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    Clinical Trial Results:
    ESTUDIO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE LA LENALIDOMIDA EN EL TRATAMIENTO DEL LUPUS ERITEMATOSO CUTÁNEO. STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF LENALIDOMIDE IN THE TREATMENT OF CUTANEOUS LUPUS ERYTHEMATOSUS.

    Summary
    EudraCT number
    		 2009-016508-21
    Trial protocol
    		 ES  
    Global end of trial date
    31 Oct 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2021
    First version publication date
    07 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ORDI-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01408199
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Josefina Cortés, VHIR, fina.cortes@vhir.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Oct 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy and safety of lenalidomide in patients with refractory Cutaneous lupus erythematosus
    Protection of trial subjects
    For all patients, there was no known hypersensitivity to thalidomide. Women were excluded from the study if pregnant, lactating or not using adequate contraception
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All patients were female and of Caucasian origin, with refractory cutaneous lupus disease, histological proven CLE with or without associated systemic lupus erythematosus (SLE) disease diagnosed according to the American College of Rheumatology (ACR) SLE classification criteria; presence of at least a grade II erythema; stable prednisone

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Lenalidomide
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide was started at 5 mg/day for 4 weeks. At that time, if no clinical improvement was observed, using the criteria specified before, dose was increased to 10 mg/day. Otherwise, lenalidomide was sustained at 5 mg/day in case of partial response or decreased progressively monthly until its withdrawal if complete response was achieved.

    Number of subjects in period 1
    		Lenalidomide
    Started
    15
    Completed
    15

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Lenalidomide
    Reporting group description
    		 -

    Primary: Patients achieving complete response

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    End point title
    		 Patients achieving complete response [1]
    End point description
    The efficacy primary endpoint was the proportion of patients achieving complete response. Clinical response was evaluated by the validated Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). Response was defined as follows: complete response (CR) as a complete resolution of the inflammatory rash (CLASI activity score = 0); partial response (PR) by at least a 50% improvement in the CLASI score by week 12 when compared to baseline, and no response when no improvement or worsening in the CLASI score was observed at the same time period
    End point type
    Primary
    End point timeframe
    12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistics is given since no comparison with any group is done (single arm)
    End point values
    		 Lenalidomide
    Number of subjects analysed
    15
    Units: percent
        number (not applicable)
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Weight decreased
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The main limitation is the absence of a randomized group control and the insufficient small sample size to draw conclusions at the histological subtype level since the majority of included patients had DLE. Further larger trials are required

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/23217273
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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