Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis (Oskira ABPM)

• Mean change from baseline in 24-hour mean ambulatory diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
• Mean change from baseline in mean daytime (6am-10pm) systolic blood pressure and diastolic blood pressure, night time (10pm-6am) systolic blood pressure and diastolic blood pressure, awake and sleeping systolic blood pressure and diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
• Mean change from baseline in clinic systolic blood pressure and diastolic blood pressure and in morning pre-dose and evening post-dose home systolic blood pressure and diastolic blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
• Mean change from completion/discontinuation to follow-up in clinical measurement of systolic blood pressure and diastolic blood pressure [ Time Frame: week 4 to week 5 ] [ Designated as safety issue: Yes ]
• Efficacy based on Disease Activity Score based on a 28 joint count (DAS28) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  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.

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

• Drug: fostamatinib
  fostamatinib 100 mg twice daily
• Drug: placebo
  placebo

• Experimental: Dosing Regimen A
  Oral treatment
  Intervention: Drug: fostamatinib
• Placebo Comparator: Dosing Regimen B
  Oral treatment
  Intervention: Drug: placebo

Inclusion Criteria:

• Male and female patients aged 18 or over diagnosed with rheumatoid arthritis after the age of 16
• Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
• Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
• Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.

Exclusion Criteria:

• Females who are pregnant or breastfeeding.
• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
• History of liver problems that have required previous investigations
• Evidence of tuberculosis infection
• Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.