Clinical trial NCT00443443: A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
Official title: A Long-Term Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rituximab
RA
Sunstone
anti-TNF
Rituxan
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2007-03-06
Enrollment: 1026
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RA who have had an inadequate response to one or more anti-TNF therapies

Brief summary: This is an observational study designed to follow patients with RA who have had an inadequate response to one or more anti-TNF therapies and who will receive Rituxan. Approximately 1000 patients in the United States with RA who have had an inadequate response to anti-TNF therapies and who will receive Rituxan therapy will be recruited. There is no protocol mandated treatment assignment in this study. Patients will be evaluated and treated according to their physician's standard practice and discretion.


Eligibility criteria: Inclusion Criteria:

* No prior use of Rituxan (except if received within 8 weeks of screening)
* Signed Informed Consent Form
* Age ≥ 18 years
* Diagnosis of RA
* Inadequate response to one or more anti-TNF therapies

Exclusion Criteria:

* Have known hypersensitivity to any component of a humanized or murine monoclonal antibody

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates, PC
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of N. AL, P.C.
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinic for Rheumatic Diseases - Research Department
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis and Rheumatology Research, PLLC
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Rheumatology Specialists, Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Advanced Arthritis Care & Research
state: Arizona
city: Fayetteville
country: United States
facility: The Arthritis Center of the Ozarks
state: Arkansas
city: Covina
country: United States
facility: Investigational Site
state: California
city: Escondido
country: United States
facility: Arthritis Medical Clinic of North County, Inc.
state: California
city: Fairfield
country: United States
facility: Solano Regional Medical Group
state: California
city: Fullerton
country: United States
facility: Clinical Trials of St. Jude Heritage Medical Group
state: California
city: Hemet
country: United States
facility: Investigational Site
state: California
city: La Jolla
country: United States
facility: Allergy and Rheumatology Medical Clinic, Inc
state: California
city: La Mesa
country: United States
facility: Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Arthritis Center of Southern Orange County
state: California
city: Loma Linda
country: United States
facility: VA Loma Linda Healthcare System
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group and Research Center of Greater Long Beach, Inc.
state: California
city: Los Angeles
country: United States
facility: Beverly Medical Associates
state: California
city: Los Angeles
country: United States
facility: Investigational Site
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research, Medical Group
state: California
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group- Rheumatology Division
state: California
city: Newport Beach
country: United States
facility: Investigational Site
state: California
city: North Hollywood
country: United States
facility: Rheumatology Associates
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Riverside
country: United States
facility: Arthritis Medical Clinic
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Torrance
country: United States
facility: Healthcare Partners Medical Group
state: California
city: Torrance
country: United States
facility: Investigational Site
state: California
city: Victorville
country: United States
facility: Desert Valley Medical Group
state: California
city: Visalia
country: United States
facility: Investigational Site
state: California
city: Whittier
country: United States
facility: Agilence Arthritis & Osteoporosis Medical Center, Inc.
state: California
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Fort Collins
country: United States
facility: Arthritis and Rheumatology Clinic of Northern Colorado, LLC
state: Colorado
city: Greeley
country: United States
facility: Greeley Medical Clinic
state: Colorado
city: Longmont
country: United States
facility: Colorado Center for Arthritis and Osteoporosis
state: Colorado
city: Bridgeport
country: United States
facility: Investigational Site
state: Connecticut
city: Danbury
country: United States
facility: Clinical Research Center of CT/NY
state: Connecticut
city: Farmington
country: United States
facility: University of CT Health Center
state: Connecticut
city: Norwich
country: United States
facility: The William W. Backus Hospital
state: Connecticut
city: Newark
country: United States
facility: Delaware Arthritis & Osteoporosis Center
state: Delaware
city: Washington
country: United States
facility: VAMC
state: District of Columbia
city: Boca Raton
country: United States
facility: RASF- Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Countryside Arthritis Center
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Naples
country: United States
facility: Investigational Site
state: Florida
city: Naples
country: United States
facility: Naples Medical Center
state: Florida
city: North Miami Beach
country: United States
facility: Arthritis & Osteoporosis Treatment Research Center, Inc.
state: Florida
city: Orange Park
country: United States
facility: Arthritis & Osteoporosis Treatment Center, P.A.
