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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:April 2012
End Date:February 2013
Contact:AstraZeneca Clinical Study Information
Email:information.centre@astrazeneca.com
Phone:800-236-9933

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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


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

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.
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