A Study of RoActemra/Actemra (Tocilizumab) in Comparison to Etanercept in Patients With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331837
First received: April 7, 2011
Last updated: October 20, 2014
Last verified: October 2014
  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 etane rcept subcutaneously weekly. The anticipated time on study drug is up to 5 years


Condition Intervention Phase
Cardiovascular Disease, Rheumatoid Arthritis
Drug: etanercept
Drug: tocilizumab [RoActemra/Actemra]
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 ]

Enrollment: 3119
Study Start Date: August 2011
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (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
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: NCT01331837

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Huntsville, Alabama, United States, 35801
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
Glendale, Arizona, United States, 85304
Paradise Valley, Arizona, United States, 85253
Peoria, Arizona, United States, 85381
Phoenix, Arizona, United States, 85027
Scottsdale, Arizona, United States, 85258
Tucson, Arizona, United States, 85712
Tucson, Arizona, United States, 85724
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Covina, California, United States, 91723
Huntington Beach, California, United States, 92646
La Jolla, California, United States, 92037
Long Beach, California, United States, 90806
Mission Viejo, California, United States, 92692
Murrieta, California, United States, 92563
Poway, California, United States, 92064
San Diego, California, United States, 92108
San Diego, California, United States, 92120
San Leandro, California, United States, 94578
Santa Maria, California, United States, 93454
Santa Monica, California, United States, 90404
Torrance, California, United States, 90509
Upland, California, United States, 91786
Whittier, California, United States, 90606
United States, Colorado
Colorado Springs, Colorado, United States, 80910
United States, Connecticut
Bridgeport, Connecticut, United States, 06606
Farmington, Connecticut, United States, 06030
Hamden, Connecticut, United States, 06518
United States, Florida
Boynton Beach, Florida, United States, 33472
Coral Gables, Florida, United States, 33134
Daytona Beach, Florida, United States, 32117
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33126
Orange Park, Florida, United States, 32073
Palm Habor, Florida, United States, 34684
Pensacola, Florida, United States, 32501
Sarasota, Florida, United States, 34292
South Miami, Florida, United States, 33143
St. Petersburg, Florida, United States, 33708
Tampa, Florida, United States, 33609
Tampa, Florida, United States, 33614
United States, Georgia
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30303
Duluth, Georgia, United States, 30096
Rome, Georgia, United States, 30165
Savannah, Georgia, United States, 31405
United States, Idaho
Boise, Idaho, United States, 83704
Boise, Idaho, United States, 83702
Coeur D'alene, Idaho, United States, 83814
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60616
Peoria, Illinois, United States, 61602
United States, Indiana
Fort Wayne, Indiana, United States, 46804
Indianapolis, Indiana, United States, 46227
South Bend, Indiana, United States, 46601
United States, Kentucky
Bowling Green, Kentucky, United States, 42101
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Monroe, Louisiana, United States, 71203
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21286
Hagerstown, Maryland, United States, 21740
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Fall River, Massachusetts, United States, 02720
Worcester, Massachusetts, United States, 01610
Worcester, Massachusetts, United States, 01605
United States, Michigan
Flint, Michigan, United States, 48503
Kalamazoo, Michigan, United States, 49009
Lansing, Michigan, United States, 48910
