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    Summary
    EudraCT Number:2004-000555-42
    Sponsor's Protocol Code Number:HMR1726D/3001-EFC6049
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2004-000555-42
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses
    Studio di fase III randomizzato, in doppio cieco, controllato versus placebo, a gruppi paralleli per la valutazione dell`efficacia e della sicurezza della teriflunomide (HMR1726)nel ridurre la frequenza delle recidive e nel ritardare l`accumulo di disabilita` fisica in pazienti affetti da sclerosi multipla con recidive.
    A.3.2Name or abbreviated title of the trial where available
    TEMSO
    TEMSO
    A.4.1Sponsor's protocol code numberHMR1726D/3001-EFC6049
    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 Sponsorsanofi-aventis Recherche & De`veloppement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameTERIFLUNOMIDE
    D.3.2Product code HMR1726
    D.3.4Pharmaceutical form 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 INNTERIFLUNOMIDE
    D.3.9.1CAS number 108605-62-5
    D.3.9.2Current sponsor codeHMR1726
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number14
    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
    Multiple sclerosis with relapses
    Riduzione delle recidive e ritardo della disabilita'
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of teriflunomide in reducing the frequency of relapses in subjects with relapsing multiple sclerosis
    Verificare l'effetto della teriflunomide nella riduzione della frequenza di recidive in pazienti affetti da sclerosi multipla (SM) recidivante.
    E.2.2Secondary objectives of the trial
    To Evaluate - the effect of teriflunomide on delaying the accumulation of disability AT 2 YEARS as assessed by the Kurtzke EDSS - the effects of teriflunomide on MRI variables, burden of disease (volume of abnormal brain tissue on MRI) and other MRI variables including number and volume of gadolinium-enhanced T1 lesions, volume of T2 lesion, volume of T1 hypointense lesions, atrophy and a composite. - the effect of teriflunomide on subject-reported fatigue as assessed by the Fatigue Impact Scale (FIS) - the safety and tolerability of teriflunomide by means of adverse event reports, physical examinations, vital signs, and laboratory evaluations
    ¿ Valutare l¿effetto della teriflunomide nel ritardare l¿accumulo di disabilita` in base alla scala di Kurtzke (Kurtzke Expanded Disability Status Scale- EDSS) ¿ Valutare gli effetti della teriflunomide sui parametri MRI,sulla gravita` della patologia (definita come volume totale di tessuto cerebrale anormale) ed altre variabili evidenziabili alla risonanza magnetica,inclusi: il numero ed il volume di lesioni T1 captanti gadolinio,volume delle lesioni T2,volume delle lesioni T1 ipodense,atrofia e ¿composite score¿.¿ Valutare l¿effetto della teriflunomide sulla stanchezza riportata dal soggetto secondo la scala FIS (Fatigue Impact Scale) ¿ Valutare la sicurezza e la tollerabilita` della teriflunomide sulla base degli eventi avversi,l¿esame fisico,i segni vitali e le analisi di laboratorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects meeting all of the following criteria will be considered for enrollment into the study: - MS subjects, aged 18 to 55, who are ambulatory (EDSS less or equal than 5.5) - Exhibiting a relapsing clinical course, with or without progression (Relapsing Remitting, Secondary Progressive or Progressive Relapsing) - Meeting McDonald¿s criteria for MS diagnosis - Experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial - No relapse onset in the preceding 60 days prior to randomization - During the 4 weeks prior to randomization, subjects must have been clinically stable, without adrenocorticotrophic hormone (ACTH) or systemic steroid treatment - Signed main informed consent form and the informed consent for HIV testing
    ¿ Soggetti affetti da sclerosi multipla, di eta` compresa fra i 18 e i 55 anni, in grado di camminare autonomamente (EDSS &lt; 5,5) ¿ Soggetti che presentano un decorso clinico di riacutizzazioni, con o senza progressioni (Relapsing Remitting, Secondary Progressive o Progressive Relapsing) ¿ Soggetti che soddisfano i criteri di McDonald per la diagnosi della SM ¿ Soggetti che hanno avuto almeno 1 ricaduta nell¿anno precedente la sperimentazione o 2 riacutizzazioni negli ultimi due anni ¿ Soggetti che non presentino sintomi di riacutizzazioni nei 60 giorni precedenti la randomizzazione ¿ Nel corso dei 30 giorni precedenti la randomizzazione, i soggetti devono trovarsi in condizioni clinicamente stabili e non aver assunto cure a base di ormone adrenocorticotropo (ACTH) o di steroidi sistemici ¿ Aver firmato il modulo per il consenso informato
    E.4Principal exclusion criteria
    Subjects with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia - Subjects with a congenital or acquired severe immunodeficiency, a history of cancer, lymphoproliferative disease, or any subject who has received lymphoid irradiation - Human immunodeficiency virus (HIV) positive status; known history of active tuberculosis not adequately treated; persistent significant or severe infection - Pregnancy, breastfeeding, subjects wishing to parent children during the course of the trial - Therapies that are disallowed - Subjects must not have used ACTH or systemic corticosteroids for 4 weeks prior to randomization - Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents - Prior use of natalizumab (Tysabri) - Prior use of interferons or cytokine therapy in the preceding 4 months; prior use of glatiramer acetate therapy in the preceding 6 months; prior use of intravenous immunoglobulins in the preceding 6 months; prior use of any investigational drug in the preceding 6 months; previous treatment with teriflunomide or leflunomide (ARAVA®) - Contraindication for MRI - Liver function impairment or persisting elevations of SGPT/ALT, serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal (ULN); - Persisting elevations of serum amylase or lipase greater than 2-fold the upper limit of normal - Known history of active hepatitis - Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin <3.0 g/dL - Known history of chronic pancreatic disease or pancreatitis - Moderate to severe impairment of renal function, as shown by serum creatinine >133 µmol/L (or >1.5 mg/dL) - Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol - Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study - History of drug or alcohol abuse - Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study - Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
    ¿ Soggetti la cui funzione midollare e` notevolmente deteriorata, o che presentano importante anemia, leucopenia o trombocitopenia; Soggetti che presentano una grave immunodeficienza congenita o acquista, una storia di cancro, malattia linfoproliferativa o soggetti che siano stati sottoposti a irradiazione a tessuti linfoidi; Positivita` all¿HIV; Storia nota di tubercolosi; Infezioni persistenti o gravi; Gravidanza; Allattamento al seno; Soggetti che desiderino avere figli nel corso della sperimentazione; Terapie non consentite;I soggetti non devono avere assunto ACTH o corticosteroidei sistemici per 4 settimane prima della randomizzazione; Uso precedente o concomitante di cladribina, mitoxantrone o altri immunosoppressori; Uso precedente di natalizumab (Tysabri); Uso precedente di interferone oppure terapia a base di citochine nei quattro mesi precedenti; Uso precedente di glatiramer acetato nei sei mesi precedenti; Uso di immunoglobuline per via endovenosa nei sei mesi precedenti; Uso di qualsiasi altro farmaco in fase sperimentale nei sei mesi precedenti; Controindicazioni relativamente all¿esecuzione della risonanza magnetica (MRI), Aumento persistente di amilasi sierica o lipasi superiore a 2 volte il limite superiore di normalita`.; Storia di malattia pancreatica cronica o pancreatine; Deficit della funzionalita` epatica o aumento persistente delle SGPT/ALT, SGOT/AST o bilirubina diretta superiore a 1,5 volte il limite superiore di normalita`; Storia di epatite attiva; Ipoproteinemia con albumina serica &lt; 3,0 g/dl.; Deficit moderato o grave della funzionalita` renale; Precedenti trattamenti con teriflunomide o leflunomide (ARAVA); Patologie cardiovascolari, epatiche, neurologiche, endocrine o altre gravi malattie sistemiche di rilevanza clinica tale da rendere l¿applicazione del protocollo o l¿interpretazione dei risultati dello studio difficile o da mettere a repentaglio la vita del soggetto a seguito della sua partecipazione allo studio; Precedenti di abuso di sostanze stupefacenti o di alcool; Condizioni mentali tali da rendere il soggetto incapace di comprendere la natura, lo scopo e le possibili conseguenze dello studio; Improbabile rispetto del protocollo da parte del soggetto, ad esempio atteggiamento scarsamente collaborativo, incapacita` a ripresentarsi ai controlli e nota incapacita` di portare a termine lo studio; Qualora il soggetto sia un ricercatore o un co-sperimentatore, un assistente, farmacista, coordinatore dello studio, appartenga allo staff o sia un membro della famiglia di coloro che sono direttamente coinvolti nella gestione del protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the annual relapse rate, defined as the number of relapses per subject-year.
    La principale variabile relativa all¿efficacia sara` il tasso annuo di riacutizzazioni, definito come numero di riacutizzazioni per soggetto-anno.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial3
    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 concerned12
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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.1.1Number of subjects for this age range: 0
    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.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state88
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 870
    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 Decision2004-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-11-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-01
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