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A Study of the Safety of Rituxan in Patients With Rheumatoid Arthritis After an Inadequate Response to Previous Anti-TNF Therapy (SUNSTONE)

Completed
Conditions
Rheumatoid Arthritis
Registration Number
NCT00443443
Lead Sponsor
Genentech, Inc.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1026
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (165)

Rheumatology Associates

🇺🇸

Dallas, Texas, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

MIMA Century Research Associates

🇺🇸

Melbourne, Florida, United States

Clinical Trials of St. Jude Heritage Medical Group

🇺🇸

Fullerton, California, United States

Samaritan Center for Medical Research, Medical Group

🇺🇸

Los Gatos, California, United States

VA Loma Linda Healthcare System

🇺🇸

Loma Linda, California, United States

Countryside Arthritis Center

🇺🇸

Clearwater, Florida, United States

Middle Georgia Arthritis Center

🇺🇸

Macon, Georgia, United States

Arthritis Center of Southern Orange County

🇺🇸

Laguna Hills, California, United States

Mission Internal Medical Group- Rheumatology Division

🇺🇸

Mission Viejo, California, United States

Valerius Medical Group and Research Center of Greater Long Beach, Inc.

🇺🇸

Long Beach, California, United States

The University of Chicago

🇺🇸

Chicago, Illinois, United States

Florida Medical Clinic, P.A.

🇺🇸

Zephyrhills, Florida, United States

Ashland Arthritis Center

🇺🇸

Ashland, Kentucky, United States

Rheumatology Associates of N. AL, P.C.

🇺🇸

Huntsville, Alabama, United States

Arthritis Medical Clinic

🇺🇸

Riverside, California, United States

Pacific Arthritis Center Medical Group

🇺🇸

Santa Maria, California, United States

Arizona Arthritis and Rheumatology Research, PLLC

🇺🇸

Paradise Valley, Arizona, United States

Naples Medical Center

🇺🇸

Naples, Florida, United States

Healthcare Partners Medical Group

🇺🇸

Torrance, California, United States

Desert Valley Medical Group

🇺🇸

Victorville, California, United States

Loyola University Medical Center

🇺🇸

Maywood, Illinois, United States

Desert Medical Advances

🇺🇸

Palm Desert, California, United States

Physicians Clinic Of Iowa

🇺🇸

Cedar Rapids, Iowa, United States

Advanced Arthritis Care & Research

🇺🇸

Scottsdale, Arizona, United States

North Georgia Rheumatology Group, PC

🇺🇸

Lawrenceville, Georgia, United States

Rockford Orthopedic Associates

🇺🇸

Rockford, Illinois, United States

Suncoast Medical Clinic, LLC

🇺🇸

St. Petersburg, Florida, United States

Arthritis & Osteoporosis Treatment Research Center, Inc.

🇺🇸

North Miami Beach, Florida, United States

Arthritis & Osteoporosis Treatment Center, P.A.

🇺🇸

Orange Park, Florida, United States

Hospital for Special Surgery

🇺🇸

New York, New York, United States

Georgia Internal Medicine Associates, PA

🇺🇸

Austell, Georgia, United States

Rheumatology Consultants PLLC

🇺🇸

Knoxville, Tennessee, United States

Prairie Rheumatology Associates, S.C.

🇺🇸

Joliet, Illinois, United States

Medical Associates Clinic PC

🇺🇸

Dubuque, Iowa, United States

Associated Internal Medicine Specialists, P.C.

🇺🇸

Battle Creek, Michigan, United States

Maryland Arthritis Care Specialists

🇺🇸

Ellicott City, Maryland, United States

Michigan Arthritis Research Center

🇺🇸

Brighton, Michigan, United States

Rheumatology Consultants, LLP

🇺🇸

Hewlett, New York, United States

Bay Rheumatology PC

🇺🇸

Great Neck, New York, United States

Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital

🇺🇸

Akron, Ohio, United States

Southwest MI Rheumatology Center

🇺🇸

Saint Joseph, Michigan, United States

Carolina Healthcare

🇺🇸

Florence, South Carolina, United States

Research Across America - New York

🇺🇸

New York, New York, United States

Arthritis Clinic & Carolina Bone & Joint

🇺🇸

Charlotte, North Carolina, United States

Carolina Medical Affiliates

🇺🇸

Spartanburg, South Carolina, United States

Strand Physician Specialists PA DBA Carolina Health Specialists

🇺🇸

Myrtle Beach, South Carolina, United States

LaFayette Clinic, PA

🇺🇸

Fayetteville, North Carolina, United States

Einstein Arthritis Center

🇺🇸

Philadelphia, Pennsylvania, United States

Carolina Rheumatology and Neurology Associates, PC

🇺🇸

Myrtle Beach, South Carolina, United States

Acme Research, L.L.C.

🇺🇸

Orangeburg, South Carolina, United States

CMC Speciality Group

🇺🇸

Crossville, Tennessee, United States

Arthritis and Rheumatic Disease Associates, PC

🇺🇸

Burke, Virginia, United States

Center for Arthritis & Rheumatic Diseases, P.C.

