Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus (ORDI-02)
Cutaneous Lupus is frequent. Approximately 70% of patients with SLE will develop cutaneous involvement at some point during course of their disease. In spite of the esthetic consequence during the acute phase, the main problem is still related to its disfiguring and incapacitating nature. Topical steroids and/or antimalarial therapy continue to be the conventional therapy. Unfortunately, approximately 30% will be refractory to these measures. For those patients, immunosuppressive therapy can be an alternative with controversial results. Several series have shown a 90% of clinical efficacy in patients treated with Thalidomide. Unfortunately, the main drawback has been the serious described side effects such as fetal malformations, polyneuropathy and drowsiness. Recently, a new thalidomide analogue, more potent, efficient and with better safety profile has been discovered. The main objective of the study is to evaluate the efficacy and safety of Lenalidomide for patients with Refractory cutaneous Lupus. Secondary objectives include evaluating the effect of this drug on the systemic manifestations of lupus disease, the adverse effects, frequency of flare after withdrawal, the sequela and the effect on the seric parameters. Methods: Twelve patients with refractory cutaneous lupus will be included. Lenalidomide will be started at 5mg/day and tapered progressively. Blood test and EMG will be performed at onset and at the end of follow up.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus|
- Proportion of patients achieving a complete response [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Proportion of patients developing a systemic lupus flare [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.
|Study Start Date:||January 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: Lenalidomide Group||
5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response
|Vall D'Hebron Hospital|
|Barcelona, Spain, 08035|
|Principal Investigator:||JOSEP ORDI-ROS, M||VALL D'HEBRON HOSPITAL|