Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Disease Modifying Anti-rheumatic Drug (DMARD) But Not Responding.

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of the study is to evaluate the effectiveness of two dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking disease modifying anti-rheumatic drug (DMARD) but not responding. The study will last for 1 year.

Key facts

Study ID

NCT01197534

Run by

AstraZeneca

People needed

913

Starts

2010-09-01

Expected to finish

2013-03-01

Last updated by the study team

2014-04-17

Who can join

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

You may qualify if…

• Active rheumatoid arthritis (RA) diagnosed after the age of 16
• Treatment with one the following disease modifying anti-rheumatic drug: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine
• 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count)and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
• At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

You may not qualify if…

• Females who are pregnant or breast feeding
• Poorly controlled hypertension
• Liver disease or significant liver function test abnormalities
• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
• Recent or significant cardiovascular disease
• Significant active or recent infection including tuberculosis
• Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment with other biological agent
• Severe renal impairment
• Neutropenia

Where it is running

• Research Site — Glendale, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Hot Springs, Arkansas, United States
• Research Site — Huntington Beach, California, United States
• Research Site — Torrance, California, United States
• Research Site — Trumbull, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Boca Raton, Florida, United States
• Research Site — Brandon, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Venice, Florida, United States
• Research Site — Zephyrhills, Florida, United States
• Research Site — Canton, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Macon, Georgia, United States
• Research Site — Boise, Idaho, United States
• Research Site — South Bend, Indiana, United States
• Research Site — Elizabethtown, Kentucky, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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