A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331837
First received: April 7, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events of RoActemra/Actemra (tocilizumab) in comparison to etanercept in patients with rheumatoid arthritis. Patients will be randomized to receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks or 50 mg etanercept subcutaneously weekly. The anticipated time on study drug is up to 5 years.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease, Rheumatoid Arthritis |
Drug: tocilizumab [RoActemra/Actemra] Drug: etanercept |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Ischemic Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Time from randomization to occurrence of the primary major adverse adverse cardiac events, defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time from randomization to occurrence of composite endpoint of major events, non-fatal coronary revascularization procedures and hospitalization for unstable angina [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2800 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2017 |
| Estimated Primary Completion Date: | April 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks
|
| Active Comparator: 2 |
Drug: etanercept
50 mg subcutaneously weekly
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Adult patients, >/=50 years of age
- Patients with moderate to severe rheumatoid arthritis >/=6 months duration
- Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD)
- History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
Exclusion Criteria:
- Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start
- Rheumatic autoimmune disease other than rheumatoid arthritis
- History of, or current, inflammatory joint disease other than rheumatoid arthritis
- Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome)
- History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
- Active current infection or history of recurrent bacterial infection
- Previous treatment with tocilizumab or etanercept
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331837
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Contacts
| Contact: Please reference Study ID Number: WA25204 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Hide Study LocationsLocations
| United States, Alabama | |
| Recruiting | |
| Birmingham, Alabama, United States, 35294-7201 | |
| Recruiting | |
| Huntsville, Alabama, United States, 35801 | |
| Recruiting | |
| Tuscaloosa, Alabama, United States, 35406 | |
| United States, Arizona | |
| Recruiting | |
| Glendale, Arizona, United States, 85304 | |
| Recruiting | |
| Paradise Valley, Arizona, United States, 85253 | |
| Recruiting | |
| Peoria, Arizona, United States, 85381 | |
| Recruiting | |
| Scottsdale, Arizona, United States, 85258 | |
| Recruiting | |
| Tucson, Arizona, United States, 85712 | |
| Recruiting | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Recruiting | |
| Jonesboro, Arkansas, United States, 72401 | |
| Terminated | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Recruiting | |
| Covina, California, United States, 91723 | |
| Recruiting | |
| Huntington Beach, California, United States, 92646 | |
| Recruiting | |
| La Jolla, California, United States, 92037 | |
| Recruiting | |
| Long Beach, California, United States, 90806 | |
| Recruiting | |
| Mission Viejo, California, United States, 92692 | |
| Recruiting | |
