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

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.