🇺🇸

Chesapeake, Virginia, United States

Presbyterian Hospital Dallas Arthritis Consultation Center

🇺🇸

Dallas, Texas, United States

Rheumatology & Pulmonary Clinic

🇺🇸

Beckley, West Virginia, United States

Rural Outreach Arthritis Center

🇺🇸

Martinsburg, West Virginia, United States

Rheumatic Disease Center

🇺🇸

Glendale, Wisconsin, United States

MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

Clinic for Rheumatic Diseases - Research Department

🇺🇸

Tuscaloosa, Alabama, United States

Arthritis Medical Clinic of North County, Inc.

🇺🇸

Escondido, California, United States

Allergy and Rheumatology Medical Clinic, Inc

🇺🇸

La Jolla, California, United States

Solano Regional Medical Group

🇺🇸

Fairfield, California, United States

Beverly Medical Associates

🇺🇸

Los Angeles, California, United States

Colorado Center for Arthritis and Osteoporosis

🇺🇸

Longmont, Colorado, United States

Greeley Medical Clinic

🇺🇸

Greeley, Colorado, United States

Arthritis and Rheumatology Clinic of Northern Colorado, LLC

🇺🇸

Fort Collins, Colorado, United States

The William W. Backus Hospital

🇺🇸

Norwich, Connecticut, United States

Delaware Arthritis & Osteoporosis Center

🇺🇸

Newark, Delaware, United States

VAMC

🇺🇸

Washington, District of Columbia, United States

RASF- Clinical Research

🇺🇸

Boca Raton, Florida, United States

Lake Rheumatology

🇺🇸

Tavares, Florida, United States

Arthritis and Osteoporosis Center of South Georgia

🇺🇸

Tifton, Georgia, United States

Valdosta Specialty Clinic

🇺🇸

Valdosta, Georgia, United States

Graves Gilbert Clinic

🇺🇸

Bowling Green, Kentucky, United States

Rheumatology Associates of Baltimore

🇺🇸

Baltimore, Maryland, United States

Lafayette Arthritis & Endocrine Clinic

🇺🇸

Lafayette, Louisiana, United States

Cascades Rheumatology

🇺🇸

Jackson, Michigan, United States

Shores Rheumatology P.C.

🇺🇸

Saint Clair Shores, Michigan, United States

Whiteside Institute for Clinical Research

🇺🇸

Duluth, Minnesota, United States

St. Paul Rheumatology PA

🇺🇸

Eagan, Minnesota, United States

Arthritis and Osteoporosis Treatment and Research Center

🇺🇸

Flowood, Mississippi, United States

Arthritis Associates, PLLC

🇺🇸

Hattiesburg, Mississippi, United States

NMMC-IMA Tupelo

🇺🇸

Tupelo, Mississippi, United States

Cape Girardeau Physician Associates

🇺🇸

Cape Girardeau, Missouri, United States

Hannibal Clinic

🇺🇸

Hannibal, Missouri, United States

North County Medicine & Rheumatology

🇺🇸

Florissant, Missouri, United States

Rheumatology and Internal Medicine Associates of West County, P.C.

🇺🇸

St. Louis, Missouri, United States

The Arthritis & Osteoporosis Center, P.C.

🇺🇸

Billings, Montana, United States

Osteoporosis and Arthritis Center

🇺🇸

Henderson, Nevada, United States

Arthritis and Osteoporosis Associates, PA

🇺🇸

Manalapan, New Jersey, United States

Rheumatology and Arthritis Associates, P.C.

🇺🇸

Medford, New Jersey, United States

Arthritis and Osteoporosis Associates

🇺🇸

Las Cruces, New Mexico, United States

The Center for Rheumatology, LLP

🇺🇸

Albany, New York, United States

The Cleveland Clinic Foundation

🇺🇸

Cleveland, Ohio, United States

Southwest Rheumatology and Research Goup, LLC

🇺🇸

Middleburg Heights, Ohio, United States

Arthritis & Rheumatic Disease Associates, LLC

🇺🇸

Monroeville, Pennsylvania, United States

Clinical Research Center of Reading, LLP

🇺🇸

West Reading, Pennsylvania, United States

Abilene Arthritis Center

🇺🇸

Abilene, Texas, United States

Texas Tech University Health Sciences Center

🇺🇸

Lubbock, Texas, United States

Arthritis Center

🇺🇸

Cincinnati, Ohio, United States

Gundersen Clinic, Ltd.

🇺🇸

Onalaska, Wisconsin, United States

San Juan Arthritis and Research Center, Inc.

🇵🇷

San Juan, Puerto Rico

Minneapolis VA Medical Center

🇺🇸

Minneapolis, Minnesota, United States

Medcenter One

🇺🇸

Bismarck, North Dakota, United States

East Bay Rheumatology Medical Group

🇺🇸

San Leandro, California, United States

Heritage Medical Associates, P.C.

🇺🇸

Nashville, Tennessee, United States

Rheumatology Associates, PC

🇺🇸

Birmingham, Alabama, United States

Phoenix Rheumatology Specialists, Ltd.

