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    Summary
    EudraCT Number:2014-001290-14
    Sponsor's Protocol Code Number:EMR200136_583
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-27
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2014-001290-14
    A.3Full title of the trial
    Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™
    Studiu clinic prospectiv faza IV privind eficacitatea tratamentului Rebif pentru pacienții cu CIS și RMS, din România, folosind dispozitivul electronic RebiSmart ™
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™
    Studiu clinic prospectiv faza IV privind eficacitatea tratamentului Rebif pentru pacienții cu CIS și RMS, din România, folosind dispozitivul electronic RebiSmart ™
    A.3.2Name or abbreviated title of the trial where available
    PROCEED
    A.4.1Sponsor's protocol code numberEMR200136_583
    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 SponsorMERCK ROMANIA SRL
    B.1.3.4CountryRomania
    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 supportMerck Romania SRL
    B.4.2CountryRomania
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMERCK ROMANIA SRL
    B.5.2Functional name of contact pointMERCK ROMANIA SRL
    B.5.3 Address:
    B.5.3.1Street Address139th Plevnei Road
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code60011
    B.5.3.4CountryRomania
    B.5.4Telephone number+40213198850
    B.5.5Fax number+40213198848
    B.5.6E-mailadina.dan@merckgroup.com
    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 REBIF
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO EUROPE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Solution for injection in cartridge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON BETA-1A
    D.3.9.1CAS number 220581-49-7
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number44
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Clinical isolated syndrome and relapse multiple sclerosis
    Sindrom Clinic Izolat si Scleroza Multipla Recidivanta
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is a chronic, inflammatory, demyelinating disease of the central nervous system and is one of the most common causes of neurological disability in young adults.
    Scleroza multipla este o boala cronica, inflamatorie, demielinizanta a sistemului nervos central și este una dintre cele mai frecvente cauze de invaliditate neurologica la adulții tineri.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 evaluate effectiveness to treatment in patients with CIS and in patients with relapsing multiple sclerosis (RMS) using RebiSmart™ to self-inject Rebif® in multi dose cartridge.
    Evaluarea eficacității tratamentului cu Rebif la pacienții cu CIS și RMS folosind RebiSmart ™
    E.2.2Secondary objectives of the trial
    To assess adherence of the treatment in patients with CIS and RMS correlated with epidemiological factors like lifestyle habits (smoking, alcohol consumption, eating disorders), demographic & geographical specificities (rural counties/cities) using RebiSmart™ to self-inject Rebif®
    To establish the relationship between adherence and relapse.
    Stabilirea relației dintre aderență și recidivă .
    Evaluarea eficacițăii, aderenței la tratament la pacienții cu CIS și RMS corelată cu factori epidemologici și de risc, cum ar fi stilul de viață (fumatul, consumul de alcool, tulburări de alimentație), factori
    demografici, locația geografica, etnie și genetică , folosind RebiSmart ™ pentru auto-injectare cu Rebif.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females between 18 to 65 years of age
    Female patients must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:
    Post-menopausal or surgically sterile, or
    Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner.
    Patients diagnosed with clinical isolated syndrome (CIS) or relapsing MS (RMS) according to the revised McDonald Criteria (2010).
    MS-treatment naïve patients or patients treated with Rebif® multi-dose injected by RebiSmart™ for no longer than 6 weeks prior to Baseline visit
    Patients that are able to self-inject with RebiSmart™ (in the opinion of the physician)
    Patients with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline
    Informed consent and patient data collection form signed
    Bărbati și femei cu varste cuprinse între 18 și 65 de ani.
    Pacientele nu trebuie să fie însărcinate, să alăpteze și trebuie să prezinte lipsa potențialului de a rămane însărcinate definit prin :
    - Post-menopauza sau steril chirurgical;
    - Utilizarea unei metode de contraceptie foarte eficientă pe durata studiului. Aceasta este definită ca o metodă din care rezultă o rată scăzută de eșec (mai puțin de 1% pe an ), atunci cand este folosită consecvent și corect și include de exemplu: implanturi contraceptive, injectabile, contraceptive orale combinate, dispozitiv intrauterin (IUD), abstinentă sexuală sau partener vasectomiza;
    - Pacienții diagnosticați cu CIS sau RMS în funcție de "Criteriile McDonald revizuite (2010)".
    - Pacienții netratați anterior sau pacienții tratați cu Rebif ® multi-doza injectat.
    de RebiSmart ™ pentru nu mai mult de 6 săptămâni înainte de vizita inițială.
    - Pacienții care sunt capabili să se auto-injecteze cu RebiSmart ™ (după opinia medicului).
    - Pacienții cu scorul la Expanded Disability Status Scale (EDSS) <6 (inclusiv) la vizita inițială.
    - Consimțământul informat și formularul de colectare a datelor pacientului semnat.
    E.4Principal exclusion criteria
    Patients experiencing a relapse within 30 days before Baseline
    Participation in other studies within 30 days before Baseline
    Received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif® multi-dose injected by RebiSmart™.
    Any visual or physical impairment that precludes the patient from self-injecting the treatment using the RebiSmart™
    Pregnancy and breast-feeding
    Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure.
    Current or past (within the last 2 years) history of alcohol or drug abuse.
    Have any contraindications to treatment with interferon beta-1a according to Summary of Product Characteristics
    Pacienți care au suferit o recidivă în termen de 30 de zile înainte de vizita inițială.
    Participarea în alte studii în termen de 30 de zile înainte de vizita inițială.
    A beneficiat de orice terapie pentru SM în termen de 6 luni înainte de înscrierea în studiu (de exemplu, medicamente care pot influenta alte boli: imunomodulatoare, imunosupresoare sau terapii combinate), cu excepția Rebif ® multi-doza de injectat prin RebiSmart™.
    Orice deficiențe vizuale sau fizice care împiedică pacientul de la auto-injectarea tratamentul cu RebiSmart ™.
    Sarcina și alăptarea
    Boli cardiace grave sau acute, cum ar fi aritmii cardiace necontrolate, angină pectorală necontrolată, cardiomiopatie sau insuficiență cardiacă congestivă necontrolată, conform opiniei investigatorului.
    Istorie curentă sau trecută (în ultimii 2 ani) de abuz de alcool sau de droguri.
    Orice contraindicație la tratamentul cu interferon beta-1a în conformitate cu Rezumatul Caracteristicilor Produsului.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients relapse free at 12 months of treatment at RMS subjects or time until the first relapse for CIS subjects.
    Proporția pacienților fara recidiva la subiecți cu RMS sau timpul până la prima recidivă pentru subiecții cu CIS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    END OF STUDY
    La finalul studiului
    E.5.2Secondary end point(s)
    Proportion of expected number of injections completed during 12 months of treatment as recorded by RebiSmart™
    Adherence is calculated as 100 x the number of injections the patient administered divided by the expected number of injections over 12 Months.
    If the patient terminates earlier than 12 months, the expected number of completed injections will be based on the patient's time on study.
    To investigate whether there is a relationship between adherence and relapse.
    Proportion of patients who prematurely terminated treatment and reasons why.
    Proportion of patients remaining free from clinical activity based on data available at 12 months of treatment.
    Proportion of disability progression free patients, defined as non-deterioration of EDSS and MRI findings.
    Reasons for missed injections.
    Mean number of relapses at 12 months of treatment
    Overall evaluation of RebiSmart™ use based on at month 12 of treatment use based on Health Resource Utilization.
    Proportion of patients with Serious Adverse Reactions (SARs) at any time during the 12 months of treatment.
    Morisky Score
    EDSS score
    Epidemiological data collection: smoking, alcohol consumption, BMI index
    Specific demographic and geographical data collection (rural counties/cities, country side)
    Proporția numărului de injecții estimate, complete în 12 luni de tratament, înregistrate de RebiSmart.
    Aderența se calculează ca 100 x numărul de injecții pe care pacientul și le-a administrat împărțit la
    numărul estimat de injecții pe parcursul a 12 luni.
    Dacă pacientul termină mai devreme de 12 luni, numărul estimat de injecții, se bazează pe timpul
    pacientului petrecut în studiu.
    Pentru a investiga dacă există o relație între aderență și recidivă.
    Proporția pacienților care au terminat prematur tratamentul și motivele.
    Proporția de pacienți rămași fară activitatea clinică a bolii pe baza datelor disponibile la 12 luni de
    tratament.
    Proporția pacienților fără progresia dizabilitătilor, definite ca non-deteriorare a EDSS și constatări MRI.
    Motive pentru injecții ratate.
    Numărul mediu de recidive la 12 luni de tratament.
    Evaluare globală a utilizarii RebiSmart™ bazat pe 12 luni de tratament.
    Evaluarea pacientului a utilizării RebiSmart ™ bazată pe utilizarea chestionarul resurselor de sănătate.
    Proporția pacienților cu reacții adverse grave (SAR), în orice moment pe parcursul celor 12 luni de
    tratament.
    Scor Morisky
    Scor EDSS
    Colectarea datelor epidemiologice: fumatul, consumul de alcool, Indicele BMI.
    Colectarea datelor specifice demografice și geografice județe rurale/urbane, zona țării).
    E.5.2.1Timepoint(s) of evaluation of this end point
    END OF STUDY
    La finalul studiului
    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 No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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
    YES
    DA
    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 months10
    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: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state100
    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 accordance with the local legislation the Sponsor will assure the cartridges availability on pharmaceutical market. If the cartridges will be not be available at the pharmaceutical market at end of the trial Merck Serono will offer the cartridges for free to the patient.
    Sponsorul va asigura disponibilitatea cartușelor pe piața farmaceutică. În cazul în care cartușele nu vor fi disponibile pe piata farmaceutica, la sfârșitul studiului, Merck Serono va oferi cartușele gratuit pentru pacienți.
    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 Decision2014-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-06
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