Petoskey, Michigan, United States, 49770
United States, Minnesota
Eagan, Minnesota, United States, 55121
Minneapolis, Minnesota, United States, 55417
Rochester, Minnesota, United States, 55905
United States, Mississippi
Flowood, Mississippi, United States, 39232
Tupelo, Mississippi, United States, 38801
United States, Montana
Kalispell,, Montana, United States, 59901
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, Nevada
Las Vegas, Nevada, United States, 89123
Las Vegas, Nevada, United States, 89128
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Berkeley Heights, New Jersey, United States, 07922
Teaneck, New Jersey, United States, 07666
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
Las Cruces, New Mexico, United States, 88011
United States, New York
Brooklyn, New York, United States, 11201
Brooklyn, New York, United States, 11203
North Massapequa, New York, United States, 11758
Olean, New York, United States, 14760
Syracuse, New York, United States, 13210
United States, North Carolina
Asheville, North Carolina, United States, 28803
Charlotte, North Carolina, United States, 28210
Charlotte, North Carolina, United States, 28204
Durham, North Carolina, United States, 27704
Hickory, North Carolina, United States, 28602
Raleigh, North Carolina, United States, 27617
Sanford, North Carolina, United States, 27330
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Minot, North Dakota, United States, 58701
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cleveland, Ohio, United States, 44109
Columbus, Ohio, United States, 43215
Columbus, Ohio, United States, 43210
Toledo, Ohio, United States, 43606
Toledo, Ohio, United States, 43623
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Hershey, Pennsylvania, United States, 17033
Indiana, Pennsylvania, United States, 15701
Limerick, Pennsylvania, United States, 19468
Perkasie, Pennsylvania, United States, 18944
Philadelphia, Pennsylvania, United States, 19152
Pittsburgh, Pennsylvania, United States, 15213-2582
Pittsburgh, Pennsylvania, United States, 15224
West Reading, Pennsylvania, United States, 19611
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Columbia, South Carolina, United States, 29204
Myrtle Beach, South Carolina, United States, 29572
United States, South Dakota
Watertown, South Dakota, United States, 57201
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
Amarillo, Texas, United States, 79124
Corpus Christi, Texas, United States, 78404
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76109
Houston, Texas, United States, 77004
Houston, Texas, United States, 77074
Mesquite, Texas, United States, 75150
Richardson, Texas, United States, 75080
San Antonio, Texas, United States, 78217
Waco, Texas, United States, 76708
United States, Virginia
Burke, Virginia, United States, 22015
Norfolk, Virginia, United States, 23502
United States, Washington
Kennewick, Washington, United States, 99336
Seattle, Washington, United States, 98104
Tacoma, Washington, United States, 98405
United States, West Virginia
Beckley, West Virginia, United States, 25801
Clarksburg, West Virginia, United States, 26301
United States, Wisconsin
Racine, Wisconsin, United States, 53406
Argentina
Buenos Aires, Argentina, C1122AAL
Buenos Aires, Argentina, C1425DTG
Buenos Aires, Argentina, C1015ABO
Buenos Aires, Argentina, C1426AAL
Buenos Aires, Argentina, C1117ABK
Buenos Aires, Argentina, C1194AAO
Buenos Aires, Argentina, C1431FWO
Buenos Aires, Argentina, C1204AAD
Ciudad Autonoma Buenos Aires, Argentina, C1221ADC
Ciudad Autonoma de Buenos Aires, Argentina, 1111
Cordoba, Argentina, 5000
Cordoba, Argentina, X5004BAL
Cordoba Pcia, Argentina, 5016
Florencio Varela, Argentina, 1888
Lujan, Argentina, 6700
Pergamino, Argentina, B2700CPM
Rosario, Argentina, S2000DSV
Rosario, Santa Fe, Argentina, S2000PBJ
San Juan, Argentina, 5400
San Miguel de Tucuman, Argentina, T4000AXL