🇺🇸

Phoenix, Arizona, United States

Denver Health Medical Center

🇺🇸

Denver, Colorado, United States

National Jewish Medical and Research Center

🇺🇸

Denver, Colorado, United States

Brookshire Rheumatology & Wellness Center

🇺🇸

Tampa, Florida, United States

Henry Ford Health System

🇺🇸

Detroit, Michigan, United States

Rheumatology Associates of Long Island

🇺🇸

Smithtown, New York, United States

Arthritis Health Associates

🇺🇸

Syracuse, New York, United States

SUNY Upstate Medical University

🇺🇸

Syracuse, New York, United States

Arthritis Center of North Georgia

🇺🇸

Gainesville, Georgia, United States

Northern Illinois Research Associates

🇺🇸

DeKalb, Illinois, United States

Arthritis Care Center, PC

🇺🇸

Moline, Illinois, United States

Lansing Rheumatology, PLLC

🇺🇸

East Lansing, Michigan, United States

Northampton Internal Medicine Associates, P.C.

🇺🇸

Florence, Massachusetts, United States

Arthritis Education and Treatment Center, PLLC

🇺🇸

Grand Rapids, Michigan, United States

Joint and Muscle Medical Care

🇺🇸

Charlotte, North Carolina, United States

Physicians East

🇺🇸

Greenville, North Carolina, United States

Columbus Arthritis Center

🇺🇸

Columbus, Ohio, United States

Carolina Arthritis Associates, P.A.

🇺🇸

Wilmington, North Carolina, United States

Crystal Arthritis Center Inc.

🇺🇸

Akron, Ohio, United States

University Hospitals Case Medical Center

🇺🇸

Orange Village, Ohio, United States

Arthritis Associates of Northwest Ohio, Inc.

🇺🇸

Toledo, Ohio, United States

Physicians Building Group, LLP

🇺🇸

Salem, Oregon, United States

Rheumatology Associates, LTD

🇺🇸

Colmar, Pennsylvania, United States

Altoona Center for Clinical Research

🇺🇸

Duncansville, Pennsylvania, United States

The Arthritis Group

🇺🇸

Philadelphia, Pennsylvania, United States

Lebanon Internal Medicine Associates, P.C.

🇺🇸

Lebanon, Pennsylvania, United States

Rheumatic Disease Clinic of Houston

🇺🇸

Houston, Texas, United States

Arthritis Clinic

🇺🇸

Carrollton, Texas, United States

Allegheny North Arthritis Center, PC

🇺🇸

Wexford, Pennsylvania, United States

Arthritis & Osteoporosis Center

🇺🇸

Midland, Texas, United States

Evergreen Clinical Research, LLC

🇺🇸

Houston, Texas, United States

Northern Virginia Center for Arthritis

🇺🇸

Reston, Virginia, United States

NDC Medical Center

🇺🇸

Norfolk, Virginia, United States

Arthritis and Rheumatic Diseases, PC

🇺🇸

Williamsburg, Virginia, United States

University of Washington Medical Center

🇺🇸

Seattle, Washington, United States

Center for Arthritis and Rheumatic Diseases

🇺🇸

San Antonio, Texas, United States

Ann Arbor Rheumatology

🇺🇸

Ann Arbor, Michigan, United States

Arthritis Clinic of Stark County, Inc.

🇺🇸

Canton, Ohio, United States

Institute of Arthritis Research

🇺🇸

Idaho Falls, Idaho, United States

University of CT Health Center

🇺🇸

Farmington, Connecticut, United States

The Arthritis Center of the Ozarks

🇺🇸

Fayetteville, Arkansas, United States

Clinical Research Center of CT/NY

🇺🇸

Danbury, Connecticut, United States

Rheumatology Associates of Central Florida, PA

🇺🇸

Orlando, Florida, United States

Mercy Arthritis and Osteoporosis Center

🇺🇸

Des Moines, Iowa, United States

Dayton Outpatient Center

🇺🇸

Dayton, Ohio, United States

Arthritis and Rheumatology Clinics of Kansas

🇺🇸

Wichita, Kansas, United States

Allergy, Immunology, Rheumatology Clinical Group

🇺🇸

Rochester, New York, United States

UNC Thurston Arthritis Research Center

🇺🇸

Chapel Hill, North Carolina, United States

Albuquerque Rehabilitation and Rheumatology, PC

🇺🇸

Albuquerque, New Mexico, United States

Arthritis Center of Rochester

🇺🇸

Rochester, New York, United States

Premier HealthCare Associates Inc.

🇺🇸

Richmond, Virginia, United States

University of Wisconsin Hospital and Clinics

🇺🇸

Madison, Wisconsin, United States

Investigational Site

🇺🇸

Tacoma, Washington, United States

Agilence Arthritis & Osteoporosis Medical Center, Inc.

🇺🇸

Whittier, California, United States

Integrative Pain Medicine

🇺🇸

Schaumburg, Illinois, United States

Allergy and Arthritis Associates

🇺🇸

Dover, New Jersey, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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