Research

Prospective, Observational Safety Study Of Patients With Granulomatosis With Polyangiitis (Wegener’s) Or Microscopic Polyangiitis Treated With Rituximab

IRB Number: 13044
(trial not enrolling new patients)

Institutional Review Board, Hospital for Special Surgery

March 28, 2014

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

  Robert F. Spiera, MD

Co-Investigators

Jessica K. Gordon, MD
Lindsay Lally, MD
Uzunma Udeh
Nina Paddu
Daniele Lerner

Summary

This prospective observational study will evaluate the long-term safety of MabThera/Rituxan (rituximab) in patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis. Data will be collected for a maximum of 4 years from patients initiated on MabThera/Rituxan therapy by their physician according to prescribing information. Recruitment is closed.

Inclusion/Exclusion Criteria

Inclusion Criteria:
• Adult patients, >/= 18 years of age
• Granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), according to Chapel Hill Consensus Conference Definitions for MPA and ACR Criteria for the Classification of GPA
• Disease severity requiring rituximab treatment per the investigator's assessment
Exclusion Criteria:
• Prior use of rituximab (except if received within 4 weeks of screening)
• Known hypersensitivity to rituximab, to any component of the product, or to murine proteins
• Pregnant or breastfeeding women
• Diagnosis of Churg-Strauss syndrome

 

Contact Information

Uzunma Udeh
udehu@hss.edu
 212.774.2123



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