PROGNO-MG: Multicenter study to explore a biomarker (profile) for the future prediction of highly active disease progression in immunotherapy-naïve myasthenia patients
Study Description
The disease activity of Myasthenia gravis (MG) can vary from mild/moderate to highly
active. According to the current guideline, therapeutic decisions for the treatment of myasthenic syndromes have so far depended on clinical disease activity. It has been
shown that early disease control within 12 months of diagnosis is crucial to prevent the disease from progressing to a myasthenic crisis. To date, however, there are no biomarkers that can predict subsequent disease activity. Such biomarkers could help to
provide patients with better care and prevent a severe course of MG.
The aim of this non-interventional, prospective observational study is therefore to determine potential biomarkers for detecting disease activity. Untreated MG patients will be observed for up to 24 months from the time of diagnosis. During this observation period, some MG patients will maintain a mild/moderate disease course, while others will develop a highly active disease course. In both patient groups, demographic data and clinical characteristics will be collected and biomaterial will be sampled. The data and samples will then be analyzed with the aim of detecting biomarkers that are associated with a later mild/moderate or highly active course at the time of diagnosis.
Overall, this study should contribute to the early identification of patients with a highly active course and thus enable more effective therapeutic decisions to be made.
Contact: Frauke Stascheit (frauke.stascheit@charite.de)
Principle Investigator: Dr. med. Frauke Stascheit - Klinik für Neurologie an der Charité Universitätsmedizin Berlin
Registration: Deutsches Register Klinischer Studien: DRKS-IDDRKS00035457
Project Partners:
iMZ Universitätsklinikum Düsseldorf
Neurologische Klinik
Heinrich-Heine-Universität
Moorenstraße 5
40225 Düsseldorf
iMZ Universitätsklinikum Münster
Klinik für Neurologie
Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
iMZ Helios Hanseklinikum Stralsund
Neurologische Klinik
Große Parower Straße 47-53
18435 Stralsund
iMZ Friedrich-Baur-Institut
LMU München
Ziemssenstr. 1a
80336 München
iMZ Köln
Universitätsklinikum Köln
Klinik für Neurologie
Kerpener Str. 62
50937 Köln
Klinik für Neurologie
Medizinische Hochschule Hannover
Carl-Neuberg-Str.1
30625 Hannover
Klinik für Neurologie
Universitätsklinikum Göttingen
Georg-August-Universität
Robert-Koch-Straße 40
37075 Göttingen
Universitätsklinikum Schleswig-Holstein
Campus Lübeck
Klinik für Neurologie
Ratzeburger Allee 160
23538 Lübeck
Universitätsklinikum Hamburg-Eppendorf
Klinik für Neurologie
Martinistraße 52
20251 Hamburg
Universitätsklinikum Freiburg
Klinik für Neurologie
Hugstetter Str. 55
79106 Freiburg im Breisgau
Funding: Alexion Pharmaceuticals
Publications:
- Stascheit F, Hotter B, Hoffmann S, Kohler S, Lehnerer S, Sputtek A, et al. Calprotectin as potential novel biomarker in myasthenia gravis. J Transl Autoimmun. 2021;4:100111.
- Stascheit F. Serum neurofilament light chain in myasthenia gravis subgroups: An exploratory cohort and case–Control study. Front Neurol. 2023;Volume 13 - 2022
- Stascheit F, Chuquisana O, Keller CW, Ambrose PA, Hoffmann S, Gross CC, et al. Complement Activation Profiles in Anti-AChR Positive Myasthenia Gravis. European Journal of Neurology. 2023;n/a(n/a)