Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01197521
Registration number
NCT01197521
Ethics application status
Date submitted
8/09/2010
Date registered
9/09/2010
Date last updated
7/04/2014
Titles & IDs
Public title
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding.
Query!
Scientific title
(OSKIRA-1): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Query!
Secondary ID [1]
0
0
2010-020743-12
Query!
Secondary ID [2]
0
0
D4300C00001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
OSKIRA - 1
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - fostamatinib
Treatment: Drugs - fostamatinib
Treatment: Drugs - placebo, fostamatinib
Experimental: Dosing Regimen A - Oral Treatment
Experimental: Dosing Regimen B - Oral Treatment
Placebo comparator: Dosing Regimen C - Oral Treatment
Treatment: Drugs: fostamatinib
fostamatinib 100 mg twice daily
Treatment: Drugs: fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
Treatment: Drugs: placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.
Query!
Assessment method [1]
0
0
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Query!
Timepoint [1]
0
0
24 weeks
Query!
Primary outcome [2]
0
0
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.
Query!
Assessment method [2]
0
0
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 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.
Query!
Timepoint [2]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [1]
0
0
ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
Query!
Assessment method [1]
0
0
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.
Query!
Timepoint [1]
0
0
1 week
Query!
Secondary outcome [2]
0
0
Proportion of Patients Achieving ACR50 up to Week 24
Query!
Assessment method [2]
0
0
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Query!
Timepoint [2]
0
0
24 weeks
Query!
Secondary outcome [3]
0
0
Proportion of Patients Achieving ACR70 up to Week 24
Query!
Assessment method [3]
0
0
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
Query!
Timepoint [3]
0
0
24 weeks
Query!
Secondary outcome [4]
0
0
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
Query!
Assessment method [4]
0
0
ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.
Query!
Timepoint [4]
0
0
24 weeks
Query!
Secondary outcome [5]
0
0
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
Query!
Assessment method [5]
0
0
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. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Query!
Timepoint [5]
0
0
12 weeks
Query!
Secondary outcome [6]
0
0
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24
Query!
Assessment method [6]
0
0
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. A DAS28-CRP score of \<2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Query!
Timepoint [6]
0
0
24 weeks
Query!
Secondary outcome [7]
0
0
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24
Query!
Assessment method [7]
0
0
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Query!
Timepoint [7]
0
0
24 weeks
Query!
Secondary outcome [8]
0
0
HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
Query!
Assessment method [8]
0
0
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing 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 higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
Query!
Timepoint [8]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [9]
0
0
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
Query!
Assessment method [9]
0
0
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
Query!
Timepoint [9]
0
0
Baseline and 24 weeks
Query!
Secondary outcome [10]
0
0
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
Query!
Assessment method [10]
0
0
SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional \& Mental Health) are derived \& normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them \& standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
Query!
Timepoint [10]
0
0
Baseline and 24 weeks
Query!
Eligibility
Key inclusion criteria
* Active rheumatoid arthritis (RA) diagnosed after the age of 16
* Currently taking methotrexate
* 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Females who are pregnant or breast feeding
* Poorly controlled hypertension
* Liver disease or significant liver function test abnormalities
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* Recent or significant cardiovascular disease
* Significant active or recent infection including tuberculosis
* Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* Severe renal impairment
* Neutropenia
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
923
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
Research Site - Camperdown
Query!
Recruitment hospital [2]
0
0
Research Site - Cairns
Query!
Recruitment hospital [3]
0
0
Research Site - Southport
Query!
Recruitment postcode(s) [1]
0
0
- Camperdown
Query!
Recruitment postcode(s) [2]
0
0
- Cairns
Query!
Recruitment postcode(s) [3]
0
0
- Southport
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Delaware
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kansas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Mississippi
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Missouri
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Montana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New Mexico
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Ohio
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Oregon
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Pennsylvania
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
South Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Tennessee
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Texas
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Berkshire
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Caba
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
CBA
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
CRD
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
TUC
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Quilmes
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
San Juan
Query!
Country [33]
0
0
Belgium
Query!
State/province [33]
0
0
Brussels
Query!
Country [34]
0
0
Belgium
Query!
State/province [34]
0
0
Yvoir
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
ES
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
PE
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
PR
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
SP
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Rio de Janeiro
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Plovdiv
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Sevlievo
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Sofia
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Veliko Tarnovo
Query!
Country [44]
0
0
Chile
Query!
State/province [44]
0
0
X Region
Query!
Country [45]
0
0
Chile
Query!
State/province [45]
0
0
Santiago
Query!
Country [46]
0
0
Estonia
Query!
State/province [46]
0
0
Parnu
Query!
Country [47]
0
0
Estonia
Query!
State/province [47]
0
0
Tallinn
Query!
