The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD). The study will last for 57 days.
OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
266
fostamatinib 100 mg twice daily
placebo
Change From Baseline in 24-hour Mean Ambulatory SBP
ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Change From Baseline in 24-hour Mean Ambulatory DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.
Time frame: 4 weeks
Change From Baseline in Mean Daytime and Night-time SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Change From Baseline in Mean Awake SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Change From Baseline in Mean Sleeping SBP and DBP by Ambulatory Blood Pressure Monitoring
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Mean Change From Baseline in Clinic SBP and DBP
Blood pressure was measured in the clinic using an automated blood pressure machine (oscillometric method). Three separate measurements were taken 2 to 5 minutes apart and the mean of the 2nd and 3rd measurements calculated. ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
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Research Site
Huntsville, Alabama, United States
Research Site
Huntington Beach, California, United States
Research Site
Santa Maria, California, United States
Research Site
Trumbull, Connecticut, United States
Research Site
Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Venice, Florida, United States
Research Site
Decatur, Georgia, United States
...and 46 more locations
Time frame: 4 weeks
Mean Change From Baseline in Morning Pre-dose Home SBP and DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Mean Change From Baseline in Evening Post-dose Home SBP and DBP
ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: 4 weeks
Mean Change From Completion/Discontinuation to Follow-up in Clinical Measurement of SBP and DBP
BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.
Time frame: Day 29 to Day 36
DAS28-CRP Improvement
ANCOVA=analysis of covariance, BID=twice daily, DAS28-CRP=Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (C-reactive protein \[CRP\]) and the patient's own assessment, FAS=full analysis set, IP=investigational product. Scores can take any positive value with a lower value indicative of a better clinical condition. Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicating a better clinical condition.
Time frame: 4 weeks