A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Inclusion Criteria:

• Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6months but not exceeding 15 years prior to Screening

• Have moderate to severe active disease despite MTX therapy defined as having more thanor equal to six swollen joints and more than or equal to six tender joints and eithererythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL

• Must have been treated with MTX for at least 6 months prior to Randomisation and on astable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening

• Female subjects who are not pregnant or nursing at Screening and who are not planningto become pregnant from Screening until 2 months after the last dose ofinvestigational product

Exclusion Criteria:

• Have been treated previously with any biological agents including any tumour necrosisfactor inhibitor

• Have a known hypersensitivity to human immunoglobulin proteins or other components ofEnbrel or SB4

• Have a positive serological test for hepatitis B or hepatitis C or have a knownhistory of infection with human immunodeficiency virus

• Have a current diagnosis of active tuberculosis

• Have had a serious infection or have been treated with intravenous antibiotics for aninfection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.

• Have any of the following conditions

1. Other inflammatory or rheumatic diseases.

2. History of any malignancy within the previous 5 years prior to Screening

3. History of lymphoproliferative disease including lymphoma.

4. History of congestive heart failure

5. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).

6. History of demyelinating disorders.