Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00011257

Trial Description

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Title

The German Multiple Sclerosis Registry of the German MS Society

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Trial Acronym

MS-Register

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URL of the Trial

http://www.msregister.de

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Brief Summary in Lay Language

In Germany, a national MS registry was initiated in 2001 under the auspices of the German MS Society (DMSG Bundesverband e.V.) in order to collect epidemiological data on the number of patients with MS, course of the disease, and information on the healthcare and social situation of MS patients in Germany.
Patients are entered into the registry if they (1) suffer from MS (according to the McDonald criteria) or clinically isolated syndromes suggestive of MS and
(2) gave written informed consent for collecting pseudonymous data. Datasets are documented on-site in the study centres by participating physicians and pooled and analysed by the MS Forschungs- und Projektentwicklungs-gGmbH (MSFP-gGmbH), a non-profit company associated to the German MS Society.

During a two-year period (2002/2003), a pilot phase has been taking place in five MS centres representing different levels of health care.
Since 2005 the MS-Register collects data from a still expanding range of centres in Germany. More than 180 centres have contributed to the data collection so far (2016). As of May 2019 186 centres are part of the network collecting up to 28.000 data sets per year.
The MS-Register has scientific advisory board that provides guidance and input for the government of data and the development of the register.

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Brief Summary in Scientific Language

The MS-Register has a focus on health system reporting related to the situation of People with MS in Germany. Specific additional research questions concerning e.g. usage of DMD are addressed via add-on modules.

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Organizational Data

  •   DRKS00011257
  •   2016/11/11
  •   [---]*
  •   no
  •   Approved
  •   142/12, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
  •   G37.8 -  Other specified demyelinating diseases of central nervous system
  •   G04.9 -  Encephalitis, myelitis and encephalomyelitis, unspecified
  •   G04.8 -  Other encephalitis, myelitis and encephalomyelitis
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Interventions/Observational Groups

  •   The MS-Register is an oberservational study. Routine examinations are done as specified by the attending physician depending on the individual disease course of the patient.
    Documentation contains the following items:
    - (sozio)demographic characteristics
    - information of the disease course (EDSS-Score, MSFC, relapse, etc.)
    - symptoms and therapy
    - care
    - medication
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

collected Data:
- the socio-economic status of the patients
- distribution of disease forms
- symptoms and their treatments
- the kind of care that is received by the PwMS
- if and the kind of treatment the PwMS receive
- how long it takes to diagnose
- disability-status

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Secondary Outcome

in add-on modules data on DMD-usage is collected

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2003/06/01
  •   50000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- MS as defined by McDonald Criteria or clinical isolated syndrom,
- written informed consent,
- primary residence in Germany