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Medical Clinic, LLC
state: Florida
city: Tampa
country: United States
facility: Brookshire Rheumatology & Wellness Center
state: Florida
city: Tavares
country: United States
facility: Lake Rheumatology
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Austell
country: United States
facility: Georgia Internal Medicine Associates, PA
state: Georgia
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology Group, PC
state: Georgia
city: Macon
country: United States
facility: Middle Georgia Arthritis Center
state: Georgia
city: Tifton
country: United States
facility: Arthritis and Osteoporosis Center of South Georgia
state: Georgia
city: Valdosta
country: United States
facility: Valdosta Specialty Clinic
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: DeKalb
country: United States
facility: Northern Illinois Research Associates
state: Illinois
city: Joliet
country: United States
facility: Prairie Rheumatology Associates, S.C.
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Moline
country: United States
facility: Arthritis Care Center, PC
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates
state: Illinois
city: Schaumburg
country: United States
facility: Integrative Pain Medicine
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians Clinic Of Iowa
state: Iowa
city: Des Moines
country: United States
facility: Mercy Arthritis and Osteoporosis Center
state: Iowa
city: Dubuque
country: United States
facility: Medical Associates Clinic PC
state: Iowa
city: Wichita
country: United States
facility: Arthritis and Rheumatology Clinics of Kansas
state: Kansas
city: Ashland
country: United States
facility: Ashland Arthritis Center
state: Kentucky
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Louisville
country: United States
facility: Rheumatology Associates
state: Kentucky
city: Lafayette
country: United States
facility: Lafayette Arthritis & Endocrine Clinic
state: Louisiana
city: Lewiston
country: United States
facility: Investigational Site
state: Maine
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Rheumatology Associates of Baltimore
state: Maryland
city: Ellicott City
country: United States
facility: Maryland Arthritis Care Specialists
state: Maryland
city: Florence
country: United States
facility: Northampton Internal Medicine Associates, P.C.
state: Massachusetts
city: Ann Arbor
country: United States
facility: Ann Arbor Rheumatology
state: Michigan
city: Battle Creek
country: United States
facility: Associated Internal Medicine Specialists, P.C.
state: Michigan
city: Brighton
country: United States
facility: Michigan Arthritis Research Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: East Lansing
country: United States
facility: Investigational Site
state: Michigan
city: East Lansing
country: United States
facility: Lansing Rheumatology, PLLC
state: Michigan
city: Grand Rapids
country: United States
facility: Arthritis Education and Treatment Center, PLLC
state: Michigan
city: Jackson
country: United States
facility: Cascades Rheumatology
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology P.C.
state: Michigan
city: Saint Joseph
country: United States
facility: Southwest MI Rheumatology Center
state: Michigan
city: Duluth
country: United States
facility: Whiteside Institute for Clinical Research
state: Minnesota
city: Eagan
country: United States
facility: St. Paul Rheumatology PA
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Flowood
country: United States
facility: Arthritis and Osteoporosis Treatment and Research Center
state: Mississippi
city: Hattiesburg
country: United States
facility: Arthritis Associates, PLLC
state: Mississippi
city: Pascagoula
country: United States
facility: Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: NMMC-IMA Tupelo
state: Mississippi
city: Cape Girardeau
country: United States
facility: Cape Girardeau Physician Associates
state: Missouri
city: Florissant
country: United States
facility: North County Medicine & Rheumatology
state: Missouri
city: Hannibal
country: United States
facility: Hannibal Clinic
state: Missouri
city: St. Louis
country: United States
facility: Rheumatology and Internal Medicine Associates of West County, P.C.
state: Missouri
city: Billings
country: United States
facility: The Arthritis & Osteoporosis Center, P.C.
state: Montana
city: Henderson
country: United States
facility: Osteoporosis and Arthritis Center
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Dover
country: United States
facility: Allergy and Arthritis Associates
state: New Jersey
city: Manalapan
country: United States
facility: Arthritis and Osteoporosis Associates, PA
state: New Jersey
city: Medford
country: United States
facility: Rheumatology and Arthritis Associates, P.C.
state: New Jersey
city: Midland Park
country: United States
facility: Investigational Site
state: New Jersey
city: Ridgewood
country: United States
facility: Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Rehabilitation and Rheumatology, PC
state: New Mexico
city: Las Cruces
country: United States
facility: Arthritis and Osteoporosis Associates
state: New Mexico
city: Los Alamos
country: United States
facility: Investigational Site
state: New Mexico
city: Albany
country: United States
facility: The Center for Rheumatology, LLP
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Garden City
country: United States
facility: Investigational Site
state: New York
city: Great Neck
country: United States
facility: Bay Rheumatology PC
state: New York
