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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00531817 |
Purpose
This 2 arm study will assess the safety and efficacy, with regard to reduction in signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with moderate to severe active rheumatoid arthritis, with an inadequate response to DMARDs. Patients will be randomized in a ratio of 2:1 to receive either tocilizumab 8mg/kg iv or placebo iv every 4 weeks; all patients will also receive stable antirheumatic therapy including permitted DMARDs. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: tocilizumab Drug: Placebo Drug: Permitted DMARDs |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double Blind, Parallel Group Study to Evaluate the Effect of Tocilizumab Versus Placebo in Reducing the Signs and Symptoms of Rheumatoid Arthritis in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis |
| Estimated Enrollment: | 570 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | June 2009 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: tocilizumab
8mg/kg iv every 4 weeks
Drug: Permitted DMARDs
As prescribed
|
| 2: Placebo Comparator |
Drug: Placebo
iv every 4 weeks
Drug: Permitted DMARDs
As prescribed
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| BIRMINGHAM, Alabama, United States, 35215 | |
| BIRMINGHAM, Alabama, United States, 35294-7201 | |
| BIRMINGHAM, Alabama, United States, 35205 | |
| MONTGOMERY, Alabama, United States, 36111 | |
| United States, Arizona | |
| SCOTTSDALE, Arizona, United States, 85251 | |
| SCOTTSDALE, Arizona, United States, 85258 | |
| PARADISE VALLEY, Arizona, United States, 85253 | |
| PEORIA, Arizona, United States, 85381 | |
| LAKE HAVASU CITY, Arizona, United States, 86403 | |
| SCOTTSDALE, Arizona, United States, 85258 | |
| United States, Arkansas | |
| JONESBORO, Arkansas, United States, 72401 | |
| United States, California | |
| SANTA MONICA, California, United States, 90404 | |
| SANTA MARIA, California, United States, 93454 | |
| VAN NUYS, California, United States, 91405 | |
| LA JOLLA, California, United States, 92037 | |
| BEVERLY HILLS, California, United States, 90211 | |
| LONG BEACH, California, United States, 90815 | |
| PASADENA, California, United States, 91107 | |
| WHITTIER, California, United States, 90606 | |
| ESCONDIDO, California, United States, 92025 | |
| UPLAND, California, United States, 91786 | |
| LOS ANGELES, California, United States, 90095 | |
| WALNUT CREEK, California, United States, 94598 | |
| United States, Colorado | |
| AURORA, Colorado, United States, 80045 | |
| COLORADO SPRINGS, Colorado, United States, 80910 | |
| United States, Connecticut | |
| TRUMBULL, Connecticut, United States, 06611 | |
| United States, District of Columbia | |
| WASHINGTON, District of Columbia, United States, 20006 | |
| United States, Florida | |
| ORLANDO, Florida, United States, 32804 | |
| TAMARAC, Florida, United States, 33321 | |
| PLANTATION, Florida, United States, 33317 | |
| DUNEDIN, Florida, United States, 34698 | |
| OCALA, Florida, United States, 34474 | |
| ORANGE PARK, Florida, United States, 32073 | |
| SARASOTA, Florida, United States, 34239 | |
| FORT LAUDERDALE, Florida, United States, 33334 | |
| MIAMI, Florida, United States, 33133 | |
| TAMPA, Florida, United States, 33609 | |
| LAKE MARY, Florida, United States, 32746 | |
| MELBOURNE, Florida, United States, 32901 | |
| PALM HARBOR, Florida, United States, 34684 | |
| United States, Georgia | |
