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    Clinical Trial Results:
    A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis

    Summary
    EudraCT number
    2006-001663-33
    Trial protocol
    GB   CZ   ES   SE   DE   IT   AT   FR  
    Global end of trial date
    14 Feb 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Jul 2016
    First version publication date
    30 Jul 2015
    Other versions
    Summary report(s)
    MYCYC serious adverse events

    Trial information

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    Trial identification
    Sponsor protocol code
    MYCYC
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00414128
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    NA: NA
    Sponsors
    Sponsor organisation name
    Cambridge University Hospitals NHS Foundation Trust
    Sponsor organisation address
    Hills Road, Cambridge, United Kingdom, CB2 0QQ
    Public contact
    David Jayne, Addenbrooke's Hospital , +44 1223 217159, dj106@cam.ac.uk
    Scientific contact
    David Jayne, Addenbrooke's Hospital , +44 1223 217159, dj106@cam.ac.uk
    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
    28 Feb 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this trial was to investigate whether a mycophenolate mofetil based induction regimen is as effective as a cyclophosphamide based induction regimen in the treatment of active ANCA associated vasculitis.
    Protection of trial subjects
    All patients were provided with a patient information sheet and provided written informed consent and were free to withdraw from the trial at any point without giving a reason. Patient confidentiality was respected according to national regulations and data was coded before computer entry to maintain confidentiality. Blood samples were coded before being sent to Addenbrooke's Hospital. Study follow up and blood tests were arranged to coincide with standard hospital appointments to avoid additional hospital visits and blood tests as much as possible. According to the trial protocol, patients who did not respond to their assigned treatment regimen, could be withdrawn from trial protocol and treated with additional therapies as required.
    Background therapy
    All patients in this trial received oral glucocorticoids. Glucocorticoid starting dose was 1mg/kg/day reducing down gradually to 5mg per day at the end of month 9 for adults and 0.05-0.075mg/kg/day for patients under the age of 17 years and to continue at this dose until study end at 18 months.
    Evidence for comparator
    Cyclophosphamide is the 'gold standard' treatment for remission induction in ANCA vasculitis. It was introduced as a therapy for ANCA vasculitis in 1970 and is associated with remission rates of 70-90% and one year survival rates of 80-90% (survival prior to the introduction of cyclophosphamide was 20%).
    Actual start date of recruitment
    12 Mar 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    100 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 73
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    New Zealand: 2
    Worldwide total number of subjects
    140
    EEA total number of subjects
    125
    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)
    1
    Adolescents (12-17 years)
    8
    Adults (18-64 years)
    86
    From 65 to 84 years
    42
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    Patient were recruited from outpatient clinics and on medical wards. The study was open to recruitment of adults from 31-Jan-2007, with paediatric inclusion from 31-Jul-2007. Last patient was recruited on 29-Jul-2011.

    Pre-assignment
    Screening details
    All patients were locally screened for eligibility. Randomisation forms were sent to the central site for all patients who were considered eligible by local sites. A total of 154 patients were screened and put forward for randomisation, 14 were excluded (6 did not meet inclusion criteria, 8 declined to participate) and 140 patients were randomise

    Period 1
    Period 1 title
    Recruitment period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    NA

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cyclophosphamide
    Arm description
    Control
    Arm type
    Control

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    5,00911E+15
    Other name
    ACT code L01AA01, CAS 50180
    Pharmaceutical forms
    Powder for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Per day dose, based on weight, age and renal function, 10 doses of a maximum of 1.2g

    Arm title
    Mycophenolate mofetil
    Arm description
    Test
    Arm type
    Test

    Investigational medicinal product name
    Cellcept (mycophenolate mofetil)
    Investigational medicinal product code
    Other name
    MA number EU/1/96/005/002, ACT code L04AA06, CAS 128794-94-5
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dosed twice daily. Maximum dose 300mg total per day.

    Number of subjects in period 1
    Cyclophosphamide Mycophenolate mofetil
    Started
    70
    70
    Completed
    70
    70

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cyclophosphamide
    Reporting group description
    Control

    Reporting group title
    Mycophenolate mofetil
    Reporting group description
    Test

    Reporting group values
    Cyclophosphamide Mycophenolate mofetil Total
    Number of subjects
    70 70 140
    Age categorical
    Whole trial
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 2 2
        Adolescents (12-17 years)
    4 4 8
        Adults (18-64 years)
    45 42 87
        From 65-84 years
    18 22 40
        85 years and over
    3 0 3
    Age continuous
    Whole trial
    Units: years
        median (full range (min-max))
    60.5 (13.5 to 87) 59.6 (9.6 to 81.8) -
    Gender categorical
    Whole trial
    Units: Subjects
        Female
    37 29 66
        Male
    33 41 74

    End points

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    End points reporting groups
    Reporting group title
    Cyclophosphamide
    Reporting group description
    Control

    Reporting group title
    Mycophenolate mofetil
    Reporting group description
    Test

    Primary: Absolute Risk Reduction - ARR (90% Confidence Interval)

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    End point title
    Absolute Risk Reduction - ARR (90% Confidence Interval)
    End point description
    Number of patients that achieved remission by six months
    End point type
    Primary
    End point timeframe
    Remission by six months
    End point values
    Cyclophosphamide Mycophenolate mofetil
    Number of subjects analysed
    70
    70
    Units: Number
    70
    70
    Statistical analysis title
    ITT
    Statistical analysis description
    ITT
    Comparison groups
    Cyclophosphamide v Mycophenolate mofetil
    Number of subjects included in analysis
    140
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    < 0.05
    Method
    Absolute Risk Difference
    Parameter type
    Risk difference (RD)
    Point estimate
    0.057
    Confidence interval
         level
    90%
         sides
    1-sided
         lower limit
    -0.073
         upper limit
    -
    Notes
    [1] - The non-inferiority margin is an absolute risk difference of 12% for remission outcomes

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious adverse events reported to trial management committee within 24 hours of occurrence followed by subsequent reporting to the MHRA according to MHRA criteria.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Please see the attachment for the serious adverse events. The non-serious adverse events have not yet been analysed.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jun 2007
    Substantial ammendement to adult protocol (Version 2A) for changes requested by MHRA- drug blood monitoring and changes to mycophenolate mofetil regimen, three additional exclusion criteria added
    26 Nov 2007
    Substantial ammendement for paediatric protocol (Version 2P) to MHRA for inclusion of children
    04 Apr 2008
    Substantial ammendment for paediatric protocol (Version 3P) changes to paediatric dosing in protocol to allow MCRN study adoption
    21 Jun 2011
    Substantial ammendment for adult protocol (Version 3A) PIS and consent forms (Version 4) for updated safety information

    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.
    None reported
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