A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy
1 other identifier
interventional
499
14 countries
168
Brief Summary
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. 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 P50-P75 for phase_3 rheumatoid-arthritis
Started May 2005
168 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
March 25, 2005
CompletedFirst Posted
Study publicly available on registry
March 28, 2005
CompletedStudy Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedNovember 2, 2016
November 1, 2016
2.5 years
March 25, 2005
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of patients with ACR 20 response
Week 24
AEs, laboratory parameters, vital signs, ECGs.
Throughout study
Secondary Outcomes (2)
Percentage of patients with ACR 50 and ACR 70 responses
Week 24
Mean changes in parameters of ACR core set
Week 24
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
- inadequate response to current anti-rheumatic therapies, including MTX;
- inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
- on stable MTX for at least 8 weeks before entering study;
- 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 screening, or planned major surgery within 6 months after entering study;
- women who are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (168)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Huntsville, Alabama, 35801, United States
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Scottsdale, Arizona, 85251, United States
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Scottsdale, Arizona, 85258, United States
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Tucson, Arizona, 85724, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Anaheim, California, 92801, United States
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Fullerton, California, 92835, United States
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Long Beach, California, 90806, United States
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Long Beach, California, 90808, United States
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Los Angeles, California, 90095, United States
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Palm Desert, California, 92260, United States
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San Diego, California, 92101, United States
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San Diego, California, 92108, United States
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Santa Maria, California, 93454, United States
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Torrance, California, 90505, United States
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Colorado Springs, Colorado, 80910, United States
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Aventura, Florida, 33180, United States
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Boca Raton, Florida, 33486, United States
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Fort Lauderdale, Florida, 33334, United States
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Palm Habor, Florida, 34684, United States
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Sarasota, Florida, 34239, United States
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Tampa, Florida, 33614, United States
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Tavares, Florida, 32778, United States
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West Palm Beach, Florida, 33407, United States
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Zephyrhills, Florida, 33540, United States
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Atlanta, Georgia, 30342, United States
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Boise, Idaho, 83702, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60611, United States
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Springfield, Illinois, 62703, United States
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Springfield, Illinois, 62704, United States
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Indianapolis, Indiana, 46202-5100, United States
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Bowling Green, Kentucky, 42102, United States
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Elizabethtown, Kentucky, 42701, United States
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Lexington, Kentucky, 40515, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70121, United States
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Portland, Maine, 04102, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21205, United States
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Wheaton, Maryland, 20902, United States
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Springfield, Massachusetts, 01107, United States
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Worcester, Massachusetts, 01605, United States
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Lansing, Michigan, 48910, United States
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Duluth, Minnesota, 55805, United States
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Rochester, Minnesota, 55905, United States
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Tupelo, Mississippi, 38802, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63131, United States
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St Louis, Missouri, 63141, United States
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Billings, Montana, 59107-5100, United States
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Missoula, Montana, 59802, United States
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Las Vegas, Nevada, 89119, United States
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Medford, New Jersey, 08055, United States
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Mercerville, New Jersey, 08619, United States
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Teaneck, New Jersey, 07666, United States
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Albany, New York, 12206, United States
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Binghamton, New York, 13905, United States
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Great Neck, New York, 11020, United States
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Johnson City, New York, 13790, United States
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New York, New York, 10003, United States
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New York, New York, 10021, United States
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Orchard Park, New York, 14127, United States
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Rochester, New York, 14618, United States
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Asheville, North Carolina, 28801, United States
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Chapel Hill, North Carolina, 27599-7280, United States
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Charlotte, North Carolina, 28210, United States
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Wilmington, North Carolina, 28401, United States
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Bismarck, North Dakota, 58501, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45219, United States
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Oklahoma City, Oklahoma, 73103, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74135, United States
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Eugene, Oregon, 97401, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Danville, Pennsylvania, 17822, United States
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Duncansville, Pennsylvania, 16635, United States
