Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

— OSKIRA-X  

Official title:

(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01242514
• Other study ID #: D4300C00005
• Secondary ID: 2010-020892-22
• Status: Terminated
• Phase: Phase 3
• First received: November 10, 2010
• Last updated: February 25, 2014
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: February 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCzech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIsrael: Ministry of HealthLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: National Pharmacy and Medicines InstituteRomania: National Medicines AgencySerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlSpain: Agencia Española de Medicamentos y Productos SanitariosUkraine: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationIndia: Drugs Controller General of IndiaArgentina: National Administration of Drugs, Food & Medical Technology (ANMAT)Brazil: National Health Surveillance AgencyChile: Instituto de Salud Pública de ChileMexico: Federal Commission for Sanitary Risks ProtectionPeru: General Directorate of Pharmaceuticals, Devices, and DrugsSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1917
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Fostamatinib
Fostamatinib 100mg twice daily
• Fostamatinib
Fostamatinib 150mg once daily
• Fostamatinib
Fostamatinib 100mg once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Had at Least 1 Adverse Event in Any Category	AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event	Entry in extension to end of study (variable duration; maximum 109 weeks)	Yes
Secondary	Mean DAS28-CRP Score	DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily	Weeks 0, 12, 24, 36 and 52	No
Secondary	Mean mTSS Score	mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily	Weeks 0 and 52	No
Secondary	Mean HAQ-DI Score	HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily	Weeks 0, 12, 24, 36 and 52	No