Evaluation of Safety and Effectiveness of Fostamatinib Compared to Placebo in Patients in Asia With Rheumatoid Arthritis

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the effectiveness of four dosing regimens of fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking methotrexate but not responding. The study will last for 12 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Male or female aged 18 and over

• Active rheumatoid arthritis (RA) diagnosed after the age of 16

• 6 or more swollen joints and 6 or more tender/painful joints from certain joints in the hands, wrists, arms and knees

• At least one of: positive result for rheumatoid factor test, either in the past or currently (blood test); x-ray showing bone erosion within the last 12 months; presence of certain antibodies in the blood (blood test)

• Currently taking methotrexate for at least 4 months (and on a stable dose for at least 6 weeks)

Exclusion Criteria:

• Females who are pregnant or breast feeding

• Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders.

• Previously taken, but not responded to, certain biological treatments for rheumatoid arthritis

• High blood pressure that is not controlled by medication

• Low levels of neutrophils in the blood (blood test).