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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01563978

Run by

AstraZeneca

People needed

266

Starts

2012-04-01

Expected to finish

2013-01-01

Last updated by the study team

2014-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Huntington Beach, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Trumbull, Connecticut, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Brandon, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Venice, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — South Bend, Indiana, United States
• Research Site — Cumberland, Maryland, United States
• Research Site — Frederick, Maryland, United States
• Research Site — Hagerstown, Maryland, United States
• Research Site — Florissant, Missouri, United States
• Research Site — Richmond Heights, Missouri, United States
• Research Site — Freehold, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Brooklyn, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Greensboro, North Carolina, United States
• Research Site — Lake Oswego, Oregon, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Austin, Texas, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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