| Murrieta, California, United States, 92563 | |
| Terminated | |
| Poway, California, United States, 92064 | |
| Terminated | |
| San Diego, California, United States, 92108 | |
| Recruiting | |
| San Diego, California, United States, 92120 | |
| Recruiting | |
| San Leandro, California, United States, 94578 | |
| Terminated | |
| Santa Maria, California, United States, 93454 | |
| Completed | |
| Santa Monica, California, United States, 90404 | |
| Recruiting | |
| Torrance, California, United States, 90509 | |
| Recruiting | |
| Upland, California, United States, 91786 | |
| Recruiting | |
| Van Nuys, California, United States, 91405 | |
| United States, Colorado | |
| Recruiting | |
| Colorado Springs, Colorado, United States, 80910 | |
| United States, Connecticut | |
| Recruiting | |
| Bridgeport, Connecticut, United States, 06606 | |
| Recruiting | |
| Farmington, Connecticut, United States, 06030 | |
| Terminated | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| Recruiting | |
| Boynton Beach, Florida, United States, 33472 | |
| Completed | |
| Coral Gables, Florida, United States, 33134 | |
| Recruiting | |
| Daytona Beach, Florida, United States, 32117 | |
| Not yet recruiting | |
| Gainesville, Florida, United States, 30501 | |
| Recruiting | |
| Jacksonville, Florida, United States, 32216 | |
| Recruiting | |
| Miami, Florida, United States, 33126 | |
| Recruiting | |
| Orange Park, Florida, United States, 32073 | |
| Recruiting | |
| Palm Habor, Florida, United States, 34684 | |
| Recruiting | |
| Pensacola, Florida, United States, 32501 | |
| Recruiting | |
| South Miami, Florida, United States, 33143 | |
| Recruiting | |
| St. Petersburg, Florida, United States, 33708 | |
| Recruiting | |
| Tampa, Florida, United States, 33614 | |
| Recruiting | |
| Tampa, Florida, United States, 33609 | |
| Recruiting | |
| Venice, Florida, United States, 34292 | |
| United States, Georgia | |
| Terminated | |
| Atlanta, Georgia, United States, 30342 | |
| Terminated | |
| Atlanta, Georgia, United States, 30303 | |
| Recruiting | |
| Duluth, Georgia, United States, 30096 | |
| Recruiting | |
| Rome, Georgia, United States, 30165 | |
| Terminated | |
| Savannah, Georgia, United States, 31405 | |
| United States, Idaho | |
| Completed | |
| Boise, Idaho, United States, 83702 | |
| Recruiting | |
| Boise, Idaho, United States, 83702 | |
| Recruiting | |
| Boise, Idaho, United States, 83704 | |
| Recruiting | |
| Coeur D'alene, Idaho, United States, 83814 | |
| Recruiting | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| Terminated | |
| Chicago, Illinois, United States, 60612 | |
| Recruiting | |
| Chicago, Illinois, United States, 60616 | |
| Recruiting | |
| Peoria, Illinois, United States, 61602 | |
| United States, Indiana | |
| Recruiting | |
| Fort Wayne, Indiana, United States, 46804 | |
| Recruiting | |
| Indianapolis, Indiana, United States, 46227 | |
| Recruiting | |
| South Bend, Indiana, United States, 46601 | |
| United States, Kentucky | |
| Recruiting | |
| Bowling Green, Kentucky, United States, 42101 | |
| Recruiting | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Louisiana | |
| Recruiting | |
| Monroe, Louisiana, United States, 71203 | |
| Recruiting | |
| New Orleans, Louisiana, United States, 70121 | |
| United States, Maryland | |
| Terminated | |
| Baltimore, Maryland, United States, 21286 | |
| Recruiting | |
| Hagerstown, Maryland, United States, 21740 | |
