A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
NCT ID: NCT00109408
Last Updated: 2016-11-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
673 participants
INTERVENTIONAL
2005-07-31
2007-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
2
Methotrexate
7.5-20mg po weekly
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
7.5-20mg po weekly
tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients of reproductive potential must be using reliable methods of contraception.
Exclusion Criteria
* treatment with methotrexate (MTX) within 6 months of entering study;
* patients who have stopped previous MTX treatment due to toxicity or lack of response;
* women who are pregnant or breast-feeding.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pavia, , Italy
Reggio Emilia, , Italy
Montgomery, Alabama, United States
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Huntington Beach, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Palm Springs, California, United States
Sacramento, California, United States
San Leandro, California, United States
Santa Maria, California, United States
Jupiter, Florida, United States
Palm Habor, Florida, United States
Palm Harbor, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Morton Grove, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Cedar Rapids, Iowa, United States
Des Moines, Iowa, United States
Bowling Green, Kentucky, United States
Baton Rouge, Louisiana, United States
Slidell, Louisiana, United States
Greenbelt, Maryland, United States
Pittsfield, Massachusetts, United States
Grand Rapids, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Eagan, Minnesota, United States
Saint Cloud, Minnesota, United States
Flowood, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Dover, New Hampshire, United States
Nashua, New Hampshire, United States
Haddon Heights, New Jersey, United States
New Brunswick, New Jersey, United States
Albany, New York, United States
Syracuse, New York, United States
Fayetteville, North Carolina, United States
Canton, Ohio, United States
Mayfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Hickory Grove, South Carolina, United States
Hixson, Tennessee, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Austin, Texas, United States
Mesquite, Texas, United States
Chesapeake, Virginia, United States
Mountlake Terrace, Washington, United States
Olympia, Washington, United States
Spokane, Washington, United States
Yakima, Washington, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Rosario, , Argentina
San Juan Bautista, , Argentina
Adelaide, , Australia
Hobart, , Australia
Shenton Park, , Australia
Sydney, , Australia
Woodville, , Australia
Woolloongabba, , Australia
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
Kitchener, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Guangzhou, , China
Hefei Anhui, , China
Jinan, , China
Copenhagen, , Denmark
Hillerød, , Denmark
Hvidovre, , Denmark
Brest, , France
Lyon, , France
Paris, , France
Rouen, , France
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Ramat Gan, , Israel
Rishon LeZiyyon, , Israel
Genova, , Italy
Milan, , Italy
Siena, , Italy
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
Vilnius, , Lithuania
Guadalajara, , Mexico
Guadalajara, , Mexico
Guadalajara, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Levanger, , Norway
Lillehammer, , Norway
Lima, , Peru
Lima, , Peru
Almada, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Belgrade, , Serbia
Niška Banja, , Serbia
Ljubljana, , Slovenia
Maribor, , Slovenia
Cape Town, , South Africa
Cape Town, , South Africa
Diepkloof, , South Africa
Pinelands, , South Africa
Radiokop, , South Africa
Alcorcón, , Spain
Barcelona, , Spain
Córdoba, , Spain
Guadalajara, , Spain
Lugo, , Spain
Salamanca, , Spain
San Cristóbal de La Laguna, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.
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.
Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.
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.
Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WA17824
Identifier Type: -
Identifier Source: org_study_id