Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Conditions

• Granulomatosis With Polyangiitis (Wegener's Granulomatosis)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  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.
• Placebo — OTHER
  Will be given at two time-points (week 16 and week 32) to subjects in the Placebo Arm.

Study Details

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.

Key Dates

Start date

Dec 31, 2015

Status verified

Mar 2018

Primary completion

Jul 31, 2017

Completion

Jul 31, 2017

Study Design

Enrollment

3 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Rituximab Arm
  All subjects in this arm will receive standard of care induction therapy, and then will receive two additional rituximab infusions at week 16 and week 32.
• Placebo Comparator: Placebo Arm
  All subjects in this arm will receive standard of care induction therapy, and then will receive two additional placebo infusions at week 16 and week 32.

Primary Outcome Measure

Proportion of patients in ENT remission without relapse at week 52 in each treatment group. [ Time Frame: Assessed at week 52 ]

Locations (1)

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