Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis

Sponsor
Cambridge University Hospitals NHS Foundation Trust
Study ID
NCT05168475
Phase
PHASE2
Status
Terminated

Conditions

  • Cogan Syndrome
  • Cryoglobulinemic Vasculitis
  • Cutaneous Polyarteritis Nodosa
  • Giant Cell Arteritis
  • IgA Vasculitis
  • Polyarteritis Nodosa
  • Primary Angiitis of Central Nervous System
  • Relapsing Polychondritis
  • Takayasu Arteritis

Eligibility Criteria

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

Interventions

  • Rituximab — BIOLOGICAL
    Hospital stock of rituximab used as intervention; biosimilars are allowed
  • Infliximab — BIOLOGICAL
    Hospital stock of infliximab is used in the trial; biosimilars are allowed
  • Tocilizumab — BIOLOGICAL
    Hospital-supplied stock.

Study Details

Vasculitis occur when the body's immune system, rather than protecting the body, attacks blood vessels, causing injury to the vessel and the part of the body it supplies with blood. Vasculitis is rare, and there are a number of different types, which can affect both adults and children. We treat vasculitis with steroids and drugs aiming to damp down the activity of the immune system, but they often cause side effects. Some patients do not improve with this treatment, or cannot tolerate it and their vasculitis worsens; this is known as refractory vasculitis. Patients with refractory vasculitis are at high risk of health complications from the disease and its therapy and are in need of newer more effective treatments with fewer side effects. Biologics are drugs which are designed to precisely target parts of the immune system and may have fewer side effects. Biologics have been used for several years to treat vasculitis, particularly anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis or AAV. However, for many of the rarer types of vasculitis, and especially those vasculitis disease types that are not ANCA-associated, there is little information to support use of biologic therapies as effective treatments. The purpose of this trial is to find out whether biologics are effective and represent value for money for participants with refractory vasculitis. The trial will include patients with Non-ANCA-associated vasculitis (NAAV)

Key Dates

Start date
Jul 14, 2021
Status verified
May 2025
Primary completion
Nov 29, 2023
Completion
Nov 29, 2023

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab
    Rituximab 1g IV on Days 1, 15 (+/-3d), 180 (+/-14d), 360 (+/-14d) and 540 (+/-14d). (Children, 750mg/m2/dose, maximum 1 g per dose).
  • Active Comparator: Infliximab
    Infliximab 5mg/kg IV on days 1, 15(+/- 3d), 43 (+/-3d), 70 (+/-3d) then every 56 days (+/-14d) thereafter.
  • Active Comparator: Tocilizumab
    Tocilizumab 8mg/kg IV (maximum 800mg) every 30 days (+/- 7d); 10 mg/kg (maximum 800 mg) for children \< 30 kg.
  • Placebo Comparator: Placebo
    Placebo may be to one of the active biologics (ie placebo to Rituximab, Placebo to Infliximab, placebo to Tocilizumab). Only 1 placebo is in a randomised sequence of interventions.

Primary Outcome Measure

Treatment Failure [ Time Frame: up to 720 days ]

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