A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Humira (adalimumab); SB5 (proposed biosimilar to adalimumab)
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 544.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis, Adalimumab

Summary:

      This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate
      the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to
      Humira® in subjects with moderate to severe RA despite MTX therapy.
    

Eligibility criteria:

        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:

               1. 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.

               2. 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:

               1. History of congestive heart failure (New York Heart Association Class III/IV).

               2. History of acute myocardial infarction or unstable angina within the previous 12
                  months prior to Screening.

               3. History of demyelinating disorders.

               4. History of any malignancy within the previous 5 years prior to Screening.

               5. History of lymphoproliferative disease including lymphoma.

               6. 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).