Back to resultsEvaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Not Responding. (OSKIRA - 1)
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
- 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)
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
Sites / Locations
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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. 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.
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 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.
Secondary Outcome Measures
ACR20 - 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. 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.
Proportion of Patients Achieving ACR50 up to 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. 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.
Proportion of Patients Achieving ACR70 up to 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. 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.
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, RA=rheumatoid arthritis. Mean refers to change at Week 24.
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
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
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 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. 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.
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 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.
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 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.
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 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01197521
Brief 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.
Acronym
OSKIRA - 1
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (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 methotrexate 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
923 (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. 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.
Time Frame
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 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.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
ACR20 - 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. 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.
Time Frame
1 week
Title
Proportion of Patients Achieving ACR50 up to 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. 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.
Time Frame
24 weeks
Title
Proportion of Patients Achieving ACR70 up to 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. 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.
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, RA=rheumatoid arthritis. Mean refers to change at Week 24.
Time Frame
24 weeks
Title
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
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
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-CRP 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. 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.
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 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.
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 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.
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 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.
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
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)
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
Anniston
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Research Site
City
Tuscaloosa
State/Province
Alabama
Country
United States
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Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
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City
Huntington Beach
State/Province
California
Country
United States
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Long Beach
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California
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United States
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City
Santa Maria
State/Province
California
Country
United States
Facility Name
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City
Santa Monica
State/Province
California
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United States
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City
Colorado Springs
State/Province
Colorado
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United States
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Bridgeport
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Connecticut
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United States
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City
Lewes
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Delaware
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United States
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Daytona Beach
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Florida
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United States
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Ocala
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Florida
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United States
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Atlanta
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Georgia
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United States
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Marietta
State/Province
Georgia
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United States
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Idaho Falls
State/Province
Idaho
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United States
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Springfield
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Illinois
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United States
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Wichita
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Kansas
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United States
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Bowling Green
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Kentucky
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United States
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Flowood
State/Province
Mississippi
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United States
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Florissant
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Missouri
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United States
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Richmond Heights
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Missouri
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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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Albuquerque
State/Province
New Mexico
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United States
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Albany
State/Province
New York
Country
United States
Facility Name
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City
Brooklyn
State/Province
New York
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United States
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City
Olean
State/Province
New York
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
Country
United States
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Research Site
City
Perrysburg
State/Province
Ohio
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United States
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City
Lake Oswego
State/Province
Oregon
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United States
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Research Site
City
Erie
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Waxford
State/Province
Pennsylvania
Country
United States
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Research Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Research Site
City
Hixson
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
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City
Houston
State/Province
Texas
Country
United States
Facility Name
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City
Mesquite
State/Province
Texas
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Reading
State/Province
Berkshire
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
State/Province
Caba
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma Bs As
State/Province
CBA
Country
Argentina
Facility Name
Research Site
City
Cordoba
State/Province
CRD
Country
Argentina
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
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City
San Miguel de Tucuman
State/Province
TUC
Country
Argentina
Facility Name
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City
Caba
Country
Argentina
Facility Name
Research Site
City
Quilmes
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Argentina
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City
San Juan
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Argentina
Facility Name
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City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Southport
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Yvoir
Country
Belgium
Facility Name
Research Site
City
Vitoria
State/Province
ES
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
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sevlievo
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
Country
Bulgaria
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
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
Paris Cedex 13
Country
France
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
Secunderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Vishakhapatnam
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Ahmedabad
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
Nagpur
State/Province
Maharshtra
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Research Site
City
Calcutta
Country
India
Facility Name
Research Site
City
Hyderabad
Country
India
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
Nuevo Leon
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
Mexicali
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
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
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
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
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
Zilina
Country
Slovakia
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
Kiev
Country
Ukraine
Facility Name
Research Site
City
Kyiv
Country
Ukraine
Facility Name
Research Site
City
Lviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Vinnytsya
Country
Ukraine
Facility Name
Research Site
City
Zaporyzhzhya
Country
Ukraine
Facility Name
Research Site
City
Warrington
State/Province
Cheshire
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
London
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
Citations:
PubMed Identifier
29669391
Citation
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.
Results Reference
derived
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 Methotrexate But Not Responding.
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