Evaluation of Tabalumab Using Auto-Injector or Prefilled Syringe in Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tabalumab Auto-Injector; Tabalumab Prefilled Syringe
Intervention description: Administered SC by auto-injector; Administered SC by prefilled syringe
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the serum concentration of tabalumab after the
      administration using either prefilled syringe or auto-injector after the initial loading dose
      and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety
      extension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory males or females ≥18 years of age

          -  Diagnosis of adult-onset RA

          -  Active RA (at least 8/68 tender and at least 8/66 swollen joints)

          -  Screening C-reactive protein (CRP) >1.2 times the upper limit of normal (ULN) or a
             screening erythrocyte sedimentation rate (ESR) >28 millimeters per hour (mm/hr)

          -  Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic
             citrullinated peptide antibody (anti-CCP Ab) test

          -  Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25
             mg/week) for at least 8 weeks prior to baseline

          -  American College of Rheumatology (ACR) functional class I, II, or III

          -  Able and willing to inject tabalumab by themselves (or have an assistant who will
             inject tabalumab) and able and willing to complete all study procedures

          -  Able and willing to have blood drawn for pharmacokinetic (PK) sampling

        Exclusion Criteria:

          -  Use of oral corticosteroids at average daily doses of >10 milligrams per day (mg/day)
             of prednisone or its equivalent within 6 weeks prior to baseline

          -  Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks
             of baseline

          -  Have previously discontinued treatment with a biologic disease-modifying antirheumatic
             drug (DMARD) or a novel drug that interrupts cytokine signaling [for example, Janus
             kinase (JAK) inhibitors] due to insufficient efficacy

          -  Participants who had discontinued biologic DMARDS for reasons other than efficacy will
             not be excluded but must have done so prior to baseline

          -  Participants who discontinued a JAK inhibitor for lack of efficacy

          -  Participants who discontinued a JAK inhibitor for reasons other than efficacy will not
             be excluded, but must have done so prior to baseline for 21 days

          -  Previous severe reaction to any biologic therapy that, in the opinion of the
             Investigator, would pose an unacceptable risk to the participant if participating in
             the study

          -  Have had an inadequate response to treatment with 3 or more of the following DMARDs
             prescribed alone or in combination at approved doses for a minimum of 90 days:
             leflunomide, azathioprine, cyclosporine, and/or sulfasalazine

          -  Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other
             immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine,
             or the use of a JAK inhibitor in the 8 weeks prior to baseline