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

March 26, 2015 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1026

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 918
        • San Juan Arthritis and Research Center, Inc.
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Rheumatology Associates, Pc
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of N. AL, P.C.
      • Tuscaloosa, Alabama, United States, 35406
        • Clinic for Rheumatic Diseases - Research Department
    • Arizona
      • Paradise Valley, Arizona, United States, 85253
        • Arizona Arthritis and Rheumatology Research, PLLC
      • Phoenix, Arizona, United States, 85006
        • Phoenix Rheumatology Specialists, Ltd.
      • Scottsdale, Arizona, United States, 85258
        • Advanced Arthritis Care & Research
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • The Arthritis Center of the Ozarks
    • California
      • Covina, California, United States, 91723
        • Investigational Site
      • Escondido, California, United States, 92025
        • Arthritis Medical Clinic of North County, Inc.
      • Fairfield, California, United States, 94534
        • Solano Regional Medical Group
      • Fullerton, California, United States, 92835
        • Clinical Trials of St. Jude Heritage Medical Group
      • Hemet, California, United States, 92543
        • Investigational Site
      • La Jolla, California, United States, 92037
        • Allergy and Rheumatology Medical Clinic, Inc
      • La Mesa, California, United States, 91941
        • Investigational Site
      • Laguna Hills, California, United States, 92653
        • Arthritis Center of Southern Orange County
      • Loma Linda, California, United States, 92357
        • VA Loma Linda Healthcare System
      • Long Beach, California, United States, 90806
        • Valerius Medical Group and Research Center of Greater Long Beach, Inc.
      • Los Angeles, California, United States, 90048
        • Beverly Medical Associates
      • Los Angeles, California, United States, 90048
        • Investigational Site
      • Los Gatos, California, United States, 95032
        • Samaritan Center for Medical Research, Medical Group
      • Mission Viejo, California, United States, 92691
        • Mission Internal Medical Group- Rheumatology Division
      • Newport Beach, California, United States, 92663
        • Investigational Site
      • North Hollywood, California, United States, 91607
        • Rheumatology Associates
      • Palm Desert, California, United States, 92260
        • Desert Medical Advances
      • Riverside, California, United States, 92501
        • Arthritis Medical Clinic
      • San Leandro, California, United States, 94578
        • East Bay Rheumatology Medical Group
      • Santa Maria, California, United States, 93454
        • Pacific Arthritis Center Medical Group
      • Torrance, California, United States, 90505
        • Investigational Site
      • Torrance, California, United States, 90503
        • HealthCare Partners Medical Group
      • Victorville, California, United States, 92395
        • Desert Valley Medical Group
      • Visalia, California, United States, 93291
        • Investigational Site
      • Whittier, California, United States, 90606
        • Agilence Arthritis & Osteoporosis Medical Center, Inc.
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
      • Fort Collins, Colorado, United States, 80528
        • Arthritis and Rheumatology Clinic of Northern Colorado, LLC
      • Greeley, Colorado, United States, 80631
        • Greeley Medical Clinic
      • Longmont, Colorado, United States, 80501
        • Colorado Center for Arthritis and Osteoporosis
    • Connecticut
      • Bridgeport, Connecticut, United States, 6606
        • Investigational Site
      • Danbury, Connecticut, United States, 6810
        • Clinical Research Center of CT/NY
      • Farmington, Connecticut, United States, 6030
        • University of CT Health Center
      • Norwich, Connecticut, United States, 6360
        • The William W. Backus Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Delaware Arthritis & Osteoporosis Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • VAMC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • RASF- Clinical Research
      • Clearwater, Florida, United States, 33761
        • Countryside Arthritis Center
      • Melbourne, Florida, United States, 32901
        • MIMA Century Research Associates
      • Naples, Florida, United States, 34102
        • Naples Medical Center
      • Naples, Florida, United States, 34102
        • Investigational Site
      • North Miami Beach, Florida, United States, 33180
        • Arthritis & Osteoporosis Treatment Research Center, Inc.
      • Orange Park, Florida, United States, 32073
        • Arthritis & Osteoporosis Treatment Center, P.A.
      • Orlando, Florida, United States, 32806
        • Rheumatology Associates of Central Florida, PA
      • Orlando, Florida, United States, 32804
        • Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Medical Clinic, LLC
      • Tampa, Florida, United States, 33618
        • Brookshire Rheumatology & Wellness Center
      • Tavares, Florida, United States, 32778
        • Lake Rheumatology
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Austell, Georgia, United States, 30106
        • Georgia Internal Medicine Associates, PA
      • Gainesville, Georgia, United States, 30501
        • Arthritis Center of North Georgia
      • Lawrenceville, Georgia, United States, 30045
        • North Georgia Rheumatology Group, PC
      • Macon, Georgia, United States, 31210
        • Middle Georgia Arthritis Center
      • Tifton, Georgia, United States, 31794
        • Arthritis and Osteoporosis Center of South Georgia
      • Valdosta, Georgia, United States, 31602
