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

• ClinicalTrials.gov Identifier: NCT01408199
• Recruitment Status: Completed
• First Posted: August 3, 2011
• Last Update Posted: August 3, 2011
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Information provided by: Hospital Universitari Vall d'Hebron Research Institute

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cortés-Hernández J, Ávila G, Vilardell-Tarrés M, Ordi-Ros J. Efficacy and safety of lenalidomide for refractory cutaneous lupus erythematosus. Arthritis Res Ther. 2012 Dec 7;14(6):R265. doi: 10.1186/ar4111.

• Responsible Party: RESEARCH INSTITUTE, VALL D'HEBRON HOSPITAL
• ClinicalTrials.gov Identifier: NCT01408199
• Other Study ID Numbers: 2009-016508-21
• First Posted: August 3, 2011
• Last Update Posted: August 3, 2011
• Last Verified: August 2011

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:

Lenalidomide; Refractory Cutaneous Lupus

Additional relevant MeSH terms:

Lenalidomide; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents