A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
NCT ID: NCT01283971
Last Updated: 2014-02-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
96 participants
INTERVENTIONAL
2011-05-31
2012-08-31
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 + Methotrexate
Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
tocilizumab [RoActemra/Actemra]
Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.
placebo to adalimumab
Placebo to adalimumab SC every 2 weeks for 24 weeks.
methotrexate
Methotrexate 10-25 mg weekly.
folate
Folate at least 5 mg weekly.
Adalimumab + Methotrexate
Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
adalimumab
Adalimumab 40 mg SC every 2 weeks.
placebo to tocilizumab
Placebo to tocilizumab IV every 4 weeks for 24 weeks.
methotrexate
Methotrexate 10-25 mg weekly.
folate
Folate at least 5 mg weekly.
Interventions
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tocilizumab [RoActemra/Actemra]
Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.
adalimumab
Adalimumab 40 mg SC every 2 weeks.
placebo to tocilizumab
Placebo to tocilizumab IV every 4 weeks for 24 weeks.
placebo to adalimumab
Placebo to adalimumab SC every 2 weeks for 24 weeks.
methotrexate
Methotrexate 10-25 mg weekly.
folate
Folate at least 5 mg weekly.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)
* Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
* On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
* Disease Activity Score (DAS28) \>3.2 at baseline
* Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Functional class IV (ACR criteria)
* History of severe allergic reaction to human, humanized or murine monoclonal antibodies
* Known active current or history of recurrent infection (including tuberculosis)
* Primary or secondary immunodeficiency (history of or currently active)
* Body weight \>150 kg
* Previous treatment with any cell-depleting therapies
* Previous treatment with tocilizumab
* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.
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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Huntsville, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Covina, California, United States
Escondido, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Lakewood, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
Westlake Village, California, United States
Whittier, California, United States
Whittier, California, United States
Bridgeport, Connecticut, United States
Hamden, Connecticut, United States
Norwich, Connecticut, United States
Newark, Delaware, United States
Aventura, Florida, United States
Fort Lauderdale, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Palm Habor, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Valdosta, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Moline, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
South Bend, Indiana, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Monroe, Louisiana, United States
Annapolis, Maryland, United States
Cumberland, Maryland, United States
Frederick, Maryland, United States
Hagerstown, Maryland, United States
Fall River, Massachusetts, United States
Worcester, Massachusetts, United States
Battle Creek, Michigan, United States
Lansing, Michigan, United States
Petoskey, Michigan, United States
Saint Claire Shores, Michigan, United States
Biloxi, Mississippi, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Clifton, New Jersey, United States
Manalapan, New Jersey, United States
New Brunswick, New Jersey, United States
Brooklyn, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Washington, North Carolina, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Lake Oswego, Oregon, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Jackson, Tennessee, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
Corpus Christi, 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
Sugar Land, Texas, United States
Arlington, Virginia, United States
Kennewick, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Clarksburg, West Virginia, United States
Franklin, Wisconsin, United States
Aalborg, , Denmark
Elsinore, , Denmark
Silkeborg, , Denmark
Helsinki, , Finland
Hyvinkää, , Finland
Jyväskylä, , Finland
Grenoble, , France
Lille, , France
Limoges, , France
Metz, , France
Montpellier, , France
Mulhouse, , France
Nantes, , France
Orléans, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Düsseldorf, , Germany
Erfurt, , Germany
Erlangen, , Germany
Frankfurt am Main, , Germany
Gommern, , Germany
Hamburg, , Germany
Hanover, , Germany
Heidelberg, , Germany
Herne, , Germany
Hildesheim, , Germany
München, , Germany
Osnabrück, , Germany
Regensburg, , Germany
Rostock, , Germany
Tübingen, , Germany
Athens, , Greece
Heraklion, , Greece
Thessaloniki, , Greece
Thessaloniki, , Greece
Florence, , Italy
Milan, , Italy
Pavia, , Italy
Pisa, , Italy
Roma, , Italy
Nijmegen, , Netherlands
Caguas, , Puerto Rico
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Ufa, , Russia
Ulyanovsk, , Russia
Sabadell, Barcelona, Spain
A Coruña, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Oviedo, Principality of Asturias, Spain
Valenica, Valencia, Spain
Barakaldo, Vizcaya, Spain
Gothenburg, , Sweden
Huddinge, , Sweden
Lund, , Sweden
Malmo, , Sweden
Umeå, , Sweden
Västerås, , Sweden
Countries
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Other Identifiers
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2010-023587-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MA25522
Identifier Type: -
Identifier Source: org_study_id
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