| FORT VALLEY, Georgia, United States, 31030 | |
| BLUE RIDGE, Georgia, United States, 30513 | |
| ATLANTA, Georgia, United States, 30342 | |
| TIFTON, Georgia, United States, 311794 | |
| United States, Idaho | |
| BOISE, Idaho, United States, 83702 | |
| NAMPA, Idaho, United States, 83687 | |
| IDAHO FALLS, Idaho, United States, 83404 | |
| United States, Illinois | |
| SPRINGFIELD, Illinois, United States, 62704 | |
| DOWNERS GROVE, Illinois, United States, 60515 | |
| United States, Indiana | |
| EVANSVILLE, Indiana, United States, 47714 | |
| MUNSTER, Indiana, United States, 46321 | |
| SOUTH BEND, Indiana, United States, 46601 | |
| United States, Kansas | |
| LEAWOOD, Kansas, United States, 66209 | |
| United States, Kentucky | |
| LEXINGTON, Kentucky, United States, 40515 | |
| BOWLING GREEN, Kentucky, United States, 42102 | |
| United States, Louisiana | |
| MONROE, Louisiana, United States, 71203 | |
| NEW ORLEANS, Louisiana, United States, 70112 | |
| BATON ROUGE, Louisiana, United States, 70810 | |
| BATON ROUGE, Louisiana, United States, 70808 | |
| United States, Maryland | |
| WHEATON, Maryland, United States, 20902 | |
| United States, Massachusetts | |
| MANSFIELD, Massachusetts, United States, 02048 | |
| WORCESTER, Massachusetts, United States, 01605 | |
| WORCESTER, Massachusetts, United States, 01610 | |
| United States, Michigan | |
| KALAMAZOO, Michigan, United States, 49009 | |
| ST CLAIR SHORES, Michigan, United States, 48080 | |
| United States, Minnesota | |
| EAGAN, Minnesota, United States, 55121 | |
| United States, Mississippi | |
| FLOWOOD, Mississippi, United States, 39232 | |
| TUPELO, Mississippi, United States, 38802 | |
| United States, Missouri | |
| ST LOUIS, Missouri, United States, 63141 | |
| FLORISSANT, Missouri, United States, 63031 | |
| United States, Montana | |
| BILLINGS, Montana, United States, 59101 | |
| MISSOULA, Montana, United States, 59802 | |
| KALISPELL, Montana, United States, 59901 | |
| United States, Nebraska | |
| GRAND ISLAND, Nebraska, United States, 68803 | |
| United States, Nevada | |
| LAS VEGAS, Nevada, United States, 89106 | |
| LAS VEGAS, Nevada, United States, 89128 | |
| RENO, Nevada, United States, 89502 | |
| United States, New Hampshire | |
| DOVER, New Hampshire, United States, 03820 | |
| United States, New Jersey | |
| FREEHOLD, New Jersey, United States, 07728 | |
| NEW BRUNSWICK, New Jersey, United States, 08903 | |
| TEANECK, New Jersey, United States, 07666 | |
| PASSAIC, New Jersey, United States, 07055 | |
| United States, New York | |
| NEW YORK, New York, United States, 10003 | |
| ORCHARD PARK, New York, United States, 14127 | |
| NEW YORK, New York, United States, 10029 | |
| SMITHTOWN, New York, United States, 11787 | |
| BRONX, New York, United States, 10451 | |
| MINEOLA, New York, United States, 11501 | |
| United States, North Carolina | |
| HICKORY, North Carolina, United States, 28601 | |
| ROCK HILL, North Carolina, United States, 29732 | |
| DURHAM, North Carolina, United States, 27704 | |
| GREENVILLE, North Carolina, United States, 27834 | |
| CHARLOTTE, North Carolina, United States, 28210 | |
| BELMONT, North Carolina, United States, 28012 | |
| CHARLOTTE, North Carolina, United States, 28209 | |
| GREENSBORO, North Carolina, United States, 27408 | |
| United States, Ohio | |
| ZANESVILLE, Ohio, United States, 43701 | |
| AKRON, Ohio, United States, 44333 | |
| MAYFIELD, Ohio, United States, 44143 | |
| BEECHWOOD, Ohio, United States, 44122 | |
| PERRYBURG, Ohio, United States, 43551 | |
