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Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus — ORDI-02  

Cutaneous Lupus Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01408199
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact
Status Completed
Phase Phase 4
Start date January 2010
Completion date August 2011
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Active, not recruiting NCT02176148 - Cutaneous Lupus Medication Experience Study
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Terminated NCT01164917 - Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus Phase 1
Completed NCT00513591 - Duke Autoimmunity in Pregnancy Registry
Terminated NCT03639857 - Study of the Efficacy of 532nm Laser and 1064 nm Laser in the Treatment of Cutaneous Lupus Erythematous Versus Topical Corticosteroids Alone N/A