A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
NCT ID: NCT00891020
Last Updated: 2012-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
886 participants
INTERVENTIONAL
2009-05-31
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
NONE
Study Groups
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Tocilizumab 8 mg/kg Monotherapy
Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous every 4 weeks for 24 weeks
Tocilizumab 4 mg/kg + DMARD
Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous every 4 weeks for 24 weeks
tocilizumab [RoActemra/Actemra]
4 mg/kg every 4 weeks for 24 weeks
Nonbiologic DMARDs of investigator's choice
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Tocilizumab 8 mg/kg + DMARD
Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous every 4 weeks for 24 weeks
Nonbiologic DMARDs of investigator's choice
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Interventions
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tocilizumab [RoActemra/Actemra]
8 mg/kg intravenous every 4 weeks for 24 weeks
tocilizumab [RoActemra/Actemra]
4 mg/kg every 4 weeks for 24 weeks
Nonbiologic DMARDs of investigator's choice
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Eligibility Criteria
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Inclusion Criteria
* moderate to severe active rheumatoid arthritis for \>6 months;
* inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
* Swollen joint count (SJC) \>/=4 and Tender joint count (TJC) \>/=4
* body weight \</=150kg
* current permitted non-biologic DMARDs must be on stable dose for \>/= 7 weeks prior to baseline;
Exclusion Criteria
* functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
* treatment with rituximab within 6 months before screening;
* intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
* known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
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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Anniston, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Tuscaloosa, Alabama, United States
Hot Springs, Arizona, United States
Paradise Valley, Arizona, United States
Peoria, Arizona, United States
Scottsdale, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Fayetteville, Arkansas, United States
Fort Smith, Arkansas, United States
Jonesboro, Arkansas, United States
Little Rock, Arkansas, United States
Covina, California, United States
Escondido, California, United States
Fullerton, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
Lakewood, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Murrieta, California, United States
Newport Beach, California, United States
Pasadena, California, United States
Sacramento, California, United States
San Diego, California, United States
San Leandro, California, United States
Santa Barbara, California, United States
Santa Maria, California, United States
Sherman Oaks, California, United States
Van Nuys, California, United States
Victorville, California, United States
Westlake Village, California, United States
Whittier, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Danbury, Connecticut, United States
Hamden, Connecticut, United States
Trumbull, Connecticut, United States
Lewes, Delaware, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Dunedin, Florida, United States
Fort Lauderdale, Florida, United States
Gainesville, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Lake Mary, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Nampa, Idaho, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Moline, Illinois, United States
Morton Grove, Illinois, United States
Peoria, Illinois, United States
Schaumburg, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
South Bend, Indiana, United States
Cedar Rapids, Iowa, United States
Lees Summit, Kansas, United States
Wichita, Kansas, 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
Columbia, Maryland, United States
Ellicott City, Maryland, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
Fall River, Massachusetts, United States
Pascagoula, Massachusetts, United States
Peabody, Massachusetts, United States
Plymouth, Massachusetts, United States
Worcester, Massachusetts, United States
Worcester, Massachusetts, United States
Battle Creek, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Petoskey, Michigan, United States
Saint Clair Shores, Michigan, United States
Duluth, Minnesota, United States
Eagan, Minnesota, United States
Edina, Minnesota, United States
Saint Louis Park, Minnesota, United States
Flowood, Mississippi, United States
Hattiesburg, Mississippi, United States
Jackson, Mississippi, United States
Tupelo, Mississippi, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Grand Island, Nebraska, United States
Lincoln, Nebraska, United States
Reno, Nevada, United States
Dover, New Hampshire, United States
Lebanon, New Hampshire, United States
Clifton, New Jersey, United States
Haddon Heights, New Jersey, United States
Manalapan, New Jersey, United States
Morristown, New Jersey, United States
New Brunswick, New Jersey, United States
Trenton, New Jersey, United States
Voorhees Township, New Jersey, United States
Las Cruces, New Mexico, United States
Albany, New York, United States
Binghamton, New York, United States
Brooklyn, New York, United States
Cooperstown, New York, United States
Hewlett, New York, United States
Lake Success, New York, United States
New York, New York, United States
Olean, New York, United States
Orchard Park, New York, United States
Plainview, New York, United States
Rochester, New York, United States
Roslyn, New York, United States
Smithtown, New York, United States
Syracuse, New York, United States
Utica, New York, United States
Asheville, North Carolina, United States
Belmont, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Rock Hill, North Carolina, United States
Wilmington, North Carolina, United States
Bismarck, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Gallipolis, Ohio, United States
Mayfield, Ohio, United States
Middleburg Heights, Ohio, United States
Perryburg, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Lake Oswego, Oregon, United States
Bethlehem, Pennsylvania, United States
Camp Hill, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Lebanon, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottstown, Pennsylvania, United States
West Reading, Pennsylvania, United States
Wexford, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Hickory Grove, South Carolina, United States
Myrtle Beach, South Carolina, United States
Hendersonville, Tennessee, United States
Hixson, Tennessee, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Amarillo, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
Nassau Bay, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Waco, Texas, United States
Burlington, Vermont, United States
Arlington, Virginia, United States
Burke, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Olympia, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Beckley, West Virginia, United States
Clarksburg, West Virginia, United States
Brookfield, Wisconsin, United States
Franklin, Wisconsin, United States
Glendale, Wisconsin, United States
Milwaukee, Wisconsin, United States
Onalaska, Wisconsin, United States
Countries
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References
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Weinblatt ME, Kremer J, Cush J, Rigby W, Teng LL, Devenport J, Singh N, Lepley D, Genovese MC. Tocilizumab as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs: twenty-four-week results of an open-label, clinical practice study. Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71. doi: 10.1002/acr.21847.
Other Identifiers
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ML22533
Identifier Type: -
Identifier Source: org_study_id