| Primary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0004.3± 7.34
- OG0011.3± 7.87
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | Inc. baseline (covariate); treatment, region, prior failure to biologic disease modifying antirheumatic drug & baseline antihypertensive use (factors) | 0.023 | | Least squares mean treatment difference | 2.93 | | | 2-Sided | 95 | 0.40 | 5.45 | | | | No | Superiority or Other | | |
|
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | Day 29 to Day 36 | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |
| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | Units on a scale | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | FOSTA 100 MG BID | Fostamatinib 100 mg bid, oral treatment | | OG001 | PLACEBO | |
| |