Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA) (OSKIRA-X)
Primary Purpose
Rheumatoid Arthritis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fostamatinib
Fostamatinib
Fostamatinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, OSKIRA, Fostamatinib
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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
Oral treatment
Oral treatment
Oral treatment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01242514
Brief Title
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
AZ decision to discontinue fostamatinib development in RA; rights to fostamatinib returned to Rigel Pharmaceuticals.
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, OSKIRA, Fostamatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1917 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
B
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
C
Arm Type
Experimental
Arm Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
Fostamatinib 100mg twice daily
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
Fostamatinib 150mg once daily
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
Fostamatinib 100mg once daily
Primary Outcome Measure Information:
Title
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
Description
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Time Frame
Entry in extension to end of study (variable duration; maximum 109 weeks)
Secondary Outcome Measure Information:
Title
Mean DAS28-CRP Score
Description
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
Time Frame
Weeks 0, 12, 24, 36 and 52
Title
Mean mTSS Score
Description
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
Time Frame
Weeks 0 and 52
Title
Mean HAQ-DI Score
Description
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
Time Frame
Weeks 0, 12, 24, 36 and 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris O'Brien, MD PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
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Anniston
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Austin
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Dallas
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Houston
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Katy
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Mesquite
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Buenos Aires
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Ciudad Autonoma Bs As
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Argentina
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Cordoba
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Argentina
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Rosario
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Argentina
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San Miguel de Tucuman
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Argentina
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Ciudad de Buenos Aires
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Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Gilly
Country
Belgium
Facility Name
Research Site
City
Liege
Country
Belgium
Facility Name
Research Site
City
Yvoir
Country
Belgium
Facility Name
Research Site
City
Goiania
State/Province
GO
Country
Brazil
Facility Name
Research Site
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Research Site
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Pleven
Country
Bulgaria
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sevlievo
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
St John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Bowmanville
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Etobicoke
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Pointe-claire
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec City
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Rimouski
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Trois-rivieres
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Osorno
State/Province
X Region
Country
Chile
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Research Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Research Site
City
Bucaramanga
State/Province
Santander
Country
Colombia
Facility Name
Research Site
City
Brno
Country
Czech Republic
Facility Name
Research Site
City
Bruntal
Country
Czech Republic
Facility Name
Research Site
City
Ceska Lipa
Country
Czech Republic
Facility Name
Research Site
City
Ceske Budejovice
Country
Czech Republic
Facility Name
Research Site
City
Hlucin
Country
Czech Republic
Facility Name
Research Site
City
Hostivice
Country
Czech Republic
Facility Name
Research Site
City
Kladno
Country
Czech Republic
Facility Name
Research Site
City
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Ostrava - Trebovice
Country
Czech Republic
Facility Name
Research Site
City
Ostrava
Country
Czech Republic
Facility Name
Research Site
City
Praha
Country
Czech Republic
Facility Name
Research Site
City
Sokolov
Country
Czech Republic
Facility Name
Research Site
City
Terezin
Country
Czech Republic
Facility Name
Research Site
City
Zlin
Country
Czech Republic
Facility Name
Research Site
City
Parnu
Country
Estonia
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Tartu
Country
Estonia
Facility Name
Research Site
City
Orleans Cedex 1
Country
France
Facility Name
Research Site
City
Aachen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Research Site
City
Halle
State/Province
Sachsen
Country
Germany
Facility Name
Research Site
City
Erlangen
Country
Germany
Facility Name
Research Site
City
Frankfurt
