Clinical trial NCT01242514: Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Official title: (OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
OSKIRA
Fostamatinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 1917
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).


Eligibility criteria: Inclusion Criteria:

* Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib
* Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).

Exclusion Criteria:

* Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003 and D4300C00004)
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Significant liver function test abnormalities or physical symptoms of hepatotoxicity
* Significant infection
* Gastrointestinal intolerance
* Cancer

Primary outcomes:
measure: Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
timeFrame: Entry in extension to end of study (variable duration; maximum 109 weeks)
Secondary outcomes:
measure: Mean DAS28-CRP Score
timeFrame: Weeks 0, 12, 24, 36 and 52
measure: Mean mTSS Score
timeFrame: Weeks 0 and 52
measure: Mean HAQ-DI Score
timeFrame: Weeks 0, 12, 24, 36 and 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Glendale
country: United States
facility: Research Site
state: Arizona
city: Mesa
country: United States
facility: Research Site
state: Arizona
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Hot Springs
country: United States
facility: Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Research Site
state: California
city: Fountain Valley
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: La Jolla
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Palo Alto
country: United States
facility: Research Site
state: California
city: Roseville
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Torrance
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Colorado Springs
country: United States
facility: Research Site
state: Colorado
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Danbury
country: United States
facility: Research Site
state: Connecticut
city: Trumbull
country: United States
facility: Research Site
state: Connecticut
city: Lewes
country: United States
facility: Research Site
state: Delaware
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Brandon
country: United States
facility: Research Site
state: Florida
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Palm Harbor
country: United States
facility: Research Site
state: Florida
city: Pinellas Park
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Tavares
country: United States
facility: Research Site
state: Florida
city: Venice
country: United States
facility: Research Site
state: Florida
city: Zephyr Hills
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Canton
country: United States
facility: Research Site
state: Georgia
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Lawrenceville
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: South Bend
country: United States
facility: Research Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Research Site
state: Iowa
city: Bowling Green
country: United States
facility: Research Site
state: Kentucky
city: Elizabethtown
country: United States
facility: Research Site
state: Kentucky
city: Cumberland
country: United States
facility: Research Site
state: Maryland
city: Frederick
country: United States
facility: Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Research Site
state: Maryland
city: Oxon Hill
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Fall River
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Lansing
country: United States
facility: Research Site
state: Michigan
city: St. Clair Shores
country: United States
facility: Research Site
state: Michigan
city: Eagan
country: United States
facility: Research Site
state: Minnesota
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Florissant
country: United States
facility: Research Site
state: Missouri
city: Richmond Heights
country: United States
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state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Kalispell
country: United States
facility: Research Site
state: Montana
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Freehold
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Las Cruces
country: United States
facility: Research Site
state: New Mexico
city: Albany
country: United States
facility: Research Site
state: New York
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Cooperstown
country: United States
facility: Research Site
state: New York
city: Olean
country: United States
facility: Research Site
state: New York
city: Roslyn
country: United States
facility: Research Site
state: New York
city: Smithtown
country: United States
facility: Research Site
state: New York
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Durham
country: United States
facility: Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Research Triangle Park
country: United States
facility: Research Site
state: North Carolina
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Mayfield Village
country: United States
facility: Research Site
state: Ohio
city: Perrysburg
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Research Site
state: Oregon
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Erie
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Waxford
country: United States
facility: Research Site
state: Pennsylvania
city: West Reading
country: United States
facility: Research Site
state: Pennsylvania
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Orangeburg
country: United States
facility: Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Research Site
state: South Dakota
city: Hixson
country: United States
facility: Research Site
state: Tennessee
city: Jackson
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Research Site
state: Texas
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Katy
country: United States
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state: Texas
city: Lubbock
country: United States
facility: Research Site
state: Texas
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: Nassau Bay
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Chesapeake
country: United States
facility: Research Site
state: Virginia
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Buenos Aires
country: Argentina
facility: Research Site
state: Caba
city: Ciudad Autonoma Bs As
country: Argentina
facility: Research Site
state: CBA
city: Cordoba
country: Argentina
facility: Research Site
state: CRD
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: TUC
city: Caba Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad Autonoma Bs As
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Quilmes
country: Argentina
facility: Research Site
