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    Clinical Trial Results:
    Prospective, Single-centre, Double-Blind, Randomised, Placebo-controlled Study Evaluating Efficacy of Adalimumab + Methotrextate Compared with Placebo + Methotrexate in Patients with Early Oligoarthritis

    Summary
    EudraCT number
    2008-004877-17
    Trial protocol
    GB  
    Global end of trial date
    16 Jan 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    07 Aug 2020
    First version publication date
    07 Aug 2020
    Other versions
    Summary report(s)
    ADEOS End of Trial report 8-10-18

    Trial information

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    Trial identification
    Sponsor protocol code
    RR08/8685
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Woodhouse Lane, Leeds, United Kingdom, LS2 9JT
    Public contact
    Dr Ai Lyn Tan, University of Leeds, 0113 3924884, A.L.Tan@leeds.ac.uk
    Scientific contact
    Dr Ai Lyn Tan, University of Leeds, 0113 3924884, A.L.Tan@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
    16 Jan 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the proportion of patients who achieve clinical remission after 24 weeks of adalimumab and methotrexate (MTX) therapy compared to methotrexate monotherapy in the management of early, persistent oligoarthritis. The defining criteria for clinical remission is absence of tender/swollen joints & CRP< 5mg/ml)
    Protection of trial subjects
    Before being enrolled in the clinical study, subjects must consent to participate after the nature, scope, and possible consequences of the clinical study have been explained in a form understandable to them. An informed consent document that includes both information about the study and the consent form will be prepared and given to the subject. This document will contain all the elements required by ICH E6 Guideline for Good Clinical Practice and any additional elements required by local regulations. The document must be in a language understandable to the subject and must specify who informed the subject. Where required by local law, the person who informs the subject must be a physician. One copy of the informed consent document will be kept in the patient’s medical notes. Further, a signed copy will be given to the patient. The patient will be given at least 24 hours to consider this information after initially receiving the patient information before the consent is taken. This process will be documented in the patient notes. After reading the informed consent document, the subject must give consent in writing. The subject's consent must be confirmed at the time of consent by the personally dated signature of the subject and by the personally dated signature of the person conducting the informed consent discussions. A copy of the signed consent document must be given to the subject. The original signed consent document will be retained by the investigator. The investigator will not undertake any measures specifically required only for the clinical study until valid consent has been obtained. The investigator must inform the subject’s primary physician about the subject’s participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Dec 2011
    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
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects presenting at the rheumatology clinic who meet all of the screening criteria will be considered for enrolment into the study.A verbal explanation of the trial and Patient Information Sheet will be provided by the attending medical staff for the patient to consider.

    Pre-assignment
    Screening details
    Assenting patients will then be formally assessed for eligibility and invited to provide informed, written consent.The written consent will be taken by a clinician with the appropriate skills and training to do so, who has signed and dated the staff authorisation/delegation log. The process of obtaining written consent will be clearly documented

    Period 1
    Period 1 title
    Main Trial Period (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    adalimumab and methotrexate (MTX) combination therapy
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    40mg 2-weekly

    Investigational medicinal product name
    Methotrexate (with folic acid combination therapy)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25mg weekly

    Arm title
    methotrextate monotherapy
    Arm description
    -
    Arm type
    Active comparator

    Investigational medicinal product name
    Methotrexate (with folic acid combination therapy)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25mg weekly

    Number of subjects in period 1
    adalimumab and methotrexate (MTX) combination therapy methotrextate monotherapy
    Started
    99998
    1
    Completed
    99998
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Main Trial Period
    Reporting group description
    -

    Reporting group values
    Main Trial Period Total
    Number of subjects
    99999 99999
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    99999 99999
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    99999 99999
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    adalimumab and methotrexate (MTX) combination therapy
    Reporting group description
    -

    Reporting group title
    methotrextate monotherapy
    Reporting group description
    -

    Primary: Number of patients in clinical remission at week 24

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    End point title
    Number of patients in clinical remission at week 24 [1]
    End point description
    number of patients in clinical remission at week 24 (defined as absence of tender/swollen joints & CRP < 5mg/L)
    End point type
    Primary
    End point timeframe
    screening- week 24
    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: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.
    End point values
    adalimumab and methotrexate (MTX) combination therapy methotrextate monotherapy
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: patients
    Notes
    [2] - data analysis is incomplete for this trial.
    [3] - data analysis is incomplete for this trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAE's were assessed at every study visit, and were reported within the regulatory guidelines
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    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: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jan 2017
    The trial had multiple substantial amendments, but a full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required.

    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.
    A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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