        • Valdosta Specialty Clinic
    • Idaho
      • Idaho Falls, Idaho, United States, 83401
        • Institute of Arthritis Research
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
      • DeKalb, Illinois, United States, 60115
        • Northern Illinois Research Associates
      • Joliet, Illinois, United States, 60435
        • Prairie Rheumatology Associates, S.C.
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Moline, Illinois, United States, 61265
        • Arthritis Care Center, PC
      • Rockford, Illinois, United States, 61107
        • Rockford Orthopedic Associates
      • Schaumburg, Illinois, United States, 60195
        • Integrative Pain Medicine
    • Iowa
      • Cedar Rapids, Iowa, United States, 52401
        • Physicians Clinic of Iowa
      • Des Moines, Iowa, United States, 50322
        • Mercy Arthritis and Osteoporosis Center
      • Dubuque, Iowa, United States, 52002
        • Medical Associates Clinic PC
    • Kansas
      • Wichita, Kansas, United States, 67220
        • Arthritis and Rheumatology Clinics of Kansas
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Ashland Arthritis Center
      • Bowling Green, Kentucky, United States, 42101
        • Graves Gilbert Clinic
      • Louisville, Kentucky, United States, 40218
        • Rheumatology Associates
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Lafayette Arthritis & Endocrine Clinic
    • Maine
      • Lewiston, Maine, United States, 4240
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigational Site
      • Baltimore, Maryland, United States, 21286
        • Rheumatology Associates of Baltimore
      • Ellicott City, Maryland, United States, 21042
        • Maryland Arthritis Care Specialists
    • Massachusetts
      • Florence, Massachusetts, United States, 1062
        • Northampton Internal Medicine Associates, P.C.
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Ann Arbor Rheumatology
      • Battle Creek, Michigan, United States, 49015
        • Associated Internal Medicine Specialists, P.C.
      • Brighton, Michigan, United States, 48116
        • Michigan Arthritis Research Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • East Lansing, Michigan, United States, 48823
        • Investigational Site
      • East Lansing, Michigan, United States, 48823
        • Lansing Rheumatology, PLLC
      • Grand Rapids, Michigan, United States, 49546
        • Arthritis Education and Treatment Center, PLLC
      • Jackson, Michigan, United States, 49203
        • Cascades Rheumatology
      • Saint Clair Shores, Michigan, United States, 48081
        • Shores Rheumatology P.C.
      • Saint Joseph, Michigan, United States, 49085
        • Southwest MI Rheumatology Center
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Whiteside Institute for Clinical Research
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology PA
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Arthritis and Osteoporosis Treatment and Research Center
      • Hattiesburg, Mississippi, United States, 39402
        • Arthritis Associates, PLLC
      • Pascagoula, Mississippi, United States, 39581
        • Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • NMMC-IMA Tupelo
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Cape Girardeau Physician Associates
      • Florissant, Missouri, United States, 63031
        • North County Medicine & Rheumatology
      • Hannibal, Missouri, United States, 63401
        • Hannibal Clinic
      • St. Louis, Missouri, United States, 63131
        • Rheumatology and Internal Medicine Associates of West County, P.C.
    • Montana
      • Billings, Montana, United States, 59101
        • The Arthritis & Osteoporosis Center, P.C.
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Osteoporosis and Arthritis Center
      • Las Vegas, Nevada, United States, 89128
        • Investigational Site
    • New Jersey
      • Dover, New Jersey, United States, 7801
        • Allergy and Arthritis Associates
      • Manalapan, New Jersey, United States, 7726
        • Arthritis And Osteoporosis Associates, Pa
      • Medford, New Jersey, United States, 8055
        • Rheumatology and Arthritis Associates, P.C.
      • Midland Park, New Jersey, United States, 7432
        • Investigational Site
      • Ridgewood, New Jersey, United States, 7450
        • Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Rehabilitation and Rheumatology, PC
      • Las Cruces, New Mexico, United States, 88011
        • Arthritis and Osteoporosis Associates
      • Los Alamos, New Mexico, United States, 87544
        • Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • The Center For Rheumatology, Llp
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Garden City, New York, United States, 11530
        • Investigational Site
      • Great Neck, New York, United States, 11021
        • Bay Rheumatology PC
      • Hewlett, New York, United States, 11557
        • Rheumatology Consultants, LLP
      • New York, New York, United States, 10021
        • Hospital For Special Surgery
      • New York, New York, United States, 10022
        • Research Across America - New York
      • Rochester, New York, United States, 14618
        • Allergy, Immunology, Rheumatology Clinical Group
      • Rochester, New York, United States, 14618
        • Arthritis Center of Rochester
      • Smithtown, New York, United States, 11787
        • Rheumatology Associates of Long Island
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Arthritis Health Associates
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Thurston Arthritis Research Center
      • Charlotte, North Carolina, United States, 28204
        • Joint and Muscle Medical Care
      • Charlotte, North Carolina, United States, 28210
        • Arthritis Clinic & Carolina Bone & Joint
      • Fayetteville, North Carolina, United States, 28304
        • LaFayette Clinic, PA
      • Greenville, North Carolina, United States, 27834
        • Physicians East
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates, P.A.
    • North Dakota
      • Bismarck, North Dakota, United States, 58506
        • Medcenter One
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center Of Akron D/B/A Akron Children's Hospital
      • Akron, Ohio, United States, 44333
        • Crystal Arthritis Center Inc.
      • Canton, Ohio, United States, 44718
        • Arthritis Clinic of Stark County, Inc.
      • Cincinnati, Ohio, United States, 45236
        • Arthritis Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43215
        • Columbus Arthritis Center
      • Dayton, Ohio, United States, 45432
        • Dayton Outpatient Center
      • Middleburg Heights, Ohio, United States, 44130
        • Southwest Rheumatology and Research Goup, LLC
      • Orange Village, Ohio, United States, 44122
        • University Hospitals Case Medical Center
      • Toledo, Ohio, United States, 43606
        • Arthritis Associates of Northwest Ohio, Inc.
    • Oregon
      • Salem, Oregon, United States, 97302
        • Physicians Building Group, LLP
    • Pennsylvania
      • Colmar, Pennsylvania, United States, 18915
        • Rheumatology Associates, LTD
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Lebanon, Pennsylvania, United States, 17042
        • Lebanon Internal Medicine Associates, P.C.
      • Monroeville, Pennsylvania, United States, 15146
        • Arthritis & Rheumatic Disease Associates, LLC
      • Philadelphia, Pennsylvania, United States, 19152
        • The Arthritis Group
      • Philadelphia, Pennsylvania, United States, 19141
        • Einstein Arthritis Center
      • West Chester, Pennsylvania, United States, 19380
        • Investigational Site
      • West Reading, Pennsylvania, United States, 19611
        • Clinical Research Center of Reading, LLP
      • Wexford, Pennsylvania, United States, 15090
        • Allegheny North Arthritis Center, PC
      • Wynnewood, Pennsylvania, United States, 19096
        • Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Rheumatology Associates
      • Florence, South Carolina, United States, 29506
        • Carolina Healthcare
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Rheumatology and Neurology Associates, PC
      • Myrtle Beach, South Carolina, United States, 29572
        • Strand Physician Specialists PA DBA Carolina Health Specialists
      • Orangeburg, South Carolina, United States, 29118
        • Acme Research, L.L.C.
      • Spartanburg, South Carolina, United States, 29303
        • Carolina Medical Affiliates
    • Tennessee
      • Crossville, Tennessee, United States, 38555
        • CMC Speciality Group
      • Knoxville, Tennessee, United States, 37909-1900
        • Rheumatology Consultants Pllc
      • Nashville, Tennessee, United States, 37203-1870
        • Heritage Medical Associates, P.C.
    • Texas
      • Abilene, Texas, United States, 79601
        • Abilene Arthritis Center
      • Bedford, Texas, United States, 76021
        • Investigational Site
      • Carrollton, Texas, United States, 75007
        • Arthritis Clinic
      • Dallas, Texas, United States, 75231
        • Investigational Site
      • Dallas, Texas, United States, 75231
        • Presbyterian Hospital Dallas Arthritis Consultation Center
      • Dallas, Texas, United States, 75235
        • Rheumatology Associates
      • Houston, Texas, United States, 77004
        • Rheumatic Disease Clinic of Houston
      • Houston, Texas, United States, 77008
        • Evergreen Clinical Research, LLC
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center
      • Midland, Texas, United States, 79701
        • Arthritis & Osteoporosis Center
      • San Antonio, Texas, United States, 78217
        • Center for Arthritis and Rheumatic Diseases
    • Virginia
      • Burke, Virginia, United States, 22015
        • Arthritis and Rheumatic Disease Associates, PC
      • Chesapeake, Virginia, United States, 23320
        • Center for Arthritis & Rheumatic Diseases, P.C.
      • Norfolk, Virginia, United States, 23502
        • NDC Medical Center
      • Portsmouth, Virginia, United States, 23701
        • Investigational Site
      • Reston, Virginia, United States, 20190
        • Northern Virginia Center for Arthritis
      • Richmond, Virginia, United States, 23294
        • Premier HealthCare Associates Inc.
      • Williamsburg, Virginia, United States, 23185
        • Arthritis and Rheumatic Diseases, PC
    • Washington
      • Kirkland, Washington, United States, 98034
        • Investigational Site
      • Seattle, Washington, United States, 98195-6428
        • University of Washington Medical Center
      • Tacoma, Washington, United States, 98405
        • Investigational Site
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology & Pulmonary Clinic
      • Martinsburg, West Virginia, United States, 25401
        • Rural Outreach Arthritis Center
    • Wisconsin
      • Glendale, Wisconsin, United States, 53217
        • Rheumatic Disease Center
      • Madison, Wisconsin, United States, 53792-3244
        • University of Wisconsin Hospital and Clinics
      • Onalaska, Wisconsin, United States, 54650
        • Gundersen Clinic, Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with RA who have had an inadequate response to one or more anti-TNF therapies

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Collaborators

Biogen

Investigators

  • Study Director: Swati Tole, M.D., M.S., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U3839g
  • BIIB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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