Discontinuation of rituximab compared with rituximab maintenance in ANCA-associated vasculitis – a randomized non-blinded controlled trial (DISRITUX)

Conditions

ANCA-associated vasculitis

Brief summary

Disease relapse rate, from randomization to relapse

Detailed description

Time to relapse (either minor or major), Proportion of patients who maintain AAV remission at 24 and 36 months., Serological response during study (ANCA positivity vs negativity), Loss of kidney function (eGFR slope from randomization+ fixed points at 12, 24, and 36 months), Start of kidney replacement therapy, Duration (number of months) and doses of RTX treatment prior to randomization, Duration (number of months) of GC exposure prior to randomization, Cumulative GC exposure from randomization to end of study end of study or relapse whichever comes first, Cumulative accrual of damage measured by the Vasculitis Damage Index (VDI) scale, Health-related quality of life measurements, Serious adverse event rate, Frequency of AEs of special interest (AESI), Health economics

Related papers

No related papers found yet.

Interventions

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease relapse rate, from randomization to relapse	—

Secondary

Measure	Time frame
Time to relapse (either minor or major), Proportion of patients who maintain AAV remission at 24 and 36 months., Serological response during study (ANCA positivity vs negativity), Loss of kidney function (eGFR slope from randomization+ fixed points at 12, 24, and 36 months), Start of kidney replacement therapy, Duration (number of months) and doses of RTX treatment prior to randomization, Duration (number of months) of GC exposure prior to randomization, Cumulative GC exposure from randomization to end of study end of study or relapse whichever comes first, Cumulative accrual of damage measured by the Vasculitis Damage Index (VDI) scale, Health-related quality of life measurements, Serious adverse event rate, Frequency of AEs of special interest (AESI), Health economics	—

Measure

Time frame

Time to relapse (either minor or major), Proportion of patients who maintain AAV remission at 24 and 36 months., Serological response during study (ANCA positivity vs negativity), Loss of kidney function (eGFR slope from randomization+ fixed points at 12, 24, and 36 months), Start of kidney replacement therapy, Duration (number of months) and doses of RTX treatment prior to randomization, Duration (number of months) of GC exposure prior to randomization, Cumulative GC exposure from randomization to end of study end of study or relapse whichever comes first, Cumulative accrual of damage measured by the Vasculitis Damage Index (VDI) scale, Health-related quality of life measurements, Serious adverse event rate, Frequency of AEs of special interest (AESI), Health economics

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Countries

Sweden

Outcome results

None listed