| Recruiting | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| Terminated | |
| Fall River, Massachusetts, United States, 02720 | |
| Recruiting | |
| Worcester, Massachusetts, United States, 01610 | |
| Recruiting | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, Michigan | |
| Recruiting | |
| Flint, Michigan, United States, 48503 | |
| Recruiting | |
| Kalamazoo, Michigan, United States, 49009 | |
| Recruiting | |
| Lansing, Michigan, United States, 48910 | |
| Recruiting | |
| Petoskey, Michigan, United States, 49770 | |
| United States, Minnesota | |
| Recruiting | |
| Eagan, Minnesota, United States, 55121 | |
| Recruiting | |
| Minneapolis, Minnesota, United States, 55417 | |
| Recruiting | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| Recruiting | |
| Flowood, Mississippi, United States, 39232 | |
| Recruiting | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Montana | |
| Recruiting | |
| Kalispell, Montana, United States, 59901 | |
| United States, Nebraska | |
| Recruiting | |
| Omaha, Nebraska, United States, 68198 | |
| United States, Nevada | |
| Terminated | |
| Las Vegas, Nevada, United States, 89123 | |
| Recruiting | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Hampshire | |
| Recruiting | |
| Lebanon, New Hampshire, United States, 03756 | |
| Recruiting | |
| Nashua, New Hampshire, United States, 03060 | |
| United States, New Jersey | |
| Terminated | |
| Berkeley Heights, New Jersey, United States, 07922 | |
| Recruiting | |
| Teaneck, New Jersey, United States, 07666 | |
| Recruiting | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New Mexico | |
| Recruiting | |
| Albuquerque, New Mexico, United States, 87102 | |
| Recruiting | |
| Las Cruces, New Mexico, United States, 88011 | |
| United States, New York | |
| Recruiting | |
| Brooklyn, New York, United States, 11201 | |
| Recruiting | |
| Brooklyn, New York, United States, 11203 | |
| Terminated | |
| North Massapequa, New York, United States, 11758 | |
| Recruiting | |
| Olean, New York, United States, 14760 | |
| Recruiting | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Recruiting | |
| Asheville, North Carolina, United States, 28803 | |
| Recruiting | |
| Charlotte, North Carolina, United States, 28210 | |
| Recruiting | |
| Charlotte, North Carolina, United States, 28204 | |
| Recruiting | |
| Durham, North Carolina, United States, 27704 | |
| Recruiting | |
| Hickory, North Carolina, United States, 28602 | |
| Recruiting | |
| Raleigh, North Carolina, United States, 27617 | |
| Recruiting | |
| Sanford, North Carolina, United States, 27330 | |
| Recruiting | |
| Wilmington, North Carolina, United States, 28401 | |
| United States, North Dakota | |
| Recruiting | |
| Minot, North Dakota, United States, 58701 | |
| United States, Ohio | |
| Recruiting | |
| Cincinnati, Ohio, United States, 45219 | |
| Recruiting | |
| Cleveland, Ohio, United States, 44109 | |
| Recruiting | |
| Columbus, Ohio, United States, 43210 | |
| Recruiting | |
| Columbus, Ohio, United States, 43215 | |
| Recruiting | |
| Perryburg, Ohio, United States, 43551 | |
| Recruiting | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oklahoma | |
| Recruiting | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Pennsylvania | |
| Recruiting | |
| Duncansville, Pennsylvania, United States, 16635 | |
| Recruiting | |
| Hershey, Pennsylvania, United States, 17033 | |
| Recruiting | |