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Philadelphia, Pennsylvania, 19140, United States
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Philadelphia, Pennsylvania, 19152, United States
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Willow Grove, Pennsylvania, 80045, United States
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Hickory Grove, South Carolina, 28602, United States
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Jackson, Tennessee, 38305, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75231-4406, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77074, United States
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Ogden, Utah, 84403, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23298, United States
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Salem, Virginia, 24153, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98195, United States
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Glendale, Wisconsin, 53217, United States
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Malvern, 3144, Australia
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Shenton Park, 6008, Australia
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Sydney, 2050, Australia
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Woolloongabba, 4102, Australia
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Aalst, 9300, Belgium
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Hasselt, 3500, Belgium
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Merksem, 2170, Belgium
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Calgary, Alberta, T2V 1P9, Canada
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Edmonton, Alberta, T5H 3V9, Canada
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Winnipeg, Manitoba, R3A 1M3, Canada
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Burlington, Ontario, L7M 4Y1, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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London, Ontario, N6A 4V2, Canada
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Mississauga, Ontario, L5M 2V8, Canada
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Newmarket, Ontario, L3Y 3R7, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Montreal, Quebec, H2L 1S6, Canada
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Amiens, 80054, France
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Bordeaux, 33076, France
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Le Kremlin-Bicêtre, 94275, France
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Lille, 59037, France
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Lyon, 69437, France
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Nice, 06202, France
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Paris, 75475, France
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Paris, 75679, France
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Strasbourg, 67098, France
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Toulouse, 31054, France
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Berlin, 10117, Germany
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Cologne, 50924, Germany
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Dresden, 01067, Germany
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Gommern, 39245, Germany
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Herne, 44652, Germany
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München, 81541, Germany
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Wiesbaden, 65191, Germany
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Würzburg, 97080, Germany
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Reykjavik, 108, Iceland
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Brescia, 25123, Italy
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Milan, 20122, Italy
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Milan, 20157, Italy
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Padua, 35128, Italy
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Pavia, 27100, Italy
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Pisa, 56100, Italy
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Udine, 33100, Italy
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Guadalajara, 44620, Mexico
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Enschede, 7511 JX, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Ponce, 00716, Puerto Rico
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Jönköping, 551 85, Sweden
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Karlstad, 65185, Sweden
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Malmo, 205 02, Sweden
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Stockholm, 171 76, Sweden
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Lausanne, 1011, Switzerland
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Basingstoke, RG24 9NA, United Kingdom
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Bath, BA1 1RL, United Kingdom
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Birmingham, B29 6JD, United Kingdom
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Cannock, WS11 5XY, United Kingdom
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Derby, DE22 3NE, United Kingdom
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Lancaster, LA1 4RP, United Kingdom
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Leeds, LS1 3EX, United Kingdom
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Liverpool, L9 7AL, United Kingdom
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London, SE1 9RT, United Kingdom
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London, SE5 9PJ, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Manchester, M41 5SL, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE1 4LP, United Kingdom
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Norwich, NR4 7UY, United Kingdom
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Oxford, OX3 7LD, United Kingdom
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Salford, M6 8HD, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Stoke-on-Trent, ST6 7AG, United Kingdom
Related Publications (5)
Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
PMID: 27889300DERIVEDKeystone EC, Anisfeld A, Ogale S, Devenport JN, Curtis JR. Continued benefit of tocilizumab plus disease-modifying antirheumatic drug therapy in patients with rheumatoid arthritis and inadequate clinical responses by week 8 of treatment. J Rheumatol. 2014 Feb;41(2):216-26. doi: 10.3899/jrheum.130489. Epub 2014 Jan 15.
PMID: 24429164DERIVEDStrand V, Burmester GR, Ogale S, Devenport J, John A, Emery P. Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study. Rheumatology (Oxford). 2012 Oct;51(10):1860-9. doi: 10.1093/rheumatology/kes131. Epub 2012 Jun 28.
PMID: 22753773DERIVEDKarsdal MA, Schett G, Emery P, Harari O, Byrjalsen I, Kenwright A, Bay-Jensen AC, Platt A. IL-6 receptor inhibition positively modulates bone balance in rheumatoid arthritis patients with an inadequate response to anti-tumor necrosis factor therapy: biochemical marker analysis of bone metabolism in the tocilizumab RADIATE study (NCT00106522). Semin Arthritis Rheum. 2012 Oct;42(2):131-9. doi: 10.1016/j.semarthrit.2012.01.004. Epub 2012 Mar 6.
PMID: 22397953DERIVEDEmery P, Keystone E, Tony HP, Cantagrel A, van Vollenhoven R, Sanchez A, Alecock E, Lee J, Kremer J. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial. Ann Rheum Dis. 2008 Nov;67(11):1516-23. doi: 10.1136/ard.2008.092932. Epub 2008 Jul 14.
PMID: 18625622DERIVED
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
March 25, 2005
First Posted
March 28, 2005
Study Start
May 1, 2005
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
November 2, 2016
Record last verified: 2016-11