A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
NCT ID: NCT01119859
Last Updated: 2013-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
326 participants
INTERVENTIONAL
2010-05-31
2012-01-31
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
Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
Tocilizumab
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Placebo to adalimumab
Adalimumab 40 mg
Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
Adalimumab
Placebo to tocilizumab
Interventions
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Tocilizumab
The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
Adalimumab
Placebo to tocilizumab
Placebo to adalimumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Rheumatoid arthritis of \> 6 months duration.
* Intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate.
* All disease-modifying anti-rheumatic drugs (DMARD) are to be withdrawn prior to receiving study drug.
* Weight ≤ 150 kg.
Exclusion Criteria
* History of or current inflammatory joint disease other than rheumatoid arthritis (RA).
* Treatment with a biologic agent at any time prior to baseline.
* Intra-articular or parenteral corticosteroids ≤ 4 weeks prior to baseline.
* Active current infection or history of recurrent bacterial, viral, fungal or mycobacterial infection.
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
Scottsdale, Arizona, United States
Hot Springs, Arkansas, United States
Little Rock, Arkansas, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Trumbull, Connecticut, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Ormond Beach, Florida, United States
Idaho Falls, Idaho, United States
Springfield, Illinois, United States
Cumberland, Maryland, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
Lincoln, Nebraska, United States
Dover, New Hampshire, United States
New Brunswick, New Jersey, United States
Hickory, North Carolina, United States
Dayton, Ohio, United States
Duncansville, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Greenville, South Carolina, United States
Hixson, Tennessee, United States
Houston, Texas, United States
Lubbock, Texas, United States
Mesquite, Texas, United States
Nassau Bay, Texas, United States
Waco, Texas, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Maroochydore, , Australia
Sydney, , Australia
Brussels, , Belgium
Liège, , Belgium
Curitiba, , Brazil
Goiânia, , Brazil
São Paulo, , Brazil
Prague, , Czechia
Helsinki, , Finland
Jyväskylä, , Finland
Baden-Baden, , Germany
Berlin, , Germany
Cologne, , Germany
Essen, , Germany
Heidelberg, , Germany
Herne, , Germany
Hildesheim, , Germany
Osnabrück, , Germany
Ratingen, , Germany
Würzburg, , Germany
Athens, , Greece
Heraklion, , Greece
Thessaloniki, , Greece
Mexicali, , Mexico
Mexico City, , Mexico
Obregón, , Mexico
Almada, , Portugal
Lisbon, , Portugal
Porto, , Portugal
A Coruña, , Spain
Barcelona, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Stockholm, , Sweden
Uppsala, , Sweden
Aarau, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Ankara, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Cannock, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Poole, , United Kingdom
Countries
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References
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Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.
Gabay C, McInnes IB, Kavanaugh A, Tuckwell K, Klearman M, Pulley J, Sattar N. Comparison of lipid and lipid-associated cardiovascular risk marker changes after treatment with tocilizumab or adalimumab in patients with rheumatoid arthritis. Ann Rheum Dis. 2016 Oct;75(10):1806-12. doi: 10.1136/annrheumdis-2015-207872. Epub 2015 Nov 27.
Dennis G Jr, Holweg CT, Kummerfeld SK, Choy DF, Setiadi AF, Hackney JA, Haverty PM, Gilbert H, Lin WY, Diehl L, Fischer S, Song A, Musselman D, Klearman M, Gabay C, Kavanaugh A, Endres J, Fox DA, Martin F, Townsend MJ. Synovial phenotypes in rheumatoid arthritis correlate with response to biologic therapeutics. Arthritis Res Ther. 2014;16(2):R90. doi: 10.1186/ar4555. Epub 2014 Apr 30.
Gabay C, Emery P, van Vollenhoven R, Dikranian A, Alten R, Pavelka K, Klearman M, Musselman D, Agarwal S, Green J, Kavanaugh A; ADACTA Study Investigators. Tocilizumab monotherapy versus adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled phase 4 trial. Lancet. 2013 May 4;381(9877):1541-50. doi: 10.1016/S0140-6736(13)60250-0. Epub 2013 Mar 18.
Other Identifiers
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2009-015845-21
Identifier Type: -
Identifier Source: secondary_id
WA19924
Identifier Type: -
Identifier Source: org_study_id
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