| MIDDLEBURG HEIGHTS, Ohio, United States, 44130 | |
| United States, Oklahoma | |
| OKLAHOMA CITY, Oklahoma, United States, 73104 | |
| OKLAHOMA CITY, Oklahoma, United States, 73103 | |
| NORMAN, Oklahoma, United States, 73069 | |
| United States, Oregon | |
| LAKE OSWEGO, Oregon, United States, 97035 | |
| PORTLAND, Oregon, United States, 97239 | |
| SALEM, Oregon, United States, 97302 | |
| United States, Pennsylvania | |
| PHILADELPHIA, Pennsylvania, United States, 19152 | |
| BETHLEHEM, Pennsylvania, United States, 10817 | |
| PITTSBURGH, Pennsylvania, United States, 15261 | |
| PHILADELPHIA, Pennsylvania, United States, 19102 | |
| WEXFORD, Pennsylvania, United States, 15090 | |
| United States, South Carolina | |
| CHARLESTON, South Carolina, United States, 29407 | |
| COLUMBIA, South Carolina, United States, 29204 | |
| FLORENCE, South Carolina, United States, 29506 | |
| GREENVILLE, South Carolina, United States, 29601 | |
| MYRTLE BEACH, South Carolina, United States, 29572 | |
| United States, South Dakota | |
| RAPID CITY, South Dakota, United States, 57702 | |
| SIOUX FALLS, South Dakota, United States, 57105 | |
| WATERTOWN, South Dakota, United States, 57201 | |
| RAPID CITY, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| MEMPHIS, Tennessee, United States, 38119 | |
| JACKSON, Tennessee, United States, 38305 | |
| KNOXVILLE, Tennessee, United States, 37909 | |
| CROSSVILLE, Tennessee, United States, 38555 | |
| HENDERSONVILLE, Tennessee, United States, 37073 | |
| NASHVILLE, Tennessee, United States, 37203 | |
| United States, Texas | |
| HOUSTON, Texas, United States, 77074 | |
| CARROLLTON, Texas, United States, 75007 | |
| BELLAIRE, Texas, United States, 77401 | |
| DALLAS, Texas, United States, 75231 | |
| SAN ANTONIO, Texas, United States, 78217 | |
| HOUSTON, Texas, United States, 77034 | |
| WACO, Texas, United States, 76708 | |
| HOUSTON, Texas, United States, 77004 | |
| TEMPLE, Texas, United States, 76508 | |
| FORT WORTH, Texas, United States, 76107 | |
| SAN ANTONIO, Texas, United States, 78229 | |
| AMARILLO, Texas, United States, 79106 | |
| MESQUITE, Texas, United States, 75150 | |
| AMARILLO, Texas, United States, 79124 | |
| SAN ANTONIO, Texas, United States, 78258 | |
| HOUSTON, Texas, United States, 77090 | |
| United States, Utah | |
| SALT LAKE CITY, Utah, United States, 84132 | |
| United States, Vermont | |
| BURLINGTON, Vermont, United States, 05401 | |
| United States, Virginia | |
| RESTON, Virginia, United States, 22102 | |
| SALEM, Virginia, United States, 24153 | |
| BURKE, Virginia, United States, 22015 | |
| United States, Washington | |
| SPOKANE, Washington, United States, 99204-2336 | |
| SEATTLE, Washington, United States, 98133 | |
| SEATTLE, Washington, United States, 98195 | |
| United States, West Virginia | |
| BECKLEY, West Virginia, United States, 25801 | |
| CLARKSBURG, West Virginia, United States, 26301 | |
| United States, Wisconsin | |
| WAUSAU, Wisconsin, United States, 54401 | |
| ONALASKA, Wisconsin, United States, 54605 | |
| MILWAUKEE, Wisconsin, United States, 53209 | |
| Puerto Rico | |
| SAN JUAN, Puerto Rico, 00918 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | ML21136 |
| Study First Received: | September 18, 2007 |
| Last Updated: | September 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00531817 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Therapeutic Uses Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Antirheumatic Agents Pharmacologic Actions |
