Granulomatosis With Polyangiitis (Wegener's Granulomatosis) Clinical Trial
Official title:
Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis
This is a phase IV, single-center, randomized, placebo-controlled pilot study that will evaluate the efficacy of rituximab at inducing otolaryngologic remission in GPA patients with active otolaryngologic disease.
Patients with GPA and active ENT disease in at least two ENT domains, as defined after
endoscopic visualization of the upper airway and audiometric evaluation by a single
otolaryngologist using a validated GPA ENT disease activity score, will be eligible for
inclusion. ENT disease may be new, grumbling or relapsing.
All patients entering the trial will receive standard induction therapy with rituximab
(375mg/m2 per week x 4). At week 16, patients will be randomized to receive maintenance
rituximab (1000mg) every 4 months or placebo infusions. The primary outcome will be assessed
at week 52. Patients will be treated with a standardized prednisone taper according to
whether they had severe or limited disease at study entry, prednisone taper will be completed
at week 16.
The investigators plan to enroll 28 patients who will be randomized in a 1:1 fashion to
rituximab or placebo. The investigators estimate accrual of these subjects will take 18
months from study initiation. Once enrolled, subjects are followed for 52 weeks until the
primary endpoint is assessed.
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