A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT00531817
Last Updated: 2012-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
619 participants
INTERVENTIONAL
2007-10-31
2011-03-31
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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Tocilizumab 8 mg/kg + DMARDs
Tocilizumab
Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Permitted DMARDs
As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
Placebo + DMARDs
Placebo
Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Permitted DMARDs
As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
Interventions
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Tocilizumab
Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Placebo
Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Permitted DMARDs
As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active rheumatoid arthritis of \>6 months duration
* Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline
Exclusion Criteria
* Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
* Unsuccessful treatment with a biologic agent, including an anti-TNF agent
* Previous treatment with tocilizumab
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
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Lake Havasu City, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Jonesboro, Arkansas, United States
Beverly Hills, California, United States
Escondido, California, United States
La Jolla, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Santa Maria, California, United States
Santa Monica, California, United States
Upland, California, United States
Van Nuys, California, United States
Walnut Creek, California, United States
Whittier, California, United States
Colorado Springs, Colorado, United States
Trumbull, Connecticut, United States
Washington D.C., District of Columbia, United States
Dunedin, Florida, United States
Fort Lauderdale, Florida, United States
Lake Mary, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orange Park, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Plantation, Florida, United States
Sarasota, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Fort Valley, Georgia, United States
Tifton, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
Downers Grove, Illinois, United States
Springfield, Illinois, United States
Evansville, Indiana, United States
Munster, Indiana, United States
South Bend, Indiana, United States
Leawood, Kansas, United States
Bowling Green, Kentucky, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
Monroe, Louisiana, United States
New Orleans, Louisiana, United States
Wheaton, Maryland, United States
Mansfield, Massachusetts, United States
Worcester, Massachusetts, United States
Worcester, Massachusetts, United States
Kalamazoo, Michigan, United States
Saint Clair Shores, Michigan, United States
Eagan, Minnesota, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
Billings, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Grand Island, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Dover, New Hampshire, United States
Freehold, New Jersey, United States
New Brunswick, New Jersey, United States
Passaic, New Jersey, United States
Teaneck, New Jersey, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Smithtown, New York, United States
The Bronx, New York, United States
Belmont, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Rock Hill, North Carolina, United States
Akron, Ohio, United States
Beechwood, Ohio, United States
Mayfield, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Zanesville, Ohio, United States
Norman, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Salem, Oregon, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wexford, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
Greenville, South Carolina, United States
Myrtle Beach, South Carolina, United States
Rapid City, South Dakota, United States
Rapid City, South Dakota, United States
Sioux Falls, South Dakota, United States
Watertown, South Dakota, United States
Crossville, Tennessee, United States
Hendersonville, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Amarillo, Texas, United States
Bellaire, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Burke, Virginia, United States
Reston, Virginia, United States
Salem, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Beckley, West Virginia, United States
Clarksburg, West Virginia, United States
Milwaukee, Wisconsin, United States
Onalaska, Wisconsin, United States
Wausau, Wisconsin, United States
San Juan, , Puerto Rico
Countries
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References
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Yazici Y, Curtis JR, Ince A, Baraf HS, Lepley DM, Devenport JN, Kavanaugh A. Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid Onset and Systemic Efficacy [ROSE] Study). Clin Exp Rheumatol. 2013 May-Jun;31(3):358-64. Epub 2013 Jan 10.
Yazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012 Feb;71(2):198-205. doi: 10.1136/ard.2010.148700. Epub 2011 Sep 26.
Other Identifiers
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ML21136
Identifier Type: -
Identifier Source: org_study_id