Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01242514




Trial ID
NCT01242514
Ethics application status
Date submitted
10/11/2010
Date registered
16/11/2010
Date last updated
25/02/2014

Titles & IDs
Public title
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
Scientific title
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
Secondary ID [1] 0 0
2010-020892-22
Secondary ID [2] 0 0
D4300C00005
Universal Trial Number (UTN)
Trial acronym
OSKIRA-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fostamatinib
Treatment: Drugs - Fostamatinib
Treatment: Drugs - Fostamatinib

Experimental: A - Oral treatment

Experimental: B - Oral treatment

Experimental: C - Oral treatment


Treatment: Drugs: Fostamatinib
Fostamatinib 100mg twice daily

Treatment: Drugs: Fostamatinib
Fostamatinib 150mg once daily

Treatment: Drugs: Fostamatinib
Fostamatinib 100mg once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Entry in extension to end of study (variable duration; maximum 109 weeks)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Weeks 0, 12, 24, 36 and 52
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Weeks 0 and 52
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Weeks 0, 12, 24, 36 and 52

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Southport
Recruitment hospital [3] 0 0
Research Site - Cairns
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Southport
Recruitment postcode(s) [3] 0 0
- Cairns
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Iowa
Country [14] 0 0
United States of America
State/province [14] 0 0
Kentucky
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Massachusetts
Country [17] 0 0
United States of America
State/province [17] 0 0
Michigan
Country [18] 0 0
United States of America
State/province [18] 0 0
Minnesota
Country [19] 0 0
United States of America
State/province [19] 0 0
Mississippi
Country [20] 0 0
United States of America
State/province [20] 0 0
Missouri
Country [21] 0 0
United States of America
State/province [21] 0 0
Montana
Country [22] 0 0
United States of America
State/province [22] 0 0
Nebraska
Country [23] 0 0
United States of America
State/province [23] 0 0
Nevada
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New Mexico
Country [26] 0 0
United States of America
State/province [26] 0 0
New York
Country [27] 0 0
United States of America
State/province [27] 0 0
North Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
South Carolina
Country [33] 0 0
United States of America
State/province [33] 0 0
South Dakota
Country [34] 0 0
United States of America
State/province [34] 0 0
Tennessee
Country [35] 0 0
United States of America
State/province [35] 0 0
Texas
Country [36] 0 0
United States of America
State/province [36] 0 0
Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Washington
Country [38] 0 0
Argentina
State/province [38] 0 0
Caba
Country [39] 0 0
Argentina
State/province [39] 0 0
CBA
Country [40] 0 0
Argentina
State/province [40] 0 0
CRD
Country [41] 0 0
Argentina
State/province [41] 0 0
Santa Fe
Country [42] 0 0
Argentina
State/province [42] 0 0
TUC
Country [43] 0 0
Argentina
State/province [43] 0 0
Caba Buenos Aires
Country [44] 0 0
Argentina
State/province [44] 0 0
Ciudad Autonoma Bs As
Country [45] 0 0
Argentina
State/province [45] 0 0
Ciudad de Buenos Aires
Country [46] 0 0
Argentina
State/province [46] 0 0
Quilmes
