LEISURE : Lenalidomide vs methotrexate in difficult-to-treat cutaneous lupus erythematosus (LEISURE trial): An assessor-blinded randomized clinical trial

Conditions

Cutaneous lupus erythematosus

Brief summary

The primary endpoint will be the proportion of patients who achieve decrease of at least 50% from baseline in the CLASI activity (CLASI-A) score (CLASI-A 50 response) at week 16 with at least 8 of CLASI-A at baseline.

Detailed description

Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 16, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 16, Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 24, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 24, Variation of Quality of life using DLQI at week 16, Variation of Quality of life using DLQI at week 24, SLE activity using SLEDAI at each visit, SLE flare using SENELA-SLEDAI Flare Index (SFI) at each visit, Variation of GCs dose between inclusion and week 24., Variation of damage in each group using CLASI-D at week 24, Variation of damage in each group using CLASI-D at week 16, Rate of adverse events during the treatment and the follow-up periods

Related papers

No related papers found yet.

Interventions

DRUGLENALIDOMIDE

DRUGMETHOTREXATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the proportion of patients who achieve decrease of at least 50% from baseline in the CLASI activity (CLASI-A) score (CLASI-A 50 response) at week 16 with at least 8 of CLASI-A at baseline.	—

Secondary

Measure	Time frame
Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 16, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 16, Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 24, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 24, Variation of Quality of life using DLQI at week 16, Variation of Quality of life using DLQI at week 24, SLE activity using SLEDAI at each visit, SLE flare using SENELA-SLEDAI Flare Index (SFI) at each visit, Variation of GCs dose between inclusion and week 24., Variation of damage in each group using CLASI-D at week 24, Variation of damage in each group using CLASI-D at week 16, Rate of adverse events during the treatment and the follow-up periods	—

Measure

Time frame

Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 16, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 16, Percentage of patients reaching CLASI-A 70, a 70% decrease from baseline CLASI-A at week 24, Proportion of participants who achieve complete or almost complete response (CLASI-A 0-3) at week 24, Variation of Quality of life using DLQI at week 16, Variation of Quality of life using DLQI at week 24, SLE activity using SLEDAI at each visit, SLE flare using SENELA-SLEDAI Flare Index (SFI) at each visit, Variation of GCs dose between inclusion and week 24., Variation of damage in each group using CLASI-D at week 24, Variation of damage in each group using CLASI-D at week 16, Rate of adverse events during the treatment and the follow-up periods

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Countries

France

Outcome results

None listed