| Indiana, Pennsylvania, United States, 15701 | |
| Terminated | |
| Limerick, Pennsylvania, United States, 19468 | |
| Recruiting | |
| Philadelphia, Pennsylvania, United States, 19152 | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| Recruiting | |
| Souderton, Pennsylvania, United States, 18964 | |
| Recruiting | |
| Wyomissing, Pennsylvania, United States, 19610 | |
| United States, South Carolina | |
| Terminated | |
| Columbia, South Carolina, United States, 29204 | |
| Recruiting | |
| Myrtle Beach, South Carolina, United States, 29572 | |
| United States, South Dakota | |
| Terminated | |
| Watertown, South Dakota, United States, 57201 | |
| United States, Tennessee | |
| Recruiting | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Recruiting | |
| Amarillo, Texas, United States, 79124 | |
| Recruiting | |
| Corpus Christi, Texas, United States, 78463 | |
| Recruiting | |
| Dallas, Texas, United States, 75231 | |
| Recruiting | |
| Fort Worth, Texas, United States, 76109 | |
| Recruiting | |
| Houston, Texas, United States, 77074 | |
| Recruiting | |
| Houston, Texas, United States, 77004 | |
| Recruiting | |
| Mesquite, Texas, United States, 75150 | |
| Terminated | |
| Richardson, Texas, United States, 75080 | |
| Recruiting | |
| San Antonio, Texas, United States, 78217 | |
| Recruiting | |
| Waco, Texas, United States, 76708 | |
| United States, Virginia | |
| Terminated | |
| Burke, Virginia, United States, 22015 | |
| Recruiting | |
| Norfolk, Virginia, United States, 23502 | |
| United States, Washington | |
| Recruiting | |
| Kennewick, Washington, United States, 99336 | |
| Terminated | |
| Seattle, Washington, United States, 98104 | |
| Terminated | |
| Tacoma, Washington, United States, 98405 | |
| United States, West Virginia | |
| Terminated | |
| Beckley, West Virginia, United States, 25801 | |
| Recruiting | |
| Clarksburg, West Virginia, United States, 26301 | |
| United States, Wisconsin | |
| Recruiting | |
| Racine, Wisconsin, United States, 53406 | |
| Argentina | |
| Recruiting | |
| Buenos Aires, Argentina, C1122AAL | |
| Recruiting | |
| Buenos Aires, Argentina, C1426AAL | |
| Recruiting | |
| Buenos Aires, Argentina, C1425DTG | |
| Recruiting | |
| Buenos Aires, Argentina, C1117ABK | |
| Recruiting | |
| Buenos Aires, Argentina, C1194AAO | |
| Recruiting | |
| Buenos Aires, Argentina, C1015ABO | |
| Recruiting | |
| Buenos Aires, Argentina, C1431FWO | |
| Recruiting | |
| Ciudad Autonoma Bs As, Argentina, 1264 | |
| Recruiting | |
| Ciudad Autonoma Buenos Aires, Argentina, C1157ADP | |
| Recruiting | |
| Ciudad Autonoma Buenos Aires, Argentina, C1221ADC | |
| Recruiting | |
| Cordoba, Argentina, X5000EDC | |
| Recruiting | |
| Cordoba, Argentina, X5004BAL | |
| Recruiting | |
| Cordoba Pcia, Argentina, 5016 | |
| Recruiting | |
| Florencio Varela, Argentina, CP1888 | |
| Recruiting | |
| Lujan, Argentina, 6700 | |
| Recruiting | |
| Pergamino, Argentina, B2700CPM | |
| Recruiting | |
| Rosario, Argentina, S2000DSV | |
| Recruiting | |
| Rosario, Santa Fe, Argentina, S2000PBJ | |
| Recruiting | |
| San Juan, Argentina, 5400 | |
| Recruiting | |
| San Miguel de Tucuman, Argentina, 4000 | |
| Recruiting | |
| Tucuman, Argentina, 4000 | |
| Austria | |
| Recruiting | |
| Graz, Austria, 8036 | |
| Recruiting | |
| Stockerau, Austria, 2000 | |
| Recruiting | |
| Wien, Austria, 1090 | |
| Recruiting | |
| Wien, Austria, 1100 | |
