Rituximab and Belimumab Combination Therapy in PR3 Vasculitis

Sponsor
Rachel Jones
Study ID
NCT03967925
Phase
PHASE2
Status
Unknown

Conditions

  • ANCA Associated Vasculitis
  • Granulomatosis With Polyangiitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belimumab — DRUG
    Sub-cutaneous injection
  • Rituximab — DRUG
    IV infusion 1g x 2
  • Prednisolone — DRUG
    20mg prednisolone tapering dose

Study Details

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.

Key Dates

Start date
Feb 1, 2019
Status verified
Feb 2022
Primary completion
Apr 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Belimumab
    Weekly 200mg SC injections of belimumab for 12 months
  • Placebo Comparator: Belimumab placebo
    Weekly SC injections of belimumab placebo for 12 months

Primary Outcome Measure

Time to PR3 ANCA negativity [ Time Frame: Analysed at 24 months ]

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