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Heidelberg
Country
Germany
Facility Name
Research Site
City
Herne
Country
Germany
Facility Name
Research Site
City
Koln
Country
Germany
Facility Name
Research Site
City
Leipzig
Country
Germany
Facility Name
Research Site
City
Muenchen
Country
Germany
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Bekescsaba
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Mako
Country
Hungary
Facility Name
Research Site
City
Sopron
Country
Hungary
Facility Name
Research Site
City
Szentes
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg-pozva
Country
Hungary
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Secunderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Gandhinagar
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Vadodara
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Mangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Udupi
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharshtra
Country
India
Facility Name
Research Site
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Madurai
State/Province
Tamil Nadu
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Kfar-saba
Country
Israel
Facility Name
Research Site
City
Ramat-gan
Country
Israel
Facility Name
Research Site
City
Rehovot
Country
Israel
Facility Name
Research Site
City
Jesi
State/Province
AN
Country
Italy
Facility Name
Research Site
City
Udine
State/Province
UD
Country
Italy
Facility Name
Research Site
City
Varese
State/Province
VA
Country
Italy
Facility Name
Research Site
City
Liepaja
Country
Latvia
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Valmiera
Country
Latvia
Facility Name
Research Site
City
Kaunas
Country
Lithuania
Facility Name
Research Site
City
Klaipeda
Country
Lithuania
Facility Name
Research Site
City
Siauliai
Country
Lithuania
Facility Name
Research Site
City
Mexicali
State/Province
Baja California
Country
Mexico
Facility Name
Research Site
City
Saltillo
State/Province
Coahuila
Country
Mexico
Facility Name
Research Site
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
JAL
Country
Mexico
Facility Name
Research Site
City
Monterrey
State/Province
NL
Country
Mexico
Facility Name
Research Site
City
Obrergon
State/Province
SON
Country
Mexico
Facility Name
Research Site
City
Chihuahua
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
Country
Mexico
Facility Name
Research Site
City
Pueblo Libre
State/Province
Lima
Country
Peru
Facility Name
Research Site
City
San Borja
State/Province
Lima
Country
Peru
Facility Name
Research Site
City
San Isidro
State/Province
Lima
Country
Peru
Facility Name
Research Site
City
Arequipa
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Bytom
Country
Poland
Facility Name
Research Site
City
Chelm Slaski
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Research Site
City
Kalisz
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Zyrardow
Country
Poland
Facility Name
Research Site
City
Aveiro
Country
Portugal
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Ploiesti
State/Province
Prahova
Country
Romania
Facility Name
Research Site
City
Braila
Country
Romania
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Petrozavodsk
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
Country
Russian Federation
Facility Name
Research Site
City
Sankt-peterburg
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Kragujevac
Country
Serbia
Facility Name
Research Site
City
Niska Banja
Country
Serbia
Facility Name
Research Site
City
Novi Sad
Country
Serbia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Poprad
Country
Slovakia
Facility Name
Research Site
City
Rimavska Sobota
Country
Slovakia
Facility Name
Research Site
City
Ruzomberok
Country
Slovakia
Facility Name
Research Site
City
Trnava
Country
Slovakia
Facility Name
Research Site
City
Zilina
Country
Slovakia
Facility Name
Research Site
City
Panorama
State/Province
Cape Town
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
State/Province
E Cape
Country
South Africa
Facility Name
Research Site
City
Kempron Park
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Research Site
City
Durban
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
Western Cape
Country
South Africa
Facility Name
Research Site
City
Stellenbosch
Country
South Africa
Facility Name
Research Site
City
Merida
State/Province
Extremadura
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Ivano-frankivsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lugansk
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Vinnytsya
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
Research Site
City
Zaporyzhzhya
Country
Ukraine
Facility Name
Research Site
City
Bracknell
State/Province
Berkshire
Country
United Kingdom
Facility Name
Research Site
City
Warrington
State/Province
Cheshire
Country
United Kingdom
Facility Name
Research Site
City
London
State/Province
Greater London
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Eastbourne
State/Province
Sussex
Country
United Kingdom
Facility Name
Research Site
City
Solihull
State/Province
West Midlands
Country
United Kingdom
Facility Name
Research Site
City
Basingstoke
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Christchurch
Country
United Kingdom
Facility Name
Research Site
City
Ipswich
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Stoke on Trent
Country
United Kingdom
Facility Name
Research Site
City
Westcliff-on-the Sea
Country
United Kingdom
Facility Name
Research Site
City
Wirral
Country
United Kingdom
12. IPD Sharing Statement
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Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
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