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Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

NCT03967925 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-03-08

No results posted yet for this study

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.

Conditions

  • ANCA Associated Vasculitis
  • Granulomatosis With Polyangiitis

Interventions

DRUG

Belimumab

Sub-cutaneous injection

DRUG

Rituximab

IV infusion 1g x 2

DRUG

Prednisolone

20mg prednisolone tapering dose

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Medical Research Council

    collaborator OTHER_GOV

  • Imperial College London

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • University of Glasgow

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Rachel Jones

    lead OTHER

Principal Investigators

  • Rachel B Jones · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2023-04-30
Completion
2023-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03967925 on ClinicalTrials.gov