Disease: Multiple Sclerosis
Type of study: Observational trial
Coordinating investigator: Andrea Kyvik Habbestad
Study directors: Kjell-Morten Myhr, Bergen, Norway, 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: In 2025, ten centres in Norway, Germany, Belgium, the Netherlands, Switzerland, Italy, and Spain included 285 patients, and 31 of them were included at Haukeland University Hospital. The last follow-up visit will be in Q1 2027. Multi-omics analyses are currently performed on available samples. The first results are expected in Q2/Q3 2027.
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