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Clinical Trials/EUCTR2017-004645-24-GB
EUCTR2017-004645-24-GB
Active, not recruiting
Phase 1

A randomized, double blind, controlled mechanistic study of rituximab and belimumab combination therapy in PR3 ANCA-associated vasculitis - (COMBIVAS)

Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 sites30 target enrollmentJune 20, 2019
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ConditionsANCA-associated vasculitisMedDRA version: 20.1 Level: PT Classification code 10050894 Term: Anti-neutrophil cytoplasmic antibody positive vasculitis System Organ Class: 10021428 - Immune system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
ANCA-associated vasculitis
Sponsor
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Enrollment
30
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 20, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge

Eligibility Criteria

Inclusion Criteria

  • •Participants are eligible to be included in the study only if all of the following criteria apply:
  • •1\. Participant must be \=18 of age at the time of signing the informed consent form.
  • •Participants who have:
  • •2\. Have a diagnosis of AAV \[granulomatosis with polyangiitis or microscopic polyangiitis]
  • •3\. Have PR3 ANCA positivity by ELISA at screening
  • •4\. Have active disease defined by one major or three minor disease activity items on BVAS/WG
  • •5\. Be capable of giving signed informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\. MPO ANCA or anti–GBM antibody positivity by ELISA
  • •2\. Presence of pulmonary haemorrhage with hypoxia at screening
  • •3\. Estimated glomerular filtration rate (eGFR) \<30 ml/min/1\.73m2 at screening
  • •4\. Have an acute or chronic infection at screening
  • •5\. Have received any B cell targeted therapy within 364 days of Day 1
  • •6\. Have received cyclophosphamide within 180 days of Day 1
  • •7\. Have received any steroid injection between 60 days of Day 1 and 14 days of screening (e.g., intramuscular \[IM], intraarticular, or IV)
  • •8\. Have received oral prednisolone \>10mg/day (or equivalent) on average over the 30 days prior to screening

Outcomes

Primary Outcomes

Not specified

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