Back to resultsEvaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding. (OSKIRA - 2)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fostamatinib
fostamatinib
placebo, fostamatinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Active rheumatoid arthritis (RA) diagnosed after the age of 16
- Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
- 4 or more swollen joints and 4 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)
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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dosing Regimen A
Dosing Regimen B
Dosing Regimen C
Arm Description
Oral Treatment
Oral Treatment
Oral Treatment
Outcomes
Primary Outcome Measures
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
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. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Secondary Outcome Measures
Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
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. Mean refers to change at Week 24.
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo
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.
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo
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.
Proportion of Patients Achieving DAS28 EULAR Response at Week 24
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, 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.
HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
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. The HAQ-DI response is a reduction from baseline in HAQ-DI score 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.
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo
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 were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented 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 drugs, PO = orally, QD = once a day.
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented 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 drugs, PO = orally, QD = once a day.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01197534
Brief Title
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
Acronym
OSKIRA - 2
Official Title
(OSKIRA-2): 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 DMARDs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.
Detailed Description
Sub-study:
Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
913 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosing Regimen A
Arm Type
Experimental
Arm Description
Oral Treatment
Arm Title
Dosing Regimen B
Arm Type
Experimental
Arm Description
Oral Treatment
Arm Title
Dosing Regimen C
Arm Type
Placebo Comparator
Arm Description
Oral Treatment
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
fostamatinib 100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
fostamatinib
Intervention Description
fostamatinib 100 mg twice daily/ 150 mg once daily
Intervention Type
Drug
Intervention Name(s)
placebo, fostamatinib
Intervention Description
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.
Primary Outcome Measure Information:
Title
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo
Description
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. BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
Description
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Time Frame
1 week
Title
Proportion of Patients Achieving ACR50, Comparison Between Fostamatinib and Placebo at Week 24
Description
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Time Frame
24 weeks
Title
Proportion of Patients Achieving ACR70, Comparison Between Fostamatinib and Placebo at Week 24
Description
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. BID = twice daily, CRP = C-reactive protein, DMARD = Disease-modifying anti-rheumatic drug, PO = orally, QD = once a day.
Time Frame
24 weeks
Title
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
Description
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. Mean refers to change at Week 24.
Time Frame
Baseline and 24 weeks
Title
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12, Comparison Between Fostamatinib and Placebo
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. 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.
Time Frame
12 weeks
Title
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24, Comparison Between Fostamatinib and Placebo
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. 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.
Time Frame
24 weeks
Title
Proportion of Patients Achieving DAS28 EULAR Response at Week 24
Description
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. BID = twice daily, 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.
Time Frame
24 weeks
Title
HAQ-DI Response - Comparison of the Change(>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
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. The HAQ-DI response is a reduction from baseline in HAQ-DI score 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.
Time Frame
Baseline and 24 weeks
Title
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo
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 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 were excluded from the analysis. ANCOVA = analysis of covariance, BID = twice daily, IP = investigational product, QD = once a day.
Time Frame
Baseline and 24 weeks
Title
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
Description
SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented 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 drugs, PO = orally, QD = once a day.
Time Frame
Baseline and 24 weeks
Title
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
Description
SF-36: 36-item Short Form Health Survey, a measure of health related quality of life. Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional and Mental Health) are derived and normalised to a scale of 0-100. Physical and mental component scores (PCS and MCS) are derived by multiplying each of these 8 scores by a constant, summing them and standardising against a population with mean of 50+/- 10. Higher scores represent a better quality of life. Mean changes from baseline score are presented 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 drugs, PO = orally, QD = once a day.