| Recruiting | |
| Wien, Austria, 1130 | |
| Belgium | |
| Terminated | |
| Bruxelles, Belgium, 1000 | |
| Recruiting | |
| Bruxelles, Belgium, 1200 | |
| Terminated | |
| Kortrijk, Belgium, 8500 | |
| Recruiting | |
| Liege, Belgium, 4000 | |
| Recruiting | |
| Merksem, Belgium, 2170 | |
| Bosnia and Herzegovina | |
| Recruiting | |
| Banja Luka, Bosnia and Herzegovina, 78000 | |
| Recruiting | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Recruiting | |
| Sarajewo, Bosnia and Herzegovina, 71000 | |
| Recruiting | |
| Tuzla, Bosnia and Herzegovina, 75000 | |
| Canada, Alberta | |
| Recruiting | |
| Edmonton, Alberta, Canada, T5M 0H4 | |
| Canada, British Columbia | |
| Terminated | |
| Powell River, British Columbia, Canada, V8A 3B6 | |
| Recruiting | |
| Victoria, British Columbia, Canada, V8P 5P6 | |
| Canada, Newfoundland and Labrador | |
| Recruiting | |
| St John's, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Recruiting | |
| St John's, Newfoundland and Labrador, Canada, A1C 5B8 | |
| Canada, Ontario | |
| Recruiting | |
| Hamilton, Ontario, Canada, L8N 1Y2 | |
| Recruiting | |
| Kitchener, Ontario, Canada, N2M 5N6 | |
| Recruiting | |
| London, Ontario, Canada, N6A 4V2 | |
| Recruiting | |
| Mississauga, Ontario, Canada, L5M 2V8 | |
| Recruiting | |
| St. Catharines, Ontario, Canada, L2N 7E4 | |
| Terminated | |
| Toronto, Ontario, Canada, M9C 2N5 | |
| Recruiting | |
| Toronto, Ontario, Canada, M5G 1Z5 | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada, H2L 1S6 | |
| Recruiting | |
| Quebec City, Quebec, Canada, G1V 3M7 | |
| Recruiting | |
| Sainte-foy, Quebec, Canada, G1W 4R4 | |
| Completed | |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Recruiting | |
| Trois-rivieres, Quebec, Canada, G8Z 1Y2 | |
| Chile | |
| Terminated | |
| La Serena, Chile, 1710216 | |
| Not yet recruiting | |
| Santiago, Chile, 7500035 | |
| Recruiting | |
| Santiago, Chile, 7501126 | |
| Recruiting | |
| Santiago, Chile, 8320112 | |
| Recruiting | |
| Temuco, Chile, 4780000 | |
| Recruiting | |
| Viña Del Mar, Chile, 2570017 | |
| Recruiting | |
| Viña Del Mar, Chile, 2520612 | |
| China | |
| Not yet recruiting | |
| Shanghai, China, 200127 | |
| Croatia | |
| Recruiting | |
| Karlovac, Croatia, 47000 | |
| Recruiting | |
| Krapinske Toplice, Croatia, 49217 | |
| Recruiting | |
| Rijeka, Croatia, 51000 | |
| Not yet recruiting | |
| Zagreb, Croatia, 10000 | |
| Recruiting | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Recruiting | |
| Brno, Czech Republic, 656 91 | |
| Recruiting | |
| Bruntal, Czech Republic, 792 01 | |
| Recruiting | |
| Hlucin, Czech Republic, 74801 | |
| Recruiting | |
| Hostivice, Czech Republic, 253 01 | |
| Recruiting | |
| Kladno, Czech Republic, 272 01 | |
| Recruiting | |
| Ostrava - Moravska Ostrava, Czech Republic, 702 00 | |
| Recruiting | |
| Praha, Czech Republic, 128 50 | |
| Recruiting | |
| Praha, Czech Republic, 140 59 | |
| Recruiting | |
| Praha 4, Czech Republic, 140 00 | |
| Not yet recruiting | |
| Praha 4 Nusle, Czech Republic, 140 00 | |
| Recruiting | |
| Sokolov, Czech Republic, 356 01 | |
| Recruiting | |
| Terezin, Czech Republic, 411 55 | |
| Recruiting | |
| Zlin, Czech Republic, 760 01 | |
| Ecuador | |
| Recruiting | |
| Cuenca, Ecuador, 101168 | |
| Recruiting | |
| Guayaquil, Ecuador, 593 | |
| Recruiting | |
| Quito, Ecuador, 1394 | |
| Recruiting | |
| Quito, Ecuador, 005932 | |
| Not yet recruiting | |
