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    Clinical Trial Results:
    Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)

    Summary
    EudraCT number
    		 2014-005418-45
    Trial protocol
    		 SE  
    Global end of trial date
    20 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions
    Summary report(s)
    		 PosterHCQ

    Trial information

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    Trial identification
    Sponsor protocol code
    HCQCVDRASLE-1.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dep of Reumatology
    Sponsor organisation address
    Östersund Hospital, Östersund, Sweden,
    Public contact
    Christine Bengtsson, Östersund hospital, +46 703850636, christine.bengtsson@umu.se
    Scientific contact
    Christine Bengtsson, Östersund hospital, +46 703850636, christine.bengtsson@umu.se
    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
    20 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effects of treatment with hydroxychloroquoine (HCQ) on traditional cardiovascular risk factor profile: blood lipid profile, B-glucose, blood pressure after 4 and 8 weeks in patients with RA and SLE. Secondary objectives: To study the effect on vascular function, measured with pulse wave velocity (PWV) and inflammatory markers including CRP, cytokines, Calprotectin and Hyaluronan (HA). To study the patient´s compliance to drug prescription and the occurring adverse events.
    Protection of trial subjects
    The patients in highest risk for developing severe adverse reactions are excluded from the study. The adverse events and reactions occurring during the study are closely monitored and the actions will be taken to treat the reactions and mitigate the risk for worsening. The short period of drug treatment (8 weeks) will decrease the likeliness of developing long-term treatment adverse reactions. To receive information in writing about the increased risk of CVD can worry the patient. However, we do have a strategy in answering the patients questions and also a structured plan for dealing with cardiovascular risk factors that need direct medical intervention. The patients will be able to reach the study nurse by phone at every site and if needed, the investiga-tor is available for answers. If risk factors for CVD are in need of direct investigation or medical treatment, the patient will be remitted for this as in clinical praxis.
    Background therapy
    		 -
    Evidence for comparator
    		 Since we could not use a placebo arm, a delayed start for half of the patients was used and patients were randomised to one of these groups. However, all patients were included, sampled and interviewed at baseline. The rationale was that we would be able to exclude the impact of "care" from the results by comparing the first 4 weeks in patients who were cared for equally but with and without study drug. The variables of interest were investigated over time in the whole study group to evaluate the change over time.
    Actual start date of recruitment
    01 May 2015
    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
    Sweden: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    32
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was started May 2015. However, due to one of the investigator´s faling ill with seroius disease, the study was postponed to 2016. Also the persons who had accepted the first time were contacted again for decision of participartion. Thus, the true recriutment period was May-August 2016

    Pre-assignment
    Screening details
    		 Total number screened: 39. 33 patients were randomized.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 8 w treatment
    Arm description
    		 Both arms added in order to evaluate effect of study drug over eight weeks treatment. Group 1 started treatment w 1 to w8, Group 2 started with 4 w non-treatment and received 8 w treatment from w 5 to 12.
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		8 w treatment
    Started
    33
    Completed
    30
    Not completed
    3
         Physician decision
    1
         Adverse event, non-fatal
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 33 patients were randomised but only 32 were started on stúdy drug due to suddenly up-coming medical problems.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 33 33
    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)
    		 32 32
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 29 29
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    8 w treatment
    Reporting group description
    		 Both arms added in order to evaluate effect of study drug over eight weeks treatment. Group 1 started treatment w 1 to w8, Group 2 started with 4 w non-treatment and received 8 w treatment from w 5 to 12.

    Primary: Blood Lipid profile

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    End point title
    		 Blood Lipid profile [1]
    End point description
    The primary endpoint is to evaluate the effect on the blood lipids; total cholesterol, triglycerides, Low density lipoprotein (LDL), High density lipoprotein (HDL) and Apo lipoproteins (ApoA1, ApoB and Lp(a)) in patients with RA and SLE. The analysis were performed at w0, w4 and w8. Measurable units as per analys: Toral cholesterol: mmol/L Triglyceride: mmol/L HDL: mmol/L LDL: mmol/L ApoA1: g/L ApoB: g/L Lp(a): nmol/L
    End point type
    Primary
    End point timeframe
    A 0 w, after 4 and 8 weeks
    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: Each patient is it´s own control. There is no comparison between groups. Non-parametric tests will be used. Mann-Whitneys test; when comparison between Groups. Statistical testing of multiple assessments over time; Kruskal-Wallis or Friedmans test and Wilcoxons test.
    End point values
    		 8 w treatment
    Number of subjects analysed
    33
    Units: units
    33
    Attachments
    		 Results Cholesterol-TG-ApoB- HbA1c
    Results TG-HDL-ApoA1-Lp(a)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time for patient conscent till he/she has completed the trial.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    8 w treatment
    Reporting group description
    		 Both arms added in order to evaluate effect of study drug over eight weeks treatment. Group 1 started treatment w 1 to w8, Group 2 started with 4 w non-treatment and received 8 w treatment from w 5 to 12.

    Serious adverse events
    		 8 w treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 8 w treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 33 (66.67%)
    Injury, poisoning and procedural complications
    Brusing
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Bleeding due to intrauterin coil
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Cardiac disorders
    Murmur
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Nervous system disorders Other, Migraine with aura
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    Dysgeusia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Eye disorders
    Presbyopi
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Cataract operation
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastrointestinal disorders
    Gastroesophageal reflux disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Obstipation
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Stomach pain
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Dry mouth
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Rach
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Skin ulceration lower limb
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety, worsening
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Psychiatrik disorders Other, Nightmares
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Infections and infestations
    Infections and infestations Other, Herpes zoster
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Upper respiratory infection
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 May 2016
    Material extended with SLE-patients from Sunderby hospital

    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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    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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