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    Clinical Trial Results:
    Evaluation of clinical value of a standardized protocol for dose reduction in patients with axial Spondyloarthritis and persistent clinical remission with anti-TNF therapy: Open-label, controlled, randomized, multicenter trial.

    Summary
    EudraCT number
    		 2011-005871-18
    Trial protocol
    		 ES  
    Global end of trial date
    10 Jun 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2022
    First version publication date
    15 Mar 2022
    Other versions
    Summary report(s)
    		 Arthritis Research & Therapy doi.org/10.1186/s13075-018-1772-z

    Trial information

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    Trial identification
    Sponsor protocol code
    REDES-TNF/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    SEFC
    Sponsor organisation address
    C/Santa Isabel 51, Madrid, Spain, 28012
    Public contact
    CRISTINA AVENDAÑO-SOLÁ, CLINICAL PHARMACOLOGY DEPARTMENT- UNIVERSITARY HOSPITAL "PUERTA DE HIERRO", 34 911916479, cavendano.hpth@salud.madrid.org
    Scientific contact
    CRISTINA AVENDAÑO-SOLÁ, CLINICAL PHARMACOLOGY DEPARTMENT- UNIVERSITARY HOSPITAL "PUERTA DE HIERRO", 34 911916479, cavendano.hpth@salud.madrid.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
    10 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Jun 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jun 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that patients with espondilartritis in remission under antiTNF therapy can maintain the remission with a maintenance dose inferior to the currently recommended dose schedule
    Protection of trial subjects
    selection criteria
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2012
    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: 126
    Worldwide total number of subjects
    126
    EEA total number of subjects
    126
    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)
    126
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Diagnosis ofxSpA according to the ASAS classification criteria on treatment with the recommended doses of commercially available TNFi (infliximab, adalimumab, etanercept or golimumab) and in sustained clinical remission defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≤ 2, no clinically active arthritis

    Period 1
    Period 1 title
    baseline
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose reduction
    Arm description
    		 Reduced dose of TNF inhibitor according to protocol
    Arm type
    		 Experimental

    Investigational medicinal product name
    TNF Inhibitor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    reduced dose according to protocol

    Arm title
    		 control
    Arm description
    		 full recommended TNFi dose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TNF Inhibitor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to approved SmPC

    Number of subjects in period 1
    		Dose reduction control
    Started
    63
    63
    Completed
    63
    63
    Period 2
    Period 2 title
    overall trial
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dose reduction
    Arm description
    		 Reduced dose of TNF inhibitor according to protocol
    Arm type
    		 Experimental

    Investigational medicinal product name
    TNF Inhibitor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    reduced dose according to protocol

    Arm title
    		 control
    Arm description
    		 full recommended TNFi dose
    Arm type
    		 Active comparator

    Investigational medicinal product name
    TNF Inhibitor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to approved SmPC

    Number of subjects in period 2
    		Dose reduction control
    Started
    63
    63
    Completed
    60
    60
    Not completed
    3
    3
         not received allocated treatment
    2
    -
         Lost to follow-up
    1
    2
         not received medication
    -
    1

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Dose reduction
    Reporting group description
    		 Reduced dose of TNF inhibitor according to protocol

    Reporting group title
    control
    Reporting group description
    		 full recommended TNFi dose
    Reporting group title
    Dose reduction
    Reporting group description
    		 Reduced dose of TNF inhibitor according to protocol

    Reporting group title
    control
    Reporting group description
    		 full recommended TNFi dose

    Primary: percentage of patients with Low Disease Activity

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    End point title
    		 percentage of patients with Low Disease Activity [1]
    End point description
    percentage of patients with Low Disease Activity (BASDAI score < 4, plus physician global assessment < 4, patient global assessment < 4 and nocturnal axial pain < 4 as assessed on a 0–10 visual analogue scale (VAS)) at one year
    End point type
    Primary
    End point timeframe
    one year
    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 the published paper
    End point values
    		 Dose reduction control
    Number of subjects analysed
    58
    55
    Units: number of patients
    58
    55
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 years
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    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: Please, see the published paper

    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.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30621746
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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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