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    Summary
    EudraCT Number:2013-002378-26
    Sponsor's Protocol Code Number:STRIX-MSext001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-08-15
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2013-002378-26
    A.3Full title of the trial
    Switch To RItuXimab in MS extension
    An extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Switch To RItuXimab in MS extension
    An extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes
    A.3.2Name or abbreviated title of the trial where available
    STRIX-MSext
    A.4.1Sponsor's protocol code numberSTRIX-MSext001
    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 SponsorVästerbottens Läns Landsting
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNeurocentrum, Västerbottens Läns Landsting
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästerbottens Läns Landsting
    B.5.2Functional name of contact pointNeurocentrum
    B.5.3 Address:
    B.5.3.1Street AddressDept of Neurology
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90185
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703796193
    B.5.5Fax number+4690134408
    B.5.6E-mailanders.svenningsson@neuro.umu.se
    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 Mabthera® Generic: Rituximab
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMabthera
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    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
    The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate.
    This extension study involves the same patients, those that consent to participate in this extension trial.
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS), which is a chronic disorder characterized by a tendency for recurrent inflammation in the central nervous system (brain and spinal cord).
    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 16.0
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the feasability and safety of switching from injectible MS treatments to Mabthera in stable relapsing remitting multiple sclerosis (RRMS).
    To study the effects on inflammatory parameters on magnetic resonance imaging when switching MS therapy to Mabthera in RRMS
    To study the development of neurodegenerative processes after therapy switch to Rituximab using quantitative MRI measurements and analysis of biomarkers for axonal damage in the cerebrospinal fluid (CSF)
    To evaluate long-term effects and safety of treatment with Mabthera in MS
    E.2.2Secondary objectives of the trial
    To make health economic assessments and compare cost – effectiveness between the present first line disease modifying drugs (DMDs) with Rituximab

    To compare patient satisfaction and health related quality of life between the present first line DMD:s and Rituximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this extension study if all of the following criteria apply:

    • Have completed the STRIX-MS trial (Eudra-CT 2010-023021-38).
    • Willing to comply with study procedures
    • In fertile females, willing to comply with effective contraceptive methods. These include birthcontrol pills, surgical sterilization of patient or partner or consistent use of condom by partner. Nonfertile women is defined as more than 5 years since menopaus or, in case of ambiguities, an FSH level above 30 IU/L
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria applies:

    • Pregnant or lactating women
    • Documented vulnerability to infections
    • Simultaneous treatment with other immunosuppressive drugs
    • Documented allergy or intolerance to Rituximab
    • Severe psychiatric condition
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is
    The proportion of patients undergoing the predefined study protocols over three years that fulfils the criteria “free from disease activity” defined as:
    o Free from clinical relapse
    o Free from contrast-enhancing MRI lesions
    o No more than one new or enlarged MRI lesion visible on T2-weighted images during the previous 12 month period
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial will run over a three year period with a possibility to continue the treatment decided on a case by case basis. Final evaluation of the results will be when all study participants have completed the full three year period.
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    • The proportion of patients free from all signs of disease activity including, in addi-tion to the primary endpoint, no new T2 lesions during the whole study period and no increase in EDSS.
    - The period included in this analysis is from month 0 in the original STRIX-MS study, ie when Rituximab was administered in the first time.
    • The degree of brain atrophy development over the course of the whole study peri-od measured as BPF as compared with age-matched healthy controls
    • The levels of Neurofilament-light values in CSF analyses, which will be compared with age-matched healthy controls as well as before Rituximab treatment started.
    • The proportion of patients undergoing the predefined study protocol that because of disease activity will either change therapy or obtain additional Rituximab infu-sions.
    • To document the safety of Rituximab treatment during long-term treatment of RRMS patients with Rituximab using a target based treatment protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be finally evaluated also after three years when last subject has had its last visit
    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 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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Treatment satisfaction
    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 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 Yes
    E.8.1.7.1Other trial design description
    Therapy switch trial, long-term extension
    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 concerned3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 74
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 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 state74
    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)
    Participants will be offered to continue treatment with Mabthera after the end of the trial if they are judged to benefit for further treatment assessed on a case by case basis
    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 Decision2013-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-12
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