Overview

A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients

Status:
Withdrawn
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Methotrexate
Criteria
Inclusion Criteria:

- Patients diagnosed with rheumatoid arthritis

- Currently on Methotrexate treatment

- Provision of informed consent

Exclusion Criteria:

- History of malignancy (except for treated squamous and basal cell carcinoma of the
skin more than 5 years prior to entry)

- Patients who were taking prescription of medications listed below:

Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450,
Lovastatin

- Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies
within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1