Systemic lupus erythematodes
Conditions
Brief summary
the change in the composition of B lineage cells in the peripheral blood and lymph nodes. These will be separate co-primary endpoints. We will investigate the differences between SLE patients treated with belimumab compared to SLE patients treated with other drugs, expecting a more profound effect in patients treated with belimumab.
Detailed description
Correlation between changes in B lineage cells in peripheral blood/tissues and clinical response. Alterations in the B cell lineage will be related to clinical response (defined as a >4 point improvement in cSLEDAI or any improvement in BILAG-2004 score) in a 2x2 chi-square test for all patients. Further secondary and exploratory outcomes are changes in B lineage cells and associated (pathogenic) T cell subsets in lymph nodes of SLE patients in comparison to the changes in the peripheral blood
Interventions
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in the composition of B lineage cells in the peripheral blood and lymph nodes. These will be separate co-primary endpoints. We will investigate the differences between SLE patients treated with belimumab compared to SLE patients treated with other drugs, expecting a more profound effect in patients treated with belimumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between changes in B lineage cells in peripheral blood/tissues and clinical response. Alterations in the B cell lineage will be related to clinical response (defined as a >4 point improvement in cSLEDAI or any improvement in BILAG-2004 score) in a 2x2 chi-square test for all patients. Further secondary and exploratory outcomes are changes in B lineage cells and associated (pathogenic) T cell subsets in lymph nodes of SLE patients in comparison to the changes in the peripheral blood | — |
Countries
Netherlands
Outcome results
None listed