A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Atacicept; Atacicept; Atacicept; Placebo matched to atacicept
Intervention description: Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.; Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.; Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.; Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atacicept; arthritis

Summary:

      This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective
      dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid
      arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha
      (TNFa) antagonist due to lack of efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic
             criteria with a disease history of at least one year

          2. Male or female greater than or equal to (>=)18-years of age at time of informed
             consent

          3. Active RA as defined by:

               -  >=8 swollen joints (66-joint count),

               -  >=8 tender joints (68-joint count), and

               -  C-reactive protein (CRP) >=10 milligram per liter (mg/L) (central laboratory)
                  and/or erythrocyte sedimentation rate (ESR) >= to 28 millimeter per hour (mm/h)

          4. Failure of at least one TNFa antagonist therapy (previously or at the time of
             screening) as specified in the protocol

          5. Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          1. Any condition, including laboratory findings or findings in the medical history or
             pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a
             contraindication for the subject's participation in the trial or that could interfere
             with the trial objectives, conduct or evaluation

          2. Treatment with biologics aiming at B cell modulation such as rituximab or belimumab
             within 2 years before study Day 1

          3. Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab
             within 3 months before study Day 1

          4. Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab
             (Remicade) or adalimumab (Humira) within 60 days before study Day 1

          5. Participation in any interventional clinical trial with an unapproved investigational
             therapy within the 3 months before the start of this study (or within 5 half-lives of
             the investigated compound before study Day 1, whichever is longer)

          6. Other protocol defined exclusion criteria could apply