Status: Recruiting

Official Title: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs and monotherapy who have an Inadequate Response to Current Non-Biologic or Biologic DMARDs

Brief Summary: This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. Patients will be randomized to receive tocilizumab either 4mg/kg iv or 8mg/kg iv with concomitant non-biologic DMARDs, or 8mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.

Study Phase: 3

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: tocilizumab [RoActemra]

• adult patients, >=18 years of age;
• moderate to severe active rheumatoid arthritis for >6 months;
• inadequate clinical response or unable to tolerate current or prior biologic or non-biologic DMARD therapy;
• SJC >/=4 and TJC >/=4
• body weight current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to baseline;

• history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• functional class IV as defined by the ACR Classification of Functional Status in rheumatoid arthritis;
• treatment with rituximab within 6 months before screening;
• intraarticular corticosteroids within 8 weeks or im/iv corticosteroids within 12 weeks prior to screening;
• known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.

This trial will be conducted at the following locations:

• BURLINGTON 05401
• WACO
• PASSAIC
• MONROE
• GRAND ISLAND
• ST LOUIS
• HOT SPRINGS
• NEW BRUNSWICK
• SACRAMENTO
• OLEAN
• SUGARLAND
• TULSA
• BATON ROUGE
• SYRACUSE
• FREEHOLD
• BIRMINGHAM
• DUNCANSVILLE
• BECKLEY
• JACKSON
• DANBURY
• NEW YORK
• BINGHAMTON
• FLOWOOD
• LITTLE ROCK
• PALM HARBOR
• WEXFORD
• MINNEAPOLIS
• HOUSTON
• KNOXVILLE
• ALBANY
• EAGAN
• SCOTTSDALE
• WORCESTER
• LOS ANGELES
• DAYTON
• HAMDEN
• SAN DIEGO
• TUSCALOOSA
• DUNEDIN
• LEBANON
• DOVER
• MESQUITE
• BIRMINGHAM
• BROOKFIELD
• MORTON GROVE
• CEDAR RAPIDS
• GLENDALE
• DALLAS
• ST CLAIR SHORES
• DALLAS
• NEW ORLEANS
• ELLICOTT CITY
• LINCOLN
• BRONX
• MOBILE
• DALLAS
• ASHEVILLE
• PETOSKEY
• BELMONT
• WHEATON
• PEORIA
• CHARLOTTE
• NEW ORLEANS
• CLARKSBURG
• MAYFIELD
• PASADENA
• JONESBORO
• CLEVELAND
• PHILADELPHIA
• ST. PETERSBURG
• LAKE OSWEGO
• DURHAM
• LEXINGTON
• ORCHARD PARK
• HUNTSVILLE
• BOCA RATON
• WORCESTER
• SHERMAN OAKS
• CINCINNATI
• KALAMAZOO
• FREDERICK
• CLEVELAND
• MURRIETA
• OKLAHOMA CITY
• VICTORVILLE
• LEES SUMMIT
• OAK CREEK
• AUSTIN
• COLUMBIA
• DALLAS
• LEWES
• GALLIPOLIS
• FLOWOOD
• WESTLAKE VILLAGE
• DULUTH
• MILWAUKEE
• LEBANON
• BRIDGEPORT
• AKRON
• MELBOURNE
• ORLANDO
• COLUMBUS
• MAYWOOD
• CHICAGO
• UTICA
• HOUSTON
• TUPELO
• KANSAS CITY
• VOORHEES
• ROCHESTER
• CHARLESTON
• ST LOUIS
• LANSING
• SPOKANE
• PEABODY
• BATON ROUGE
• ROCK ISLAND
• HICKORY
• ROSLYN
• NASHVILLE
• AMARILLO
• PEORIA
• NASHVILLE
• AMARILLO
• PEORIA
• WILLOW GROVE
• JACKSON
• NAPLES
• ONALASKA
• LONG BEACH
• TACOMA
• WILMINGTON
• HIXSON
• SAN ANTONIO
• SANTA MARIA
• TULSA
• PITTSBURGH
• FORT WORTH
• RENO
• SAN ANTONIO
• ESCONDIDO
• ROCK HILL
• KALISPELL
• PERRYBURG
• RALEIGH
• CHARLOTTE
• HOUSTON
• ST LOUIS
• NEWPORT BEACH
• LAKE SUCCESS
• BROOKLYN
• SCOTTSDALE
• BOISE
• TUCSON
• ROCHESTER
• IDAHO FALLS
• PHILADELPHIA
• BETHLEHEM
• OLYMPIA
• BATTLE CREEK
• COLUMBIA
• HATTIESBURG
• LAKE HAUASU CITY
• PLYMOUTH
• MINNEAPOLIS
• CAMP HILL
• ZANESVILLE
• OKLAHOMA CITY
• HADDON HEIGHTS
• LA JOLLA
• ARLINGTON
• CHARLESTON
• FAYETTEVILLE
• TAMPA
• EVANSVILLE
• SOUTH BEND
• NEW YORK
• BOSTON
• MONTGOMERY
• FORT LAUDERDALE
• POTTSTOWN
• CHARLOTTE
• PASCAGOULA
• GREENVILLE
• MIAMI
• TRUMBULL
• ST LOUIS
• CARROLLTON
• SAN DIEGO
• PALM HARBOR
• HUNTINGTON BEACH
• AUSTIN
• BURKE
• PARADISE VALLEY
• MORRISTOWN
• OKLAHOMA CITY
• CHICAGO
• AUSTIN
• VERNON HILLS
• DENVER
• SAN LEANDRO
• SMITHTOWN
• SOUTH MIAMI
• SPRINGFIELD
• MILWAUKEE
• JACKSONVILLE
• EDINA
• SAN ANTONIO
• RACINE
• VIRGINIA BEACH
• CINCINNATI
• OCALA
• HARTFORD
• COOPERSTOWN
• CLEARWATER
• NAMPA
• SANTA BARBARA
• GAINESVILLE
• MYRTLE BEACH
• COLUMBUS
• LAKEWOOD
• WICHITA
• FALL RIVER
• LAS CRUCES
• FORT WAYNE
• LAGUNA HILLS
• TYLER
• CHAPEL HILL
• LUBBOCK
• ANISTON
• DULUTH
• FULLERTON
• ATLANTA
• COLORADO SPRINGS
• GAINESVILLE
• HEWLETT
• COVINA
• RICHMOND
• MIDDLEBURG HEIGHTS
• SIOUX FALLS
• LAKE MARY
• BISMARCK
• MYRTLE BEACH
• PHILADELPHIA
• AVENTURA
• COLUMBUS
• TAMPA
• FORT SMITH
• SARASOTA
• ORANGE PARK
• HOUSTON
• FLORISSANT
• SCHAUMBURG
• WEST READING
• BOWLING GREEN
• AVENTURA
• WHITTIER
• VAN NUYS
• MIAMI
• MINOT
• BALTIMORE
• MEMPHIS
• PLAINVIEW
• CHICAGO
• COLUMBIA
• OMAHA
• HENDERSONVILLE
• VALDOSTA
• RIDGEWOOD
• BEVERLY HILLS
• TRENTON
• GAINESVILLE