A Phase 4 interventional study of Lenalidomide in Cutaneous Lupus, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-03.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Phase 4, Interventional, and Treatment
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.
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
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Drug: Lenalidomide
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
Clinical response will be evaluated by the validated CLASI score. Complete response will be considered when CLASI score=0 following treatment.
Time frame: 3 months
Proportion of patients developing a side effect
Time frame: 12 months
Proportion of patients developing a systemic lupus flare
Systemic activity will be assess by the SLEDAI score. Disease activity will be considered with a SLEDAI score \> or = 6.
Time frame: 6 months
Proportion of patients increasing anti-dsDNA levels
Anti-dsDNA titers will be mesured by ELISA at each visist.
Time frame: 12 months
Proportion of patients having a cutaenous flare following treatment withdrawal
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)
Time frame: 12 months
Proportion of patients with an increase CLASI damage score following treatment.
Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.
Time frame: 12 months
This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute