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NCT Number: NCT01408199

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

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.

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Key information

Conditions

Cutaneous Lupus

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vall D'Hebron Hospital

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lenalidomide

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Acronym: ORDI-02

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Aug 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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