A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis
Launched by HOFFMANN-LA ROCHE · Nov 3, 2009
Trial Information
Current as of August 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult patients ≥ 18 years of age.
- • Rheumatoid arthritis of ≤ 2 years duration.
- • Disease Activity Score 28 (DAS28) \> 3.2.
- • Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints.
- • Rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative \> 1 erosion required at screening).
- • Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
- Exclusion Criteria:
- • Previous treatment with tocilizumab.
- • Previous treatment with methotrexate or biologic agent.
- • Rheumatic autoimmune disease other than rheumatoid arthritis (RA).
- • History of or current inflammatory joint disease other than RA.
- • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Huntsville, Alabama, United States
Tulsa, Oklahoma, United States
Vernon Hills, Illinois, United States
Amarillo, Texas, United States
Sugar Land, Texas, United States
Glendale, Wisconsin, United States
Greenville, South Carolina, United States
Porto Alegre, Rs, Brazil
San Diego, California, United States
Huntington Beach, California, United States
Bethlehem, Pennsylvania, United States
Houston, Texas, United States
Lubbock, Texas, United States
Spokane, Washington, United States
Cedar Rapids, Iowa, United States
Peoria, Arizona, United States
Springfield, Illinois, United States
Oklahoma City, Oklahoma, United States
Winnipeg, Manitoba, Canada
Trois Rivieres, Quebec, Canada
Worcester, Massachusetts, United States
Houston, Texas, United States
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
St. Catharines, Ontario, Canada
Montreal, Quebec, Canada
Tacoma, Washington, United States
Medellin Antioquia, , Colombia
Trumbull, Connecticut, United States
Anniston, Alabama, United States
Mesa, Arizona, United States
Los Alamitos, California, United States
San Diego, California, United States
Palm Harbor, Florida, United States
Palm Harbor, Florida, United States
Tampa, Florida, United States
Moline, Illinois, United States
Morton Grove, Illinois, United States
Baton Rouge, Louisiana, United States
Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
Haddon Heights, New Jersey, United States
Asheville, North Carolina, United States
Wyomissing, Pennsylvania, United States
San Antonio, Texas, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Maroochydore, Queensland, Australia
Goiania, Go, Brazil
Curtiba, Pr, Brazil
Vancouver, British Columbia, Canada
Kitchener, Ontario, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Cahors, , France
Marseille, , France
Montpellier, , France
Berlin, , Germany
Heidelberg, , Germany
Köln, , Germany
Osnabrück, , Germany
Budapest, , Hungary
Debrecen, , Hungary
Reggio Emilia, Emilia Romagna, Italy
Genova, Liguria, Italy
Mexicali, , Mexico
Mexico, , Mexico
Timaru, , New Zealand
Panama City, , Panama
Elblag, , Poland
Szczecin, , Poland
Oviedo, Asturias, Spain
Guadalajara, , Spain
Beijing, , China
Shanghai, , China
Berlin, , Germany
Hamburg, , Germany
Herne, , Germany
Ratingen, , Germany
Ashkelon, , Israel
Haifa, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Bridgeport, Connecticut, United States
Clifton, New Jersey, United States
Vancouver, British Columbia, Canada
St John's, Newfoundland And Labrador, Canada
Quebec, , Canada
Ponce, , Puerto Rico
Manchester, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Manila, , Philippines
North Shields, , United Kingdom
Derby, , United Kingdom
Guangzhou, , China
Juiz De Fora, Mg, Brazil
Saint Petersburg, , Russian Federation
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Hyvinkää, , Finland
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Rosario, , Argentina
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Camperdown, New South Wales, Australia
Woodville, South Australia, Australia
Hobart, Tasmania, Australia
Malvern, Victoria, Australia
Murdoch, Western Australia, Australia
Innsbruck, , Austria
Wien, , Austria
Wien, , Austria
Goiania, Go, Brazil
Campinas, Sp, Brazil
Sao Paulo, Sp, Brazil
Sao Paulo, Sp, Brazil
Saskatoon, Saskatchewan, Canada
Beijing, , China
Bogota, , Colombia
Medellin, , Colombia
Køge, , Denmark
Helsinki, , Finland
Mulhouse, , France
Orleans, , France
Paris, , France
Toulouse, , France
Bad Nauheim, , Germany
Baden Baden, , Germany
Dresden, , Germany
Erlangen, , Germany
Hildesheim, , Germany
München, , Germany
Würzburg, , Germany
Athens, , Greece
Larissa, , Greece
Guatemala City, , Guatemala
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Hong Kong, , Hong Kong
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Tuen Mun, , Hong Kong
Eger, , Hungary
Cork, , Ireland
Dublin, , Ireland
Dublin, , Ireland
Afula, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Ramat Gan, , Israel
Napoli, Campania, Italy
Bologna, Emilia Romagna, Italy
Roma, Lazio, Italy
Roma, Lazio, Italy
Magenta, Lombardia, Italy
Milano, Lombardia, Italy
Monserrato, Sardegna, Italy
Skopje, , Macedonia, The Former Yugoslav Republic Of
Culiacán Rosales, Sinaloa, Mexico
Guadalajara, , Mexico
Morelia, , Mexico
Saltillo, , Mexico
Torreon, , Mexico
Auckland, , New Zealand
Hamilton, , New Zealand
Lima, , Peru
Lima, , Peru
San Juan De Miraflores, , Peru
Manila, , Philippines
Manila, , Philippines
Bytom, , Poland
Lublin, , Poland
Poznan, , Poland
Warszawa, , Poland
Coimbra, , Portugal
Lisboa, , Portugal
Porto, , Portugal
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Ryazan, , Russian Federation
Saratov, , Russian Federation
Tula, , Russian Federation
Yaroslavl, , Russian Federation
Bloemfontein, , South Africa
Durban, , South Africa
Port Elizabeth, , South Africa
Stellenbosch, , South Africa
Merida, Badajoz, Spain
Santander, Cantabria, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
San Sebastian De Los Reyes, Madrid, Spain
Madrid, , Spain
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Sevilla, , Spain
Huddinge, , Sweden
Stockholm, , Sweden
Bangkok, , Thailand
Bangkok, , Thailand
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Songkhla, , Thailand
Istanbul, , Turkey
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Cannock, , United Kingdom
Dudley, , United Kingdom
Maidstone, , United Kingdom
Sheffield, , United Kingdom
Stoke On Trent, , United Kingdom
Torquay, , United Kingdom
Wirral, , United Kingdom
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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