An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies
NCT ID: NCT00720798
Last Updated: 2014-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2067 participants
INTERVENTIONAL
2005-09-30
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Tocilizumab
For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
Disease-modifying anti-rheumatic drugs
Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.
Non-steroidal anti-inflammatory drugs
Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.
Oral corticosteroids
Oral corticosteroids (≤ 10 mg/day) were permitted during the study.
Interventions
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Tocilizumab
For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.
Disease-modifying anti-rheumatic drugs
Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.
Non-steroidal anti-inflammatory drugs
Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.
Oral corticosteroids
Oral corticosteroids (≤ 10 mg/day) were permitted during the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
* Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
* Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
* Previous treatment with any cell-depleting therapies, including investigational agents.
* Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Palm Springs, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Diego, California, United States
San Jose, California, United States
San Leandro, California, United States
Santa Maria, California, United States
Torrance, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Newark, Delaware, United States
Aventura, Florida, United States
Delray Beach, Florida, United States
Fort Lauderdale, Florida, United States
Palm Habor, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Morton Grove, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Indianapolis, Indiana, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Bowling Green, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreverport, Louisiana, United States
Slidell, Louisiana, United States
Portland, Maine, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
Pittsfield, Massachusetts, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Eagan, Minnesota, United States
Saint Cloud, Minnesota, United States
Saint Louis Park, Minnesota, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
Dover, New Hampshire, United States
Haddon Heights, New Jersey, United States
New Brunswick, New Jersey, United States
Passaic, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Binghamton, New York, United States
Great Neck, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Plainview, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Bismarck, North Dakota, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Medford, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Danville, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Johnston, Rhode Island, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Hickory Grove, South Carolina, United States
Hixson, Tennessee, United States
Jackson, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
Burlington, Vermont, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Mountlake Terrace, Washington, United States
Olympia, Washington, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Glendale, Wisconsin, United States
La Crosse, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
San Juan Bautista, , Argentina
Hobart, , Australia
Malvern, , Australia
Shenton Park, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Hasselt, , Belgium
Merksem, , Belgium
Campinas, , Brazil
Goiânia, , Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Sainte-Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Beijing, , China
Beijing, , China
Guangzhou, , China
Hefei Anhui, , China
Jinan, , China
Shanghai, , China
Shanghai, , China
San José, , Costa Rica
Hradec Králové, , Czechia
Prague, , Czechia
Prague, , Czechia
Hellerup, , Denmark
Helsinki, , Finland
Jyväskylä, , Finland
Amiens, , France
Bordeaux, , France
Boulogne-Billancourt, , France
Brest, , France
Grenoble, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Nice, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Rouen, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Toulouse, , France
Aachen, , Germany
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Essen, , Germany
Gommern, , Germany
Herne, , Germany
Hildesheim, , Germany
München, , Germany
München, , Germany
Osnabrück, , Germany
Sendenhorst, , Germany
Wiesbaden, , Germany
Würzburg, , Germany
Hong Kong, , Hong Kong
Tuenmen, , Hong Kong
Reykjavik, , Iceland
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Rishon LeZiyyon, , Israel
Brescia, , Italy
Genova, , Italy
Milan, , Italy
Padua, , Italy
Pavia, , Italy
Pisa, , Italy
Siena, , Italy
Udine, , Italy
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Guadalajara, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Tijuana, , Mexico
Nijmegen, , Netherlands
Levanger, , Norway
Lillehammer, , Norway
Panama City, , Panama
Lima, , Peru
Lima, , Peru
Lisbon, , Portugal
Ponce, , Puerto Rico
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tula, , Russia
Belgrade, , Serbia
Niška Banja, , Serbia
Ljubljana, , Slovenia
Maribor, , Slovenia
Cape Town, , South Africa
Cape Town, , South Africa
Diepkloof, , South Africa
Durban, , South Africa
Pinelands, , South Africa
Pretoria, , South Africa
Radiokop, , South Africa
Barakaldo, , Spain
Barcelona, , Spain
Madrid, , Spain
Málaga, , Spain
Pontevedra, , Spain
Santiago de Compostela, , Spain
Stockholm, , Sweden
Umeå, , Sweden
Lausanne, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Basingstoke, , United Kingdom
Birmingham, , United Kingdom
Cannock, , United Kingdom
Derby, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Oxford, , United Kingdom
Southampton, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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References
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Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
Other Identifiers
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WA18696
Identifier Type: -
Identifier Source: org_study_id
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