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

Cutaneous Lupus Clinical Trial

— ORDI-02  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408199
• Other study ID #: 2009-016508-21
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2011
• Last updated: August 2, 2011
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Cutaneous Lupus

Intervention

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

Locations

Country	Name	City	State
Spain	Vall D'Hebron Hospital	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Proportion of patients developing a side effect		12 months	Yes
Secondary	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.	6 months	Yes
Secondary	Proportion of patients increasing anti-dsDNA levels	Anti-dsDNA titers will be mesured by ELISA at each visist.	12 months	Yes
Secondary	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)	12 months	Yes
Secondary	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.	12 months	No