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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2015-005749-30
    Sponsor's Protocol Code Number:2015-00887
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-04-28
    Trial 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 number2015-005749-30
    A.3Full title of the trial
    A randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study
    EN RANDOMISERAD, DUBBELBLIND, PLACEBOKONTROLLERAD MULTICENTERSTUDIE SOM UTVÄRDERAR SÄKERHET OCH EFFEKT AV RITUXIMAB (Mabthera) HOS PATIENTER MED NYDEBUTERAD GENERALISERAD MYASTENIA GRAVIS (MG).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenght
    En klinisk studie som utvärderar effekt och säkerhet av rituximab för personer med nydebuterad myastenia gravis, en autoimmun sjukdom som påverkar muskelstyrkan
    A.3.2Name or abbreviated title of the trial where available
    Rinomax
    Rinomax
    A.4.1Sponsor's protocol code number2015-00887
    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 SponsorKarolinska Institutet
    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 supportSwedish Research Council
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact point Neuroimmunology Unit CMM L8;4
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska University Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+46851779840
    B.5.5Fax number+46851773757
    B.5.6E-mailfredrik.piehl@ki.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
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Concentrate for 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 INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    New onset myasthenia gravis
    Nydebuterad myastenia gravis
    E.1.1.1Medical condition in easily understood language
    New onset myasthenia gravis
    Nydebuterad myastenia gravis
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if rituximab is more effective than placebo to achieve minimal clinical MG symptoms without need of high doses of oral corticosteroids at 16 weeks after treatment
    Att utvärdera om rituximab är mer effektivt än placebo för att uppnå minimala kliniska MG symptom utan behov av högre doser orala kortikosteroider vid 16 veckor efter behandling.
    E.2.2Secondary objectives of the trial
    Is Rituximab more effective than placebo in achieving improvement in standardized QMG at 24 weeks after treatment?

    Is Rituximab more effective than placebo in achieving improvement in the ability to perform activities of daily live at 16 weeks after treatment?

    Is Rituximab more effective than placebo in achieving improvement in experienced quality of life at 16 weeks after treatment?
    Är rituximab mer effektivt än placebo för att uppnå förbättring i standardiserat muskulärt uttröttbarhetstest vid 24 veckor efter behandling?

    Är rituximab mer effektivt än placebo för att uppnå förbättring i förmåga att utföra aktiviteter i dagliga livet vid 16 veckor efter behandling?

    Är rituximab mer effektivt än placebo för att uppnå förbättring i upplevd livskvalitet vid 16 veckor efter behandling?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with oculo bulbar, bulbar or generalized MG ≥ 18 years of age and not more than 12 months ago estimated the onset of symptoms of generalized symptoms or neurophysiological detection of generalized disease.
    2. The diagnosis of MG should be produced by the following tests:
    Clinical neurological status with motor effects consistent with MG, and at least two of the following:
    A positive serological test for anti-acetylcholine receptor antibodies (AChR),
    and / or
    b. For MG typical deviation during neurophysiological testing of the neuromuscular transmission with single fiber electromyography (SFEMG) and / or repetitive nerve stimulation (RNS)
    and/or
    c Positive choline esterase blocker response, e.g. edrophonium and/or oral cholinesterase inhibitors, as judged by the treating physician.
    3. MGFA clinical classification Class II to IV at screening.
    4. Quantitative MG score ≥ 6 at screening
    5. Women of childbearing potential must have a negative pregnancy test.
    6. Patients must have given written informed consent.
    7. Patients must be able and willing to comply with all study procedures.
    1. Patienter med okulobulbär, bulbär eller generaliserad MG ≥ 18 års ålder och högst 12 månader sedan uppskattad symptomdebut av generaliserade symptom eller neurofysiologisk detektion av generaliserad sjukdom.
    2. Diagnosen MG ska ställas genom följande tester:
    Kliniskt neurologiskt status med motorisk påverkan förenlig med MG och minst två av följande:
    A. Positivt serologiskt test för anti-acetylkolinreceptor-antikroppar (AChR),
    och/eller
    B. För MG typisk avvikelse vid neurofysiologisk testning av neuromuskulär transmission med singel fiber elektromyografi (SFEMG) och/eller upprepad nervstimulering (RNS),
    och/eller
    C.Positivt antikolinesterastest, t.ex. edrofoniumkloridtest eller förbättring av MG-symptom med orala kolinesterashämmare enligt den behandlande läkarens bedömning.
    3. MGFA klinisk klassificering klass II till IV vid screening.
    4. Kvantitativt MG score ≥ 6 vid screening
    5. Kvinnor i fertil ålder måste ha ett negativt graviditetstest.
    6. Patienter måste ha lämnat skriftligt informerat samtycke.
    7. Patienterna måste kunna och vara villiga att följa alla studieprocedurer.
    E.4Principal exclusion criteria
    1. Weakness that only affect ocular or periocular muscles (MGFA class I).
    2. MG crisis at screening (MGFA Class V)
    3. Already implemented thymectomy. In order to avoid difficulties to evaluate the effect of the study drug, thymectomy, in cases where it is indicated, should be scheduled to the follow-up period, ie after the first 24 weeks.
    4. Strong suspicion of thymoma, where a thymectomy is indicated within 24 weeks according to the treating physician.
    5. Active tumor disease, if not adequately treated.
    6. Pregnancy and lactation.
    7. Ongoing acute or chronic viral or systemic bacterial infections including HIV, latent hepatitis B, which is clinically significant, according to the study doctor's opinion and not treated with appropriate antibiotics / antiviral drug.
    8. Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
    9. 9. Previously use of immunosuppressive drugs, including rituximab, azathioprine, cyclosporine and MMF. Prednisolone at a dose of ≤40mg / d within 3 months and IVIG and PLEX 12 months of the screening date is not an exclusion criterion. Also note that this does not apply to treatment with immunosuppressive drugs / corticosteroids (except rituximab) in another indication than MG, provided that it is > 12 months since the treatment ended.10. Hypersensitivity to the active substance or to murine proteins or to any of the excipients of the study drug
    11. Participation in another trial to study drug or exposure to any other study drugs, study product or study procedures within 30 days prior to screening.
    12. Any medical condition which, according to the study physician's opinion, may interfere with the patient's participation in the study, pose any additional risk to the patient, or that complicate the assessment of patients
    1. Svaghet som endast påverkar okulära eller periokulära muskler (MGFA klass I).
    2. MG-kris vid screening (MGFA klass V)
    3. Redan genomförd tymektomi. För att undvika svårigheter med att utvärdera effekten av studieläkemedlet ska tymektomi, i de fall det är indicerat, planeras till uppföljningsperioden, dvs först efter de första 24 veckorna.
    4. Stark misstanke om tymom och där tymektomi enligt behandlande läkare bör genomföras inom 24 veckor.
    5. Aktiv tumörsjukdom, om denna inte är adekvat behandlad
    6. Graviditet eller amning.
    7. Någon pågående akut eller kronisk viral eller systemisk bakteriell infektion inklusive HIV, latent hepatit B, som är kliniskt signifikant enligt studieläkarens åsikt och som inte behandlats med lämpliga antibiotika/antiviralt läkemedel.
    8. Svår hjärtsvikt (New York Heart Association klass IV) eller svår okontrollerad hjärtsjukdom .
    9. Tidigare användning av immunosuppressiva läkemedel inkluderande rituximab, azatioprin, ciklosporin och MMF. Användning av Prednisolon i en dos om ≤40mg/d inom 3 månader och IVIG och PLEX 12 månader från screeningdatumet utgör ej ett exklusionskriterium. Observera också att detta ej gäller behandling med immunosuppressiva läkemedel/kortokosteroider (undantaget rituximab) på annan indikation än MG, förutsatt att det gått >12 månader sedan behandlingen avslutats.
    10. Överkänslighet mot den aktiva substansen eller mot murina proteiner eller mot något annat hjälpämne i studieläkemedlet
    11. Deltagande i någon annan prövning av studieläkemedel eller exponering för något annat studieläkemedel, studieprodukt eller studieprocedurer inom 30 dagar före screening.
    12. Något medicinskt tillstånd som, enligt studieläkarens åsikt, kan interferera med patientens deltagande i studien, utgör någon ytterligare risk för patienten, eller som försvårar bedömningen av patienterna
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with a QMG score ≤4 and daily prednisone dose ≤10mg 16 weeks after treatment
    Andel av patienter med QMG poäng ≤ 4 och en daglig Prednisolondos ≤ 10mg vid 16 veckor efter behandling
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 16 weeks after treatment
    Vid 16 veckor efter behandling
    E.5.2Secondary end point(s)
    QMG score at 24 weeks after treatment
    MG-ADL score at 16 weeks after treatment
    MG-QOL scores at 16 weeks after treatment
    QMG poäng vid 24 veckor efter behandling
    MG-ADL poäng vid 16 veckor efter behandling
    MG-QOL poäng vid 16 veckor efter behandling
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 16 and 24 weeks after treatment
    Vid 16 och 24 veckor efter behandling
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    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
    Last visit of the last subject undergoing the trial
    Sista besök av den sista försökspersonen i studien
    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 months5
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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)
    After completion of the study, the patient will be treated according to the clinical judgment of the treating physician
    Patienten kommer efter studiens avslut att behandlas enligt klinisk bedömning av den behandlande läkaren.
    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 Decision2016-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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