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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01408199
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : August 3, 2011
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute

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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Drug: Lenalidomide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study To Evaluate The Safety And Efficacy Of Lenalidomide For The Treatment Of Refractory Cutaneous Lupus
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Lenalidomide Group Drug: Lenalidomide
5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response

Primary Outcome Measures :
  1. Proportion of patients achieving a complete response [ Time Frame: 3 months ]
    Clinical response will be evaluated by the validated CLASI score. Complete response will be considered when CLASI score=0 following treatment.

  2. Proportion of patients developing a side effect [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Proportion of patients developing a systemic lupus flare [ Time Frame: 6 months ]
    Systemic activity will be assess by the SLEDAI score. Disease activity will be considered with a SLEDAI score > or = 6.

  2. Proportion of patients increasing anti-dsDNA levels [ Time Frame: 12 months ]
    Anti-dsDNA titers will be mesured by ELISA at each visist.

  3. Proportion of patients having a cutaenous flare following treatment withdrawal [ Time Frame: 12 months ]
    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)

  4. Proportion of patients with an increase CLASI damage score following treatment. [ Time Frame: 12 months ]
    Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01408199

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Vall D'Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
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Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: RESEARCH INSTITUTE, VALL D'HEBRON HOSPITAL Identifier: NCT01408199    
Other Study ID Numbers: 2009-016508-21
First Posted: August 3, 2011    Key Record Dates
Last Update Posted: August 3, 2011
Last Verified: August 2011
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Refractory Cutaneous Lupus
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents