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    The EU Clinical Trials Register currently displays   36123   clinical trials with a EudraCT protocol, of which   5939   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-003140-12
    Sponsor's Protocol Code Number:LEF-HCQinpSS
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-26
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003140-12
    A.3Full title of the trial
    Optimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome
    Optimaliseren van DMARD-therapie voor het primaire Syndroom van Sjogren - Leflunomide en Hydroxychloroquine combinatie therapie voor patienten met het primaire Syndroom van Sjogren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome
    Leflunomide en Hydroxychloroquine combinatie therapie voor het primaire Syndroom van Sjogren
    A.3.2Name or abbreviated title of the trial where available
    LEF-HCQ combination therapy in pSS
    LEF-HCQ combinatie therapie v bij pSS
    A.4.1Sponsor's protocol code numberLEF-HCQinpSS
    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 SponsorUMC Utrecht
    B.1.3.4CountryNetherlands
    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 supportZonMw
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointA.A. Kruize
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887557358
    B.5.6E-maila.kruize@umcutrecht.nl
    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 Leflunomide Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.1Product nameLeflunomide mylan
    D.3.4Pharmaceutical form Capsule
    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 INNLEFLUNOMIDE
    D.3.9.1CAS number 75706-12-6
    D.3.9.4EV Substance CodeSUB08424MIG
    D.3.10 Strength
    D.3.10.1Concentration unit Bq/mg becquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    D.3.11.13.1Other medicinal product typeDisease Modifying Anti Rheumatic Drug
    D.IMP: 2
    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 holderEuro Registratie Collectief BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.1Product namePlaquenil
    D.3.4Pharmaceutical form Capsule
    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 Bq/mg becquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Yes
    D.3.11.13.1Other medicinal product typeDisease Modifying Anti-Rheumatic drug
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sjogren's Syndrome
    Syndroom van Sjogren
    E.1.1.1Medical condition in easily understood language
    Sjogren's Syndrome
    Syndroom van Sjogren
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10040766
    E.1.2Term Sjogren's disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10040765
    E.1.2Term Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reduction in disease activity, measured by ESSDAI (EULAR Sjogren's syndrome disease activity index)
    Afname van ziekteactiviteit, gemeten door middel van de ESSDAI (EULAR Sjogren's syndrome disease activity index)
    E.2.2Secondary objectives of the trial
    Improvement of dryness measured by stimulated whole saliva output
    Verbetering van droogheidssymptomen, gemeten door bepalen van gestimuleerde speekselproductie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) women, age 18-75 years
    2) pSS diagnosed according to the American-European Consensus Criteria, revised in 2002
    3) lymphocyte focus score (local lymphocytic infiltrates) ≥1 in sublablial salivary gland specimen.
    4) ESSDAI ≥ 5
    5) presence of autoantibodies directed to pSS-related SSA and/or SSB nuclear antigens
    6) use of a reliable method of contraception
    7) signed written informed consent
    1) vrouwelijk geslacht, 18-75 jaar
    2) gediagnosticeerd met pSS volgens de American-European Consensus Critera, herzien in 2002
    3) Lymfocyt Focus Score (lokale infiltraties van lymfocyten) ≥1 in sublabiaal speekselklierbiopt
    4) ESSDAI ≥ 5
    5) aanwezigheid van auto-antilichamen gericht tegen pSS-gerelateerde SSA en/of SSB nucleaire antigenen
    6) gebruik van betrouwbare vorm van anticonceptie
    7) ondertekende informed consent
    E.4Principal exclusion criteria
    1) Pregnancy or the wish to conceive during the study or within 2 years after the study
    2) Breastfeeding
    3) Therapy-resistent hypertension
    4) Maculopathy or retinitis pigmentosa
    5) Secondary Sjogren’s Syndrome
    6) Hepatic or renal impairment
    7) Severe infection (including hepatitis B,C or HIV)
    8) Malignancy other than mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
    9) Significant cytopenia
    10) Concomitant cardiac- and inflammatory bowel disease
    11) Sarcoidosis
    12) Usage of LEF of HCQ <6 months prior to inclusion
    13) Usage of immunosuppressive drugs, with the exception of a stable dose of non- steroidal inflammatory drugs and a stable, low dose (≤7.5 mg) of oral corticosteroids
    14) Inadequate mastery of the Dutch language
    1) Zwangerschap of de wens tot conceptie tijdens de studie of binnen twee jaar na afronding van de studie
    2) Borstvoeding
    3) Therapie-resistente hypertensie
    4) Maculopathie of retinitis pigmentosa
    5) Secundair Syndroom van Sjogren
    6) Stoornissen in nier- of leverfuncties
    7) Ernstige infectie (incl hepatitis B en C, HIV)
    8) Maligniteit, anders dan mucosa-associated lymphoid tissue MALT) lymphoma
    9) Significante cytopenie
    10) Begeleidende cardiale- en inflammatoire darm ziekten
    11) Sarcoidose
    12) Gebruik van LEF of HCQ < 6 maanden voorafgaand aan inclusie
    13) Gebruik van immunosuppressieve medicatie, muv een stabiele dosis NSDAID en een stabiele, lage (≤7.5 mg) orale corticosteroiden
    14) Onvoldoende beheersing van de Nederlandse taal
    E.5 End points
    E.5.1Primary end point(s)
    Improvement of disease activity measured by ESSDAI
    Vermindering van ziekte-activiteit gemeten dmv ESSDAI
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment with either LEF and HCQ, or placebo-LEF and placebo-HCQ
    Na 24 weken behandeling met ofwel LEF en HCQ, ofwel placebo-LEF en placebo-HCQ
    E.5.2Secondary end point(s)
    Dryness measured by stimulated whole saliva
    Droogheid gemeten door gestimuleerde speekselproductie
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 24 weeks of treatment with either LEF and HCQ, or placebo
    Na 24 weken behandeling met ofwel LEF en HCQ, ofwel placebo
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunologic response
    Immunologische respons
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Last visit of the last patient included
    Laatste bezoek van de laatst geincludeerde patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state30
    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)
    In case a patient experiences benefits from the therapy, the patient is allowed to continue the therapy.
    Follow-up will proceed as was common practice before entering the trial.
    Indien een patiente gunstige effecten ondervindt van de combinatietherapie, mag zij deze na de studie blijven voortzetten.
    Follow-up zal na de studie plaatsvinden zoals dat gebruikelijk was voor de betreffende patiente voordat zij startte met de studie.
    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 Decision2015-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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