A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT ID: NCT00106574
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1220 participants
INTERVENTIONAL
2005-04-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
2
Placebo
iv every 4 weeks
Interventions
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Placebo
iv every 4 weeks
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* inadequate response to current anti-rheumatic therapies, including 1 or more traditional DMARDs;
* stable DMARD therapy for at least 8 weeks before entering study;
* patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
* patients who have previously failed treatment with an anti-tumor necrosis factor agent;
* women who are pregnant or breast-feeding.
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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Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Palm Desert, California, United States
Palo Alto, California, United States
San Jose, California, United States
Upland, California, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Delray Beach, Florida, United States
Jupiter, Florida, United States
Palm Habor, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Indianapolis, Indiana, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreverport, Louisiana, United States
Frederick, Maryland, United States
Boston, Massachusetts, United States
Lansing, Michigan, United States
Duluth, Minnesota, United States
Eagan, Minnesota, United States
Saint Louis Park, Minnesota, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
Clifton, New Jersey, United States
Haddon Heights, New Jersey, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Plainview, New York, United States
Roslyn, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Gallipolis, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Rockledge, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Johnston, Rhode Island, United States
Charleston, South Carolina, United States
Hixson, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
Burlington, Vermont, United States
Arlington, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Vancouver, Washington, United States
La Crosse, Wisconsin, United States
Milwaukee, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
Parkville, , Australia
Sydney, , Australia
Campinas, , Brazil
Goiânia, , Brazil
Rio de Janeiro, , Brazil
Winnipeg, Manitoba, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
San José, , Costa Rica
Hradec Králové, , Czechia
Prague, , Czechia
Prague, , Czechia
Helsinki, , Finland
Jyväskylä, , Finland
Boulogne-Billancourt, , France
Clermont-Ferrand, , France
Grenoble, , France
Limoges, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Paris, , France
Pierre-Bénite, , France
Rennes, , France
Saint-Etienne, , France
Tours, , France
Aachen, , Germany
Essen, , Germany
Hildesheim, , Germany
München, , Germany
Osnabrück, , Germany
Sendenhorst, , Germany
Stuttgart, , Germany
Hong Kong, , Hong Kong
Tuenmen, , Hong Kong
León, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Tijuana, , Mexico
Panama City, , Panama
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tula, , Russia
Durban, , South Africa
Pretoria, , South Africa
Radiokop, , South Africa
Barakaldo, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Pontevedra, , Spain
Santiago de Compostela, , Spain
Stockholm, , Sweden
Umeå, , Sweden
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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References
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Welsh P, Tuckwell K, McInnes IB, Sattar N. Effect of IL-6 receptor blockade on high-sensitivity troponin T and NT-proBNP in rheumatoid arthritis. Atherosclerosis. 2016 Nov;254:167-171. doi: 10.1016/j.atherosclerosis.2016.10.016. Epub 2016 Oct 8.
Keystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.
Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.
Genovese MC, McKay JD, Nasonov EL, Mysler EF, da Silva NA, Alecock E, Woodworth T, Gomez-Reino JJ. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum. 2008 Oct;58(10):2968-80. doi: 10.1002/art.23940.
Other Identifiers
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WA18063
Identifier Type: -
Identifier Source: org_study_id