| Quito, Ecuador, 5932 | |
| France | |
| Recruiting | |
| Amiens, France, 80054 | |
| Recruiting | |
| Bordeaux, France, 33076 | |
| Recruiting | |
| Clermont Ferrand, France, 63003 | |
| Recruiting | |
| Corbeil Essonnes, France, 91106 | |
| Recruiting | |
| Echirolles, France, 38434 | |
| Recruiting | |
| Lyon, France, 69003 | |
| Recruiting | |
| Orléans, France, 45067 | |
| Recruiting | |
| Paris, France, 75571 | |
| Recruiting | |
| Paris, France, 75679 | |
| Recruiting | |
| Paris, France, 75651 | |
| Recruiting | |
| Rennes, France, 35033 | |
| Terminated | |
| Roubaix, France, 59056 | |
| Recruiting | |
| Rouen, France, 76031 | |
| Recruiting | |
| Saint-etienne, France, 42055 | |
| Recruiting | |
| Strasbourg, France, 67098 | |
| Recruiting | |
| Toulouse, France, 31059 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 10117 | |
| Recruiting | |
| Berlin, Germany, 14059 | |
| Recruiting | |
| Dresden, Germany, 01307 | |
| Recruiting | |
| Erlangen, Germany, 91056 | |
| Recruiting | |
| Erlangen, Germany, 91054 | |
| Recruiting | |
| Frankfurt, Germany, 60528 | |
| Recruiting | |
| Hamburg, Germany, 20246 | |
| Recruiting | |
| Hamburg, Germany, 22081 | |
| Recruiting | |
| Herne, Germany, 44652 | |
| Recruiting | |
| Hildesheim, Germany, 31134 | |
| Recruiting | |
| Koeln, Germany, 50937 | |
| Recruiting | |
| Leipzig, Germany, 04103 | |
| Recruiting | |
| Muenchen, Germany, 80337 | |
| Recruiting | |
| Muenchen, Germany, 81541 | |
| Recruiting | |
| Osnabrueck, Germany, 49074 | |
| Recruiting | |
| Ratingen, Germany, 40882 | |
| Greece | |
| Recruiting | |
| Athens, Greece, 11527 | |
| Recruiting | |
| Athens, Greece, 15121 | |
| Recruiting | |
| Crete, Greece, 71110 | |
| Recruiting | |
| Larissa, Greece, 41110 | |
| Recruiting | |
| Thessaloniki, Greece, 54642 | |
| Completed | |
| Thessaloniki, Greece, 546 36 | |
| Hungary | |
| Recruiting | |
| Budapest, Hungary, 1027 | |
| Recruiting | |
| Budapest, Hungary, 1033 | |
| Recruiting | |
| Budapest, Hungary, 1036 | |
| Recruiting | |
| Debrecen, Hungary, 4032 | |
| Recruiting | |
| Eger, Hungary, 3300 | |
| Recruiting | |
| Gyula, Hungary, 5700 | |
| Recruiting | |
| MOR, Hungary, 8060 | |
| Recruiting | |
| Szekesfehervar, Hungary, 8000 | |
| Recruiting | |
| Szekszard, Hungary, 7100 | |
| Recruiting | |
| Zalaegerszeg, Hungary, 8901 | |
| India | |
| Recruiting | |
| Ahmedabad, India, 380015 | |
| Recruiting | |
| Ahmedabad, India, 380009 | |
| Recruiting | |
| Bangalore, India, 560017 | |
| Recruiting | |
| Banglore, India, 560034 | |
| Recruiting | |
| Hubli, India, 580020 | |
| Recruiting | |
| Hyderabad, India, 500034 | |
| Recruiting | |
| Nagpur, India, 440010 | |
| Not yet recruiting | |
| New Delhi, India, 110076 | |
| Israel | |
| Recruiting | |
| Ashkelon, Israel, 78306 | |
| Recruiting | |
| Beer Yaacov, Israel, 70300 | |
| Recruiting | |
| Haifa, Israel, 34362 | |
| Recruiting | |
| Ramat Gan, Israel, 52621 | |
| Italy | |
| Recruiting | |
| Arenzano, Italy, 16011 | |
| Recruiting | |
| Bergamo, Italy, 24100 | |
| Recruiting | |
| Catania, Italy, 95124 | |
| Recruiting | |
| Firenze, Italy, 50141 | |
| Recruiting | |
| Genova, Italy, 16132 | |
| Recruiting | |
| Milano, Italy, 20162 | |
| Recruiting | |
| Napoli, Italy, 80131 | |
| Recruiting | |
| Napoli, Italy, 80144 | |
| Recruiting | |
| Prato, Italy, 59100 | |
| Recruiting | |
| Telese Terme, Italy, 82037 | |
| Recruiting | |
| Varese, Italy, 21100 | |
