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
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab PFS and Pen
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A study comparing the use of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects
      with Rheumatoid Arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Are male or female aged 18-55 years at the time of signing the informed consent form.

          2. 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.

          3. Subjects who are considered by the Investigator to be a suitable candidate for
             self-administering adalimumab treatment

          4. Must be able to provide informed consent, which must be obtained prior to any study
             related procedures.

        Exclusion Criteria:

          1. Have been treated previously with any biologic agents including any tumour necrosis
             factor inhibitor.

          2. Have a known hypersensitivity to human immunoglobulin proteins or other components of
             SB5.

          3. 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.

          4. 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.

          5. Have a history of chronic or recurrent infection (such as chronic renal infection,
             chronic chest infection or recurrent urinary infection).

          6. Have any of the following conditions:

               1. History of congestive heart failure (New York Heart Association Class III/IV)

               2. History of demyelinating disorders (such as multiple sclerosis or Guillain-Barré
                  syndrome).

               3. 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.

               4. History of lymphoproliferative disease including lymphoma or melanoma.

               5. Any other disease or disorder which, in the opinion of the Investigator, will put
                  the subject at risk if they are enrolled.