Multicentric prognostic observational study on biomarker profile in immunotherapy-naïve patients with highly active generalized myasthenia gravis (PROGNO-MG): a study protocol
BACKGROUND: Myasthenia gravis has a variable disease course. Early identification of patients with a highly active disease is crucial to prevent myasthenic exacerbations and crisis, necessitating more aggressive immunotherapy. However, no biomarkers currently exist to identify patients at risk for highly active disease course. OBJECTIVE: ) generalized Myasthenia gravis (gMG). METHODS: gMG patients will be enrolled and followed up for 24 months. Blood samples and clinical data will be collected biannually. Biomarkers (calprotectin, neurofilament light chain, ITIH3, complement activation, kappa free light chains, and exploratory proteome-analyses and immune cell phenotyping) will be measured and their association with clinical outcomes will be evaluated. PERSPECTIVE: gMG patients. TRIAL REGISTRATION: The study is registered in the German clinical trial register (DRKS00035457).
Authors
- Felix Kohle (ORCID: https://orcid.org/0000-0002-4429-0367)
- Peter Trillenberg (ORCID: https://orcid.org/0000-0002-3434-0295)
- Christina B. Schroeter (ORCID: https://orcid.org/0000-0002-1391-7817)
- Niklas Huntemann (ORCID: https://orcid.org/0000-0003-0015-8484)
- Frauke Stascheit (ORCID: https://orcid.org/0000-0001-5306-7880)
- Michael Schroeter (ORCID: https://orcid.org/0000-0001-8441-4793)
- Franz Felix Konen (ORCID: https://orcid.org/0000-0002-8609-5674)
- Jörn Peter Sieb
- Tobias Hegelmaier
- Ulrike Grittner (ORCID: https://orcid.org/0000-0003-2595-0224)
- Daniel Schulze
- Andreas Meisel
- Tobias Ruck
- Sophie Lehnerer
- Stefanie Glaubitz
- Christopher Nelke
- Jan D. Lünemann
- Sven Meuth
- Christian Wolfgang Keller
- Julian Großkreutz
- Thomas Skripuletz
- Jana Zschüntzsch
- Charlotte Schubert
- Heinz Wiendl
- Benedikt Schoser
Institutions
- Universität Hamburg (DE)
- University of Cologne (DE)
- University Medical Center Freiburg (DE)
- Medizinische Hochschule Hannover (DE)
- Humboldt-Universität zu Berlin (DE)
- University Hospital Münster (DE)
- University Medical Center Hamburg-Eppendorf (DE)
- University Hospital Schleswig-Holstein (DE)
- Universitätsmedizin Göttingen (DE)
- Friedrich Baur Stiftung (DE)
- Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE)
- BG University Hospital Bergmannsheil Bochum (DE)
- University of Applied Sciences Stralsund (DE)
- University Hospital Cologne (DE)
- Heinrich Heine University Düsseldorf (DE)
- Charité - Universitätsmedizin Berlin (DE)
- Ludwig-Maximilians-Universität München (DE)
- University of Lübeck (DE)
Publication Details
- Journal
- Neurological Research and Practice
- Published
- 2026-05-12
- DOI
- https://doi.org/10.1186/s42466-026-00482-8
- Primary Topic
- Myasthenia Gravis and Thymoma
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Charité – Universitätsmedizin Berlin