Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Criteria
Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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