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Rheumatoid ArthritisSUNSTONENCT00443443

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

An observational study of Rheumatoid Arthritis, run by Genentech, Inc. at 193 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
1,026 participants
Where
193 sitesin 2 countries
Study dates
Jan 2007to Sep 2013
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

193 sites in 2 countries.

193 sites in 2 countries

United States192 sites

  • Abilene Arthritis Center

    Abilene, Texas, 79601

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

    Akron, Ohio, 44308

  • Crystal Arthritis Center Inc.

    Akron, Ohio, 44333

  • The Center for Rheumatology, LLP

    Albany, New York, 12206

  • Albuquerque Rehabilitation and Rheumatology, PC

    Albuquerque, New Mexico, 87102

  • Ann Arbor Rheumatology

    Ann Arbor, Michigan, 48105

  • Ashland Arthritis Center

    Ashland, Kentucky, 41101

  • Georgia Internal Medicine Associates, PA

    Austell, Georgia, 30106

  • Investigational Site

    Baltimore, Maryland, 21237

  • Rheumatology Associates of Baltimore

    Baltimore, Maryland, 21286

  • Associated Internal Medicine Specialists, P.C.

    Battle Creek, Michigan, 49015

  • Rheumatology & Pulmonary Clinic

    Beckley, West Virginia, 25801

  • Investigational Site

    Bedford, Texas, 76021

  • The Arthritis & Osteoporosis Center, P.C.

    Billings, Montana, 59101

  • Rheumatology Associates, PC

    Birmingham, Alabama, 35205

  • Medcenter One

    Bismarck, North Dakota, 58506

  • RASF- Clinical Research

    Boca Raton, Florida, 33486

  • Graves Gilbert Clinic

    Bowling Green, Kentucky, 42101

  • Investigational Site

    Bridgeport, Connecticut, 6606

  • Michigan Arthritis Research Center

    Brighton, Michigan, 48116

  • Arthritis and Rheumatic Disease Associates, PC

    Burke, Virginia, 22015

  • Arthritis Clinic of Stark County, Inc.

    Canton, Ohio, 44718

  • Cape Girardeau Physician Associates

    Cape Girardeau, Missouri, 63703

  • Arthritis Clinic

    Carrollton, Texas, 75007

  • Physicians Clinic Of Iowa

    Cedar Rapids, Iowa, 52401

  • UNC Thurston Arthritis Research Center

    Chapel Hill, North Carolina, 27599

  • Rheumatology Associates

    Charleston, South Carolina, 29407

  • Joint and Muscle Medical Care

    Charlotte, North Carolina, 28204

  • Arthritis Clinic & Carolina Bone & Joint

    Charlotte, North Carolina, 28210

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

    Chesapeake, Virginia, 23320

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago

    Chicago, Illinois, 60637

  • Arthritis Center

    Cincinnati, Ohio, 45236

  • Countryside Arthritis Center

    Clearwater, Florida, 33761

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Rheumatology Associates, LTD

    Colmar, Pennsylvania, 18915

  • Columbus Arthritis Center

    Columbus, Ohio, 43215

  • Investigational Site

    Covina, California, 91723

  • CMC Speciality Group

    Crossville, Tennessee, 38555

  • Investigational Site

    Dallas, Texas, 75231

  • Presbyterian Hospital Dallas Arthritis Consultation Center

    Dallas, Texas, 75231

  • Rheumatology Associates

    Dallas, Texas, 75235

  • Clinical Research Center of CT/NY

    Danbury, Connecticut, 6810

  • Dayton Outpatient Center

    Dayton, Ohio, 45432

  • Northern Illinois Research Associates

    DeKalb, Illinois, 60115

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • National Jewish Medical and Research Center

    Denver, Colorado, 80206

  • Mercy Arthritis and Osteoporosis Center

    Des Moines, Iowa, 50322

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Allergy and Arthritis Associates

    Dover, New Jersey, 7801

  • Medical Associates Clinic PC

    Dubuque, Iowa, 52002

  • Whiteside Institute for Clinical Research

    Duluth, Minnesota, 55805

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology PA

    Eagan, Minnesota, 55121

  • Investigational Site

    East Lansing, Michigan, 48823

  • Lansing Rheumatology, PLLC

    East Lansing, Michigan, 48823

  • Maryland Arthritis Care Specialists

    Ellicott City, Maryland, 21042

  • Arthritis Medical Clinic of North County, Inc.

    Escondido, California, 92025

  • Solano Regional Medical Group

    Fairfield, California, 94534

  • University of CT Health Center

    Farmington, Connecticut, 6030

  • The Arthritis Center of the Ozarks

    Fayetteville, Arkansas, 72703

  • LaFayette Clinic, PA

    Fayetteville, North Carolina, 28304

  • Northampton Internal Medicine Associates, P.C.

