A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis

Inclusion criteria

• Are male or female aged 18-75 years at the time of signing the informed consent form.
• Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months but not exceeding 15 years prior to Screening.
• Have moderate to severe active disease despite MTX therapy defined as:

• More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
• Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
• Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
• Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.

Exclusion criteria

• Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
• Have a known hypersensitivity to human immunoglobulin proteins or other components of Humira or SB5.
• Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
• Have a current diagnosis of active tuberculosis (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
• Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
• Have a history of chronic or recurrent infection.
• Have any of the following conditions:

• History of congestive heart failure (New York Heart Association Class III/IV).
• History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
• History of demyelinating disorders.
• History of any malignancy within the previous 5 years prior to Screening.
• History of lymphoproliferative disease including lymphoma.
• Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
• Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).