Rheumatoid Arthritis Clinical Trial
— SUNSTONEOfficial 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)
| Verified date | March 2015 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1026 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | San Juan Arthritis and Research Center, Inc. | San Juan | |
| United States | Abilene Arthritis Center | Abilene | Texas |
| United States | Children's Hospital Medical Center of Akron d/b/a Akron Children's Hospital | Akron | Ohio |
| United States | Crystal Arthritis Center Inc. | Akron | Ohio |
| United States | The Center for Rheumatology, LLP | Albany | New York |
| United States | Albuquerque Rehabilitation and Rheumatology, PC | Albuquerque | New Mexico |
| United States | Ann Arbor Rheumatology | Ann Arbor | Michigan |
| United States | Ashland Arthritis Center | Ashland | Kentucky |
| United States | Georgia Internal Medicine Associates, PA | Austell | Georgia |
| United States | Investigational Site | Baltimore | Maryland |
| United States | Rheumatology Associates of Baltimore | Baltimore | Maryland |
| United States | Associated Internal Medicine Specialists, P.C. | Battle Creek | Michigan |
| United States | Rheumatology & Pulmonary Clinic | Beckley | West Virginia |
| United States | Investigational Site | Bedford | Texas |
| United States | The Arthritis & Osteoporosis Center, P.C. | Billings | Montana |
| United States | Rheumatology Associates, PC | Birmingham | Alabama |
| United States | Medcenter One | Bismarck | North Dakota |
| United States | RASF- Clinical Research | Boca Raton | Florida |
| United States | Graves Gilbert Clinic | Bowling Green | Kentucky |
| United States | Investigational Site | Bridgeport | Connecticut |
| United States | Michigan Arthritis Research Center | Brighton | Michigan |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Arthritis and Rheumatic Disease Associates, PC | Burke | Virginia |
| United States | Arthritis Clinic of Stark County, Inc. | Canton | Ohio |
| United States | Cape Girardeau Physician Associates | Cape Girardeau | Missouri |
| United States | Arthritis Clinic | Carrollton | Texas |
| United States | Physicians Clinic Of Iowa | Cedar Rapids | Iowa |
| United States | UNC Thurston Arthritis Research Center | Chapel Hill | North Carolina |
| United States | Rheumatology Associates | Charleston | South Carolina |
| United States | Arthritis Clinic & Carolina Bone & Joint | Charlotte | North Carolina |
| United States | Joint and Muscle Medical Care | Charlotte | North Carolina |
| United States | Center for Arthritis & Rheumatic Diseases, P.C. | Chesapeake | Virginia |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | The University of Chicago | Chicago | Illinois |
| United States | Arthritis Center | Cincinnati | Ohio |
| United States | Countryside Arthritis Center | Clearwater | Florida |
| United States | MetroHealth Medical Center | Cleveland | Ohio |
| United States | The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | Rheumatology Associates, LTD | Colmar | Pennsylvania |
| United States | Columbus Arthritis Center | Columbus | Ohio |
| United States | Investigational Site | Covina | California |
| United States | CMC Speciality Group | Crossville | Tennessee |
| United States | Investigational Site | Dallas | Texas |
| United States | Presbyterian Hospital Dallas Arthritis Consultation Center | Dallas | Texas |
| United States | Rheumatology Associates | Dallas | Texas |
| United States | Clinical Research Center of CT/NY | Danbury | Connecticut |
| United States | Dayton Outpatient Center | Dayton | Ohio |
| United States | Northern Illinois Research Associates | DeKalb | Illinois |
| United States | Denver Health Medical Center | Denver | Colorado |
| United States | National Jewish Medical and Research Center | Denver | Colorado |
| United States | Mercy Arthritis and Osteoporosis Center | Des Moines | Iowa |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Allergy and Arthritis Associates | Dover | New Jersey |
| United States | Medical Associates Clinic PC | Dubuque | Iowa |
| United States | Whiteside Institute for Clinical Research | Duluth | Minnesota |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | St. Paul Rheumatology PA | Eagan | Minnesota |
| United States | Investigational Site | East Lansing | Michigan |
| United States | Lansing Rheumatology, PLLC | East Lansing | Michigan |
| United States | Maryland Arthritis Care Specialists | Ellicott City | Maryland |
| United States | Arthritis Medical Clinic of North County, Inc. | Escondido | California |
| United States | Solano Regional Medical Group | Fairfield | California |
| United States | University of CT Health Center | Farmington | Connecticut |
| United States | LaFayette Clinic, PA | Fayetteville | North Carolina |
| United States | The Arthritis Center of the Ozarks | Fayetteville | Arkansas |
| United States | Carolina Healthcare | Florence | South Carolina |
