An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis

Inclusion criteria

• Are male or female aged 18-55 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 prior to Screening.
• Subjects who are considered by the Investigator to be a suitable candidate for self-administering adalimumab treatment
• Must be able to provide informed consent, which must be obtained prior to any study related procedures.

Exclusion criteria

• Have been treated previously with any biologic agents including any tumour necrosis factor inhibitor.
• Have a known hypersensitivity to human immunoglobulin proteins or other components of SB5.
• 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 indicated by a positive QuantiFERON® Gold test result.
• Have had a serious infection (such as sepsis, abscess, opportunistic infections or invasive fungal infection including histoplasmosis) or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to first dose of IP. Nonsignificant infections do not need to be considered exclusionary at the discretion of the Investigator.
• Have a history of chronic or recurrent infection (such as chronic renal infection, chronic chest infection or recurrent urinary infection).
• Have any of the following conditions:

• History of congestive heart failure (New York Heart Association Class III/IV)
• History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré syndrome).
• History of any malignancy (other than lymphoproliferative disease and melanoma, see Exclusion Criteria 10.f) within the previous 5 years prior to Screening except completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.
• History of lymphoproliferative disease including lymphoma or melanoma.
• Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.