| Latvia | |
| Recruiting | |
| Bauska, Latvia, 3901 | |
| Recruiting | |
| Daugavpils, Latvia, 5417 | |
| Recruiting | |
| Liepaja, Latvia, 3401 | |
| Recruiting | |
| Riga, Latvia, LV-1002 | |
| Recruiting | |
| Riga, Latvia, 1021 | |
| Recruiting | |
| Riga, Latvia, 1005 | |
| Recruiting | |
| Riga, Latvia, LV 1002 | |
| Lithuania | |
| Recruiting | |
| Alytus, Lithuania, 62114 | |
| Recruiting | |
| Klaipeda, Lithuania, 92288 | |
| Recruiting | |
| Siauliai, Lithuania, 76231 | |
| Suspended | |
| Vilnius, Lithuania, 06122 | |
| Malaysia | |
| Recruiting | |
| Ipoh, Malaysia, 30990 | |
| Recruiting | |
| Kuala Lumpur, Malaysia, 68100 | |
| Recruiting | |
| Kuching, Malaysia, 93586 | |
| Recruiting | |
| Penang, Malaysia, 10990 | |
| Recruiting | |
| Selangor, Malaysia, 47500 | |
| Recruiting | |
| Selangor, Malaysia, 46150 | |
| Mexico | |
| Recruiting | |
| Chihuahua, Mexico, 31000 | |
| Recruiting | |
| Chihuahua, Mexico, 31238 | |
| Recruiting | |
| Ciudad Obregon, Mexico, 85000 | |
| Recruiting | |
| Cuernavaca, Mexico, 62270 | |
| Recruiting | |
| Culiacan, Mexico, 80000 | |
| Recruiting | |
| Distrito Federal, Mexico, 06600 | |
| Recruiting | |
| Durango, Mexico, 37240 | |
| Recruiting | |
| Guadalajara, Mexico, 45040 | |
| Recruiting | |
| Guadalajara, Mexico, 44500 | |
| Not yet recruiting | |
| Leon, Mexico, 37000 | |
| Recruiting | |
| Merida, Mexico, 97134 | |
| Recruiting | |
| Mexicali, Mexico, 21100 | |
| Recruiting | |
| Mexico, Mexico, 06700 | |
| Recruiting | |
| Mexico, Mexico, 06100 | |
| Recruiting | |
| Mexico, Mexico, 03100 | |
| Recruiting | |
| Mexico City, Mexico, 14080 | |
| Completed | |
| Mexico City, Mexico, 06700 | |
| Recruiting | |
| Mexico Df, Mexico, 11850 | |
| Recruiting | |
| Naucalpan, Mexico, 53120 | |
| Recruiting | |
| Saltillo, Mexico, 25000 | |
| Recruiting | |
| San Luis Potosi, Mexico, 78220 | |
| Recruiting | |
| San Luis Potosí, Mexico, 78200 | |
| Recruiting | |
| Tijuana, Mexico, 22010 | |
| Recruiting | |
| Torreon, Mexico, 27000 | |
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1056 AB | |
| Recruiting | |
| Dordrecht, Netherlands, 3318AT | |
| Terminated | |
| Roosendaal, Netherlands, 4708 AE | |
| Recruiting | |
| Schiedam, Netherlands, 3118 JH | |
| Philippines | |
| Recruiting | |
| Cebu City, Philippines, 6000 | |
| Recruiting | |
| Iloilo City, Philippines, 5000 | |
| Recruiting | |
| Lipa City, Philippines, 4217 | |
| Recruiting | |
| Makati City, Philippines, 1229 | |
| Poland | |
| Recruiting | |
| Bydgoszcz, Poland, 85-168 | |
| Recruiting | |
| Elblag, Poland, 82-300 | |
| Recruiting | |
| Krakow, Poland, 311 21 | |
| Recruiting | |
| Krakow, Poland, 30-119 | |
| Recruiting | |
| Lublin, Poland, 20-607 | |
| Recruiting | |
| Szczecin, Poland, 71-252 | |
| Recruiting | |
| Ustron, Poland, 43-450 | |
| Recruiting | |
| Warszawa, Poland, 02-118 | |
| Recruiting | |
| Warszawa, Poland, 02-653 | |
| Recruiting | |
| Wroclaw, Poland, 50-556 | |
| Recruiting | |
| Zyrardow, Poland, 96-300 | |
| Romania | |
| Recruiting | |
| Brasov, Romania, 500365 | |
| Recruiting | |
| Bucharest, Romania, 020125 | |
| Recruiting | |
| Bucharest, Romania, 020475 | |
| Recruiting | |
| Bucuresti, Romania, Sector 1 0 | |
| Recruiting | |
| Bucuresti, Romania, 020983 | |
| Recruiting | |
| Cluj-napoca, Romania, 400349 | |
| Recruiting | |
| Cluj-napoca, Romania, 400130 | |
| Recruiting | |
| Iasi, Romania, 700656 | |
| Recruiting | |