Country [48]
0
0
Estonia
Query!
State/province [48]
0
0
Tartu
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Orleans Cedex 1
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Paris Cedex 13
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Balatonfured
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Bekescsaba
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Budapest
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Debrecen
Query!
Country [55]
0
0
Hungary
Query!
State/province [55]
0
0
Mako
Query!
Country [56]
0
0
Hungary
Query!
State/province [56]
0
0
Sopron
Query!
Country [57]
0
0
Hungary
Query!
State/province [57]
0
0
Szentes
Query!
Country [58]
0
0
Hungary
Query!
State/province [58]
0
0
Zalaegerszeg-pozva
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Andhra Pradesh
Query!
Country [60]
0
0
India
Query!
State/province [60]
0
0
Gujarat
Query!
Country [61]
0
0
India
Query!
State/province [61]
0
0
Karnataka
Query!
Country [62]
0
0
India
Query!
State/province [62]
0
0
Maharshtra
Query!
Country [63]
0
0
India
Query!
State/province [63]
0
0
Uttar Pradesh
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Calcutta
Query!
Country [65]
0
0
India
Query!
State/province [65]
0
0
Hyderabad
Query!
Country [66]
0
0
Mexico
Query!
State/province [66]
0
0
Coahuila
Query!
Country [67]
0
0
Mexico
Query!
State/province [67]
0
0
Distrito Federal
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
JAL
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Nuevo Leon
Query!
Country [70]
0
0
Mexico
Query!
State/province [70]
0
0
SON
Query!
Country [71]
0
0
Mexico
Query!
State/province [71]
0
0
Chihuahua
Query!
Country [72]
0
0
Mexico
Query!
State/province [72]
0
0
Mexicali
Query!
Country [73]
0
0
Mexico
Query!
State/province [73]
0
0
San Luis Potosi
Query!
Country [74]
0
0
Peru
Query!
State/province [74]
0
0
Lima
Query!
Country [75]
0
0
Peru
Query!
State/province [75]
0
0
Arequipa
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Bytom
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Chelm Slaski
Query!
Country [78]
0
0
Poland
Query!
State/province [78]
0
0
Grodzisk Mazowiecki
Query!
Country [79]
0
0
Poland
Query!
State/province [79]
0
0
Katowice
Query!
Country [80]
0
0
Poland
Query!
State/province [80]
0
0
Krakow
Query!
Country [81]
0
0
Poland
Query!
State/province [81]
0
0
Warszawa
Query!
Country [82]
0
0
Poland
Query!
State/province [82]
0
0
Wroclaw
Query!
Country [83]
0
0
Poland
Query!
State/province [83]
0
0
Zyrardow
Query!
Country [84]
0
0
Slovakia
Query!
State/province [84]
0
0
Bratislava
Query!
Country [85]
0
0
Slovakia
Query!
State/province [85]
0
0
Poprad
Query!
Country [86]
0
0
Slovakia
Query!
State/province [86]
0
0
Rimavska Sobota
Query!
Country [87]
0
0
Slovakia
Query!
State/province [87]
0
0
Zilina
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Donetsk
Query!
Country [89]
0
0
Ukraine
Query!
State/province [89]
0
0
Ivano-frankivsk
Query!
Country [90]
0
0
Ukraine
Query!
State/province [90]
0
0
Kharkiv
Query!
Country [91]
0
0
Ukraine
Query!
State/province [91]
0
0
Kiev
Query!
Country [92]
0
0
Ukraine
Query!
State/province [92]
0
0
Kyiv
Query!
Country [93]
0
0
Ukraine
Query!
State/province [93]
0
0
Lviv
Query!
Country [94]
0
0
Ukraine
Query!
State/province [94]
0
0
Odessa
Query!
Country [95]
0
0
Ukraine
Query!
State/province [95]
0
0
Vinnytsya
Query!
Country [96]
0
0
Ukraine
Query!
State/province [96]
0
0
Zaporyzhzhya
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Cheshire
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Christchurch
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Ipswich
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
London
Query!
Country [101]
0
0
United Kingdom
Query!
State/province [101]
0
0
Westcliff-on-the Sea
Query!
Country [102]
0
0
United Kingdom
Query!
State/province [102]
0
0
Wirral
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 1 year.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01197521
Query!
Trial related presentations / publications
Kjelgaard-Petersen CF, Platt A, Braddock M, Jenkins MA, Musa K, Graham E, Gantzel T, Slynn G, Weinblatt ME, Karsdal MA, Thudium CS, Bay-Jensen AC. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Sep;70(9):1419-1428. doi: 10.1002/art.40527. Epub 2018 Jul 24.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Neil MacKillop, MD PhD
Query!
Address
0
0
AstraZeneca
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01197521
Download to PDF