A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
NCT ID: NCT00106522
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
499 participants
INTERVENTIONAL
2005-05-31
2007-11-30
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
Methotrexate
10-25mg weekly
tocilizumab [RoActemra/Actemra]
4mg/kg iv every 4 weeks
2
Methotrexate
10-25mg weekly
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
3
Methotrexate
10-25mg weekly
Placebo
iv every 4 weeks
Interventions
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Methotrexate
10-25mg weekly
Placebo
iv every 4 weeks
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
tocilizumab [RoActemra/Actemra]
4mg/kg iv every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* inadequate response to current anti-rheumatic therapies, including MTX;
* inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
* on stable MTX for at least 8 weeks before entering study;
* patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
* 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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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Fullerton, California, United States
Long Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
San Diego, California, United States
San Diego, California, United States
Santa Maria, California, United States
Torrance, California, United States
Colorado Springs, Colorado, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Palm Habor, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tavares, Florida, United States
West Palm Beach, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Bowling Green, Kentucky, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Duluth, Minnesota, United States
Rochester, Minnesota, United States
Tupelo, Mississippi, 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
Missoula, Montana, United States
Las Vegas, Nevada, United States
Medford, New Jersey, United States
Mercerville, New Jersey, United States
Teaneck, New Jersey, United States
Albany, New York, United States
Binghamton, New York, United States
Great Neck, New York, United States
Johnson City, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Wilmington, North Carolina, United States
Bismarck, North Dakota, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Eugene, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Danville, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Hickory Grove, South Carolina, United States
Jackson, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Ogden, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Salem, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Glendale, Wisconsin, United States
Malvern, , Australia
Shenton Park, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Aalst, , Belgium
Hasselt, , Belgium
Merksem, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Burlington, Ontario, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Amiens, , France
Bordeaux, , France
Le Kremlin-Bicêtre, , France
Lille, , France
Lyon, , France
Nice, , France
Paris, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Gommern, , Germany
Herne, , Germany
München, , Germany
Wiesbaden, , Germany
Würzburg, , Germany
Reykjavik, , Iceland
Brescia, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Pavia, , Italy
Pisa, , Italy
Udine, , Italy
Guadalajara, , Mexico
Enschede, , Netherlands
Nijmegen, , Netherlands
Ponce, , Puerto Rico
Jönköping, , Sweden
Karlstad, , Sweden
Malmo, , Sweden
Stockholm, , Sweden
Lausanne, , Switzerland
Basingstoke, , United Kingdom
Bath, , United Kingdom
Birmingham, , United Kingdom
Cannock, , United Kingdom
Derby, , United Kingdom
Lancaster, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Manchester, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Norwich, , United Kingdom
Oxford, , United Kingdom
Salford, , United Kingdom
Southampton, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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References
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Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
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.
Strand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. doi: 10.1093/rheumatology/kes131. Epub 2012 Jun 28.
Karsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.
Emery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.
Other Identifiers
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WA18062
Identifier Type: -
Identifier Source: org_study_id