Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis

Inclusion Criteria:

• Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of thefollowing criteria:

1. Subjects who developed RA within one year after onset of RA.

2. Subjects who have never received MTX before (MTX naive)

3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）

4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibodypositive, Rheumatoid factor positive, Presence of X-ray erosion） for poorprognostic factors. The anti-CCP antibody positive is essential for everypatient.

Exclusion Criteria:

• Patients who have a diagnosis of any other type of inflammatory arthritis.

• Patients who have a secondary, non-inflammatory type of arthritis.

• Patients who have used with MTX, reflunomide, or any other biologics prior to thestart of study drug administration.

• Patients who have NYHA (New York Heart Association) Class III or IV congestive heartfailure

• Patients who currently have, or who have a history of, tuberculosis.

• Patients who have a high risk of infection (with a current infectious disease, achronic infectious disease, a history of serious infectious disease)

• Patients who currently have, or have a history of, malignant tumor

• Female patients who are breastfeeding or pregnant, who are of childbearing potential