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    Summary
    EudraCT Number:2012-005262-35
    Sponsor's Protocol Code Number:16401
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-26
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-005262-35
    A.3Full title of the trial
    BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®
    A.3.2Name or abbreviated title of the trial where available
    BENEFIT 11
    A.4.1Sponsor's protocol code number16401
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref 'EU CTR'/Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.com
    D. IMP Identification
    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
    Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS)
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10071068
    E.1.2Term Clinically isolated syndrome
    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 objectives are to describe the disease course (conversion to clinically-definite multiple sclerosis [CDMS]), change in disability, cognitive function, resource use, and employment status, in relation to treatment with Interferon beta-1b.

    Patients that cannot participate in a physical/face-to-face visit will have the option of being assessed via telephone on selected key outcomes, in an attempt to keep the patient ascertainment as high as possible.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess magnetic resonance imaging (MRI) and optical coherence tomography (OCT) parameters, treatment history, quality of life (QoL) parameters, fatigue and depression, the choice of MS-specific medication, and to investigate tolerability of Interferon beta-1b in the full former clinically-isolated syndrome (CIS) cohort as well as in subgroups of patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients with CIS or MS who have been treated at least once in BENEFIT Study 304747.

    2. Patients who do not qualify for one or more interventional assessments (eg, MRI due to severe claustrophobia) are invited to participate in the other assessments of this study.

    3. Written informed consent
    E.4Principal exclusion criteria
    1. Patients who meet any of the following criteria at the time of screening will be excluded from the study:
    ● Patients who, according to the investigator’s judgment, have medical, psychiatric, or other conditions that compromise the patient’s ability to understand the purpose of the study.

    2. Patients who meet any of the following criteria at the time of screening will be excluded from interventional MRI assessment. However, they should be encouraged to still participate in the study:
    ● Pregnant or nursing (including pumping for storage and feeding).
    ● Contraindications to MRI examination (eg, inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, or patients with implanted defibrillators or other metallic devices not approved for MRI).

    3. Patients who meet any of the following criteria at the time of screening will be excluded from contrast media administration. However, they may undergo MRI assessment:
    ● Contraindication to the use of gadolinium-containing contrast agents (including patients who are suspected for or known to have nephrogenic systemic fibrosis).
    ● History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen, including drugs and contrast agents.
    ● Received any contrast agent within 72 hours prior to the study MRI, or scheduled to receive any contrast agent within 72 hours after the study MRI.
    ● Renal insufficiency, defined by baseline glomerular filtration rate. Estimated value ≥ 30 mL/min/1.73 m2 derived from a serum creatinine result within 2 weeks prior to gadolinium-containing contrast agent injection is needed. Any patient on hemodialysis or peritoneal dialysis is excluded from contrast media administration. If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRI should be used. The core lab value should not be used if not available prior to the MRI.
    ● Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period.
    ● Known history of severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association Class IV) or known prolonged QT syndrome.
    ● Suspected clinical instability or unpredictability of the clinical course during the study (eg, due to previous surgery or acute stroke).
    E.5 End points
    E.5.1Primary end point(s)
    Regular face-to-face site visit:
    ● Relapses
    ● Conversion to CDMS, to MS by McDonald criteria (2001, 2010), and / or to secondary progressive multiple sclerosis (disease course)
    ● Expanded Disability Status Scale (EDSS) including DSS 3 and 6 information, Multiple Sclerosis Functional Composite (MSFC) (disability and disability progression) and Multiple Sclerosis Severity Score (MSSS)
    ● Paced Auditory Serial Addition Test (PASAT) and Symbol Digit Modalities Test (SDMT) (cognitive function)
    ● Resource use and employment status

    Telephone assessment for patients unable to visit site with selected outcomes:
    ● Relapses
    ● Telephone EDSS
    ● Conversion to CDMS (disease course)
    ● Resource use and vocational status
    ● Choice of and adherence to MS-specific medication
    ● Center of Epidemiological Studies Depression Scale (CES-D) (depression)
    ● Fatigue Scale for Sensory and Motor Functions (FSMC) (fatigue)
    ● Functional Assessment of Multiple Sclerosis (FAMS) and European Quality of Life - 5 Dimensions (EQ-5D) (QoL)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Relapses, disease course, EDSS milestones and medication history - retrospective assessment since subject's last visit in any of the previous BENEFIT studies up to 11 years.

    Resource use - retrospective baseline assessment and 11 year visit.

    Cognitive function, depression, fatigue, QoL - cross-sectional assessment (only or in addition to a retrospective assessment) at approximately 11 years after randomization.

    Please refer to Figure 4.2 in the Protocol for full details of assessments for the different endpoints in this study.
    E.5.2Secondary end point(s)
    Regular face-to-face site visit:
    ● Diagnosis and disease course
    ● MRI parameters
    ● OCT parameters
    ● Visual acuity and ophthalmological findings
    ● CES-D (depression)
    ● FSMC (fatigue)
    ● Choice of and adherence to MS-specific medication
    ● FAMS and EQ-5D (QoL)
    ● Deoxyribonucleic acid [DNA], ribonucleic acid [RNA], biomarkers
    ● Vitamin D
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease course and medication history - retrospective assessment since subject's last visit in any of the previous BENEFIT studies up to 11 years.

    MRI, OCT, depression, fatigue, QoL, genetics, evaluation of biomarkers and vitamin D - cross-sectional assessment (only or in addition to a retrospective assessment) at approximately 11 years after randomization.

    Please refer to Figure 4.2 in the Protocol for full details of assessments for the different endpoints in this study.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hungary
    Israel
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Slovenia
    Spain
    Sweden
    Switzerland
    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
    For each participating EU country, the end of the study according to the EU Clinical Trial Directive will be reached when the last visit of the last patient for all centers in the respective country has occurred.

    As for this study, MRI and OCT data will be generated and collected after last-patient last visit (LPLV); the end of the study as a whole will be the date when the clean data base is available.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days15
    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: 468
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-03-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 425
    F.4.2.2In the whole clinical trial 468
    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)
    Not applicable.
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-18
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