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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients with Rheumatoid Arthritis

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

fostamatinib
                    100 mg twice daily

Research Site

Age Continuous

Gender, Male/Female

Race/Ethnicity, Customized

ANCOVA=analysis of covariance, BID=twice daily, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and with a valid measurement for this type of blood pressure assessment.

Change from baseline in 24-hour mean ambulatory SBP

ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product.

The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle.The analysis population for each endpoint includes patients from the FAS still on IP at 4 weeks and had a valid measurement for this type of blood pressure assessment.

Change from baseline in 24-hour mean ambulatory DBP

Day 28 daytime SBP

Day 28 daytime DBP

Day 28 night-time SBP

Day 28 night-time DBP

ANCOVA=analysis of covariance, BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

Change from baseline in mean daytime SBP (Day 28)

Change from baseline in mean daytime DBP (Day 28)

Change from baseline in mean night-time SBP (Day 28)

Change from baseline in mean night-time DBP (Day 28)

Change from baseline in mean daytime and night-time SBP and DBP by ambulatory blood pressure monitoring

Day 28 awake SBP

Day 28 awake DBP

Change from baseline in mean awake SBP (Day 28)

Change from baseline in mean awake DBP (Day 28)

Change from baseline in mean awake SBP and DBP by ambulatory blood pressure monitoring

Day 28 sleeping SBP

Day 28 sleeping DBP

Change from baseline in mean sleeping SBP

Change from baseline in mean sleeping DBP

Change from baseline in mean sleeping SBP and DBP by ambulatory blood pressure monitoring

Day 29 SBP

Day 29 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.

Change from baseline in clinic SBP (Day 29)

Change from baseline in clinic DBP (Day 29)

Mean change from baseline in clinic SBP and DBP

Weekly average pre-dose SBP (Week 4)

Weekly average pre-dose DBP (Week 4)

Change from baseline in weekly average pre-dose home SBP (Week 4)

Change from baseline in weekly average pre-dose home DBP (Week 4)

Mean change from baseline in morning pre-dose home SBP and DBP

Weekly average post-dose SBP (Week 4) 

Weekly average post-dose DBP (Week 4) 

Change from baseline in weekly average post-dose home SBP (Week 4)

Change from baseline in weekly average post-dose home DBP (Week 4)

Mean change from baseline in evening post-dose home SBP and DBP

BID=twice daily, DBP=diastolic blood pressure, FAS=full analysis set, IP=investigational product, SBP=systolic blood pressure.

The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes patients from the FAS still on IP at Day 36 and with a valid measurement for this type of blood pressure assessment.

Mean change from completion/discontinuation to follow-up in clinical measurement of SBP and DBP

Day 8

Day 15

Day 29

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.

Improvement from baseline at Day 29. Non-responder imputation has been applied following premature withdrawal, or any dose of background disease modifying antirheumatic drug increased or any other RA treatment initiated including DMARDs, anti-TNFs or other biologics, or receiving any parenteral steroids, or for patients with no post baseline data.

The FAS includes those randomised patients who received at least 1 dose of IP. Patients were analysed by randomised treatment in accordance with the intention to treat principle. The analysis population for each endpoint includes those patients from the FAS who were still on IP at 4 weeks and had a valid measurement for this type of assessment. 

DAS28-CRP improvement

Overall Study

A total of 131 patients failed screening.

Dave Goldstraw

The DAS28 is based on a count of 28 swollen and tender joints, with a score ranging from 0 to 9.4, and can be used to objectively evaluate a patient's response to treatment.

Arms	Assigned Interventions
Experimental: Dosing Regimen A Oral treatment	Drug: fostamatinib fostamatinib 100 mg twice daily
Placebo Comparator: Dosing Regimen B Oral treatment	Drug: placebo placebo

Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients with Rheumatoid Arthritis - Oskira ABPM

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR Synopsis

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator