NCT02626845

Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Granulomatosis With Polyangiitis (Wegener's Granulomatosis)

Interventions

Type	Name	Description
DRUG	Rituximab	Standard of care induction with Rituximab: 375mg/m2 weekly x 4 weeks. Once randomized, the rituximab dose will be 1000mg IV every 4 months x 2.
OTHER	Placebo	Will be given at two time-points (week 16 and week 32) to subjects in the Placebo Arm.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-12-10
• Last updated: 2018-03-22

Locations

1 site across 1 country: United States