| United States | Northampton Internal Medicine Associates, P.C. | Florence | Massachusetts |
| United States | North County Medicine & Rheumatology | Florissant | Missouri |
| United States | Arthritis and Osteoporosis Treatment and Research Center | Flowood | Mississippi |
| United States | Arthritis and Rheumatology Clinic of Northern Colorado, LLC | Fort Collins | Colorado |
| United States | Clinical Trials of St. Jude Heritage Medical Group | Fullerton | California |
| United States | Arthritis Center of North Georgia | Gainesville | Georgia |
| United States | Investigational Site | Garden City | New York |
| United States | Rheumatic Disease Center | Glendale | Wisconsin |
| United States | Arthritis Education and Treatment Center, PLLC | Grand Rapids | Michigan |
| United States | Bay Rheumatology PC | Great Neck | New York |
| United States | Greeley Medical Clinic | Greeley | Colorado |
| United States | Physicians East | Greenville | North Carolina |
| United States | Hannibal Clinic | Hannibal | Missouri |
| United States | Arthritis Associates, PLLC | Hattiesburg | Mississippi |
| United States | Investigational Site | Hemet | California |
| United States | Osteoporosis and Arthritis Center | Henderson | Nevada |
| United States | Rheumatology Consultants, LLP | Hewlett | New York |
| United States | Evergreen Clinical Research, LLC | Houston | Texas |
| United States | Rheumatic Disease Clinic of Houston | Houston | Texas |
| United States | Rheumatology Associates of N. AL, P.C. | Huntsville | Alabama |
| United States | Institute of Arthritis Research | Idaho Falls | Idaho |
| United States | Cascades Rheumatology | Jackson | Michigan |
| United States | Prairie Rheumatology Associates, S.C. | Joliet | Illinois |
| United States | Investigational Site | Kirkland | Washington |
| United States | Rheumatology Consultants PLLC | Knoxville | Tennessee |
| United States | Allergy and Rheumatology Medical Clinic, Inc | La Jolla | California |
| United States | Investigational Site | La Mesa | California |
| United States | Lafayette Arthritis & Endocrine Clinic | Lafayette | Louisiana |
| United States | Arthritis Center of Southern Orange County | Laguna Hills | California |
| United States | Arthritis and Osteoporosis Associates | Las Cruces | New Mexico |
| United States | Investigational Site | Las Vegas | Nevada |
| United States | North Georgia Rheumatology Group, PC | Lawrenceville | Georgia |
| United States | Lebanon Internal Medicine Associates, P.C. | Lebanon | Pennsylvania |
| United States | Investigational Site | Lewiston | Maine |
| United States | VA Loma Linda Healthcare System | Loma Linda | California |
| United States | Valerius Medical Group and Research Center of Greater Long Beach, Inc. | Long Beach | California |
| United States | Colorado Center for Arthritis and Osteoporosis | Longmont | Colorado |
| United States | Investigational Site | Los Alamos | New Mexico |
| United States | Beverly Medical Associates | Los Angeles | California |
| United States | Investigational Site | Los Angeles | California |
| United States | Samaritan Center for Medical Research, Medical Group | Los Gatos | California |
| United States | Rheumatology Associates | Louisville | Kentucky |
| United States | Texas Tech University Health Sciences Center | Lubbock | Texas |
| United States | Middle Georgia Arthritis Center | Macon | Georgia |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | Arthritis and Osteoporosis Associates, PA | Manalapan | New Jersey |
| United States | Rural Outreach Arthritis Center | Martinsburg | West Virginia |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Rheumatology and Arthritis Associates, P.C. | Medford | New Jersey |
| United States | MIMA Century Research Associates | Melbourne | Florida |
| United States | Southwest Rheumatology and Research Goup, LLC | Middleburg Heights | Ohio |
| United States | Arthritis & Osteoporosis Center | Midland | Texas |
| United States | Investigational Site | Midland Park | New Jersey |
| United States | Minneapolis VA Medical Center | Minneapolis | Minnesota |
| United States | Mission Internal Medical Group- Rheumatology Division | Mission Viejo | California |
| United States | Arthritis Care Center, PC | Moline | Illinois |
| United States | Arthritis & Rheumatic Disease Associates, LLC | Monroeville | Pennsylvania |
| United States | Carolina Rheumatology and Neurology Associates, PC | Myrtle Beach | South Carolina |
| United States | Strand Physician Specialists PA DBA Carolina Health Specialists | Myrtle Beach | South Carolina |
| United States | Investigational Site | Naples | Florida |
| United States | Naples Medical Center | Naples | Florida |
| United States | Heritage Medical Associates, P.C. | Nashville | Tennessee |
| United States | Hospital for Special Surgery | New York | New York |
| United States | Research Across America - New York | New York | New York |
