to study search History

The German Multiple Sclerosis Registry of the German MS Society

Organizational Data

DRKS-ID:
DRKS00011257
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2016-11-11
Last update in DRKS:
2023-07-05
Registration type:
Retrospective

Acronym/abbreviation of the study

MS-Register

URL of the study

http://www.msregister.de

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 prevalence of patients with MS in Germany, the disease course and the healthcare and social situation of MS patients in Germany. Adult patients with primary residence in Germany are entered into the registry if they (1) suffer from MS (according to the McDonald criteria) or clinically isolated syndrome (CIS) suggestive of MS and (2) gave written informed consent for collecting pseudonymised 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 185 centres have contributed to the data collection so far (2020). Most recently, nearly 13,000 patients were recorded annually by the DMSG-awarded centers, with an average of two consultations per patient 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.

Brief summary in scientific language

The MS-Register has a focus on health care situation of People with MS in Germany. Specific additional research questions concerning e.g. usage of DMD, adverse events, pregnancies are addressed via add-on modules.

Health condition or problem studied

ICD10:
G35 - Multiple sclerosis
ICD10:
G37.8 - Other specified demyelinating diseases of central nervous system
ICD10:
G04.9 - Encephalitis, myelitis and encephalomyelitis, unspecified
ICD10:
G04.8 - Other encephalitis, myelitis and encephalomyelitis
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
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 - pharmacovigilance

Endpoints

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 - adverse events - pregnancies
Secondary outcome:
in add-on modules data on DMD-usage is collected

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Eine Übersicht aller aktuellen Rekrutierungsstandorte finden Sie unter 'https://www.dmsg.de/service/kliniken-und-praxen' Deutschland

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2003-06-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
50000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- MS as defined by McDonald Criteria or clinical isolated syndrom, - written informed consent, - primary residence in Germany

Exclusion Criteria

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

Addresses

Primary Sponsor

MS Forschungs- und Projektentwicklungs-gGmbH
Krausenstr. 50
30171 Hannover
Germany
Telephone:
+49 511 444 599 55
Fax:
+49 511 49535642
Contact per E-Mail
URL:
http://www.msregister.de
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

MS Forschungs- und Projektentwicklungs-gGmbH
Alexander Stahmann
Krausenstr. 50
30171 Hannover
Germany
Telephone:
+49 511 444 599 54
Fax:
+49 511 495 356 42
Contact per E-Mail
URL:
http://www.msregister.de

Contact for Public Queries

MS Forschungs- und Projektentwicklungs-gGmbH
MS-Register Team
Krausenstr. 50
30171 Hannover
Germany
Telephone:
+49 511 444 599 55
Fax:
+49 511 495 356 42
Contact per E-Mail
URL:
http://www.msregister.de

Principal Investigator

MS Forschungs- und Projektentwicklungs-gGmbH
Alexander Stahmann
Krausenstr. 50
30171 Hannover
Germany
Telephone:
+49 511 444 599 54
Fax:
+49 511 495 356 42
Contact per E-Mail
URL:
http://www.msregister.de

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Novartis Pharma GmbH
Roonstraße 25
90429 Nürnberg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Merck Serono GmbH
Alsfelder Straße 17
64289 Darmstadt
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Biogen GmbH
Riedenburger Straße 7
81677 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Bristol-Myers Squibb GmbH & Co. KGaA
Arnulfstr. 29
80636 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Innovationsfonds Gemeinsamer Bundesausschuss
Gutenbergstraße 13
10587 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Private sponsorship (foundations, study societies, etc.)

Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V.
Krausenstr. 50
30171 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dmsg.de

Private sponsorship (foundations, study societies, etc.)

DMS Stiftung
Krausenstr. 50
30171 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Institutional budget, no external funding (budget of sponsor/PI)

MS Forschungs- und Projektentwicklungs-gGmbH
Krausenstr. 50
30171 Hannover
Germany
Telephone:
+49 511 444 599 55
Fax:
+49 495 356 42
Contact per E-Mail
URL:
http://www.msregister.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie
Versbacher Str. 9
97078 Würzburg
Germany
Telephone:
+49-931-3148315
Fax:
+49-931-3187520
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2012-06-19
Ethics committee number:
142/12
Vote of the Ethics Committee:
Approved
Date of the vote:
2012-07-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
On the website (https://www.msregister.de/en/research/nutzung-von-registerdaten-use-and-access/), a form for requesting the use of registry data is available. A group of authors develops a project idea and submits an application with concrete questions to the MS registry. After a positive statement by the scientific support group and a positive decision by the management of the MS Registry, a publication agreement is signed by the first author, the responsible biometrician/ statistician and the MSFP. The first author and the MSFP receive a copy. The results of the analysis are made available digitally to the first author. A publication should be completed and submitted within 6 months of the results being made available. Deviations from this procedure must be clarified in advance with the scientific support group and the MSFP.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
Flachenecker, Peter, und Kristin Stuke. „National MS registries“. Journal of neurology 255, Nr. 6 (2008): 102–108.
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.
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
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 P, Stuke K, Elias W, Freidel M, Haas J, Pitschnau-Michel D, Schimrigk S, Zettl UK, Rieckmann P. Multiple sclerosis registry in Germany: results of the extension phase 2005/2006. Dtsch Arztebl Int. 2008 Feb;105(7):113-9. doi: 10.3238/arztebl.2008.0113. Epub 2008 Feb 15. PMID: 19633761; PMCID: PMC2696719.
Flachenecker P, Buckow K, Pugliatti M, Kes VB, Battaglia MA, Boyko A, Confavreux C, Ellenberger D, Eskic D, Ford D, Friede T, Fuge J, Glaser A, Hillert J, Holloway E, Ioannidou E, Kappos L, Kasilingam E, Koch-Henriksen N, Kuhle J, Lepore V, Middleton R, Myhr KM, Orologas A, Otero S, Pitschnau-Michel D, Rienhoff O, Sastre-Garriga J, Schyns-Liharska T, Sutovic D, Thalheim C, Trojano M, Vlasov YV, Yaldizli O; EUReMS Consortium. Multiple sclerosis registries in Europe - results of a systematic survey. Mult Scler. 2014 Oct;20(11):1523-32. doi: 10.1177/1352458514528760. Epub 2014 Apr 28. PMID: 24777278.
Flachenecker P, Khil L, Bergmann S, Kowalewski M, Pascu I, Pérez-Miralles F, Sastre-Garriga J, Zwingers T. Development and pilot phase of a European MS register. J Neurol. 2010 Oct;257(10):1620-7. doi: 10.1007/s00415-010-5578-4. Epub 2010 May 5. PMID: 20443020.
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 PS, Buckow K, Ellenberger D, Friede T, Pitschnau-Michel D, Fuge J, Stüve O, Zettl UK; German Multiple Sclerosis Registry of the German National MS Society. Patients characteristics influencing the longitudinal utilization of steroids in multiple sclerosis--an observational study. Eur J Clin Invest. 2015 Jun;45(6):587-93. doi: 10.1111/eci.12450. Epub 2015 May 9. PMID: 25868705.
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 K, Flachenecker P, Zettl UK, Elias WG, Freidel M, Haas J, Pitschnau-Michel D, Schimrigk S, Rieckmann P. Symptomatology of MS: results from the German MS Registry. J Neurol. 2009 Nov;256(11):1932-5. doi: 10.1007/s00415-009-5257-5. Epub 2009 Jul 23. PMID: 19629565.
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.
ACTRIMS-ECTRIMS MSBoston 2014: Poster Sessions 2. Mult Scler. 2014 Sep;20(1 Suppl):285-496. doi: 10.1177/1352458514547846. PMID: 25205049; PMCID: PMC4244175.