    Florence, Massachusetts, 1062

  • Carolina Healthcare

    Florence, South Carolina, 29506

  • North County Medicine & Rheumatology

    Florissant, Missouri, 63031

  • Arthritis and Osteoporosis Treatment and Research Center

    Flowood, Mississippi, 39232

  • Arthritis and Rheumatology Clinic of Northern Colorado, LLC

    Fort Collins, Colorado, 80528

  • Clinical Trials of St. Jude Heritage Medical Group

    Fullerton, California, 92835

  • Arthritis Center of North Georgia

    Gainesville, Georgia, 30501

  • Investigational Site

    Garden City, New York, 11530

  • Rheumatic Disease Center

    Glendale, Wisconsin, 53217

  • Arthritis Education and Treatment Center, PLLC

    Grand Rapids, Michigan, 49546

  • Bay Rheumatology PC

    Great Neck, New York, 11021

  • Greeley Medical Clinic

    Greeley, Colorado, 80631

  • Physicians East

    Greenville, North Carolina, 27834

  • Hannibal Clinic

    Hannibal, Missouri, 63401

  • Arthritis Associates, PLLC

    Hattiesburg, Mississippi, 39402

  • Investigational Site

    Hemet, California, 92543

  • Osteoporosis and Arthritis Center

    Henderson, Nevada, 89052

  • Rheumatology Consultants, LLP

    Hewlett, New York, 11557

  • Rheumatic Disease Clinic of Houston

    Houston, Texas, 77004

  • Evergreen Clinical Research, LLC

    Houston, Texas, 77008

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

    Huntsville, Alabama, 35801

  • Institute of Arthritis Research

    Idaho Falls, Idaho, 83401

  • Cascades Rheumatology

    Jackson, Michigan, 49203

  • Prairie Rheumatology Associates, S.C.

    Joliet, Illinois, 60435

  • Investigational Site

    Kirkland, Washington, 98034

  • Rheumatology Consultants PLLC

    Knoxville, Tennessee, 37909-1900

  • Allergy and Rheumatology Medical Clinic, Inc

    La Jolla, California, 92037

  • Investigational Site

    La Mesa, California, 91941

  • Lafayette Arthritis & Endocrine Clinic

    Lafayette, Louisiana, 70503

  • Arthritis Center of Southern Orange County

    Laguna Hills, California, 92653

  • Arthritis and Osteoporosis Associates

    Las Cruces, New Mexico, 88011

  • Investigational Site

    Las Vegas, Nevada, 89128

  • North Georgia Rheumatology Group, PC

    Lawrenceville, Georgia, 30045

  • Lebanon Internal Medicine Associates, P.C.

    Lebanon, Pennsylvania, 17042

  • Investigational Site

    Lewiston, Maine, 4240

  • VA Loma Linda Healthcare System

    Loma Linda, California, 92357

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

    Long Beach, California, 90806

  • Colorado Center for Arthritis and Osteoporosis

    Longmont, Colorado, 80501

  • Investigational Site

    Los Alamos, New Mexico, 87544

  • Beverly Medical Associates

    Los Angeles, California, 90048

  • Investigational Site

    Los Angeles, California, 90048

  • Samaritan Center for Medical Research, Medical Group

    Los Gatos, California, 95032

  • Rheumatology Associates

    Louisville, Kentucky, 40218

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • Middle Georgia Arthritis Center

    Macon, Georgia, 31210

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-3244

  • Arthritis and Osteoporosis Associates, PA

    Manalapan, New Jersey, 7726

  • Rural Outreach Arthritis Center

    Martinsburg, West Virginia, 25401

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Rheumatology and Arthritis Associates, P.C.

    Medford, New Jersey, 8055

  • MIMA Century Research Associates

    Melbourne, Florida, 32901

  • Southwest Rheumatology and Research Goup, LLC

    Middleburg Heights, Ohio, 44130

  • Arthritis & Osteoporosis Center

    Midland, Texas, 79701

  • Investigational Site

    Midland Park, New Jersey, 7432

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • Mission Internal Medical Group- Rheumatology Division

    Mission Viejo, California, 92691

  • Arthritis Care Center, PC

    Moline, Illinois, 61265

  • Arthritis & Rheumatic Disease Associates, LLC

    Monroeville, Pennsylvania, 15146

  • Carolina Rheumatology and Neurology Associates, PC

    Myrtle Beach, South Carolina, 29572

  • Strand Physician Specialists PA DBA Carolina Health Specialists

    Myrtle Beach, South Carolina, 29572

  • Investigational Site

    Naples, Florida, 34102

  • Naples Medical Center

    Naples, Florida, 34102

  • Heritage Medical Associates, P.C.

    Nashville, Tennessee, 37203-1870

  • Hospital for Special Surgery

    New York, New York, 10021

  • Research Across America - New York

    New York, New York, 10022

  • Delaware Arthritis & Osteoporosis Center

    Newark, Delaware, 19713

  • Investigational Site

    Newport Beach, California, 92663

  • NDC Medical Center

    Norfolk, Virginia, 23502

  • Rheumatology Associates

    North Hollywood, California, 91607

  • Arthritis & Osteoporosis Treatment Research Center, Inc.

    North Miami Beach, Florida, 33180

  • The William W. Backus Hospital

    Norwich, Connecticut, 6360

  • Gundersen Clinic, Ltd.

