Obinutuzumab for systemic lupus erythematosus pure membranous nephropathy: a phase II trial (OBLUMEN)

Conditions

systemic lupus erythematosus pure membranous nephropathy

Brief summary

At W52 after the first obinutuzumab infusion : Complete Renal Response (CRR) AND No intercurrent event

Detailed description

To quantify adverse events, serious adverse events, and adverse events of special interest (neutropenia, new cancer, infusion related events, infections) between the first obinutuzumab infusion and W52., To quantify the proportion of patient with no-kidney response (NKR), partial renal response (PRR), complete renal response (CRR) and renal relapses without any intercurrent event during follow-up at W52., To quantify the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during follow-up at W52., To assess the proportion of patients that are free from corticosteroids at W52, To assess the quality of life of patients at W52

Related papers

No related papers found yet.

Interventions

DRUGGazyvaro 1

DRUG000 mg concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
At W52 after the first obinutuzumab infusion : Complete Renal Response (CRR) AND No intercurrent event	—

Secondary

Measure	Time frame
To quantify adverse events, serious adverse events, and adverse events of special interest (neutropenia, new cancer, infusion related events, infections) between the first obinutuzumab infusion and W52., To quantify the proportion of patient with no-kidney response (NKR), partial renal response (PRR), complete renal response (CRR) and renal relapses without any intercurrent event during follow-up at W52., To quantify the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during follow-up at W52., To assess the proportion of patients that are free from corticosteroids at W52, To assess the quality of life of patients at W52	—

Measure

Time frame

To quantify adverse events, serious adverse events, and adverse events of special interest (neutropenia, new cancer, infusion related events, infections) between the first obinutuzumab infusion and W52., To quantify the proportion of patient with no-kidney response (NKR), partial renal response (PRR), complete renal response (CRR) and renal relapses without any intercurrent event during follow-up at W52., To quantify the proportion of patients reaching immunologic remission (normalization C3 and C4 levels and negativation of anti-dsDNA) and the number of renal and extrarenal flares during follow-up at W52., To assess the proportion of patients that are free from corticosteroids at W52, To assess the quality of life of patients at W52

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Outcome results

None listed