Clinical Trial Page

Summary
EudraCT Number:2006-000606-23
Sponsor's Protocol Code Number:26756
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2012-03-15
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2006-000606-23
A.3Full title of the trial
Post-authorization safety study to check the potential association between the safety
profile of beta interferon 1a and the body mass index or pharmacodynamics during the
titration phase
Estudio post-autorización de seguridad para determinar la posible asociación entre el perfil de seguridad de interferón beta-1a y el índice de masa corporal o los marcadores farmacodinámicos durante la fase de escalado de dosis.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
?Post-authorization safety study to check the potential association between the safety
profile of beta interferon 1a and the body mass index or pharmacodynamics during the
titration phase
Estudio post-autorización de seguridad para determinar la posible asociación entre el perfil de seguridad de interferón beta-1a y el índice de masa corporal o los marcadores farmacodinámicos durante la fase de escalado de dosis.
A.3.2Name or abbreviated title of the trial where available
PASS-PD del escalado de dosis de Rebif
PASS-PD del escalado de dosis de Rebif
A.4.1Sponsor's protocol code number26756
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, S.L.
B.1.3.4CountrySpain
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, S.L.
B.4.2CountrySpain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationMerck, S.L.
B.5.2Functional name of contact pointNuria
B.5.3 Address:
B.5.3.1Street AddressMaría de Molina 40
B.5.3.2Town/ citymadrid
B.5.3.3Post code28006
B.5.3.4CountrySpain
B.5.4Telephone number917 454 462
B.5.5Fax number917 454 447
B.5.6E-mailnuria.monsalve@merck.es
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 22 y 44 mcg
D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe
D.2.1.2Country which granted the Marketing AuthorisationSpain
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 nameInterferon-beta-1a
D.3.4Pharmaceutical form Solution for injection
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.3.9.1CAS 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 microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number22
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) Yes
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 typeInterferon beta 1a
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
Not applicalbe
Esclerosis múltiple remitente recurrente
E.1.1.1Medical condition in easily understood language
Not applicable
Esclerosis múltiple remitente recurrente
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 10028245
E.1.2Term 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
Verificar la posible asociación entre parámetros farmacodinámicos y acontecimientos adversos en el escalado de dosis inicial del tratamiento
E.2.2Secondary objectives of the trial
Objetivos secundarios: Los objetivos secundarios son:
?Determinar la posible influencia de la dosis según el índice de masa corporal.
?Determinar si alguna reacción adversa se asocia con un parámetro farmacodinámico
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1.El paciente tiene EM recidivante
2.Asignación a un protocolo de tratamiento con interferón beta-1a a dosis altas.
3.Edad entre 18 y 60 años
4.El paciente tiene una puntuación en la EDSS <5,5.
5.Uno o más brotes en el año previo.
6.Contracepción eficaz.
E.4Principal exclusion criteria
1.EM primaria progresiva o EM secundaria progresiva sin recidivas superpuestas.
2.Tratamiento previo con interferón beta (beta-1b o beta-1a)
3.Embarazo o lactancia.
4.Tratamiento previo con inmunomoduladores o inmunosupresors.
5.Alteraciones hematológicas o hepáticas importantes (clínicas o analíticas)
6.Enfermedad importante que interfiera con la valoración del estudio o con la realización del mismo.
7.Participación simultánea en otro estudio experimental.
8.Alergia conocida al producto o a sus excipientes.
E.5 End points
E.5.1Primary end point(s)
El parámetro principal es la asociación (positiva o negativa) entre los parámetros farmacodinámicos y la presencia de acontecimientos adversos.
E.5.1.1Timepoint(s) of evaluation of this end point
Days 14, 28 and 56
Días 14, 28 y 56
E.5.2Secondary end point(s)
La posible asociación relevante, positiva o negativa (r > 0.5 ó < -0.5), entre marcadores farmacodinámicos y acontecimientos adversos, se precisará el nivel plasmático de cada uno de los marcadores biológicos (beta2-microglobulina, neopterina, 2?5? OAS), así como cada uno de las reacciones adversas más frecuentes clínicas (síndrome gripal, dolor de cabeza) y analíticas (aumento de las transaminasas, disminución de los leucocitos y plaquetas).
E.5.2.1Timepoint(s) of evaluation of this end point
Dias 14, 28 y 56
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 No
E.6.4Safety Yes
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 Yes
E.6.13.1Other scope of the trial description
Inmunogenicidad
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 Information not present in EudraCT
E.8.1.2Open Information not present in EudraCT
E.8.1.3Single blind Information not present in EudraCT
E.8.1.4Double blind Information not present in EudraCT
E.8.1.5Parallel group Information not present in EudraCT
E.8.1.6Cross over Information not present in EudraCT
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Information not present in EudraCT
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
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 Information not present in EudraCT
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
Not applicable
Cierre de la base de datos
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 months3
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months3
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 84
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)
No aplica
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 Decision2006-11-23
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-07-14
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2010-11-15

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