city: San Juan
country: Argentina
facility: Research Site
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: Southport
country: Australia
facility: Research Site
state: Queensland
city: Cairns
country: Australia
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Gilly
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Goiania
country: Brazil
facility: Research Site
state: GO
city: Recife
country: Brazil
facility: Research Site
state: PE
city: Curitiba
country: Brazil
facility: Research Site
state: PR
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sevlievo
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Bowmanville
country: Canada
facility: Research Site
state: Ontario
city: Etobicoke
country: Canada
facility: Research Site
state: Ontario
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Pointe-claire
country: Canada
facility: Research Site
state: Quebec
city: Quebec City
country: Canada
facility: Research Site
state: Quebec
city: Rimouski
country: Canada
facility: Research Site
state: Quebec
city: Trois-rivieres
country: Canada
facility: Research Site
state: Quebec
city: Osorno
country: Chile
facility: Research Site
state: X Region
city: Santiago
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
state: Atlantico
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Research Site
state: Santander
city: Brno
country: Czech Republic
facility: Research Site
city: Bruntal
country: Czech Republic
facility: Research Site
city: Ceska Lipa
country: Czech Republic
facility: Research Site
city: Ceske Budejovice
country: Czech Republic
facility: Research Site
city: Hlucin
country: Czech Republic
facility: Research Site
city: Hostivice
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Liberec
country: Czech Republic
facility: Research Site
city: Ostrava - Trebovice
country: Czech Republic
facility: Research Site
city: Ostrava
country: Czech Republic
facility: Research Site
city: Praha
country: Czech Republic
facility: Research Site
city: Sokolov
country: Czech Republic
facility: Research Site
city: Terezin
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Parnu
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Orleans Cedex 1
country: France
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
state: Nordrhein Westfalen
city: Halle
country: Germany
facility: Research Site
state: Sachsen
city: Erlangen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Herne
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Muenchen
country: Germany
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Bekescsaba
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Mako
country: Hungary
facility: Research Site
city: Sopron
country: Hungary
facility: Research Site
city: Szentes
country: Hungary
facility: Research Site
city: Zalaegerszeg-pozva
country: Hungary
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Research Site
state: Gujarat
city: Gandhinagar
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Udupi
country: India
facility: Research Site
state: Karnataka
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Nagpur
country: India
facility: Research Site
state: Maharshtra
city: Coimbatore
country: India
facility: Research Site
state: Tamil Nadu
city: Madurai
country: India
facility: Research Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Research Site
state: Uttar Pradesh
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Kfar-saba
country: Israel
facility: Research Site
city: Ramat-gan
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Jesi
country: Italy
facility: Research Site
state: AN
city: Udine
country: Italy
facility: Research Site
state: UD
city: Varese
country: Italy
facility: Research Site
state: VA
city: Liepaja
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Siauliai
country: Lithuania
facility: Research Site
city: Mexicali
country: Mexico
facility: Research Site
state: Baja California
city: Saltillo
country: Mexico
facility: Research Site
state: Coahuila
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Research Site
state: JAL
city: Monterrey
country: Mexico
facility: Research Site
state: NL
city: Obrergon
country: Mexico
facility: Research Site
state: SON
city: Chihuahua
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Pueblo Libre
country: Peru
facility: Research Site
state: Lima
city: San Borja
country: Peru
facility: Research Site
state: Lima
city: San Isidro
country: Peru
facility: Research Site
state: Lima
city: Arequipa
country: Peru
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Chelm Slaski
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Kalisz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zyrardow
country: Poland
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
state: Prahova
city: Braila
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Sankt-peterburg
country: Russian Federation
facility: Research Site
city: Voronezh
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Poprad
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Ruzomberok
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Zilina
country: Slovakia
facility: Research Site
city: Panorama
country: South Africa
facility: Research Site
state: Cape Town
city: Port Elizabeth
country: South Africa
facility: Research Site
state: E Cape
city: Kempron Park
country: South Africa
facility: Research Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: Kwazulu Natal
city: Cape Town
country: South Africa
facility: Research Site
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Research Site
city: Merida
country: Spain
facility: Research Site
state: Extremadura
city: Barcelona
country: Spain
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Ivano-frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsya
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Zaporyzhzhya
country: Ukraine
facility: Research Site
city: Bracknell
country: United Kingdom
facility: Research Site
state: Berkshire
city: Warrington
country: United Kingdom
facility: Research Site
state: Cheshire
city: London
country: United Kingdom
facility: Research Site
state: Greater London
city: Maidstone
country: United Kingdom
facility: Research Site
state: Kent
city: Eastbourne
country: United Kingdom
facility: Research Site
state: Sussex
city: Solihull
country: United Kingdom
facility: Research Site
state: West Midlands
city: Basingstoke
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Christchurch
country: United Kingdom
facility: Research Site
city: Ipswich
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Stoke on Trent
country: United Kingdom
facility: Research Site
city: Westcliff-on-the Sea
country: United Kingdom
facility: Research Site
city: Wirral
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Chris O'Brien, MD PhD
role: STUDY_DIRECTOR
References: