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Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

NCT02626845 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-03-22

No results posted yet for this study

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.

Conditions

  • Granulomatosis With Polyangiitis (Wegener's Granulomatosis)

Interventions

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.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Robert F Spiera, MD · Hospital for Special Surgery, New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02626845 on ClinicalTrials.gov