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Exclusion Criteria

- non determinable MS disease course (except CIS)
- missing ability to consent

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Addresses

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    • MS Forschungs- und Projektentwicklungs-gGmbH
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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    • MS Forschungs- und Projektentwicklungs-gGmbH
    • Mr.  Alexander  Stahmann 
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • MS Forschungs- und Projektentwicklungs-gGmbH
    • MS-Register  Team 
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • DMS Stiftung
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • MS Forschungs- und Projektentwicklungs-gGmbH
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V.
    • Krausenstr. 50
    • 30171  Hannover
    • Germany
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    end of 1:1-Block address contact otherSupport
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Stahmann A et al. The German MS Register: update on immunotherapy. Mult Scler. 2016 Sep 1;22(3 suppl):589–90. doi: 10.1177/1352458516663086
  •   Flachenecker, P., U. K. Zettl, U. Götze, K. Stuke, W. Elias, M. Eulitz, J. Haas, M. Pette, D. Pitschnau-Michel, und S. Schimrigk. „MS-Register in Deutschland: abschliessende Ergebnisse der Pilotphase“. NEUROLOGIE UND REHABILITATION 13, Nr. 4 (2007): 193.
  •   Flachenecker, Peter, Kristin Stuke, Wolfgang Elias, Matthias Freidel, Judith Haas, Dorothea Pitschnau-Michel, Sebastian Schimrigk, Uwe K. Zettl, und Peter Rieckmann. „Multiple-Sklerose-Register in Deutschland“. Dtsch Ärztebl 105 (2008): 113–119.
  •   Flachenecker, Peter, Karoline Buckow, Maura Pugliatti, Vanja Bašić Kes, Mario A. Battaglia, Alexey Boyko, Christian Confavreux, u. a. „Multiple Sclerosis Registries in Europe – Results of a Systematic Survey“. Multiple Sclerosis Journal, 28. April 2014, 1523–32. doi:10.1177/1352458514528760.
  •   Flachenecker, Peter, Laura Khil, Sverrir Bergmann, Mariusz Kowalewski, Ion Pascu, Francisco Pérez-Miralles, Jaume Sastre-Garriga, und Thomas Zwingers. „Development and Pilot Phase of a European MS Register“. Journal of Neurology 257, Nr. 10 (1. Oktober 2010): 1620–27. doi:10.1007/s00415-010-5578-4.
  •   Flachenecker, Peter, und Kristin Stuke. „National MS registries“. Journal of neurology 255, Nr. 6 (2008): 102–108.
  •   Khil, Laura, Peter Flachenecker, Uwe K. Zettl, Wolfgang Elias, Matthias Freidel, Judith Haas, Dorothea Pitschnau-Michel, Sebastian Schimrigk, und Peter Rieckmann. „Patientenversorgung bei Multipler Sklerose: Vergleich der Basisdaten verschiedener Versorgungsstrukturen im Deutschen MS-Register“. In Abstractband des 82. Kongresses der Deutschen Gesellschaft für Neurologie mit Fortbildungsakademie. Nürnberg, 2009.
  •   Khil, Laura, Peter Flachenecker, Uwe K. Zettl, Wolfgang Elias, Matthias Freidel, Judith Haas, Dorothea Pitschnau-Michel, Sebastian Schimrigk, und P Riekmann. „Update on the German MS Register: Immunotherapy and Drug Discontinuation“. Multiple Sclerosis 15, Nr. 9 Suppl (1. September 2009): S151–269. doi:10.1177/1352458509106963.
  •   Rommer, Paulus S., Karoline Buckow, David Ellenberger, Tim Friede, Dorothea Pitschnau-Michel, Jan Fuge, Olaf Stüve, Uwe K. Zettl, und the German Multiple Sclerosis (MS) Registry of the German National MS Society (DMSG). „Patients characteristics influencing the longitudinal utilization of steroids in multiple sclerosis – an observational study“. European Journal of Clinical Investigation 45, Nr. 6 (1. Juni 2015): 587–93. doi:10.1111/eci.12450.
