Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist

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 methotrexate and have had an inadequate response to a single TNF-alpha antagonist. The study will last for approximately six months.

Key facts

Study ID

NCT01197755

Run by

AstraZeneca

People needed

323

Starts

2010-09-01

Expected to finish

2013-02-01

Last updated by the study team

2014-04-07

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
• Currently taking methotrexate
• 6 or more swollen joints and 6 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 12months 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 anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
• Severe renal impairment
• Neutropenia

Where it is running

• Research Site — Huntsville, Alabama, United States
• Research Site — Tuscaloosa, Alabama, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Scottsdale, Arizona, United States
• Research Site — Hot Springs, Arkansas, United States
• Research Site — Glendale, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — Santa Maria, California, United States
• Research Site — Torrance, California, United States
• Research Site — Tustin, California, United States
• Research Site — Upland, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Bridgeport, Connecticut, United States
• Research Site — Trumbull, Connecticut, United States
• Research Site — Lewes, Delaware, United States
• Research Site — Brandon, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Ocala, 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 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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