Time Frame
Baseline and 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active rheumatoid arthritis (RA) diagnosed after the age of 16
Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
4 or more swollen joints and 4 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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil MacKillop, MD PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
Country
United States
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Research Site
City
Glendale
State/Province
Arizona
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United States
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Mesa
State/Province
Arizona
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United States
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Phoenix
State/Province
Arizona
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United States
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Scottsdale
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Arizona
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United States
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Tucson
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Arizona
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United States
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Hot Springs
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Arkansas
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United States
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Huntington Beach
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California
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United States
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Torrance
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California
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United States
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Trumbull
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Connecticut
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United States
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Washington
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District of Columbia
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United States
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Boca Raton
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Florida
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United States
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Brandon
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Florida
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United States
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Jacksonville
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Florida
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United States
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Miami
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Florida
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United States
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Orlando
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Florida
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United States
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Tampa
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Florida
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United States
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Venice
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Florida
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United States
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Zephyr Hills
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Florida
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United States
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Canton
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Georgia
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United States
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Decatur
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Georgia
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United States
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Macon
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Georgia
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United States
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Boise
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Idaho
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United States
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South Bend
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Indiana
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United States
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Elizabethtown
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Kentucky
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United States
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Crofton
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Maryland
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United States
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Cumberland
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Maryland
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United States
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Hagerstown
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Maryland
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United States
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Kalamazoo
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Michigan
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United States
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Flowood
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Mississippi
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United States
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St. Louis
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Missouri
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United States
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Kalispell
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Montana
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United States
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Omaha
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Nebraska
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United States
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Manalapan
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New Jersey
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United States
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Las Cruces
State/Province
New Mexico
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United States
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Brooklyn
State/Province
New York
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United States
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Rochester
State/Province
New York
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United States
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City
Roslyn
State/Province
New York
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United States
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City
Syracuse
State/Province
New York
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United States
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Charlotte
State/Province
North Carolina
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United States
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Durham
State/Province
North Carolina
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United States
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Dayton
State/Province
Ohio
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United States
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City
Duncansville
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Pennsylvania
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United States
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Philadelphia
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Pennsylvania
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United States
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West Reading
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Pennsylvania
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United States
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Greenville
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South Carolina
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United States
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Orangeburg
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South Carolina
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United States
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Memphis
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Tennessee
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United States
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Amarillo
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Texas
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United States
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Austin
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Texas
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United States
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Dallas
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Texas
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United States
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Houston
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Texas
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United States
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Lubbock
State/Province
Texas
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United States
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Mesquite
State/Province
Texas
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United States
Facility Name
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San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Bowmanville
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
Trois-rivieres
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Reading
Country
Canada
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
Liberec
Country
Czech Republic
Facility Name
Research Site
City
Ostrava - Trebovice
Country
Czech Republic
Facility Name
Research Site
City
Praha 11
Country
Czech Republic
Facility Name
Research Site
City
Praha 2
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
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
Erlangen
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Muenchen
Country
Germany
Facility Name
Research Site
City
Hyderabad
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
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
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
Country
India
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Beer Yaakov
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Kfar-saba
Country
Israel
Facility Name
Research Site
City
Petah-tikva
Country
Israel
Facility Name
Research Site
City
Ramat Gan
Country
Israel
Facility Name
Research Site
City
Ramat-gan
Country
Israel
Facility Name
Research Site
City
Rehovot
Country
Israel
Facility Name
Research Site
City
Tel Aviv
Country
Israel
Facility Name
Research Site
City
Jesi
State/Province
AN
Country
Italy
Facility Name
Research Site
City
Legnano
State/Province
MI
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
Aveiro
Country
Portugal
Facility Name
Research Site
City
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Baia Mare
Country
Romania
Facility Name
Research Site
City
Brailari
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Ploiesti
Country
Romania
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
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
Kz-natal
Country
South Africa
Facility Name
Research Site
City
Cape Town
State/Province
W Cape
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
Country
South Africa
Facility Name
Research Site
City
Stellenbosch
Country
South Africa
Facility Name
Research Site
City
La Laguna (tenerife)
State/Province
Canarias
Country
Spain
Facility Name
Research Site
City
Merida
State/Province
Extremadura
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Getafe
Country
Spain
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Simferopol
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Zaporizhzhya
Country
Ukraine
Facility Name
Research Site
City
Zaporyzhzhya
Country
Ukraine
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
London
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Research Site
City
Stoke on Trent
Country
United Kingdom
Facility Name
Research Site
City
Swindon
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=421&filename=CSR-D8480C00039.pdf
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URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1202&filename=CSR-D1700C00004.pdf
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URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=2264&filename=CSR-1939IL-0551.pdf
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Related Info
Learn more about this trial
Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.
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