A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT ID: NCT00106548
Last Updated: 2010-06-11
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
623 participants
INTERVENTIONAL
2007-10-31
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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1
tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
Methotrexate
10-25mg/week
2
tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
Methotrexate
10-25mg/week
3
Placebo
iv / month
Methotrexate
10-25mg/week
Interventions
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tocilizumab [RoActemra/Actemra]
4mg/kg iv / month
tocilizumab [RoActemra/Actemra]
8mg/kg iv / month
Placebo
iv / month
Methotrexate
10-25mg/week
Eligibility Criteria
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Inclusion Criteria
* inadequate response to a stable dose of MTX;
* patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
* prior treatment failure with an anti-tumor necrosis factor agent;
* 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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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Adelaide, , Australia
Douglas, , Australia
Maroochydore, , Australia
Shenton Park, , Australia
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Vienna, , Austria
Porto Alegre, , Brazil
São Paulo, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Burlington, Ontario, Canada
Newmarket, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Hong Kong, , China
Hong Kong, , China
Besançon, , France
Créteil, , France
Le Mans, , France
Montpellier, , France
Paris, , France
Paris, , France
Paris, , France
Bad Bramstedt, , Germany
Bad Nauheim, , Germany
Baden-Baden, , Germany
Berlin, , Germany
Cologne, , Germany
Erlangen, , Germany
Heidelberg, , Germany
Tübingen, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Pécs, , Hungary
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Ferrara, , Italy
Gazzi, , Italy
Palermo, , Italy
Siena, , Italy
Udine, , Italy
Chihuahua City, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
San Luis Potosí City, , Mexico
Singapore, , Singapore
Singapore, , Singapore
Piešťany, , Slovakia
Bern, , Switzerland
Lausanne, , Switzerland
Sankt Gallen, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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References
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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.
Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.
Garnero P, Thompson E, Woodworth T, Smolen JS. Rapid and sustained improvement in bone and cartilage turnover markers with the anti-interleukin-6 receptor inhibitor tocilizumab plus methotrexate in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a substudy of the multicenter double-blind, placebo-controlled trial of tocilizumab in inadequate responders to methotrexate alone. Arthritis Rheum. 2010 Jan;62(1):33-43. doi: 10.1002/art.25053.
Smolen JS, Beaulieu A, Rubbert-Roth A, Ramos-Remus C, Rovensky J, Alecock E, Woodworth T, Alten R; OPTION Investigators. Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial. Lancet. 2008 Mar 22;371(9617):987-97. doi: 10.1016/S0140-6736(08)60453-5.
Other Identifiers
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WA17822
Identifier Type: -
Identifier Source: org_study_id
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