Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III)
A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.
Sponsor: Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 64
Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)
Time frame: Week 64
Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32
Time frame: Baseline, Week 32
Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32
Time frame: Baseline, Week 32
Secondary Endpoints
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32
Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells
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 natio…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →