Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rituximab; Atacicept; Placebo matched to atacicept
Intervention description: Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.; Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.; Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the safety and tolerability of combined
      treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA)
      receiving re-treatment with rituximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects

          -  Greater than and equal to (>=) 18 years of age at the time of Informed Consent

          -  Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR)
             criteria with a disease history of at least 12 months

          -  Subjects must have active disease defined by DAS28 >3.2

          -  Subjects must have received previous treatment with rituximab and must be candidates
             for re-treatment with rituximab

          -  Female subjects of childbearing potential must be willing to avoid pregnancy by using
             an adequate method of contraception for 4 weeks before study day 1 (SD1), during the
             treatment period and for 12 months after the last dose of rituximab, and must have a
             negative urine pregnancy test at the screening visit and SD1

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Current neurological disease excluding migraine

          -  Inflammatory joint disease other than rheumatoid arthritis

          -  Any contraindication to rituximab as per national label

          -  Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for
             less than 3 months or change in dosing regimen within 28 days before SD1, or
             methotrexate dose regimen >25 mg/week

          -  Participation in any interventional clinical trial within 1 month before SD1 (or
             within 5 half-lives of the investigated compound before SD1, whichever is longer)

          -  Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing
             regimen within 28 days before SD1

          -  Active or latent tuberculosis within the year before screening or major infection
             requiring hospitalization or intravenous anti-infectives within 28 days before SD1

          -  Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)

          -  Known hypersensitivity to atacicept or to any of the components of the formulated
             atacicpet

          -  Known hypersensitivity to rituximab, to any of the components of the formulated
             rituximab or to murine proteins

          -  Breastfeeding or pregnancy

          -  Other protocol defined exclusion criteria could apply