DUPI REDUCE trial (DUPIlumab dose REDUCtion in patients with controlled atopic Eczema): a multicenter, low-intervention, non-inferiority randomized controlled trial, embedded in the TREAT NL registry.

Conditions

Atopic eczema

Brief summary

The mean Eczema Area and Severity Index (EASI) at week 16.

Detailed description

EASI at week 24., Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)., Patient self-reported Global Assessment of disease severity (PtGA)., Peak Pruritus Numerical Rating Scale (NRS)., Patient-Oriented Eczema Measure (POEM)., Dermatology Life Quality Index (DLQI)., Recap of atopic eczema (RECAP)., Dupilumab costs., EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers., Adapted iMCQ (iMTA Medical Consumption Questionnaire)., Adapted iPCQ (iMTA Productivity Cost Questionnaire)., Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire)., Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA)., Percentage of dropouts and reasons., Dupilumab serum trough levels of 40 patients.

Related papers

No related papers found yet.

Interventions

DRUGDupixent 300 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The mean Eczema Area and Severity Index (EASI) at week 16.	—

Secondary

Measure	Time frame
EASI at week 24., Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)., Patient self-reported Global Assessment of disease severity (PtGA)., Peak Pruritus Numerical Rating Scale (NRS)., Patient-Oriented Eczema Measure (POEM)., Dermatology Life Quality Index (DLQI)., Recap of atopic eczema (RECAP)., Dupilumab costs., EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers., Adapted iMCQ (iMTA Medical Consumption Questionnaire)., Adapted iPCQ (iMTA Productivity Cost Questionnaire)., Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire)., Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA)., Percentage of dropouts and reasons., Dupilumab serum trough levels of 40 patients.	—

Measure

Time frame

EASI at week 24., Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD)., Patient self-reported Global Assessment of disease severity (PtGA)., Peak Pruritus Numerical Rating Scale (NRS)., Patient-Oriented Eczema Measure (POEM)., Dermatology Life Quality Index (DLQI)., Recap of atopic eczema (RECAP)., Dupilumab costs., EuroQol-5 dimensions-5 level/Youth (EQ-5D-5L): adults and caregivers., Adapted iMCQ (iMTA Medical Consumption Questionnaire)., Adapted iPCQ (iMTA Productivity Cost Questionnaire)., Adapted iVICQ (iMTA Valuation of Informal Care Questionnaire)., Number of adverse events of special interests (AEoSIs), severe adverse events, serious adverse events and suspected unexpected serious adverse reactions (SUSARs), categorized according to medical dictionary for regulatory activities (MedDRA)., Percentage of dropouts and reasons., Dupilumab serum trough levels of 40 patients.

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Countries

Netherlands

Outcome results

None listed