Disease: Multiple Sclerosis
Type of study: Observational trial
Coordinating investigator: Kjell-Morten Myhr
Study directors: Luisa María Villar Guimerans, Hospital Universitario Ramón y Cajal, Madrid, Spain, & Marta Alarcon Riquelme, University of Granada, Granada, Spain
Background: Targeted treatment of immune mediated diseases is a general challenge due to heterogenous disease courses and treatment responses. There is a lack of biomarkers to guide treatment decisions and adjustment of therapies due to clinical, laboratory or imaging defined breakthrough disease activity.
The objective of this study is to evaluate the efficacy and safety of different immunomodulatory therapies for different immune mediated diseases, to define treatment response biomarkers to develop personalised therapies within inflammatory bowel diseases, rheumatological diseases, respiratory diseases, and multiple sclerosis.
Design: This is a multicentre observational study of treatment response of immunomodulatory therapies for different immune mediated diseases The primary endpoint is to define biomarkers for treatment response of immunomodulatory therapies for different immune mediated diseases.
Status: Ten centres in Norway, Germany, Belgium, the Netherlands, Switzerland, Italy, and Spain aim to include at least 280 patients, and by early December 2024, we have included 272 patients. Inclusion target is expected to be met by 2024, and initial biomarkers analyses are in progress.
Participating centres
- Haukeland University Hospital, Bergen
- The University of Bergen
- Hospital Universitario Ramón y Cajal, Madrid, Spain
- Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
- Academic Medical Centre, University of Amsterdam, the Netherlands
- Charité-Universitätsmedizin Berlin, Germany
- Universiteit Hasselt, Belgium
- The University of Basel, Basel, Switzerland
- Hospital Clinic of Barcelona, Barcelona, Spain
- University of Genova, Genova, Italy
- Hospital Reina Sofía, Córdoba, Spain
Funding
- Haukeland University Hospital, Bergen, Norway
- The University of Bergen, Norway
- Horizon 2020 / IMI European Union
- Participating centres