A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
NCT ID: NCT01194414
Last Updated: 2016-06-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1262 participants
INTERVENTIONAL
2010-09-30
2013-08-31
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
TRIPLE
Study Groups
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Tocilizumab SC
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
tocilizumab SC
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
placebo to tocilizumab IV
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
Tocilizumab IV
Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
tocilizumab IV
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
placebo to tocilizumab SC
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
Tocilizumab SC Then Tocilizumab IV
Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study.
tocilizumab SC
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
tocilizumab IV
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
placebo to tocilizumab IV
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
Tocilizumab IV Then Tocilizumab SC
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
tocilizumab SC
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
tocilizumab IV
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
placebo to tocilizumab SC
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
Interventions
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tocilizumab SC
Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
tocilizumab IV
Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
placebo to tocilizumab SC
Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
placebo to tocilizumab IV
Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
Disease-modifying antirheumatic drugs (DMARDs)
stable dose as prescribed
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
* Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
* Inadequate response to current DMARD therapy
* Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
* Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
Exclusion Criteria
* Rheumatic autoimmune disease other than RA
* Functional class IV (ACR classification)
* Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
* Prior history of or current inflammatory joint disease other than RA
* Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
* Previous treatment with tocilizumab
* Active current or history of recurrent 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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Huntsville, Alabama, United States
Tuscaloosa, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Long Beach, California, United States
Los Angeles, California, United States
Upland, California, United States
Van Nuys, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Delray Beach, Florida, United States
Miami, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Pinellas Park, Florida, United States
South Miami, Florida, United States
Tampa, Florida, United States
Coeur d'Alene, Idaho, United States
Morton Grove, Illinois, United States
Wichita, Kansas, United States
Monroe, Louisiana, United States
Petoskey, Michigan, United States
Saint Claire Shores, Michigan, United States
Eagan, Minnesota, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Clifton, New Jersey, United States
Manalapan, New Jersey, United States
Voorhees Township, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Binghamton, New York, United States
Orchard Park, New York, United States
Asheville, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Olympia, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Wenatchee, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
Adelaide, , Australia
Adelaide, , Australia
Clayton, , Australia
Geelong, , Australia
Hobart, , Australia
Malvern East, , Australia
Maroochydore, , Australia
New Lambton, , Australia
Curitiba, , Brazil
Goiânia, , Brazil
Juiz de Fora, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Ottawa, Ontario, Canada
St. Catharines, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Rimouski, Quebec, Canada
Sainte-Foy, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Barranquilla, , Colombia
Bogotá, , Colombia
Bordeaux, , France
Le Mans, , France
Marseille, , France
Montpellier, , France
Nantes, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Bad Bramstedt, , Germany
Berlin, , Germany
Berlin, , Germany
Cologne, , Germany
Dresden, , Germany
Essen, , Germany
Freiburg im Breisgau, , Germany
Gommern, , Germany
Heidelberg, , Germany
Herne, , Germany
Hildesheim, , Germany
Ludwigshafen, , Germany
Osnabrück, , Germany
Ratingen, , Germany
Rostock, , Germany
Würzburg, , Germany
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Arenzano, , Italy
Bergamo, , Italy
Catania, , Italy
Cona (ferrara), , Italy
Genova, , Italy
Napoli, , Italy
Pavia, , Italy
Pisa, , Italy
Potenza, , Italy
Reggio Emilia, , Italy
Udine, , Italy
Varese, , Italy
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Culiacán, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexico Ctiy, , Mexico
Mérida, , Mexico
Miexico City, , Mexico
Morelia, , Mexico
Obregón, , Mexico
Querétaro, , Mexico
Saltillo, , Mexico
Torreón, , Mexico
Auckland, , New Zealand
Hamilton, , New Zealand
Tauranga, , New Zealand
Wellington, , New Zealand
Lima, , Peru
Lima, , Peru
Lima, , Peru
Cebu, , Philippines
Manila, , Philippines
Quezon, , Philippines
Bialystok, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Ponce, , Puerto Rico
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Iași, , Romania
Moscow, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Novosibirsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Ulyanovsk, , Russia
Yaroslavl, , Russia
Yaroslavl, , Russia
Singapore, , Singapore
Cape Town, , South Africa
Durban, , South Africa
Parktown, , South Africa
Port Elizabeth, , South Africa
Stellenbosch, , South Africa
A Coruña, , Spain
Barakaldo, , Spain
Bilbao, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Mérida, , Spain
San Cristóbal de La Laguna, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Torrelavega, , Spain
Valencia, , Spain
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Cambridge, , United Kingdom
Cannock, , United Kingdom
Coventry, , United Kingdom
Eastbourne, , United Kingdom
Exeter, , United Kingdom
Harrogate, , United Kingdom
Ipswich, , United Kingdom
London, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Northampton, , United Kingdom
Nottingham, , United Kingdom
Westcliffe-on-sea, , United Kingdom
Countries
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References
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Burmester GR, Rubbert-Roth A, Cantagrel A, Hall S, Leszczynski P, Feldman D, Rangaraj MJ, Roane G, Ludivico C, Bao M, Rowell L, Davies C, Mysler EF. Efficacy and safety of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional DMARDs in patients with RA at week 97 (SUMMACTA). Ann Rheum Dis. 2016 Jan;75(1):68-74. doi: 10.1136/annrheumdis-2015-207281. Epub 2015 Jun 8.
Other Identifiers
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2010-018375-22
Identifier Type: -
Identifier Source: secondary_id
WA22762
Identifier Type: -
Identifier Source: org_study_id
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