To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate

The primary objectives are to determine the relationship between blood levels of CDP6038 and suppression of C-reactive Protein (CRP) following single doses given as intravenous (IV) infusion or subcutaneous (SC) injection to Rheumatoid Arthritis (RA) patients. The safety of CDP6038 will also be evaluated.

The secondary objectives of the study include determination of the absolute bioavailability of CDP6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose CDP6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.

Inclusion Criteria:

• RA > 6 months duration on stable Methotrexate
• ≤9 swollen and ≤9 tender joints (28 joint count)
• Minimum Screening CRP of 0.5mg/L

Exclusion Criteria:

• Participation in previous studies with defined agents and durations
• Previous treatment with defined agents and durations
• Presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response
• Pregnancy
• Positive tests/signs of possible latent/active tuberculosis
• Positive HIV
• Drug addiction or alcohol abuse