A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)
A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy
Sponsor: EMD Serono + Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP) at Week 26
Time frame: Week 26
Secondary Endpoints
Percentage of Participants Achieving American College of Rheumatology 50 Response Based on CRP (ACR50-CRP) at Week 26
Percentage of Participants Achieving American College of Rheumatology 70 Response Based on CRP (ACR70-CRP) at Week 26
Percentage of Participants Achieving Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) of Less Than or Equal to (<=) 3.2 at Week 26
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 wi…
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