Tucuman, Argentina, 4000
Austria
Graz, Austria, 8036
Stockerau, Austria, 2000
Wien, Austria, 1090
Wien, Austria, 1100
Wien, Austria, 1130
Belgium
Bruxelles, Belgium, 1200
Bruxelles, Belgium, 1000
Kortrijk, Belgium, 8500
Liege, Belgium, 4000
Merksem, Belgium, 2170
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 78000
Sarajevo, Bosnia and Herzegovina, 71000
Sarajevo, Bosnia and Herzegovina, 71 000
Tuzla, Bosnia and Herzegovina, 75000
Canada, Alberta
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Powell River, British Columbia, Canada, V8A 3B6
Victoria, British Columbia, Canada, V8P 5P6
Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1A 5E8
St John's, Newfoundland and Labrador, Canada, A1C 5B8
Canada, Ontario
Etobicoke, Ontario, Canada, M9C 5N2
Hamilton, Ontario, Canada, L8N 1Y2
Kitchener, Ontario, Canada, N2M 5N6
London, Ontario, Canada, N6A 4V2
Mississauga, Ontario, Canada, L5M 2V8
St. Catharines, Ontario, Canada, L2N 7E4
Toronto, Ontario, Canada, M5G 1Z5
Canada, Quebec
Montreal, Quebec, Canada, H2L 1S6
Quebec City, Quebec, Canada, G1V 3M7
Sherbrooke, Quebec, Canada, J1H 5N4
Trois-rivieres, Quebec, Canada, G8Z 1Y2
Canada
Quebec, Canada, G1W 4R4
Chile
La Serena, Chile, 1700000
Santiago, Chile, 7500035
Santiago, Chile, 7501126
Santiago, Chile, 7500000
Santiago, Chile, 8320112
Temuco, Chile, 4780000
Viña del Mar, Chile, 2570017
Viña del Mar, Chile, 2520612
Croatia
Karlovac, Croatia, 47000
Krapinske Toplice, Croatia, 49217
Rijeka, Croatia, 51000
Zagreb, Croatia, 10000
Czech Republic
Brno, Czech Republic, 656 91
Bruntal, Czech Republic, 792 01
Hlucin, Czech Republic, 748 01
Hostivice, Czech Republic, 253 01
Kladno, Czech Republic, 272 01
Ostrava - Moravska Ostrava, Czech Republic, 702 00
Praha, Czech Republic, 140 59
Praha, Czech Republic, 128 50
Praha 4, Czech Republic, 140 00
Sokolov, Czech Republic, 356 01
Terezin, Czech Republic, 411 55
Zlin, Czech Republic, 748 01
Ecuador
Cuenca, Ecuador, 101168
Guayaquil, Ecuador, 593
Guayaquil, Ecuador, EC090114
Quito, Ecuador, 005932
Quito, Ecuador, EC170517
France
Amiens, France, 80054
Bordeaux, France, 33000
Clermont Ferrand, France, 63003
Corbeil Essonnes, France, 91106
Echirolles, France, 38434
Lyon, France, 69003
Orléans, France, 45067
Paris, France, 75679
Paris, France, 75651
Paris, France, 75571
Rennes, France, 35033
Roubaix, France, 59056
Rouen, France, 76031
Saint-Etienne, France, 42055
Strasbourg, France, 67098
Toulouse, France, 31059
Germany
Berlin, Germany, 14059
Berlin, Germany, 10117
Dresden, Germany, 01307
Erlangen, Germany, 91056
Erlangen, Germany, 91054
Frankfurt, Germany, 60528
Hamburg, Germany, 20246
Hamburg, Germany, 22081
Herne, Germany, 44649
Hildesheim, Germany, 31134
Koeln, Germany, 50937
Leipzig, Germany, 04103
Muenchen, Germany, 81541
München, Germany, 80337
Osnabrueck, Germany, 49074
Ratingen, Germany, 40882
Greece
Athens, Greece, 15121
Athens, Greece, 115 27
Crete, Greece, 71110
Larissa, Greece, 411 10
Thessaloniki, Greece, 54 642
Thessaloniki, Greece, 546 36
Thessaloniki, Greece
Hungary
Budapest, Hungary, 1027
Budapest, Hungary, 1033
Budapest, Hungary, 1036
Debrecen, Hungary, 4032
Eger, Hungary, 3300
Gyula, Hungary, 5700
Mor, Hungary, 8060
Szekesfehervar, Hungary, 8000
Szekszard, Hungary, 7100
Zalaegerszeg, Hungary, 8901
India
Ahmedabad, India, 380015
Ahmedabad, India, 380009
Bangalore, India, 560017
Banglore, India, 560034
Hubli, India, 580020
Hyderabad, India, 500034
Nagpur, India, 440010
Israel
Ashkelon, Israel, 78278
Beer Yaacov, Israel, 6093000
Haifa, Israel, 34362
Ramat Gan, Israel, 5262000
Tel Aviv, Israel, 64239
Italy
Napoli, Campania, Italy, 80144
Napoli, Campania, Italy, 80131
Telese Terme, Campania, Italy, 82037
Arenzano, Liguria, Italy, 16011
Genova, Liguria, Italy, 16132
Bergamo, Lombardia, Italy, 24128
Milano, Lombardia, Italy, 20162
Varese, Lombardia, Italy, 21100
Catania, Sicilia, Italy, 95124
Firenze, Toscana, Italy, 50141
Prato, Toscana, Italy, 59100
