Status:
COMPLETED
Study To Evaluate The Safety And Efficacy Of Lenalidomide For Refractory Cutaneous Lupus
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
Cutaneous Lupus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 acu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01408199
Start Date
January 1 2010
End Date
August 1 2011
Last Update
August 3 2011
Active Locations (1)
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1
Vall D'Hebron Hospital
Barcelona, Barcelona, Spain, 08035