Rituximab and Belimumab Combination Therapy in PR3 COMBIVAS

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Brief Title

Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

Official Title

A Randomised, Double Blind, Controlled Mechanistic Study of Rituximab and Belimumab Combination Therapy in PR3 ANCA-associated Vasculitis

Brief 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Time to PR3 ANCA negativity

Secondary Outcome

 Proportion of participants with PR3 ANCA negativity

Condition

ANCA Associated Vasculitis

Intervention

Belimumab

Study Arms / Comparison Groups

 Belimumab
Description:  Weekly 200mg SC injections of belimumab for 12 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

February 1, 2019

Completion Date

February 2023

Primary Completion Date

February 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03967925

Organization ID

206852


Responsible Party

Sponsor-Investigator

Study Sponsor

Rachel Jones

Collaborators

 GlaxoSmithKline

Study Sponsor

, , 


Verification Date

July 2020