city: Hewlett
country: United States
facility: Rheumatology Consultants, LLP
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Research Across America - New York
state: New York
city: Rochester
country: United States
facility: Allergy, Immunology, Rheumatology Clinical Group
state: New York
city: Rochester
country: United States
facility: Arthritis Center of Rochester
state: New York
city: Smithtown
country: United States
facility: Rheumatology Associates of Long Island
state: New York
city: Syracuse
country: United States
facility: Arthritis Health Associates
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Chapel Hill
country: United States
facility: UNC Thurston Arthritis Research Center
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Medical Care
state: North Carolina
city: Charlotte
country: United States
facility: Arthritis Clinic & Carolina Bone & Joint
state: North Carolina
city: Fayetteville
country: United States
facility: LaFayette Clinic, PA
state: North Carolina
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates, P.A.
state: North Carolina
city: Bismarck
country: United States
facility: Medcenter One
state: North Dakota
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital
state: Ohio
city: Akron
country: United States
facility: Crystal Arthritis Center Inc.
state: Ohio
city: Canton
country: United States
facility: Arthritis Clinic of Stark County, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Arthritis Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Columbus Arthritis Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Outpatient Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Rheumatology and Research Goup, LLC
state: Ohio
city: Orange Village
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Toledo
country: United States
facility: Arthritis Associates of Northwest Ohio, Inc.
state: Ohio
city: Salem
country: United States
facility: Physicians Building Group, LLP
state: Oregon
city: Colmar
country: United States
facility: Rheumatology Associates, LTD
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Lebanon
country: United States
facility: Lebanon Internal Medicine Associates, P.C.
state: Pennsylvania
city: Monroeville
country: United States
facility: Arthritis & Rheumatic Disease Associates, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Arthritis Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: West Chester
country: United States
facility: Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Wexford
country: United States
facility: Allegheny North Arthritis Center, PC
state: Pennsylvania
city: Wynnewood
country: United States
facility: Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Rheumatology Associates
state: South Carolina
city: Florence
country: United States
facility: Carolina Healthcare
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Rheumatology and Neurology Associates, PC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Strand Physician Specialists PA DBA Carolina Health Specialists
state: South Carolina
city: Orangeburg
country: United States
facility: Acme Research, L.L.C.
state: South Carolina
city: Spartanburg
country: United States
facility: Carolina Medical Affiliates
state: South Carolina
city: Crossville
country: United States
facility: CMC Speciality Group
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants PLLC
state: Tennessee
city: Nashville
country: United States
facility: Heritage Medical Associates, P.C.
state: Tennessee
city: Abilene
country: United States
facility: Abilene Arthritis Center
state: Texas
city: Bedford
country: United States
facility: Investigational Site
state: Texas
city: Carrollton
country: United States
facility: Arthritis Clinic
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Presbyterian Hospital Dallas Arthritis Consultation Center
state: Texas
city: Dallas
country: United States
facility: Rheumatology Associates
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinic of Houston
state: Texas
city: Houston
country: United States
facility: Evergreen Clinical Research, LLC
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Midland
country: United States
facility: Arthritis & Osteoporosis Center
state: Texas
city: San Antonio
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Texas
city: Burke
country: United States
facility: Arthritis and Rheumatic Disease Associates, PC
state: Virginia
city: Chesapeake
country: United States
facility: Center for Arthritis & Rheumatic Diseases, P.C.
state: Virginia
city: Norfolk
country: United States
facility: NDC Medical Center
state: Virginia
city: Portsmouth
country: United States
facility: Investigational Site
state: Virginia
city: Reston
country: United States
facility: Northern Virginia Center for Arthritis
state: Virginia
city: Richmond
country: United States
facility: Premier HealthCare Associates Inc.
state: Virginia
city: Williamsburg
country: United States
facility: Arthritis and Rheumatic Diseases, PC
state: Virginia
city: Kirkland
country: United States
facility: Investigational Site
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic
state: West Virginia
city: Martinsburg
country: United States
facility: Rural Outreach Arthritis Center
state: West Virginia
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Onalaska
country: United States
facility: Gundersen Clinic, Ltd.
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: San Juan Arthritis and Research Center, Inc.
Study officials:
affiliation: Genentech, Inc.
name: Swati Tole, M.D., M.S.
role: STUDY_DIRECTOR
References: