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

Last updated: March 26, 2015
Sponsor: Genentech, Inc.
Overall Status: Completed

Phase

N/A

Condition

Joint Injuries

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00443443
U3839g
BIIB
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Have known hypersensitivity to any component of a humanized or murine monoclonalantibody

Study Design

Total Participants: 1026
Study Start date:
January 01, 2007
Estimated Completion Date:
September 30, 2013

Connect with a study center

  • San Juan Arthritis and Research Center, Inc.

    San Juan, 918
    Puerto Rico

    Site Not Available

  • Rheumatology Associates, PC

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Rheumatology Associates of N. AL, P.C.

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Clinic for Rheumatic Diseases - Research Department

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • Arizona Arthritis and Rheumatology Research, PLLC

    Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • Phoenix Rheumatology Specialists, Ltd.

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Advanced Arthritis Care & Research

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • The Arthritis Center of the Ozarks

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Investigational Site

    Covina, California 91723
    United States

    Site Not Available

  • Arthritis Medical Clinic of North County, Inc.

    Escondido, California 92025
    United States

    Site Not Available

  • Solano Regional Medical Group

    Fairfield, California 94534
    United States

    Site Not Available

  • Clinical Trials of St. Jude Heritage Medical Group

    Fullerton, California 92835
    United States

    Site Not Available

  • Investigational Site

    Hemet, California 92543
    United States

    Site Not Available

  • Allergy and Rheumatology Medical Clinic, Inc

    La Jolla, California 92037
    United States

    Site Not Available

  • Investigational Site

    La Mesa, California 91941
    United States

    Site Not Available

  • Arthritis Center of Southern Orange County

    Laguna Hills, California 92653
    United States

    Site Not Available

  • VA Loma Linda Healthcare System

    Loma Linda, California 92357
    United States

    Site Not Available

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

    Long Beach, California 90806
    United States

    Site Not Available

  • Beverly Medical Associates

    Los Angeles, California 90048
    United States

    Site Not Available

  • Investigational Site

    Los Angeles, California 90048
    United States

    Site Not Available

  • Samaritan Center for Medical Research, Medical Group

    Los Gatos, California 95032
    United States

    Site Not Available

  • Mission Internal Medical Group- Rheumatology Division

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • Rheumatology Associates

    North Hollywood, California 91607
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California 92260
    United States

    Site Not Available

  • Arthritis Medical Clinic

    Riverside, California 92501
    United States

    Site Not Available

  • East Bay Rheumatology Medical Group

    San Leandro, California 94578
    United States

    Site Not Available

  • Pacific Arthritis Center Medical Group

    Santa Maria, California 93454
    United States

    Site Not Available

  • Healthcare Partners Medical Group

    Torrance, California 90503
    United States

    Site Not Available

  • Investigational Site

    Torrance, California 90505
    United States

    Site Not Available

  • Desert Valley Medical Group

    Victorville, California 92395
    United States

    Site Not Available

  • Investigational Site

    Visalia, California 93291
    United States

    Site Not Available

  • Agilence Arthritis & Osteoporosis Medical Center, Inc.

    Whittier, California 90606
    United States

    Site Not Available

  • Denver Health Medical Center

    Denver, Colorado 80204
    United States

    Site Not Available

  • National Jewish Medical and Research Center

    Denver, Colorado 80206
    United States

    Site Not Available

  • Arthritis and Rheumatology Clinic of Northern Colorado, LLC

    Fort Collins, Colorado 80528
    United States

    Site Not Available

  • Greeley Medical Clinic

    Greeley, Colorado 80631
    United States

    Site Not Available

  • Colorado Center for Arthritis and Osteoporosis

    Longmont, Colorado 80501
    United States

    Site Not Available

  • Investigational Site

    Bridgeport, Connecticut 6606
    United States

    Site Not Available

  • Clinical Research Center of CT/NY

    Danbury, Connecticut 6810
    United States

    Site Not Available

  • University of CT Health Center

    Farmington, Connecticut 6030
    United States

    Site Not Available

  • The William W. Backus Hospital

    Norwich, Connecticut 6360
    United States

    Site Not Available

  • Delaware Arthritis & Osteoporosis Center

    Newark, Delaware 19713
    United States

    Site Not Available

  • VAMC

    Washington, District of Columbia 20422
    United States

    Site Not Available

  • RASF- Clinical Research

    Boca Raton, Florida 33486
    United States

    Site Not Available

  • Countryside Arthritis Center

    Clearwater, Florida 33761
    United States

    Site Not Available

  • MIMA Century Research Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Investigational Site

    Naples, Florida 34102
    United States

    Site Not Available

  • Naples Medical Center

    Naples, Florida 34102
    United States

    Site Not Available

  • Arthritis & Osteoporosis Treatment Research Center, Inc.

    North Miami Beach, Florida 33180
    United States

    Site Not Available

  • Arthritis & Osteoporosis Treatment Center, P.A.

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Investigational Site

    Orlando, Florida 32804
    United States

    Site Not Available

  • Rheumatology Associates of Central Florida, PA

    Orlando, Florida 32806
    United States

    Site Not Available

  • Suncoast Medical Clinic, LLC

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Brookshire Rheumatology & Wellness Center

    Tampa, Florida 33618
    United States

    Site Not Available

  • Lake Rheumatology

    Tavares, Florida 32778
    United States

    Site Not Available

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Georgia Internal Medicine Associates, PA

    Austell, Georgia 30106
    United States

    Site Not Available

  • Arthritis Center of North Georgia

    Gainesville, Georgia 30501
    United States

    Site Not Available

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia 30045
    United States

    Site Not Available

  • Middle Georgia Arthritis Center

    Macon, Georgia 31210
    United States

    Site Not Available

  • Arthritis and Osteoporosis Center of South Georgia

    Tifton, Georgia 31794
    United States

    Site Not Available

  • Valdosta Specialty Clinic

    Valdosta, Georgia 31602
    United States

    Site Not Available

  • Institute of Arthritis Research

    Idaho Falls, Idaho 83401
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • The University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Northern Illinois Research Associates

    DeKalb, Illinois 60115
    United States

    Site Not Available

  • Prairie Rheumatology Associates, S.C.

    Joliet, Illinois 60435
    United States

    Site Not Available

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Arthritis Care Center, PC

    Moline, Illinois 61265
    United States

    Site Not Available

  • Rockford Orthopedic Associates

    Rockford, Illinois 61107
    United States

    Site Not Available

  • Integrative Pain Medicine

    Schaumburg, Illinois 60195
    United States

    Site Not Available

  • Physicians Clinic Of Iowa

    Cedar Rapids, Iowa 52401
    United States

    Site Not Available

  • Mercy Arthritis and Osteoporosis Center

    Des Moines, Iowa 50322
    United States

    Site Not Available

  • Medical Associates Clinic PC

    Dubuque, Iowa 52002
    United States

    Site Not Available

  • Arthritis and Rheumatology Clinics of Kansas

    Wichita, Kansas 67220
    United States

    Site Not Available

  • Ashland Arthritis Center

    Ashland, Kentucky 41101
    United States

    Site Not Available

  • Graves Gilbert Clinic

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Rheumatology Associates

    Louisville, Kentucky 40218
    United States

    Site Not Available

  • Lafayette Arthritis & Endocrine Clinic

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Investigational Site

    Lewiston, Maine 4240
    United States

    Site Not Available

  • Investigational Site

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Rheumatology Associates of Baltimore

    Baltimore, Maryland 21286
    United States

    Site Not Available

  • Maryland Arthritis Care Specialists

    Ellicott City, Maryland 21042
    United States

    Site Not Available

  • Northampton Internal Medicine Associates, P.C.

    Florence, Massachusetts 1062
    United States

    Site Not Available

  • Ann Arbor Rheumatology

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Associated Internal Medicine Specialists, P.C.

    Battle Creek, Michigan 49015
    United States

    Site Not Available

  • Michigan Arthritis Research Center

    Brighton, Michigan 48116
    United States

    Site Not Available

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Investigational Site

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • Lansing Rheumatology, PLLC

    East Lansing, Michigan 48823
    United States

    Site Not Available

  • Arthritis Education and Treatment Center, PLLC

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • Cascades Rheumatology

    Jackson, Michigan 49203
    United States

    Site Not Available

  • Shores Rheumatology P.C.

    Saint Clair Shores, Michigan 48081
    United States

    Site Not Available

  • Southwest MI Rheumatology Center

    Saint Joseph, Michigan 49085
    United States

    Site Not Available

  • Whiteside Institute for Clinical Research

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • St. Paul Rheumatology PA

    Eagan, Minnesota 55121
    United States

    Site Not Available

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Arthritis and Osteoporosis Treatment and Research Center

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Arthritis Associates, PLLC

    Hattiesburg, Mississippi 39402
    United States

    Site Not Available

  • Investigational Site

    Pascagoula, Mississippi 39581
    United States

    Site Not Available

  • NMMC-IMA Tupelo

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • Cape Girardeau Physician Associates

    Cape Girardeau, Missouri 63703
    United States

    Site Not Available

  • North County Medicine & Rheumatology

    Florissant, Missouri 63031
    United States

    Site Not Available

  • Hannibal Clinic

    Hannibal, Missouri 63401
    United States

    Site Not Available

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

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • The Arthritis & Osteoporosis Center, P.C.

    Billings, Montana 59101
    United States

    Site Not Available

  • Osteoporosis and Arthritis Center

    Henderson, Nevada 89052
    United States

    Site Not Available

  • Investigational Site

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Allergy and Arthritis Associates

    Dover, New Jersey 7801
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates, PA

    Manalapan, New Jersey 7726
    United States

    Site Not Available

  • Rheumatology and Arthritis Associates, P.C.

    Medford, New Jersey 8055
    United States

    Site Not Available

  • Investigational Site

    Midland Park, New Jersey 7432
    United States

    Site Not Available

  • Investigational Site

    Ridgewood, New Jersey 7450
    United States

    Site Not Available

  • Albuquerque Rehabilitation and Rheumatology, PC

    Albuquerque, New Mexico 87102
    United States

    Site Not Available

  • Arthritis and Osteoporosis Associates

    Las Cruces, New Mexico 88011
    United States

    Site Not Available

  • Investigational Site

    Los Alamos, New Mexico 87544
    United States

    Site Not Available

  • The Center for Rheumatology, LLP

    Albany, New York 12206
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Investigational Site

    Garden City, New York 11530
    United States

    Site Not Available

  • Bay Rheumatology PC

    Great Neck, New York 11021
    United States

    Site Not Available

  • Rheumatology Consultants, LLP

    Hewlett, New York 11557
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • Research Across America - New York

    New York, New York 10022
    United States

    Site Not Available

  • Allergy, Immunology, Rheumatology Clinical Group

    Rochester, New York 14618
    United States

    Site Not Available

  • Arthritis Center of Rochester

    Rochester, New York 14618
    United States

    Site Not Available

  • Rheumatology Associates of Long Island

    Smithtown, New York 11787
    United States

    Site Not Available

  • Arthritis Health Associates

    Syracuse, New York 13210
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • UNC Thurston Arthritis Research Center

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Arthritis Clinic & Carolina Bone & Joint

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Joint and Muscle Medical Care

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • LaFayette Clinic, PA

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Carolina Arthritis Associates, P.A.

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Medcenter One

    Bismarck, North Dakota 58506
    United States

    Site Not Available

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

    Akron, Ohio 44308
    United States

    Site Not Available

  • Crystal Arthritis Center Inc.

    Akron, Ohio 44333
    United States

    Site Not Available

  • Arthritis Clinic of Stark County, Inc.

