Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus (ORDI-02)
|ClinicalTrials.gov Identifier: NCT01408199|
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cutaneous Lupus||Drug: Lenalidomide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus|
|Study Start Date :||January 2010|
|Primary Completion Date :||August 2010|
|Study Completion Date :||August 2011|
|Experimental: Lenalidomide Group||
5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response
- Proportion of patients achieving a complete response [ Time Frame: 3 months ]Clinical response will be evaluated by the validated CLASI score. Complete response will be considered when CLASI score=0 following treatment.
- Proportion of patients developing a side effect [ Time Frame: 12 months ]
- Proportion of patients developing a systemic lupus flare [ Time Frame: 6 months ]Systemic activity will be assess by the SLEDAI score. Disease activity will be considered with a SLEDAI score > or = 6.
- Proportion of patients increasing anti-dsDNA levels [ Time Frame: 12 months ]Anti-dsDNA titers will be mesured by ELISA at each visist.
- Proportion of patients having a cutaenous flare following treatment withdrawal [ Time Frame: 12 months ]Cutaneous flare will be defined by at least one CLASi > or= 2 in those patients with a previous complete resolution of the inflammatory rash (CLASI=0)
- Proportion of patients with an increase CLASI damage score following treatment. [ Time Frame: 12 months ]Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408199
|Vall D'Hebron Hospital|
|Barcelona, Spain, 08035|
|Principal Investigator:||JOSEP ORDI-ROS, M||VALL D'HEBRON HOSPITAL|