    Onalaska, Wisconsin, 54650

  • University Hospitals Case Medical Center

    Orange, Ohio, 44122

  • Arthritis & Osteoporosis Treatment Center, P.A.

    Orange Park, Florida, 32073

  • Acme Research, L.L.C.

    Orangeburg, South Carolina, 29118

  • Investigational Site

    Orlando, Florida, 32804

  • Rheumatology Associates of Central Florida, PA

    Orlando, Florida, 32806

  • Desert Medical Advances

    Palm Desert, California, 92260

  • Arizona Arthritis and Rheumatology Research, PLLC

    Paradise Valley, Arizona, 85253

  • Investigational Site

    Pascagoula, Mississippi, 39581

  • Einstein Arthritis Center

    Philadelphia, Pennsylvania, 19141

  • The Arthritis Group

    Philadelphia, Pennsylvania, 19152

  • Phoenix Rheumatology Specialists, Ltd.

    Phoenix, Arizona, 85006

  • Investigational Site

    Portsmouth, Virginia, 23701

  • Northern Virginia Center for Arthritis

    Reston, Virginia, 20190

  • Premier HealthCare Associates Inc.

    Richmond, Virginia, 23294

  • Investigational Site

    Ridgewood, New Jersey, 7450

  • Arthritis Medical Clinic

    Riverside, California, 92501

  • Allergy, Immunology, Rheumatology Clinical Group

    Rochester, New York, 14618

  • Arthritis Center of Rochester

    Rochester, New York, 14618

  • Rockford Orthopedic Associates

    Rockford, Illinois, 61107

  • Shores Rheumatology P.C.

    Saint Clair Shores, Michigan, 48081

  • Southwest MI Rheumatology Center

    Saint Joseph, Michigan, 49085

  • Physicians Building Group, LLP

    Salem, Oregon, 97302

  • Center for Arthritis and Rheumatic Diseases

    San Antonio, Texas, 78217

  • East Bay Rheumatology Medical Group

    San Leandro, California, 94578

  • Pacific Arthritis Center Medical Group

    Santa Maria, California, 93454

  • Integrative Pain Medicine

    Schaumburg, Illinois, 60195

  • Advanced Arthritis Care & Research

    Scottsdale, Arizona, 85258

  • University of Washington Medical Center

    Seattle, Washington, 98195-6428

  • Rheumatology Associates of Long Island

    Smithtown, New York, 11787

  • Carolina Medical Affiliates

    Spartanburg, South Carolina, 29303

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

    St Louis, Missouri, 63131

  • Suncoast Medical Clinic, LLC

    St. Petersburg, Florida, 33701

  • Arthritis Health Associates

    Syracuse, New York, 13210

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Investigational Site

    Tacoma, Washington, 98405

  • Brookshire Rheumatology & Wellness Center

    Tampa, Florida, 33618

  • Lake Rheumatology

    Tavares, Florida, 32778

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Arthritis and Osteoporosis Center of South Georgia

    Tifton, Georgia, 31794

  • Arthritis Associates of Northwest Ohio, Inc.

    Toledo, Ohio, 43606

  • Healthcare Partners Medical Group

    Torrance, California, 90503

  • Investigational Site

    Torrance, California, 90505

  • NMMC-IMA Tupelo

    Tupelo, Mississippi, 38801

  • Clinic for Rheumatic Diseases - Research Department

    Tuscaloosa, Alabama, 35406

  • Valdosta Specialty Clinic

    Valdosta, Georgia, 31602

  • Desert Valley Medical Group

    Victorville, California, 92395

  • Investigational Site

    Visalia, California, 93291

  • VAMC

    Washington D.C., District of Columbia, 20422

  • Investigational Site

    West Chester, Pennsylvania, 19380

  • Clinical Research Center of Reading, LLP

    West Reading, Pennsylvania, 19611

  • Allegheny North Arthritis Center, PC

    Wexford, Pennsylvania, 15090

  • Agilence Arthritis & Osteoporosis Medical Center, Inc.

    Whittier, California, 90606

  • Arthritis and Rheumatology Clinics of Kansas

    Wichita, Kansas, 67220

  • Arthritis and Rheumatic Diseases, PC

    Williamsburg, Virginia, 23185

  • Carolina Arthritis Associates, P.A.

    Wilmington, North Carolina, 28401

  • Investigational Site

    Wynnewood, Pennsylvania, 19096

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33542

Other trials in United States

Puerto Rico1 site

  • San Juan Arthritis and Research Center, Inc.

    San Juan, 918

Other trials in Puerto Rico

About this study

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)

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.

Keywords
Rituximab, RA, Sunstone, anti-TNF, Rituxan
Medical subject headings
Arthritis, Rheumatoid

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,026 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00443443
Sponsor's protocol ID
U3839g
Other IDs
BIIB
Acronym
SUNSTONE
Status last verified
Mar 2015
First submitted
2 Mar 2007
Last updated
30 Mar 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Genentech, Inc. at 193 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00443443.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.

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