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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01408199
First received: July 19, 2011
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Cutaneous Lupus
 Drug: Lenalidomide
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

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

  • Proportion of patients developing a side effect [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

  • Proportion of patients increasing anti-dsDNA levels [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Anti-dsDNA titers will be mesured by ELISA at each visist.

  • Proportion of patients having a cutaenous flare following treatment withdrawal [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)

  • Proportion of patients with an increase CLASI damage score following treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sequelae will be evaluated but the CLASI score, damage area. Any increase in the score compared to initial scores will be considered as sequelae.


Enrollment: 15
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408199

Locations
Spain
Vall D'Hebron Hospital
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
Principal Investigator: JOSEP ORDI-ROS, M VALL D'HEBRON HOSPITAL
  More Information

No publications provided

Responsible Party: RESEARCH INSTITUTE, VALL D'HEBRON HOSPITAL
ClinicalTrials.gov Identifier: NCT01408199     History of Changes
Other Study ID Numbers: 2009-016508-21
Study First Received: July 19, 2011
Last Updated: August 2, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Lenalidomide
Refractory Cutaneous Lupus

Additional relevant MeSH terms:
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013