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 PS, Eichstädt K, Ellenberger D, Flachenecker P, Friede T, Haas J, Kleinschnitz C, Pöhlau D, Rienhoff O, Stahmann A, Zettl UK. Symptomatology and symptomatic treatment in multiple sclerosis: Results from a nationwide MS registry. Mult Scler. 2019 Oct;25(12):1641-1652. doi: 10.1177/1352458518799580. Epub 2018 Sep 19. PMID: 30230952.
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. Epub 2018 Jul 24. PMID: 30096682.
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
1. Glaser A, Stahmann A, Meissner T, Flachenecker P, Horáková D, Zaratin P, u. a. Multiple sclerosis registries in Europe – An updated mapping survey. Multiple Sclerosis and Related Disorders. Januar 2019;27:171–8.
Ellenberger D. et al. Is benign MS 'benign'? ECTRIMS 2019 - ECTRIMS Online Library; Sep 12 2019
Haas J. et al. Employment outcomes in paediatric onset MS - ECTRIMS 2019; ECTRIMS Online Library; Sep 11 2019
Zettl et al. "Unterschiede in der Dauer bis zur MS-Diagnosestellung in Deutschland". DGN 2019
Ellenberger et al. "Unterschiede in der Zeit bis zur ersten krankheitsmodifizierenden Therapie bei MS-Erkrankten mit schubförmigem Verlauf in Deutschland". DGN 2019
Rommer PS, Ellenberger D, Hellwig K, Haas J, Pöhlau D, Stahmann A, Zettl UK, "Relapsing and progressive MS: the sex-specific perspective" on behalf of the Scientific Advisory Group of the German MS-Register by the German MS Society, 2020: Therapeutic Advances in Neurological Disorders published online: September 2020
Ohle LM, Ellenberger D, Flachenecker P, Friede T, Haas J, Hellwig K, Parciak T, Warnke C, Paul F, Zettl UK, Stahmann A. Chances and challenges of a long-term data repository in multiple sclerosis: 20th birthday of the German MS registry. Sci Rep. 2021 Jun 25;11(1):13340. doi: 10.1038/s41598-021-92722-x. PMID: 34172792; PMCID: PMC8233364.
Blaschke SJ, Ellenberger D, Flachenecker P, Hellwig K, Paul F, Pöhlau D, Kleinschnitz C, Rommer PS, Rueger MA, Zettl UK, Stahmann A, Warnke C. Time to diagnosis in multiple sclerosis: Epidemiological data from the German Multiple Sclerosis Registry. Mult Scler. 2022 May;28(6):865-871. doi: 10.1177/13524585211039753. Epub 2021 Aug 27. PMID: 34449299.
Simpson-Yap S, De Brouwer E, Kalincik T, Rijke N, Hillert JA, Walton C, Edan G, Moreau Y, Spelman T, Geys L, Parciak T, Gautrais C, Lazovski N, Pirmani A, Ardeshirdavanai A, Forsberg L, Glaser A, McBurney R, Schmidt H, Bergmann AB, Braune S, Stahmann A, Middleton R, Salter A, Fox RJ, van der Walt A, Butzkueven H, Alroughani R, Ozakbas S, Rojas JI, van der Mei I, Nag N, Ivanov R, Sciascia do Olival G, Dias AE, Magyari M, Brum D, Mendes MF, Alonso RN, Nicholas RS, Bauer J, Chertcoff AS, Zabalza A, Arrambide G, Fidao A, Comi G, Peeters L. Associations of Disease-Modifying Therapies With COVID-19 Severity in Multiple Sclerosis. Neurology. 2021 Nov 9;97(19):e1870-e1885. doi: 10.1212/WNL.0000000000012753. Epub 2021 Oct 5. PMID: 34610987; PMCID: PMC8601210.
Ellenberger D, Parciak T, Brola W, Hillert J, Middleton R, Stahmann A, Thalheim C, Flachenecker P, 2022: "Comparison of employment among people with Multiple Sclerosis across Europe",MSJ-ETC Article, April 2022. doi: 10.1177/20552173221090653
Simpson-Yap S, Pirmani A, Kalincik T, De Brouwer E, Geys L, Parciak T, Helme A, Rijke N, Hillert JA, Moreau Y, Edan G, Sharmin S, Spelman T, McBurney R, Schmidt H, Bergmann AB, Braune S, Stahmann A, Middleton RM, Salter A, Bebo B, Van der Walt A, Butzkueven H, Ozakbas S, Boz C, Karabudak R, Alroughani R, Rojas JI, van der Mei IA, Sciascia do Olival G, Magyari M, Alonso RN, Nicholas RS, Chertcoff AS, de Torres AZ, Arrambide G, Nag N, Descamps A, Costers L, Dobson R, Miller A, Rodrigues P, Prčkovska V, Comi G, Peeters LM. Updated Results of the COVID-19 in MS Global Data Sharing Initiative: Anti-CD20 and Other Risk Factors Associated With COVID-19 Severity. Neurol Neuroimmunol Neuroinflamm. 2022 Aug 29;9(6):e200021. doi: 10.1212/NXI.0000000000200021. PMID: 36038263; PMCID: PMC9423711.
Date of first publication of study results:
2009-09-08
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry