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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00443443
First received: March 2, 2007
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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.


Condition Phase
Rheumatoid Arthritis
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Enrollment: 1026
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443443

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00443443     History of Changes
Other Study ID Numbers: U3839g, BIIB
Study First Received: March 2, 2007
Last Updated: September 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Rituximab
RA
Sunstone
anti-TNF
Rituxan

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014