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

A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis

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.

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