| United States | Delaware Arthritis & Osteoporosis Center | Newark | Delaware |
| United States | Investigational Site | Newport Beach | California |
| United States | NDC Medical Center | Norfolk | Virginia |
| United States | Rheumatology Associates | North Hollywood | California |
| United States | Arthritis & Osteoporosis Treatment Research Center, Inc. | North Miami Beach | Florida |
| United States | The William W. Backus Hospital | Norwich | Connecticut |
| United States | Gundersen Clinic, Ltd. | Onalaska | Wisconsin |
| United States | Arthritis & Osteoporosis Treatment Center, P.A. | Orange Park | Florida |
| United States | University Hospitals Case Medical Center | Orange Village | Ohio |
| United States | Acme Research, L.L.C. | Orangeburg | South Carolina |
| United States | Investigational Site | Orlando | Florida |
| United States | Rheumatology Associates of Central Florida, PA | Orlando | Florida |
| United States | Desert Medical Advances | Palm Desert | California |
| United States | Arizona Arthritis and Rheumatology Research, PLLC | Paradise Valley | Arizona |
| United States | Investigational Site | Pascagoula | Mississippi |
| United States | Einstein Arthritis Center | Philadelphia | Pennsylvania |
| United States | The Arthritis Group | Philadelphia | Pennsylvania |
| United States | Phoenix Rheumatology Specialists, Ltd. | Phoenix | Arizona |
| United States | Investigational Site | Portsmouth | Virginia |
| United States | Northern Virginia Center for Arthritis | Reston | Virginia |
| United States | Premier HealthCare Associates Inc. | Richmond | Virginia |
| United States | Investigational Site | Ridgewood | New Jersey |
| United States | Arthritis Medical Clinic | Riverside | California |
| United States | Allergy, Immunology, Rheumatology Clinical Group | Rochester | New York |
| United States | Arthritis Center of Rochester | Rochester | New York |
| United States | Rockford Orthopedic Associates | Rockford | Illinois |
| United States | Shores Rheumatology P.C. | Saint Clair Shores | Michigan |
| United States | Southwest MI Rheumatology Center | Saint Joseph | Michigan |
| United States | Physicians Building Group, LLP | Salem | Oregon |
| United States | Center for Arthritis and Rheumatic Diseases | San Antonio | Texas |
| United States | East Bay Rheumatology Medical Group | San Leandro | California |
| United States | Pacific Arthritis Center Medical Group | Santa Maria | California |
| United States | Integrative Pain Medicine | Schaumburg | Illinois |
| United States | Advanced Arthritis Care & Research | Scottsdale | Arizona |
| United States | University of Washington Medical Center | Seattle | Washington |
| United States | Rheumatology Associates of Long Island | Smithtown | New York |
| United States | Carolina Medical Affiliates | Spartanburg | South Carolina |
| United States | Rheumatology and Internal Medicine Associates of West County, P.C. | St. Louis | Missouri |
| United States | Suncoast Medical Clinic, LLC | St. Petersburg | Florida |
| United States | Arthritis Health Associates | Syracuse | New York |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | Investigational Site | Tacoma | Washington |
| United States | Brookshire Rheumatology & Wellness Center | Tampa | Florida |
| United States | Lake Rheumatology | Tavares | Florida |
| United States | Arthritis and Osteoporosis Center of South Georgia | Tifton | Georgia |
| United States | Arthritis Associates of Northwest Ohio, Inc. | Toledo | Ohio |
| United States | Healthcare Partners Medical Group | Torrance | California |
| United States | Investigational Site | Torrance | California |
| United States | NMMC-IMA Tupelo | Tupelo | Mississippi |
| United States | Clinic for Rheumatic Diseases - Research Department | Tuscaloosa | Alabama |
| United States | Valdosta Specialty Clinic | Valdosta | Georgia |
| United States | Desert Valley Medical Group | Victorville | California |
| United States | Investigational Site | Visalia | California |
| United States | VAMC | Washington | District of Columbia |
| United States | Investigational Site | West Chester | Pennsylvania |
| United States | Clinical Research Center of Reading, LLP | West Reading | Pennsylvania |
| United States | Allegheny North Arthritis Center, PC | Wexford | Pennsylvania |
| United States | Agilence Arthritis & Osteoporosis Medical Center, Inc. | Whittier | California |
| United States | Arthritis and Rheumatology Clinics of Kansas | Wichita | Kansas |
| United States | Arthritis and Rheumatic Diseases, PC | Williamsburg | Virginia |
| United States | Carolina Arthritis Associates, P.A. | Wilmington | North Carolina |
| United States | Investigational Site | Wynnewood | Pennsylvania |
| United States | Florida Medical Clinic, P.A. | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. | Biogen |
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