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

NCT01408199 | Completed Phase 4 DMC

• 1 other identifier: 2009-016508-21
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lenalidomide; Refractory Cutaneous Lupus

Outcome Measures

Primary Outcomes (2)

• 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.

  3 months

• Proportion of patients developing a side effect

  12 months

Secondary Outcomes (4)

• Proportion of patients developing a systemic lupus flare

  6 months

• Proportion of patients increasing anti-dsDNA levels

  12 months

• Proportion of patients having a cutaenous flare following treatment withdrawal

  12 months

• Proportion of patients with an increase CLASI damage score following treatment.

  12 months

Study Arms (1)

Lenalidomide Group

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

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

Lenalidomide Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Histologically proven cutaneous lupus erythematosus with or without associated systemic disease
• Presence of at least a grade II erythema as assessed by the validated modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
• Cutaneous lesions involving more than 18% of the body surface calculated according to the rule of the nines, or history of severe side effects or lack of efficacy following thalidomide therapy, in cutaneous lupus disease refractory to conventional treatment with antimalarials and topical steroids.
• No pregnancy or wish to become pregnant during the study period.

You may not qualify if:

• Pregnancy, breastfeeding or the use of not adequate contraception.
• Severe thrombocytopenia (\<30x10E9 cells/L) or leucopoenia (\<1500x10E9), known at least 30 days prior to the onset of the study,
• Previous history of arterial/venous thrombosis,
• Presence of antiphospholipid antibodies
• Presence of moderate-severe renal impairment (FG \<30 ml/min)
• Progressive renal disease.
• Lack of written informed consent prior to participation in the study.
• Presence of a concomitant systemic flare that may require other systemic treatments for its control
• Any psychiatric o social disease that may interfere with the study and follow-up
• HIV, B or C hepatitis

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Vall D'Hebron Hospital

Barcelona, Barcelona, 08035, Spain

Location

Related Publications (1)

• Cortes-Hernandez J, Avila G, Vilardell-Tarres M, Ordi-Ros J. Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus. Arthritis Res Ther. 2012 Dec 7;14(6):R265. doi: 10.1186/ar4111.

  PMID: 23217273 DERIVED

MeSH Terms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• JOSEP ORDI-ROS, M

  VALL D'HEBRON HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: August 3, 2011
• Study Start: January 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2011
• Last Updated: August 3, 2011

Record last verified: 2011-08

Locations

ES (1)