A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
ROSE
A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)
1 other identifier
interventional
619
2 countries
157
Brief Summary
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to severe active rheumatoid arthritis with an inadequate response to DMARDs. Patients were randomized in a ratio of 2:1 to receive either tocilizumab 8 mg/kg intravenously (IV) or placebo IV every 4 weeks. All patients also received stable antirheumatic therapy, including permitted DMARDs. The anticipated time on study treatment was 3-12 months and the target sample size was 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 Oct 2007
Typical duration for phase_3 rheumatoid-arthritis
157 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
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedResults Posted
Study results publicly available
August 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedAugust 20, 2012
August 1, 2012
1.7 years
September 18, 2007
July 6, 2010
August 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24
Improvement must be seen in tender and swollen joint counts and in at least 3 of the following 5 parameters. Patient and physician assessment of patient disease activity (DA) in previous 24 hours on a visual analog scale (VAS, no DA to maximum DA); patient assessment of pain in previous 24 hours on a VAS (none to unbearable); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein or, if missing, erythrocyte sedimentation rate.
Baseline to Week 24
Secondary Outcomes (10)
Percentage of Patients With an Improvement of at Least 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20, ACR50, ACR70) From Baseline at Weeks 4, 8, 12, 16, 20, and 24
Baseline to Weeks 4, 8, 12, 16, 20, 24
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 4, 8, 12, 16, 20, and 24
Baseline to Weeks 4, 8, 12, 16, 20, 24
Percentage of Patients With European League Against Rheumatism (EULAR) Good, Moderate, or no Response at Weeks 4, 8, 12, 16, 20, and 24
Baseline to Weeks 4, 8, 12, 16, 20, and 24
Mean Change From Baseline in the Routine Assessment Patient Index Data (RAPID) Score at Weeks 4, 8, 12, 16, 20, and 24
Baseline to Weeks 4, 8, 12, 16, 20, and 24
Mean Change From Baseline in 12-Item Short Form Health Survey v2 (SF-12) Scores at Weeks 4, 8, 12, 16, 20, and 24
Baseline to Weeks 4, 8, 12, 16, 20, and 24
- +5 more secondary outcomes
Study Arms (2)
Tocilizumab 8 mg/kg + DMARDs
EXPERIMENTALPlacebo + DMARDs
PLACEBO COMPARATORInterventions
Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
As prescribed. The following DMARDs were permitted in this study: methotrexate (MTX), chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These DMARDs could be used alone or in combination, except for the combination of MTX and leflunomide, which was not allowed.
Eligibility Criteria
You may qualify if:
- Adult patients, ≥18 years of age
- Active rheumatoid arthritis of \>6 months duration
- Received permitted DMARDs each at a stable dose for at least 7 weeks prior to baseline
You may not qualify if:
- Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis
- Major surgery within 8 weeks prior to screening or planned within 6 months following randomization
- Unsuccessful treatment with a biologic agent, including an anti-TNF agent
- Previous treatment with tocilizumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (157)
Unknown Facility
Birmingham, Alabama, 35205, United States
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Birmingham, Alabama, 35215, United States
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Birmingham, Alabama, 35294-7201, United States
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Montgomery, Alabama, 36111, United States
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Lake Havasu City, Arizona, 86403, United States
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Paradise Valley, Arizona, 85253, United States
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Peoria, Arizona, 85381, United States
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Scottsdale, Arizona, 85251, United States
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Scottsdale, Arizona, 85258, United States
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Jonesboro, Arkansas, 72401, United States
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Beverly Hills, California, 90211, United States
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Escondido, California, 92025, United States
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La Jolla, California, 92037, United States
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Long Beach, California, 90815, United States
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Los Angeles, California, 90095, United States
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Pasadena, California, 91107, United States
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Santa Maria, California, 93454, United States
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Santa Monica, California, 90404, United States
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Upland, California, 91786, United States
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Van Nuys, California, 91405, United States
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Walnut Creek, California, 94598, United States
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Whittier, California, 90606, United States
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Colorado Springs, Colorado, 80910, United States
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Trumbull, Connecticut, 06611, United States
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Washington D.C., District of Columbia, 20006, United States
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Dunedin, Florida, 34698, United States
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Fort Lauderdale, Florida, 33334, United States
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Lake Mary, Florida, 32746, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33133, United States
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Ocala, Florida, 34474, United States
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Orange Park, Florida, 32073, United States
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Orlando, Florida, 32804, United States
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Palm Harbor, Florida, 34684, United States
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Plantation, Florida, 33317, United States
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Sarasota, Florida, 34239, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33609, United States
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Atlanta, Georgia, 30342, United States
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Blue Ridge, Georgia, 30513, United States
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Fort Valley, Georgia, 31030, United States
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Tifton, Georgia, 311794, United States
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Boise, Idaho, 83702, United States
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Idaho Falls, Idaho, 83404, United States
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Nampa, Idaho, 83687, United States
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Downers Grove, Illinois, 60515, United States
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Springfield, Illinois, 62704, United States
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Evansville, Indiana, 47714, United States
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Munster, Indiana, 46321, United States
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South Bend, Indiana, 46601, United States
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Leawood, Kansas, 66209, United States
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Bowling Green, Kentucky, 42102, United States
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Lexington, Kentucky, 40515, United States
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Baton Rouge, Louisiana, 70808, United States
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Baton Rouge, Louisiana, 70810, United States
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Monroe, Louisiana, 71203, United States
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New Orleans, Louisiana, 70112, United States
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Wheaton, Maryland, 20902, United States
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Mansfield, Massachusetts, 02048, United States
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Worcester, Massachusetts, 01605, United States
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Worcester, Massachusetts, 01610, United States
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Kalamazoo, Michigan, 49009, United States