  •   Stuke, Kristin, Peter Flachenecker, Uwe K. Zettl, Wolfgang Elias, Matthias Freidel, Judith Haas, Dorothea Pitschnau-Michel, Sebastian Schimrigk, und Peter Rieckmann. „MS-Register in Deutschland 2008: Symptomatik der MS“. In Abstractband des 81. Kongresses der Deutschen Gesellschaft für Neurologie mit Fortbildungsakademie. Hamburg, 2008.
  •   Stuke, Kristin, Peter Flachenecker, Uwe K. Zettl, Wolfgang G. Elias, Matthias Freidel, Judith Haas, Dorothea Pitschnau-Michel, Sebastian Schimrigk, und Peter Rieckmann. „Symptomatology of MS: Results from the German MS Registry“. Journal of Neurology 256, Nr. 11 (1. November 2009): 1932–35. doi:10.1007/s00415-009-5257-5.
  •   Skierlo, S., P. S. Rommer, und U. K. Zettl. „Symptomatic Treatment in Multiple Sclerosis—interim Analysis of a Nationwide Registry“. Acta Neurologica Scandinavica, 1. Juni 2016, n/a-n/a. doi:10.1111/ane.12612.
  •   Stahmann, Alexander, Carola Meyer, Mahsa Lee, und Karoline Buckow. „PRO-Dokumentation von Lebensqualitätsdaten im MS-Register der Deutschen Multiplen Sklerose Gesellschaft (DMSG), Bundesverband e.V.“ Forum der Medizin_Dokumentation und Medizin_Informatik - mdi 17, Nr. 1 (März 2015): 18–19.
  •   Stahmann, Alexander, Karoline Buckow, David Ellenberger, Mahsa Lee, Carola Meyer, und Michaela Mai. „Das MS-Register der DMSG als Plattform für die MS-Forschung“. In 88. Kongress der Deutschen Gesellschaft für Neurologie mit Fortbildungsakademie - Abstracts -, 119–20. Düsseldorf, 2015. doi:URN: nbn:de:101:1-201509012166.
  •   Flachenecker, Peter, Karoline Buckow, und on behalf of the EUReMS Consortium. „Assessment of the patient’s perspective in the European Register for Multiple Sclerosis (EUReMS): study protocol of the PRO study“. Multiple Sclerosis (Houndmills, Basingstoke, England) 20, Nr. 1 Suppl (September 2014): 285–496. doi:10.1177/1352458514547846.
  •   Thiel S, Leypoldt F, Röpke L, Wandinger KP, Kümpfel T, Aktas O, u. a. Neuroimmunologische Register in Deutschland. Aktuelle Neurol. Februar 2018;45(01):7–23.
  •   Rommer et. al. "Symptomatology and symptomatic treatment in multiple sclerosis: Results from a nationwide MS registry". Multiple Sclerosis Journal. 2018. doi: 10.1177/1352458518799580
  •   Ellenberger D, Eichstädt K, Flachenecker P, Friede T, Haas J, Kleinschnitz C, Pöhlau D, Rienhoff O, Stahmann A, Zettl UK, Rommer PS. Decreasing longitudinal use of glucocorticosteroids in multiple sclerosis. Mult Scler Relat Disord. 2018 Oct;25:173-174. doi: 10.1016/j.msard.2018.07.040.
  •   Zettl, Uwe K., Kerstin Eichstädt, David Ellenberger, Peter Flachenecker, Tim Friede, Judith Haas, Christoph Kleinschnitz, u. a. „MS in Deutschland: Symptome und Behandlungsdefzite - Aktuelle Daten aus dem MS-Register der DMSG für die MS-Forschung“. Neurotransmitter 29, Nr. 6 (8. Juni 2018): 36–39. doi:10.1007/s15016-018-6423-8.
  •   A. Stahmann , F. Fneish , K. Eichstädt , P. Flachenecker , T. Friede , J. Haas , C. Kleinschnitz , D. Pöhlau , O. Rienhoff , P.S. Rommer , U.K. Zettl. "Disease modifying treatments (DMTs) in Germany - changes in treatment patterns". ECTRIMS Online Library. Oct. 10, 2018
  •   Ellenberger D. "Decline in PPMS Diagnosis? – The German View". ECTRIMS Online Library. Oct. 26, 2017
  •   Haas J. "Age at diagnosis over the last decades – Analysis of the German MS Registry". ECTRIMS Online Library. Oct. 27, 2017
  •   Stahmann, Alexander, Kerstin Eichstädt, David Ellenberger, Tina Meißner, Carola Meyer, Uwe K. Zettl, und Paulus S. Rommer. „MS in Deutschland: Symptome und Behandlungsdefizite aktuelle Daten aus dem MS-Register der DMSG“. In 90. Kongress der Deutschen Gesellschaft für Neurologie - Abstracts -. Leipzig, 2017
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* This entry means the parameter is not applicable or has not been set.