    Canton, Ohio 44718
    United States

    Site Not Available

  • Arthritis Center

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Columbus Arthritis Center

    Columbus, Ohio 43215
    United States

    Site Not Available

  • Dayton Outpatient Center

    Dayton, Ohio 45432
    United States

    Site Not Available

  • Southwest Rheumatology and Research Goup, LLC

    Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • University Hospitals Case Medical Center

    Orange Village, Ohio 44122
    United States

    Site Not Available

  • Arthritis Associates of Northwest Ohio, Inc.

    Toledo, Ohio 43606
    United States

    Site Not Available

  • Physicians Building Group, LLP

    Salem, Oregon 97302
    United States

    Site Not Available

  • Rheumatology Associates, LTD

    Colmar, Pennsylvania 18915
    United States

    Site Not Available

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Lebanon Internal Medicine Associates, P.C.

    Lebanon, Pennsylvania 17042
    United States

    Site Not Available

  • Arthritis & Rheumatic Disease Associates, LLC

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • Einstein Arthritis Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • The Arthritis Group

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Investigational Site

    West Chester, Pennsylvania 19380
    United States

    Site Not Available

  • Clinical Research Center of Reading, LLP

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Allegheny North Arthritis Center, PC

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

  • Investigational Site

    Wynnewood, Pennsylvania 19096
    United States

    Site Not Available

  • Rheumatology Associates

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Carolina Healthcare

    Florence, South Carolina 29506
    United States

    Site Not Available

  • Carolina Rheumatology and Neurology Associates, PC

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Strand Physician Specialists PA DBA Carolina Health Specialists

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Acme Research, L.L.C.

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Carolina Medical Affiliates

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • CMC Speciality Group

    Crossville, Tennessee 38555
    United States

    Site Not Available

  • Rheumatology Consultants PLLC

    Knoxville, Tennessee 37909-1900
    United States

    Site Not Available

  • Heritage Medical Associates, P.C.

    Nashville, Tennessee 37203-1870
    United States

    Site Not Available

  • Abilene Arthritis Center

    Abilene, Texas 79601
    United States

    Site Not Available

  • Investigational Site

    Bedford, Texas 76021
    United States

    Site Not Available

  • Arthritis Clinic

    Carrollton, Texas 75007
    United States

    Site Not Available

  • Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

  • Presbyterian Hospital Dallas Arthritis Consultation Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Rheumatology Associates

    Dallas, Texas 75235
    United States

    Site Not Available

  • Evergreen Clinical Research, LLC

    Houston, Texas 77008
    United States

    Site Not Available

  • Rheumatic Disease Clinic of Houston

    Houston, Texas 77004
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center

    Lubbock, Texas 79430
    United States

    Site Not Available

  • Arthritis & Osteoporosis Center

    Midland, Texas 79701
    United States

    Site Not Available

  • Center for Arthritis and Rheumatic Diseases

    San Antonio, Texas 78217
    United States

    Site Not Available

  • Arthritis and Rheumatic Disease Associates, PC

    Burke, Virginia 22015
    United States

    Site Not Available

  • Center for Arthritis & Rheumatic Diseases, P.C.

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • NDC Medical Center

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Investigational Site

    Portsmouth, Virginia 23701
    United States

    Site Not Available

  • Northern Virginia Center for Arthritis

    Reston, Virginia 20190
    United States

    Site Not Available

  • Premier HealthCare Associates Inc.

    Richmond, Virginia 23294
    United States

    Site Not Available

  • Arthritis and Rheumatic Diseases, PC

    Williamsburg, Virginia 23185
    United States

    Site Not Available

  • Investigational Site

    Kirkland, Washington 98034
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195-6428
    United States

    Site Not Available

  • Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia 25801
    United States

    Site Not Available

  • Rural Outreach Arthritis Center

    Martinsburg, West Virginia 25401
    United States

    Site Not Available

  • Rheumatic Disease Center

    Glendale, Wisconsin 53217
    United States

    Site Not Available

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin 53792-3244
    United States

    Site Not Available

  • Gundersen Clinic, Ltd.

    Onalaska, Wisconsin 54650
    United States

    Site Not Available

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