| Judet Timis, Romania, 300020 | |
| Recruiting | |
| Ploiesti, Romania, 100337 | |
| Recruiting | |
| Romania, Romania, 700127 | |
| Recruiting | |
| Targoviste, Romania, 130083 | |
| Recruiting | |
| Targu Mures, Romania, 540142 | |
| Russian Federation | |
| Recruiting | |
| Barnaul, Russian Federation, 656024 | |
| Recruiting | |
| Barnaul, Russian Federation, 656038 | |
| Recruiting | |
| Kazan, Russian Federation, 420097 | |
| Recruiting | |
| Kemerovo, Russian Federation, 650002 | |
| Recruiting | |
| Moscow, Russian Federation, 115522 | |
| Recruiting | |
| Moscow, Russian Federation, 115093 | |
| Recruiting | |
| Moscow, Russian Federation, 123060 | |
| Recruiting | |
| Moscow, Russian Federation, 121374 | |
| Recruiting | |
| Novosibirsk, Russian Federation, 630099 | |
| Recruiting | |
| Novosibirsk, Russian Federation, 630068 | |
| Recruiting | |
| Ryazan, Russian Federation, 390026 | |
| Recruiting | |
| Saratov, Russian Federation, 410002 | |
| Recruiting | |
| St Petersburg, Russian Federation, 194291 | |
| Recruiting | |
| Stavropol, Russian Federation, 355017 | |
| Recruiting | |
| Voronezh, Russian Federation, 394066 | |
| Recruiting | |
| Yaroslavl, Russian Federation, 150007 | |
| Serbia | |
| Recruiting | |
| Belgrade, Serbia, 11000 | |
| Recruiting | |
| Niska Banja, Serbia, 18205 | |
| South Africa | |
| Recruiting | |
| Cape Town, South Africa, 7925 | |
| Recruiting | |
| Diepkloof, South Africa, 1862 | |
| Recruiting | |
| Johannesburg, South Africa, 2193 | |
| Recruiting | |
| Pretoria, South Africa, 0002 | |
| Spain | |
| Recruiting | |
| Barakaldo, Spain, 48903 | |
| Recruiting | |
| Castellon, Spain, 12004 | |
| Recruiting | |
| Madrid, Spain, 28007 | |
| Recruiting | |
| Merida, Spain, 97500 | |
| Recruiting | |
| Málaga, Spain, 29009 | |
| Recruiting | |
| S. Cristobal de La Laguna, Spain, 38320 | |
| Recruiting | |
| Sabadell, Spain, 08208 | |
| Terminated | |
| San Sebastian de Los Reyes, Spain, 28702 | |
| Recruiting | |
| Santiago de Compostela, Spain, 15706 | |
| Recruiting | |
| Sevilla, Spain, 41009 | |
| Recruiting | |
| Torrelavega, Spain, 39300 | |
| Recruiting | |
| Vizcaya, Spain, 48013 | |
| Turkey | |
| Recruiting | |
| Antalya, Turkey, 07058 | |
| Recruiting | |
| Edirne, Turkey, 22030 | |
| Recruiting | |
| Erzurum, Turkey, 25050 | |
| Recruiting | |
| Trabzon, Turkey, 61100 | |
| United Kingdom | |
| Terminated | |
| Birmingham, United Kingdom, B29 6JD | |
| Recruiting | |
| Cambridge, United Kingdom, CB2 0QQ | |
| Recruiting | |
| Cannock, United Kingdom, WS11 5XY | |
| Recruiting | |
| Dudley, United Kingdom, DY1 2HQ | |
| Recruiting | |
| Leicester, United Kingdom, LE1 5WW | |
| Recruiting | |
| London, United Kingdom, E11 1NR | |
| Recruiting | |
| London, United Kingdom, EC1M 6BQ | |
| Recruiting | |
| London, United Kingdom, SE5 9RS | |
| Recruiting | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Recruiting | |
| Salford, United Kingdom, M6 8HD | |
| Recruiting | |
| Southampton, United Kingdom, SO16 6YD | |
| Recruiting | |
| Westcliffe-on-sea, United Kingdom, SS0 0RY | |
| Recruiting | |
| Wrightington, United Kingdom, WN6 9EP | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01331837 History of Changes |
| Other Study ID Numbers: | WA25204, 2010-020065-24 |
| Study First Received: | April 7, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Cardiovascular Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013