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    Summary
    EudraCT Number:2015-003618-26
    Sponsor's Protocol Code Number:215ON203
    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:2015-11-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003618-26
    A.3Full title of the trial
    A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
    Estudio multicéntrico de seguimiento para evaluar los resultados clínicos y electrofisiológicos a largo plazo de pacientes inscritos previamente en el estudio 215ON201
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Follow-Up Study to Look at Long-Term Responses in Subjects who previously took part in Study 215ON201
    Estudio de seguimiento para evaluar los resultados a largo plazo de pacientes inscritos previamente en el estudio 215ON201
    A.3.2Name or abbreviated title of the trial where available
    RENEWed
    A.4.1Sponsor's protocol code number215ON203
    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 SponsorBiogen Idec Research Limited
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec Research Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Research Limited
    B.5.2Functional name of contact point215ON203 Clinical Trial Team
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number34600162637
    B.5.5Fax number4401628501010
    B.5.6E-mailclinicaltrials@biogen.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 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 nameBIIB033
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    D.3.9.2Current sponsor codeBIIB033
    D.3.9.3Other descriptive nameHuman anti-LINGO-1 monoclonal antibody
    D.3.9.4EV Substance CodeSUB118957
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    Acute Optic Neuritis
    Neuritis óptica aguda
    E.1.1.1Medical condition in easily understood language
    Acute Optic Neuritis
    Neuritis óptica aguda
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10030942
    E.1.2Term Optic neuritis
    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
    The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study 215ON201 2 years (+ 4 months) after the last study visit.
    El objetivo principal de este estudio es evaluar la latencia del potencial evocado visual de campo completo (full field visual evoked potential, FF-VEP) en pacientes inscritos en el estudio 215ON201 2 años (+ 4 meses) después de la última visita del estudio.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess clinical progression and severity of CNS demyelinating disease in subjects who were enrolled in Study 215ON201 2 years (+ 4 months) after the last study visit.
    El objetivo secundario consiste en evaluar la progresión clínica y la gravedad de la enfermedad desmielinizante en el sistema nervioso central (SNC) en los pacientes inscritos en el estudio 215ON201 2 años (+ 4 meses) después de la última visita del estudio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Multifocal Visual Evoked Potential (mfVEP) assessment for patients that participated in the mfVEP Sub-Study in Study 215ON201
    Evaluación del potencial evocado visual en pacientes inscritos en el estudio 215ON201
    E.3Principal inclusion criteria
    1. Must have participated in Study 215ON201 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study 215ON201).
    2. Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
    1. Deben haber participado en el estudio 215ON201 y haber recibido al menos 1 dosis de BIIB033 o placebo, según el protocolo, en los 2 años (+ 4 meses) anteriores al día 1 de este estudio (2 años desde la semana 32 o desde la visita prevista de la semana 32 si el paciente no completó todas las visitas del estudio 215ON201).
    2. Capacidad del paciente de comprender el objetivo y los riesgos del estudio, y de otorgar el consentimiento informado firmado y fechado, así como la autorización para usar información sanitaria confidencial de acuerdo con las normativas nacionales y locales sobre la privacidad de los pacientes.
    E.4Principal exclusion criteria
    1. Not previously enrolled in Study 215ON201.
    2. Inability to comply with study requirements.
    3. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrolment.
    4. Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of gadolinium (Gd) but will otherwise be allowed to participate in the study, including MRI assessments not requiring the use of Gd.
    5. Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.
    1. No haber estado inscrito en el estudio 215ON201.
    2. Incapacidad para cumplir con los requisitos del estudio.
    3. Otra razón no especificada que, en opinión del investigador o de Biogen, haga que el sujeto no sea apto para la inscripción.
    4. No se permitirá que los pacientes con una función renal reciente, como valores de creatinina sérica por encima del límite superior de la normalidad, reciban la administración de Gd, pero se permitirá que estos pacientes participen en el estudio y que realicen evaluaciones de RM que no precisan el uso de Gd.
    5. Las mujeres deben disponer de una prueba de embarazo reciente y no deben estar en periodo de lactancia antes de las exploraciones de RM con Gd.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in FF-VEP latency of the affected eye as compared to the baseline of the fellow eye at 2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.
    El análisis principal será el cambio de la latencia del FF-VEP del ojo afectado, en comparación con el valor inicial del otro ojo, 2 años (+ 4 meses) después de la evaluación de la última visita del estudio (semana 32) en el estudio 215ON201.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.
    2 años (+ 4 meses) después de la evaluación de la última visita del estudio (semana 32) en el estudio 215ON201
    E.5.2Secondary end point(s)
    - Evaluate incidence of CDMS and time to diagnosis of CDMS.
    - Evaluate severity of CNS demyelinating disease with Expanded Disability Status Scale (EDSS) and multiple sclerosis functional composite (MSFC).
    - Evaluate change in disease activity from baseline with brain MRI with and without gadolinium (Gd). MRI analysis will include the number of Gd-enhanced lesions and the volume of T2 lesions.
    -Evaluar la incidencia de esclerosis múltiple clínicamente definida (EMCD) y el tiempo transcurrido hasta el diagnóstico de la EMCD.
    -Evaluar la gravedad de la enfermedad desmielinizante del SNC con la escala ampliada del estado de discapacidad (Expanded Disability Status Scale, EDSS) y la escala funcional compuesta de esclerosis múltiple (multiple sclerosis functional composite, MSFC)
    -Evaluar el cambio en la actividad de la enfermedad desde el inicio mediante resonancia magnética (RM) cerebral con y sin gadolinio (Gd). El análisis de RM incluirá:
    ? Número de lesiones potenciadas con Gd
    ? Volumen de lesiones en T2
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.
    2 años (+ 4 meses) después de la evaluación de la última visita del estudio (semana 32) en el estudio 215ON201
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Follow-up study. No IMP is being administered.
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Canada
    Czech Republic
    Denmark
    Germany
    Hungary
    Italy
    Spain
    Sweden
    United Kingdom
    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 subject, last visit for final collection of data.
    Último paciente, última visita para la recopilación final 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 months0
    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 months0
    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 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: 80
    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 Yes
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 80
    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 IMP is being administered in this study. Subjects will continue on their normal care during and after the study.
    No se adminitrará medicación en este estudio. Los pacientes continuaran con sus cuidados normales durante y despúes del estudio.
    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 Decision2016-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-23
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