Country [47] 0 0
Argentina
State/province [47] 0 0
San Juan
Country [48] 0 0
Belgium
State/province [48] 0 0
Brussels
Country [49] 0 0
Belgium
State/province [49] 0 0
Gent
Country [50] 0 0
Belgium
State/province [50] 0 0
Gilly
Country [51] 0 0
Belgium
State/province [51] 0 0
Liege
Country [52] 0 0
Belgium
State/province [52] 0 0
Yvoir
Country [53] 0 0
Brazil
State/province [53] 0 0
GO
Country [54] 0 0
Brazil
State/province [54] 0 0
PE
Country [55] 0 0
Brazil
State/province [55] 0 0
PR
Country [56] 0 0
Brazil
State/province [56] 0 0
SP
Country [57] 0 0
Brazil
State/province [57] 0 0
Rio de Janeiro
Country [58] 0 0
Bulgaria
State/province [58] 0 0
Pleven
Country [59] 0 0
Bulgaria
State/province [59] 0 0
Plovdiv
Country [60] 0 0
Bulgaria
State/province [60] 0 0
Sevlievo
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Sofia
Country [62] 0 0
Canada
State/province [62] 0 0
Alberta
Country [63] 0 0
Canada
State/province [63] 0 0
British Columbia
Country [64] 0 0
Canada
State/province [64] 0 0
Manitoba
Country [65] 0 0
Canada
State/province [65] 0 0
Newfoundland and Labrador
Country [66] 0 0
Canada
State/province [66] 0 0
Ontario
Country [67] 0 0
Canada
State/province [67] 0 0
Quebec
Country [68] 0 0
Chile
State/province [68] 0 0
X Region
Country [69] 0 0
Chile
State/province [69] 0 0
Santiago
Country [70] 0 0
Colombia
State/province [70] 0 0
Atlantico
Country [71] 0 0
Colombia
State/province [71] 0 0
Cundinamarca
Country [72] 0 0
Colombia
State/province [72] 0 0
Santander
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Brno
Country [74] 0 0
Czech Republic
State/province [74] 0 0
Bruntal
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Ceska Lipa
Country [76] 0 0
Czech Republic
State/province [76] 0 0
Ceske Budejovice
Country [77] 0 0
Czech Republic
State/province [77] 0 0
Hlucin
Country [78] 0 0
Czech Republic
State/province [78] 0 0
Hostivice
Country [79] 0 0
Czech Republic
State/province [79] 0 0
Kladno
Country [80] 0 0
Czech Republic
State/province [80] 0 0
Liberec
Country [81] 0 0
Czech Republic
State/province [81] 0 0
Ostrava - Trebovice
Country [82] 0 0
Czech Republic
State/province [82] 0 0
Ostrava
Country [83] 0 0
Czech Republic
State/province [83] 0 0
Praha
Country [84] 0 0
Czech Republic
State/province [84] 0 0
Sokolov
Country [85] 0 0
Czech Republic
State/province [85] 0 0
Terezin
Country [86] 0 0
Czech Republic
State/province [86] 0 0
Zlin
Country [87] 0 0
Estonia
State/province [87] 0 0
Parnu
Country [88] 0 0
Estonia
State/province [88] 0 0
Tallinn
Country [89] 0 0
Estonia
State/province [89] 0 0
Tartu
Country [90] 0 0
France
State/province [90] 0 0
Orleans Cedex 1
Country [91] 0 0
Germany
State/province [91] 0 0
Nordrhein Westfalen
Country [92] 0 0
Germany
State/province [92] 0 0
Sachsen
Country [93] 0 0
Germany
State/province [93] 0 0
Erlangen
Country [94] 0 0
Germany
State/province [94] 0 0
Frankfurt
Country [95] 0 0
Germany
State/province [95] 0 0
Hamburg
Country [96] 0 0
Germany
State/province [96] 0 0
Heidelberg
Country [97] 0 0
Germany
State/province [97] 0 0
Herne
Country [98] 0 0
Germany
State/province [98] 0 0
Koln
Country [99] 0 0
Germany
State/province [99] 0 0
Leipzig
Country [100] 0 0
Germany
State/province [100] 0 0
Muenchen
Country [101] 0 0
Hungary
State/province [101] 0 0
Balatonfured
Country [102] 0 0
Hungary
State/province [102] 0 0
Bekescsaba
Country [103] 0 0
Hungary
