
Be capable of giving signed informed consent

Exclusion Criteria

MPO ANCA or anti-GBM antibody positivity by ELISA at screening
Presence of pulmonary haemorrhage with hypoxia at screening
Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 at screening
Have an acute serious or chronic infection at screening
Have received any B cell targeted therapy within 364 days of Day 1
Have received any steroid injection (e.g., intramuscular [IM], intraarticular, or IV) within 60 days of Day 1 (unless given during or 14 days before screening period)
Have received >1.5mg methylprednisolone (IV) between 14 days prior to screening and Day 1 (including Day 1)
Have received oral prednisolone >10mg/day (or equivalent) on average over the 30 days prior to screening
Have undetectable peripheral blood B cells at screening
Have IgG <400mg/dl at screening
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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