An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis - Full Text View

Purpose

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.

Condition
Wegener's Granulomatosis, Microscopic Polyangiitis

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab

Resource links provided by NLM:

MedlinePlus related topics: Wegener's Granulomatosis

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Safety: Incidence of serious infections (infections that are serious adverse events [SAEs] or non-SAE infections treated with iv antimicrobials) [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: Incidence of serious adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of serious adverse events in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of serious infections in patients who receive retreatment with MabThera/Rituxan [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Proportion of patients experiencing serious infusion-related reactions [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Proportion of patients experiencing any serious adverse events during or within 24 hours after MabThera/Rituxan infusion [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of serious cardiac adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of serious vascular adverse events [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of malignancy, excluding non-melanoma skin cancer [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]
Safety: Incidence of fatal outcomes [ Time Frame: approximately 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2012
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	April 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts
Cohort

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with granulomatosis with polyangiitis or microscopic polyangiitis treated with MabThera/Rituxan

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613599

Contacts

Contact: Please reference Study ID Number: WA27893 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, Arizona
	Recruiting
Scottsdale, Arizona, United States, 85025
United States, California
	Recruiting
Los Angeles, California, United States, 90048
United States, Florida
	Recruiting
Jacksonville, Florida, United States, 32224
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
	Recruiting
Baltimore, Massachusetts, United States, 21224
	Recruiting
Boston, Massachusetts, United States, 02118-2393
	Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
	Recruiting
Rochester, Minnesota, United States, 55905
United States, New York
	Recruiting
New York, New York, United States, 10021
United States, North Carolina
	Recruiting
Chapel Hill, North Carolina, United States, 27516
	Recruiting
Durham, North Carolina, United States, 27710
United States, Ohio
	Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States, 19104
	Recruiting
Pittsburgh, Pennsylvania, United States, 15261
United States, Utah
	Recruiting
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01613599 History of Changes
Other Study ID Numbers:	WA27893
Study First Received:	June 4, 2012
Last Updated:	November 30, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Wegener Granulomatosis
Systemic Vasculitis
Microscopic Polyangiitis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases

Autoimmune Diseases
Immune System Diseases
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 23, 2013