State/province [103] 0 0
Budapest
Country [104] 0 0
Hungary
State/province [104] 0 0
Debrecen
Country [105] 0 0
Hungary
State/province [105] 0 0
Mako
Country [106] 0 0
Hungary
State/province [106] 0 0
Sopron
Country [107] 0 0
Hungary
State/province [107] 0 0
Szentes
Country [108] 0 0
Hungary
State/province [108] 0 0
Zalaegerszeg-pozva
Country [109] 0 0
India
State/province [109] 0 0
Andhra Pradesh
Country [110] 0 0
India
State/province [110] 0 0
Gujarat
Country [111] 0 0
India
State/province [111] 0 0
Karnataka
Country [112] 0 0
India
State/province [112] 0 0
Maharashtra
Country [113] 0 0
India
State/province [113] 0 0
Maharshtra
Country [114] 0 0
India
State/province [114] 0 0
Tamil Nadu
Country [115] 0 0
India
State/province [115] 0 0
Uttar Pradesh
Country [116] 0 0
Israel
State/province [116] 0 0
Ashkelon
Country [117] 0 0
Israel
State/province [117] 0 0
Haifa
Country [118] 0 0
Israel
State/province [118] 0 0
Kfar-saba
Country [119] 0 0
Israel
State/province [119] 0 0
Ramat-gan
Country [120] 0 0
Israel
State/province [120] 0 0
Rehovot
Country [121] 0 0
Italy
State/province [121] 0 0
AN
Country [122] 0 0
Italy
State/province [122] 0 0
UD
Country [123] 0 0
Italy
State/province [123] 0 0
VA
Country [124] 0 0
Latvia
State/province [124] 0 0
Liepaja
Country [125] 0 0
Latvia
State/province [125] 0 0
Riga
Country [126] 0 0
Latvia
State/province [126] 0 0
Valmiera
Country [127] 0 0
Lithuania
State/province [127] 0 0
Kaunas
Country [128] 0 0
Lithuania
State/province [128] 0 0
Klaipeda
Country [129] 0 0
Lithuania
State/province [129] 0 0
Siauliai
Country [130] 0 0
Mexico
State/province [130] 0 0
Baja California
Country [131] 0 0
Mexico
State/province [131] 0 0
Coahuila
Country [132] 0 0
Mexico
State/province [132] 0 0
Distrito Federal
Country [133] 0 0
Mexico
State/province [133] 0 0
JAL
Country [134] 0 0
Mexico
State/province [134] 0 0
NL
Country [135] 0 0
Mexico
State/province [135] 0 0
SON
Country [136] 0 0
Mexico
State/province [136] 0 0
Chihuahua
Country [137] 0 0
Mexico
State/province [137] 0 0
San Luis Potosi
Country [138] 0 0
Peru
State/province [138] 0 0
Lima
Country [139] 0 0
Peru
State/province [139] 0 0
Arequipa
Country [140] 0 0
Poland
State/province [140] 0 0
Bytom
Country [141] 0 0
Poland
State/province [141] 0 0
Chelm Slaski
Country [142] 0 0
Poland
State/province [142] 0 0
Grodzisk Mazowiecki
Country [143] 0 0
Poland
State/province [143] 0 0
Kalisz
Country [144] 0 0
Poland
State/province [144] 0 0
Katowice
Country [145] 0 0
Poland
State/province [145] 0 0
Krakow
Country [146] 0 0
Poland
State/province [146] 0 0
Lodz
Country [147] 0 0
Poland
State/province [147] 0 0
Warszawa
Country [148] 0 0
Poland
State/province [148] 0 0
Wroclaw
Country [149] 0 0
Poland
State/province [149] 0 0
Zyrardow
Country [150] 0 0
Portugal
State/province [150] 0 0
Aveiro
Country [151] 0 0
Portugal
State/province [151] 0 0
Coimbra
Country [152] 0 0
Portugal
State/province [152] 0 0
Lisboa
Country [153] 0 0
Portugal
State/province [153] 0 0
Porto
Country [154] 0 0
Romania
State/province [154] 0 0
Prahova
Country [155] 0 0
Romania
State/province [155] 0 0
Braila
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Moscow
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Nizhniy Novgorod
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Petrozavodsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Ryazan
