A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
NCT ID: NCT01232569
Last Updated: 2015-07-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
656 participants
INTERVENTIONAL
2011-03-31
2013-11-30
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 162 mg sc
Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
Tocilizumab 162 mg
Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Placebo sc
Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.
Placebo
Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Interventions
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Tocilizumab 162 mg
Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Placebo
Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
* Receiving treatment on an outpatient basis.
* Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
* On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
* Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
* Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
* History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.
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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Peoria, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Fullerton, California, United States
San Diego, California, United States
San Leandro, California, United States
West Hills, California, United States
Trumbull, Connecticut, United States
Boca Raton, Florida, United States
Jupiter, Florida, United States
Ormond Beach, Florida, United States
Sarasota, Florida, United States
Gainesville, Georgia, United States
Idaho Falls, Idaho, United States
Meridan, Idaho, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Crofton, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Flowood, Mississippi, United States
Jackson, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Brooklyn, New York, United States
Belmont, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Wexford, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Tacoma, Washington, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
San Miguel de Tucumán, , Argentina
Cairns, , Australia
Kogarah, , Australia
Curitiba, , Brazil
Goiânia, , Brazil
Juiz de Fora, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Salvador, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Vitória, , Brazil
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Calgary, Alberta, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Pointe-Claire, Quebec, Canada
Bogotá, , Colombia
Chia-cundinamarca, , Colombia
Medellín, , Colombia
Athens, , Greece
Athens, , Greece
Thessaloniki, , Greece
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Budapest, , Hungary
Debrecen, , Hungary
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Ramat Gan, , Israel
Rishon LeZiyyon, , Israel
Tel Aviv, , Israel
Batu Caves, , Malaysia
Kota Kinabalu, , Malaysia
Kuala Lumpur, , Malaysia
Chihuahua City, , Mexico
Culiacán, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexicali, , Mexico
Mérida, , Mexico
México, , Mexico
Morelia, , Mexico
Obregón, , Mexico
Querétaro, , Mexico
Querétaro, , Mexico
Otahuhu, , New Zealand
Panama City, , Panama
Cebu, , Philippines
Davao City, , Philippines
Manila, , Philippines
Bytom, , Poland
Działdowo, , Poland
Elblag, , Poland
Kościan, , Poland
Krakow, , Poland
Torun, , Poland
Warsaw, , Poland
Kemerovo, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Petrozavodsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Voronezh, , Russia
Durban, , South Africa
Pinelands, , South Africa
Pretoria, , South Africa
A Coruña, , Spain
Oviedo, , Spain
Seville, , Spain
Fribourg, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Zurich, , Switzerland
Bangkok, , Thailand
Bangkok, , Thailand
Countries
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References
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Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, Merrill JT, Rowell L, Nasmyth-Miller C, Bao M, Wright S, Pope JE. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1653-61. doi: 10.1002/acr.22384.
Other Identifiers
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2010-019912-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NA25220
Identifier Type: -
Identifier Source: org_study_id
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