A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis
1 other identifier
interventional
673
18 countries
147
Brief Summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Jul 2005
147 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2005
CompletedFirst Posted
Study publicly available on registry
April 28, 2005
CompletedStudy Start
First participant enrolled
July 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedNovember 2, 2016
November 1, 2016
2.4 years
April 27, 2005
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with ACR 20 response
Week 24
Secondary Outcomes (4)
Percentage of patients with ACR 20 response
Week 8
Percentage of patients with ACR 50 and ACR 70 responses
Week 24
Mean change in parameters of ACR core set
Week 24
AEs, laboratory parameters, vital signs.
Throughout study
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients at least 18 years of age with active RA for at least 3 months;
- patients of reproductive potential must be using reliable methods of contraception.
You may not qualify if:
- major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
Unknown Facility
Montgomery, Alabama, 36111, United States
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Mesa, Arizona, 85208, United States
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Paradise Valley, Arizona, 85253, United States
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Phoenix, Arizona, 85013, United States
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Little Rock, Arkansas, 72205, United States
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Huntington Beach, California, 92646, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90045, United States
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Palm Springs, California, 92262, United States
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Sacramento, California, 95825, United States
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San Leandro, California, 94578, United States
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Santa Maria, California, 93454, United States
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Jupiter, Florida, 33458, United States
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Palm Habor, Florida, 34684, United States
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Palm Harbor, Florida, 34684, United States
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Port Orange, Florida, 32127, United States
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Tampa, Florida, 33609, United States
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Tampa, Florida, 33614, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Morton Grove, Illinois, 60053, United States
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Springfield, Illinois, 62704, United States
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Indianapolis, Indiana, 46202, United States
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Cedar Rapids, Iowa, 52401, United States
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Des Moines, Iowa, 50322, United States
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Bowling Green, Kentucky, 42102, United States
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Baton Rouge, Louisiana, 70808, United States
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Slidell, Louisiana, 70458, United States
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Greenbelt, Maryland, 20770, United States
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Pittsfield, Massachusetts, 01201, United States
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Grand Rapids, Michigan, 49546, United States
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Kalamazoo, Michigan, 49048, United States
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Lansing, Michigan, 48910, United States
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Eagan, Minnesota, 55121, United States
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Saint Cloud, Minnesota, 56303, United States
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Flowood, Mississippi, 39232, United States
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Tupelo, Mississippi, 38802, United States
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St Louis, Missouri, 63117, United States
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St Louis, Missouri, 63131, United States
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Dover, New Hampshire, 03820, United States
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Nashua, New Hampshire, 03060, United States
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Haddon Heights, New Jersey, 08035, United States
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New Brunswick, New Jersey, 08903, United States
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Albany, New York, 12206, United States
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Syracuse, New York, 13210, United States
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Fayetteville, North Carolina, 28304, United States
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Canton, Ohio, 44718, United States
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Mayfield, Ohio, 44143, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73109, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74135, United States
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Duncansville, Pennsylvania, 16635, United States
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Philadelphia, Pennsylvania, 19152, United States
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Willow Grove, Pennsylvania, 19090, United States
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Wyomissing, Pennsylvania, 19610, United States
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Charleston, South Carolina, 29406, United States
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Columbia, South Carolina, 29204, United States
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Greenville, South Carolina, 29601, United States
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Hickory Grove, South Carolina, 28602, United States
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Hixson, Tennessee, 37343, United States
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Nashville, Tennessee, 37203, United States
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Amarillo, Texas, 79124, United States
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Austin, Texas, 78705, United States
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Mesquite, Texas, 75150, United States
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Chesapeake, Virginia, 23320, United States
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Mountlake Terrace, Washington, 98043, United States
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Olympia, Washington, 98502, United States
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Spokane, Washington, 99204, United States
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Yakima, Washington, 98902, United States
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1428DQG, Argentina
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Rosario, S2000PBJ, Argentina
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San Juan Bautista, B1878DVB, Argentina
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Adelaide, 5041, Australia
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Hobart, 7000, Australia
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Shenton Park, 6008, Australia
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Sydney, 2050, Australia
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Woodville, 5011, Australia
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Woolloongabba, 4102, Australia
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Victoria, British Columbia, V8V 3P9, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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Winnipeg, Manitoba, R3A 1M4, Canada
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St. John's, Newfoundland and Labrador, A1A 5E8, Canada
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Burlington, Ontario, L7M 4Y1, Canada
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Hamilton, Ontario, L8N 2B6, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Ottawa, Ontario, K1H 1A2, Canada
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Guangzhou, 510630, China
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Hefei Anhui, 230022, China
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Jinan, 250012, China
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Copenhagen, 2400, Denmark
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Hillerød, 3400, Denmark
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Hvidovre, 2650, Denmark
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Brest, 29609, France
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Lyon, 69437, France
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Paris, 75679, France
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Rouen, 76031, France
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Ashkelon, 78306, Israel
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Beersheba, 8410101, Israel
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Haifa, 31048, Israel
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Haifa, 34354, Israel
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Kfar Saba, 44281, Israel
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Ramat Gan, 52621, Israel
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Rishon LeZiyyon, 70300, Israel
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Genova, 16132, Italy
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Milan, 20157, Italy
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Pavia, 27100, Italy
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Reggio Emilia, 42100, Italy
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Siena, 53100, Italy
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Kaunas, 50009, Lithuania
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Klaipėda, 92288, Lithuania
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Panevezys, 35144, Lithuania
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Šiauliai, 76231, Lithuania
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Vilnius, LT-08661, Lithuania
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Guadalajara, 44340, Mexico
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Guadalajara, 44620, Mexico
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Guadalajara, 45235, Mexico
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Mexico City, 06700, Mexico
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Mexico City, 07760, Mexico
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Mexico City, 14050, Mexico
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Levanger, 7600, Norway
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Lillehammer, 2609, Norway
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Lima, 11, Peru
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Lima, 13, Peru
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Almada, 2801-951, Portugal
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Lisbon, 1050-34, Portugal
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Lisbon, 1349-019, Portugal
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Belgrade, 11000, Serbia
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Niška Banja, 18250, Serbia
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Cape Town, 4001, South Africa
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Cape Town, 7500, South Africa
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Diepkloof, 1862, South Africa
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Pinelands, 7405, South Africa
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Radiokop, 2040, South Africa
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Alcorcón, 28922, Spain
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Barcelona, 08035, Spain
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Córdoba, 14004, Spain
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Guadalajara, 19002, Spain
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Lugo, 27004, Spain
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Salamanca, 37007, Spain
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San Cristóbal de La Laguna, 38320, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46017, Spain
Related Publications (5)
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.
PMID: 33413588DERIVEDStrand 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.
PMID: 28955499DERIVEDJones 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.
PMID: 27909081DERIVEDWang 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.
PMID: 22491018DERIVEDJones 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.
PMID: 19297346DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2005
First Posted
April 28, 2005
Study Start
July 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11