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Saint Clair Shores, Michigan, 48080, United States
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Eagan, Minnesota, 55121, United States
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Flowood, Mississippi, 39232, United States
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Tupelo, Mississippi, 38802, United States
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Florissant, Missouri, 63031, United States
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St Louis, Missouri, 63141, United States
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Billings, Montana, 59101, United States
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Kalispell, Montana, 59907, United States
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Missoula, Montana, 59802, United States
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Grand Island, Nebraska, 68803, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89128, United States
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Reno, Nevada, 89502, United States
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Dover, New Hampshire, 03820, United States
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Freehold, New Jersey, 07728, United States
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New Brunswick, New Jersey, 08903, United States
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Passaic, New Jersey, 07055, United States
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Teaneck, New Jersey, 07666, United States
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Mineola, New York, 11501, United States
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New York, New York, 10003, United States
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New York, New York, 10029, United States
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Orchard Park, New York, 14127, United States
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Smithtown, New York, 11787, United States
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The Bronx, New York, 10451, United States
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Belmont, North Carolina, 28012, United States
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Charlotte, North Carolina, 28209, United States
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Charlotte, North Carolina, 28210, United States
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Durham, North Carolina, 27704, United States
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Greensboro, North Carolina, 27408, United States
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Greenville, North Carolina, 27834, United States
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Hickory, North Carolina, 28601, United States
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Rock Hill, North Carolina, 29732, United States
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Akron, Ohio, 44333, United States
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Beechwood, Ohio, 44122, United States
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Mayfield, Ohio, 44143, United States
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Middleburg Heights, Ohio, 44130, United States
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Perrysburg, Ohio, 43551, United States
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Zanesville, Ohio, 43701, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73104, United States
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Lake Oswego, Oregon, 97035, United States
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Portland, Oregon, 97239, United States
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Salem, Oregon, 97302, United States
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Bethlehem, Pennsylvania, 10817, United States
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Philadelphia, Pennsylvania, 19102, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15261, United States
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Wexford, Pennsylvania, 15090, United States
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Willow Grove, Pennsylvania, 80045, United States
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Charleston, South Carolina, 29407, United States
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Columbia, South Carolina, 29204, United States
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Florence, South Carolina, 29506, United States
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Greenville, South Carolina, 29601, United States
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Myrtle Beach, South Carolina, 29572, United States
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Rapid City, South Dakota, 57701, United States
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Rapid City, South Dakota, 57702, United States
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Sioux Falls, South Dakota, 57105, United States
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Watertown, South Dakota, 57201, United States
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Crossville, Tennessee, 38555, United States
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Hendersonville, Tennessee, 37073, United States
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Jackson, Tennessee, 38305, United States
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Knoxville, Tennessee, 37909, United States
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Memphis, Tennessee, 38119, United States
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Nashville, Tennessee, 37203, United States
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Amarillo, Texas, 79106, United States
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Amarillo, Texas, 79124, United States
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Bellaire, Texas, 77401, United States
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Carrollton, Texas, 75007, United States
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Dallas, Texas, 75231, United States
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Fort Worth, Texas, 76107, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77034, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77090, United States
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Mesquite, Texas, 75150, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Temple, Texas, 76508, United States
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Waco, Texas, 76708, United States
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Salt Lake City, Utah, 84132, United States
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Burlington, Vermont, 05401, United States
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Burke, Virginia, 22015, United States
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Reston, Virginia, 22102, United States
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Salem, Virginia, 24153, United States
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Seattle, Washington, 98133, United States
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Seattle, Washington, 98195, United States
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Spokane, Washington, 99204-2336, United States
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Beckley, West Virginia, 25801, United States
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Clarksburg, West Virginia, 26301, United States
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Milwaukee, Wisconsin, 53209, United States
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Onalaska, Wisconsin, 54605, United States
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Wausau, Wisconsin, 54401, United States
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San Juan, 00918, Puerto Rico
Related Publications (2)
Yazici Y, Curtis JR, Ince A, Baraf HS, Lepley DM, Devenport JN, Kavanaugh A. Early effects of tocilizumab in the treatment of moderate to severe active rheumatoid arthritis: a one-week sub-study of a randomised controlled trial (Rapid Onset and Systemic Efficacy [ROSE] Study). Clin Exp Rheumatol. 2013 May-Jun;31(3):358-64. Epub 2013 Jan 10.
PMID: 23305631DERIVEDYazici Y, Curtis JR, Ince A, Baraf H, Malamet RL, Teng LL, Kavanaugh A. Efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis and a previous inadequate response to disease-modifying antirheumatic drugs: the ROSE study. Ann Rheum Dis. 2012 Feb;71(2):198-205. doi: 10.1136/ard.2010.148700. Epub 2011 Sep 26.
PMID: 21949007DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
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
September 18, 2007
First Posted
September 19, 2007
Study Start
October 1, 2007
Primary Completion
June 1, 2009
Study Completion
March 1, 2011
Last Updated
August 20, 2012
Results First Posted
August 4, 2010
Record last verified: 2012-08