Atacicept in Anti-Tumor Necrosis Factor Alpha-naïve Subjects With Rheumatoid Arthritis (AUGUST II)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo matched to atacicept; Atacicept: with loading dose; Atacicept; Adalimumab
Intervention description: Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.; Atacicept will be administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.; Atacicept will be administered subcutaneously at a dose of 150 mg once a week for 25 weeks.; Adalimumab (Humira®) will be administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis; Atacicept; Adalimumab; Humira®

Summary:

      The primary objective of this study is to evaluate the efficacy of atacicept compared to
      placebo in the treatment of signs and symptoms in a subject population with active rheumatoid
      arthritis (RA), inadequate response to methotrexate (MTX) and no previous exposure to
      anti-tumor necrosis factor alpha (anti-TNFalpha) therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects greater than or equal to (>=) 18 years of age at the time of
             informed consent who have RA satisfying American College of Rheumatology (ACR)
             criteria with a disease history of at least 6 months

          -  Subjects must have active disease, defined by >=8 swollen joints (out of 66), >=8
             tender joints (out of 68) and CRP >=10 milligram per liter (mg/L) and/or erythrocyte
             sedimentation rate (ESR) >=28 millimeter per hour (mm/hr), despite treatment with MTX
             at a dose of >=15 milligram per week (mg/week) for greater than (>) 3 months

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  Inflammatory joint disease other than RA

          -  Previous or concurrent treatment with any approved or investigational biological
             compound for RA, including but not restricted to any anti-TNFalpha agents, rituximab,
             abatacept, tocilizumab, interleukin-1 receptor antagonist (IL-1Ra) and belimumab

          -  Treatment with disease-modifying anti-rheumatic drug (DMARDs) other than MTX

          -  Participation in any interventional clinical trial within 1 month before study Day 1

          -  MTX dose >25 mg/week, prednisone dose >10 mg/day (or equivalent), or change in steroid
             or non-steroidal anti-inflammatory drug (NSAID) dosing regimen within 28 days before
             study Day 1

          -  Immunization with live vaccine or immunoglobulin (Ig) treatment within 28 days before
             study Day 1 or need for such treatment during the study (including follow-up)

          -  Any history or presence of active or latent tuberculosis, major infection requiring
             hospitalization or intravenous anti-infectives within 28 days before study Day 1

          -  Other major concurrent illness or organ dysfunction as specified in the protocol

          -  Serum IgG below 6 gram per liter (g/L)

          -  Known hypersensitivity to atacicept or to any of the components of the formulated
             atacicept

          -  Other protocol-defined exclusion criteria could apply