Immunoglobulin G4 related Disease (IgG4-RD)
Conditions
Brief summary
• PK parameters, including maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), terminal half-life (t½), clearance (CL), and volume of distribution at steady-state (Vss), • Change from baseline in CD20+ B cell counts, • Incidence of adverse events, serious adverse events, events of interest (EOIs), and change from baseline in laboratory parameters and vital signs
Detailed description
• Disease activity endpoints include: - Time-to-first treated flare across 52 weeks - Proportion of flare-free participants across 52 weeks - Annualized flare rate across 52 weeks, • Presence of antidrug antibodies (ADA) before and after initiation of treatment, • Percent reduction from baseline in daily glucocorticoid dose at week 52 taken for the purpose of IgG4 RD control
Interventions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • PK parameters, including maximum plasma concentration (Cmax), area under the plasma concentration-time curve (AUC), terminal half-life (t½), clearance (CL), and volume of distribution at steady-state (Vss), • Change from baseline in CD20+ B cell counts, • Incidence of adverse events, serious adverse events, events of interest (EOIs), and change from baseline in laboratory parameters and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| • Disease activity endpoints include: - Time-to-first treated flare across 52 weeks - Proportion of flare-free participants across 52 weeks - Annualized flare rate across 52 weeks, • Presence of antidrug antibodies (ADA) before and after initiation of treatment, • Percent reduction from baseline in daily glucocorticoid dose at week 52 taken for the purpose of IgG4 RD control | — |
Outcome results
None listed