The effects of rituximab and obinutuzumab on lymphocyte subsets in peripheral blood and lymphoid tissues of SLE patients

The effects of rituximab and obinutuzumab on lymphocyte subsets in peripheral blood and lymphoid tissues of SLE patients - Rituximab and obinutuzumab in SLE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56559

Enrollment

Registered

2023-03-16

Start date

2023-11-01

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

RTX 2x1000mg vs. OBI 2x1000mg + 100mg methylprednisolone (two-week interval)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: SLE patients who: 1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria, 2. have a SLEDAI-2K score >=6. 3. are aged between 18-75 4. are clinically determined to have severity of disease and refractoriness that supports the off-label use of anti-CD20 therapy

Exclusion criteria

Exclusion criteria: - Patients who are not able to give informed consent. - Pregnancy - Severe renal impairment (eGFR

Design outcomes

Primary

Measure	Time frame
The proportion of patients with depletion of total CD19+ and other B lineage cells in the peripheral blood (quantitative using ImmunoSeq analysis) and lymph nodes, defined as a decrease of >2 points on a 4-point semi-quantitative scale. These will be separate co-primary endpoints. We will statistically test the difference in the proportions of patients with depletion by these criteria in RTX- versus OBI-treated patients.	—

Measure

Time frame

The proportion of patients with depletion of total CD19+ and other B lineage cells in the peripheral blood (quantitative using ImmunoSeq analysis) and lymph nodes, defined as a decrease of >2 points on a 4-point semi-quantitative scale. These will be separate co-primary endpoints. We will statistically test the difference in the proportions of patients with depletion by these criteria in RTX- versus OBI-treated patients.

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Secondary

Measure	Time frame
Correlation between CD19+ lymphocyte (and other B lineage cells) depletion in peripheral blood/tissues and clinical response. Depletion (defined as a decrease of >2 points on a 4-point semi-quantitative scale of CD19+ cells in the lymph node) 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 20 patients. Further secondary and exploratory outcomes are changes in B lineage cells and associated (pathogenic) T cell subsets in lymph nodes and skin of SLE patients in comparison to the changes in the peripheral blood compartment, analyses to investigate whether change in B lineage cells and associated (pathogenic) T cell subsets in tissues is associated with clinical outcomes and/or known serological biomarkers such as antidsDNA and complement components C3 and C4.	—

Measure

Time frame

Correlation between CD19+ lymphocyte (and other B lineage cells) depletion in peripheral blood/tissues and clinical response. Depletion (defined as a decrease of >2 points on a 4-point semi-quantitative scale of CD19+ cells in the lymph node) 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 20 patients. Further secondary and exploratory outcomes are changes in B lineage cells and associated (pathogenic) T cell subsets in lymph nodes and skin of SLE patients in comparison to the changes in the peripheral blood compartment, analyses to investigate whether change in B lineage cells and associated (pathogenic) T cell subsets in tissues is associated with clinical outcomes and/or known serological biomarkers such as antidsDNA and complement components C3 and C4.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)