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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2014-005418-45
    Sponsor's Protocol Code Number:HCQCVDRASLE-1.1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-18
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2014-005418-45
    A.3Full title of the trial
    Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Are risk factors factors of pertaining to or involving the heart and blood vessels and markers characterized or caused by inflammation in
    Rheumatoid Arthritis (a chronic, systemic inflammatory disorder that primarily affects joints) and Systemic Lupus Erythematosus (systemic disease in which the body’s immune system mistakenly attacks healthy tissue)improved? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE)
    A.3.2Name or abbreviated title of the trial where available
    HCQCVDRASLE
    A.4.1Sponsor's protocol code numberHCQCVDRASLE-1.1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChristine Bengtsson
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportÖstersund Hospital
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationÖstersund hospital
    B.5.2Functional name of contact pointChristine Bengtsson
    B.5.3 Address:
    B.5.3.1Street AddressÖstersund Hospital
    B.5.3.2Town/ cityÖstersund
    B.5.3.3Post code83183
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703805636
    B.5.5Fax number+4663154949
    B.5.6E-mailchristine.bengtsson@regionjh.se
    B.Sponsor: 2
    B.1.1Name of SponsorSolveig Wållberg-Jonsson
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNorrland University Hospital
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationÖstersund Hospital
    B.5.2Functional name of contact pointChristine Bengtsson
    B.5.3 Address:
    B.5.3.1Street AddressÖstersund Hospital
    B.5.3.2Town/ cityÖstersund
    B.5.3.3Post code831 83
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703850636
    B.5.5Fax number+4663154949
    B.5.6E-mailchristine.bengtsson@regionjh.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Plaquenil
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYDROXYCHLOROQUINE
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis and Systemic Lupus Erythematosus
    E.1.1.1Medical condition in easily understood language
    A serious illness that damages your joints and makes them swell, stiff and painful and an inflammatory disease of connective tissue with eg fever, weakness, fatigability, joint pains and skin lesions.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the of HCQ treatment effects on traditional cardiovascular risk factor profile: blood lipid profile, B-glucose, blood pressure after 4 and 8 weeks in patients with RA and SLE.
    E.2.2Secondary objectives of the trial
    To study the effect on vascular function, measured with pulse wave velocity (PWV) and inflammatory markers including cytokines, Calprotectin and Hyaluronan (HA).
    To study the patient´s compliance to drug pre-scription and the occurring adverse events.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female, 18-65 years of age, who has given written consent for his/her par-ticipation to the study
    ACR criteria for RA and SLE
    < 10mg Prednisolon daily doses
    Low-medium disease activity DAS28 <4.6-RA, SLEDAI-2k <6 SLE (Arthritis accepted)
    E.4Principal exclusion criteria
    • Antimalarial medication less than5 ½-t= 250 days before study inclusion visit
    • High disease activity, where cortison ad-justment is predictable
    • Pleuritis or Pericarditis – SLE
    • Impaired visus and/or colour vision
    • Hypertension >160/95
    • Diabetes
    Short life expectancy due to other comor-bidity
    Documented allergy or intolerance to study drug
    Severe psychiatric condition or other reason that jeopardize compliance with fol-low up.
    On fertile females, pregnancy assessed by anamnesis and pregnancy test
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to evaluate the effect of treatment on the blood lipids; Total Choles-terol (TC), Triglycerides (TG), Low density lipoprotein (LDL), High density lipoprotein (HDL) and apolipoproteins in patients with RA and SLE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 and 8 weeks of treatment.
    E.5.2Secondary end point(s)
    Pulse wave velocity analyses after HCQ-medication
    Blood-glucose- and HbA1c levels after HCQ-medication
    Calprotectin levels in serum after HCQ-medication
    Hyaluronan size – and concentration in serum after HCQ-medication
    Compliance to treatment; Adverse events, Compliance to drug prescription
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4, week 8 and week 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lack of treatment
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue with the study medication outside the study if their treating physician deems so as it is available for presciption - or another suitable treatment regim/medication is employed, based on the individual patient´s needs.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-30
    P. End of Trial
    P.End of Trial StatusCompleted
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