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Sankt-peterburg
Country [161] 0 0
Russian Federation
State/province [161] 0 0
Voronezh
Country [162] 0 0
Russian Federation
State/province [162] 0 0
Yaroslavl
Country [163] 0 0
Serbia
State/province [163] 0 0
Belgrade
Country [164] 0 0
Serbia
State/province [164] 0 0
Kragujevac
Country [165] 0 0
Serbia
State/province [165] 0 0
Niska Banja
Country [166] 0 0
Serbia
State/province [166] 0 0
Novi Sad
Country [167] 0 0
Slovakia
State/province [167] 0 0
Bratislava
Country [168] 0 0
Slovakia
State/province [168] 0 0
Poprad
Country [169] 0 0
Slovakia
State/province [169] 0 0
Rimavska Sobota
Country [170] 0 0
Slovakia
State/province [170] 0 0
Ruzomberok
Country [171] 0 0
Slovakia
State/province [171] 0 0
Trnava
Country [172] 0 0
Slovakia
State/province [172] 0 0
Zilina
Country [173] 0 0
South Africa
State/province [173] 0 0
Cape Town
Country [174] 0 0
South Africa
State/province [174] 0 0
E Cape
Country [175] 0 0
South Africa
State/province [175] 0 0
Gauteng
Country [176] 0 0
South Africa
State/province [176] 0 0
Kwazulu Natal
Country [177] 0 0
South Africa
State/province [177] 0 0
Western Cape
Country [178] 0 0
South Africa
State/province [178] 0 0
Stellenbosch
Country [179] 0 0
Spain
State/province [179] 0 0
Extremadura
Country [180] 0 0
Spain
State/province [180] 0 0
Barcelona
Country [181] 0 0
Ukraine
State/province [181] 0 0
Donetsk
Country [182] 0 0
Ukraine
State/province [182] 0 0
Ivano-frankivsk
Country [183] 0 0
Ukraine
State/province [183] 0 0
Kharkiv
Country [184] 0 0
Ukraine
State/province [184] 0 0
Kyiv
Country [185] 0 0
Ukraine
State/province [185] 0 0
Lugansk
Country [186] 0 0
Ukraine
State/province [186] 0 0
Lutsk
Country [187] 0 0
Ukraine
State/province [187] 0 0
Lviv
Country [188] 0 0
Ukraine
State/province [188] 0 0
Odessa
Country [189] 0 0
Ukraine
State/province [189] 0 0
Simferopol
Country [190] 0 0
Ukraine
State/province [190] 0 0
Vinnytsia
Country [191] 0 0
Ukraine
State/province [191] 0 0
Vinnytsya
Country [192] 0 0
Ukraine
State/province [192] 0 0
Zaporizhzhya
Country [193] 0 0
Ukraine
State/province [193] 0 0
Zaporyzhzhya
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Berkshire
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Cheshire
Country [196] 0 0
United Kingdom
State/province [196] 0 0
Greater London
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Kent
Country [198] 0 0
United Kingdom
State/province [198] 0 0
Sussex
Country [199] 0 0
United Kingdom
State/province [199] 0 0
West Midlands
Country [200] 0 0
United Kingdom
State/province [200] 0 0
Basingstoke
Country [201] 0 0
United Kingdom
State/province [201] 0 0
Cambridge
Country [202] 0 0
United Kingdom
State/province [202] 0 0
Christchurch
Country [203] 0 0
United Kingdom
State/province [203] 0 0
Ipswich
Country [204] 0 0
United Kingdom
State/province [204] 0 0
Nottingham
Country [205] 0 0
United Kingdom
State/province [205] 0 0
Stoke on Trent
Country [206] 0 0
United Kingdom
State/province [206] 0 0
Westcliff-on-the Sea
Country [207] 0 0
United Kingdom
State/province [207] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the long term safety and tolerability of
fostamatinib in patients with rheumatoid arthritis (RA).
Trial website
https://clinicaltrials.gov/show/NCT01242514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chris O'Brien, MD PhD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries