NCT01408199

Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus

Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cutaneous Lupus

Interventions

Type	Name	Description
DRUG	Lenalidomide	5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2011-08-03
• Last updated: 2011-08-03

Locations

1 site across 1 country: Spain