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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    Clinical Trial Results:
    RETREAT(F) (REmoval of Treatment for patients in REmission in psoriatic ArThritis – Feasibility study). A randomised controlled trial to compare withdrawal of therapy versus continuing therapy in low disease states in psoriatic arthritis – feasibility study, RCT Arm

    Summary
    EudraCT number
    2012-003736-23
    Trial protocol
    GB  
    Global end of trial date
    02 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Mar 2020
    First version publication date
    06 Mar 2020
    Other versions
    Summary report(s)
    Retreat AE Tables
    RETREAT publication

    Trial information

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    Trial identification
    Sponsor protocol code
    RR11/9229
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Dr P Helliwell, University for Leeds, 0113 3923064, p.helliwell@leeds.ac.uk
    Scientific contact
    Dr P Helliwell, University for Leeds, 0113 3923064, p.helliwell@leeds.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
    02 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    For this feasibility study we wish to know the proportion of eligible patients who are willing to undergo treatment withdrawal and the proportion remaining in minimal disease at the end of the study period. Within the three month treatment withdrawal period, a minimal disease activity (MDA) score of 5 or more (achievement of the minimal disease activity criteria) will be used to confirm continuing low disease activity. A person not achieving the MDA criteria at any of the monthly assessment time points will be deemed to be experiencing a flare of their disease. The proportion of patients who flare will also be used to inform the full study.
    Protection of trial subjects
    All information collected during the course of the trial will be kept strictly confidential. Information will be held securely on paper and electronically will comply with all aspects of the Data Protection Act 1998. An Independent Trial Steering Group (TSG) will meet before the start of patient recruitment and just after the last patient has been reviewed at the three month visitThe study will be reviewed by a data monitoring and ethics committee (DMEC).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    14
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    All patients which met the inclusion criteria were invited to attend an initial screening visit where consent was obtained. Patients were recruited from outpatient clinics in the UK. at baseline a full assessment was undertaken and the patient was randomized at a ratio of 2:1 in favor of the withdrawal arm.

    Pre-assignment
    Screening details
    Participants attended an initial screening visit (visit 0) where consent was obtained; a clinical assessment was undertaken; and MDA was confirmed utilizing the MDA criteria.

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Withdrawal Arm
    Arm description
    Patients randomized to drug withdrawal will undergo a phased withdrawal of medication where the last treatment added will be the first treatment withdrawn. Drugs will be withdrawn to doses routinely administered. Treatment will be withdrawn in a stepwise fashion phasing out and stopping over three months. Participants will be reviewed in clinic on 4 occasions 1 month apart (after screening) to manage treatment changes and monitor withdrawal response using the MDA criteria above. It is anticipated that the majority of patients will be taking TNF inhibitors at enrolment and up to one third will be taking methotrexate alone.
    Arm type
    Experimental

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    step-wise reduction of 2.5 mg per week until cessation

    Investigational medicinal product name
    Sulfasalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Leflunomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Cyclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    week 0, 2, 4, 8

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    week 8 or 10

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    week 0, 4, 8

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    week 6

    Arm title
    Standard Care Arm
    Arm description
    Patients in this group will continue with their current therapy for the duration of the study. However, the treating clinician will be free to change their treatment if clinically indicated to do so (e.g., escalate treatment doses if patient is relapsing or decrease/change treatment if there are side-effects). Patients in this group will be seen at the same intervals as the intervention arm.
    Arm type
    Control

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    step-wise reduction of 2.5 mg per week until cessation

    Investigational medicinal product name
    Sulfasalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Leflunomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Cyclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    dose halved for 6 weeks and then stopped

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    week 0, 2, 4, 8

    Investigational medicinal product name
    Infliximab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    week 8 or 10

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    week 0, 4, 8

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    week 6

    Number of subjects in period 1
    Withdrawal Arm Standard Care Arm
    Started
    11
    6
    Completed
    11
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Withdrawal Arm
    Reporting group description
    Patients randomized to drug withdrawal will undergo a phased withdrawal of medication where the last treatment added will be the first treatment withdrawn. Drugs will be withdrawn to doses routinely administered. Treatment will be withdrawn in a stepwise fashion phasing out and stopping over three months. Participants will be reviewed in clinic on 4 occasions 1 month apart (after screening) to manage treatment changes and monitor withdrawal response using the MDA criteria above. It is anticipated that the majority of patients will be taking TNF inhibitors at enrolment and up to one third will be taking methotrexate alone.

    Reporting group title
    Standard Care Arm
    Reporting group description
    Patients in this group will continue with their current therapy for the duration of the study. However, the treating clinician will be free to change their treatment if clinically indicated to do so (e.g., escalate treatment doses if patient is relapsing or decrease/change treatment if there are side-effects). Patients in this group will be seen at the same intervals as the intervention arm.

    Reporting group values
    Withdrawal Arm Standard Care Arm Total
    Number of subjects
    11 6 17
    Age categorical
    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 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    8 6 14
        From 65-84 years
    3 0 3
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    5 2 7
        Male
    6 4 10

    End points

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    End points reporting groups
    Reporting group title
    Withdrawal Arm
    Reporting group description
    Patients randomized to drug withdrawal will undergo a phased withdrawal of medication where the last treatment added will be the first treatment withdrawn. Drugs will be withdrawn to doses routinely administered. Treatment will be withdrawn in a stepwise fashion phasing out and stopping over three months. Participants will be reviewed in clinic on 4 occasions 1 month apart (after screening) to manage treatment changes and monitor withdrawal response using the MDA criteria above. It is anticipated that the majority of patients will be taking TNF inhibitors at enrolment and up to one third will be taking methotrexate alone.

    Reporting group title
    Standard Care Arm
    Reporting group description
    Patients in this group will continue with their current therapy for the duration of the study. However, the treating clinician will be free to change their treatment if clinically indicated to do so (e.g., escalate treatment doses if patient is relapsing or decrease/change treatment if there are side-effects). Patients in this group will be seen at the same intervals as the intervention arm.

    Primary: Overall Flare Status

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    End point title
    Overall Flare Status [1]
    End point description
    Actual number of patients who experienced a flare are captured, though expressed in percentage from in the attached publication.
    End point type
    Primary
    End point timeframe
    The trial Primary endpoint was to determine how controlled withdrawal of trial treatment impacted on flare rates compared to standard treatment in patients with stable low disease activity psoratic RA, to see if remission can be sustained.
    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: Please see attached publication for all exploratory statistical analysis's performed in the trial.
    End point values
    Withdrawal Arm Standard Care Arm
    Number of subjects analysed
    11
    6
    Units: No of Patients who relapsed.
    6
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    AEs will be collected for all patients from randomisation until the last dose of treatment with a protocol IMP. AEs will be evaluated for duration and intensity according to the NCRI Common Toxicity Criteria.
    Adverse event reporting additional description
    Information about AEs, whether volunteered by the patient, discovered by the investigator questioning or detected through physical examination, laboratory test or other investigation will be collected and recorded on the CRF.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No Serious Adverse Events were recorded on the trial. For details of all adverse events, please see the attached document, retreat AE tables.pdf

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2012
    MHRA CTA application amended to update the supply arrangements of two of the IMP's, as the research team requested to use generic hospital stock instead of the previous agreed supplier

    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.
    N/A

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/25644584
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