TerminatedPhase 4

Rituximab for the Otolaryngologic Manifestations of Granulomatosis With Polyangiitis

Stopped: Slow recruitment

United States3 participantsStarted 2015-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must have met at least 2 of the 5 modified ACR classification criteria for GPA. These do not need to be present at the time of study entry. The modified ACR criteria are:
✓. Active GPA in the ENT domain within 1 month prior to screening, where the active disease is defined as a score of ≥2 on a GPA ENT disease activity score (7 items scored as 1= present 0= absent) performed by direct endoscopic visualization of the upper airway and audiometric evaluation by a single expert otolaryngologist. Items included in the GPA ENT disease activity score are:
✓. Age 18 and older
✓. Willing and able to comply with treatment and follow-up procedures
✓. Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for twelve months after completion of treatment.
✓. Willing and able to provide written informed consent

Exclusion criteria

✕. Creatinine \>4.0mg/dl
✕. Respiratory failure requiring mechanical ventilatory support
✕. Previous treatment with rituximab (Rituxan® ) within 6 months of screening
✕. History of severe allergic or anaphylactic reaction or serious infusion reaction while receiving rituximab
✕. Failure to respond to previous course of rituximab (Rituxan®) administered for treatment of GPA, as determined by the discretion of the PI

What they're measuring

Proportion of patients in ENT remission without relapse at week 52 in each treatment group.

Timeframe: Assessed at week 52

Trial details

NCT IDNCT02626845

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07

View on ClinicalTrials.gov More Granulomatosis With Polyangiitis (Wegener's Granulomatosis) trials