Latvia
Bauska, Latvia, 3901
Daugavpils, Latvia, 5417
Liepaja, Latvia, 3400
Riga, Latvia, 1005
Riga, Latvia, 1021
Riga, Latvia, LV 1002
Riga, Latvia, LV-1002
Lithuania
Alytus, Lithuania, 62114
Klaipeda, Lithuania, 92288
Siauliai, Lithuania, 76231
Vilnius, Lithuania, 06122
Malaysia
Ipoh, Malaysia, 30990
Kuala Lumpur, Malaysia, 68100
Kuching, Malaysia, 93586
Penang, Malaysia, 10990
Selangor, Malaysia, 46150
Selangor, Malaysia, 47500
Mexico
Chihuahua, Mexico, 31238
Chihuahua, Mexico, 31000
Ciudad Obregon, Mexico, 85000
Cuernavaca, Mexico, 62270
Culiacan, Mexico, 80000
Delegacion Benito Juarez, Mexico, 03100
Distrito Federal, Mexico, 06600
Durango, Mexico, 37240
Guadalajara, Mexico, 45040
Guadalajara, Mexico, 44500
Merida, Mexico, 97134
Mexicali, Mexico, 21100
Mexico, Mexico, 06100
Mexico, Mexico, 03100
Mexico City, Mexico, 06700
Mexico City, Mexico, 14080
Mexico Df, Mexico, 11850
Miexico City, Mexico, 06700
Saltillo, Mexico, 25000
San Luis Potosi S.L.P., Mexico, 78240
San Luis Potosí, Mexico, 78200
Tijuana, Mexico, 22010
Torreon, Mexico, 27000
Netherlands
Amsterdam, Netherlands, 1056 AB
Dordrecht, Netherlands, 3318AT
Roosendaal, Netherlands, 4708 AE
Schiedam, Netherlands, 3118 JH
Philippines
Cebu City, Philippines, 6000
Iloilo City, Philippines, 5000
Lipa City, Philippines, 4217
Makati City, Philippines, 1229
Poland
Bydgoszcz, Poland, 85-168
Elblag, Poland, 82-300
Krakow, Poland, 30-119
Krakow, Poland, 31-121
Lublin, Poland, 20-607
Nadarzyn, Poland, 05-830
Szczecin, Poland, 71-252
Ustron, Poland, 43-450
Warszawa, Poland, 02-118
Warszawa, Poland, 02-653
Wroclaw, Poland, 50-556
Romania
Brasov, Romania, 500365
Bucharest, Romania, 020475
Bucuresti, Romania, 020983
Bucuresti, Romania, 011172
Cluj-Napoca, Romania, 400130
Cluj-Napoca, Romania, 400349
Iasi, Romania, 700127
Iasi, Romania, 700656
Ploiesti, Romania, 100337
Sector 2, Romania, 020125
Targoviste, Romania, 130083
Targu Mures, Romania, 540142
Timisoara, Romania, 300194
Russian Federation
Barnaul, Russian Federation, 656038
Barnaul, Russian Federation, 656024
Kazan, Russian Federation, 420097
Kemerovo, Russian Federation, 650002
Moscow, Russian Federation, 123060
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 115093
Moscow, Russian Federation, 121374
Novosibirsk, Russian Federation, 630099
Novosibirsk, Russian Federation, 630068
Ryazan, Russian Federation, 390026
Saratov, Russian Federation, 410002
St Petersburg, Russian Federation, 194291
Stavropol, Russian Federation, 355017
Tomsk, Russian Federation, 634063
Voronezh, Russian Federation, 394066
Yaroslavl, Russian Federation, 150007
Serbia
Belgrade, Serbia, 11000
Belgrade, Serbia, 11040
Belgrade, Serbia, 11070
Niska Banja, Serbia, 18205
South Africa
Cape Town, South Africa, 7925
Diepkloof, South Africa, 1862
Johannesburg, South Africa, 2193
Pretoria, South Africa, 0002
Spain
Merida, Badajoz, Spain, 06800
Sabadell, Barcelona, Spain, 08208
Torrelavega, Cantabria, Spain, 39300
Santiago de Compostela, La Coruña, Spain, 15706
San Sebastian de los Reyes, Madrid, Spain, 28702
Málaga, Malaga, Spain, 29009
Seville, Sevilla, Spain, 41071
S. Cristobal de la Laguna, Tenerife, Spain, 38320
Barakaldo, Vizcaya, Spain, 48903
Castellon, Spain, 12004
Madrid, Spain, 28007
Vizcaya, Spain, 48013
Turkey
Antalya, Turkey, 07058
Edirne, Turkey, 22030
Erzurum, Turkey, 25050
Trabzon, Turkey, 61100
United Kingdom
Birmingham, United Kingdom, B29 6JD
Cambridge, United Kingdom, CB2 0QQ
Cannock, United Kingdom, WS11 5XY
Dudley, United Kingdom, DY1 2HQ
Leicester, United Kingdom, LE1 5WW
London, United Kingdom, E1 1BB
London, United Kingdom, SE5 9RS
London, United Kingdom, E11 1NR
Newcastle upon Tyne, United Kingdom, NE1 4LP
Salford, United Kingdom, M6 8HD
Southampton, United Kingdom, SO16 6YD
Westcliffe-on-sea, United Kingdom, SS0 0RY
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: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014