The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,917
Fostamatinib 100mg twice daily
Fostamatinib 150mg once daily
Fostamatinib 100mg once daily
Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Time frame: Entry in extension to end of study (variable duration; maximum 109 weeks)
Mean DAS28-CRP Score
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
Time frame: Weeks 0, 12, 24, 36 and 52
Mean mTSS Score
mTSS: modified total sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
Time frame: Weeks 0 and 52
Mean HAQ-DI Score
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily
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Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Huntsville, Alabama, United States
Research Site
Tuscaloosa, Alabama, United States
Research Site
Glendale, Arizona, United States
Research Site
Mesa, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Tucson, Arizona, United States
Research Site
Hot Springs, Arkansas, United States
...and 298 more locations
Time frame: Weeks 0, 12, 24, 36 and 52