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    Clinical Trial Results:
    Triple therapy in early active rheumatoid arthritis

    Summary
    EudraCT number
    		 2004-002006-30
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jun 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Apr 2019
    First version publication date
    05 Apr 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RN02RH001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NHS Greater Glasgow and Clyde
    Sponsor organisation address
    West Glasgow Ambulatory Care Hospital, Dalnair Street, Glasgow, United Kingdom, G3 8SW
    Public contact
    Dr M. Travers, NHS Greater Glasgow and Clyde, 0044 141 232 1813, Maureen.travers@ggc.scot.nhs.uk
    Scientific contact
    Dr Duncan Porter , NHS Greater Glasgow and Clyde, 0044 141 452 6176 , 0044 141 452 6176, duncan.porter@ggc.scot.nhs.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
    01 Mar 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Mar 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the trial is to test the hypothesis that improved, sustained disease control (with acceptable toxicity) will result from early triple therapy with methotrexate, hydroxychloroquine and sulphasalazine. The specific research questions that will be addressed are: 1) Does early triple therapy in the treatment of early active rheumatoid arthritis confer significant benefits in terms of disease control when compared to a 'step up' strategy for the use of disease modifying drug therapy?
    Protection of trial subjects
    As part of the study patients required to attend hospital visits and investigations which could be above those considered to be standard care. The visit schedule and the number and type of investigations were fully explained to the the patient verbally and in writing via the patient information sheet to ensure patients were fully aware what was entailed in the prior to them consenting into the study. The patient information sheet also fully explained the design of the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2002
    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: 96
    Worldwide total number of subjects
    96
    EEA total number of subjects
    96
    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)
    96
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 263 were screened between 01/02/2003 and 01/03/2005. Of these 96 patients weer enrolled in the study.

    Pre-assignment
    Screening details
    		 A total of 263 patients with newly diagnosed rheumatoid arthritis screened

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 step up group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector, Tablet
    Routes of administration
    Oral use, Subcutaneous use
    Dosage and administration details
    7.5mg / week escalating to max 25 mg / week

    Investigational medicinal product name
    Sulphasalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    500 mg daily, increasing weekly to target dose 40 mg/kg/week) (or max tolerated dose)

    Investigational medicinal product name
    hydroxychloroquine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg / day

    Arm title
    		 Triple therapy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Suspension for injection in pre-filled injector
    Routes of administration
    Oral use, Subcutaneous use
    Dosage and administration details
    7.5 mg / week dose escalated to max 25mg / week

    Investigational medicinal product name
    Sulphasalazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1g / day escalating to 40mg / kg per day

    Investigational medicinal product name
    hydroxychloroquine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200mg / day

    Number of subjects in period 1
    		step up group Triple therapy
    Started
    47
    49
    Completed
    44
    47
    Not completed
    3
    2
         Adverse event, serious fatal
    -
    1
         Lost to follow-up
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 96 96
    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)
    		 96 96
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 74 74
        Male
    		 22 22

    End points

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    End points reporting groups
    Reporting group title
    step up group
    Reporting group description
    		 -

    Reporting group title
    Triple therapy
    Reporting group description
    		 -

    Primary: Mean change in disease activity score 28

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    End point title
    		 Mean change in disease activity score 28 [1]
    End point description
    End point type
    Primary
    End point timeframe
    0 - 12 months
    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: Uploader not involved in the trial and not aware of the details of the statistical analysis performed
    End point values
    		 step up group Triple therapy
    Number of subjects analysed
    44
    47
    Units: Mean change
        number (not applicable)
    -4.0
    -3.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    01/09/2002 - 06/06/2006
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    SAEs
    Reporting group description
    		 All

    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 Non Serious Adverse Events collected
    Serious adverse events
    		 SAEs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 96 (10.42%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic renal cell carcinoma
         subjects affected / exposed [2]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Investigations
    Galstones, ERCP and sphincterectomy
         subjects affected / exposed [3]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Intertrochanteric fracture Left Hip
         subjects affected / exposed [4]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal rupture
         subjects affected / exposed [5]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Possible TIA
         subjects affected / exposed [6]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Congestive cardiac failure
         subjects affected / exposed [7]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed [8]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial Infection
         subjects affected / exposed [9]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed [10]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    dyspepsia
         subjects affected / exposed [11]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Fractured Humerus
         subjects affected / exposed [12]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Thoracic Herpes Zoster
         subjects affected / exposed [13]
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: No Non Serious Adverse Events collected
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 SAEs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 96 (0.00%)

    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
    For support, Contact us.
    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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