Lupus Erythematosus, Systemic
Conditions
Brief summary
Treatment failure rate during the 2 years study period
Detailed description
Reduction of disease relevant autoantibodies, in particular anti-dsDNA autoantibody production at 28 weeks, Total renal response rate at 28 weeks, Regression of immune complex-mediated excessive neutrophil extracellular traps (NET) formation at 28 weeks, Sustained, long-term B-cell depletion during 104 weeks, Sustained reduction of relevant anti-nuclear autoantibodies, including seroconversion during 104 weeks, Sustained regression of immune complex-mediated excessive neutrophil extracellular traps (NET) formation during 104 weeks, Safety and toxicity monitoring according to Common toxicity Criteria (CTC) developed by the National Cancer Institute (NCI) with the use of Common Terminology Criteria for Adverse Events (CTCAE), Evaluate the reduction of concomitant immunosuppression and the number of moderate and severe flares during study follow-up
Interventions
Sponsors
Academisch Ziekenhuis Leiden, Academisch Ziekenhuis Leiden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment failure rate during the 2 years study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of disease relevant autoantibodies, in particular anti-dsDNA autoantibody production at 28 weeks, Total renal response rate at 28 weeks, Regression of immune complex-mediated excessive neutrophil extracellular traps (NET) formation at 28 weeks, Sustained, long-term B-cell depletion during 104 weeks, Sustained reduction of relevant anti-nuclear autoantibodies, including seroconversion during 104 weeks, Sustained regression of immune complex-mediated excessive neutrophil extracellular traps (NET) formation during 104 weeks, Safety and toxicity monitoring according to Common toxicity Criteria (CTC) developed by the National Cancer Institute (NCI) with the use of Common Terminology Criteria for Adverse Events (CTCAE), Evaluate the reduction of concomitant immunosuppression and the number of moderate and severe flares during study follow-up | — |
Countries
Netherlands
Outcome results
None listed