Rheumatoid arthritis
Conditions
Brief summary
Incidence and grading of severity of Injection Related Reactions (IRR) and toxicity after administration of daratumumab until week 12, AE and SAE due to IMP (both, daratumumab and abatacept) throughout the whole study, Percentage of subjects with ACPA seroconversion (below the laboratory reference level for positivity)
Interventions
DRUGDARZALEX 1800 mg solution for injection
Sponsors
Charite Universitaetsmedizin Berlin KöR
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and grading of severity of Injection Related Reactions (IRR) and toxicity after administration of daratumumab until week 12, AE and SAE due to IMP (both, daratumumab and abatacept) throughout the whole study, Percentage of subjects with ACPA seroconversion (below the laboratory reference level for positivity) | — |
Countries
Germany
Outcome results
None listed