G35
Conditions
Interventions
Group 1: Patients with a diagnosis of multiple sclerosis (MS) or clinical isolated syndrome (CIS) who receive treatment with fingolimod, mitoxantrone, alemtuzumab, dymethylfumarate (BG-12), teriflunom
Sponsors
Bundesministerium für Bildung und Forschung Dienstsitz Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with multiple sclerosis (MS) or clinical isolated syndrome (CIS), with an age of =18 years and a) treated de novo, or b) treated with fingolimod, mitoxantrone, alemtuzumab, dymethylfumarate (BG-12), teriflunomide, or other in future approved MS therapies independent of therapy duration, or d) treated with interferone-beta 1a i.m./s.c., interferone-beta 1b s.c., glatirameracetate, or azathiorprine for = 3 years.
Exclusion criteria
Exclusion criteria: Patients wihtout a diagnosed MS, except clinical isolated syndrome (CIS), or patients with MS younger than 18 years. Patients treated with MSlong-term therapy (>3 years) or treatment with off-label therapies. Patients who are treated with tysabri are enrolled into the Tysabri-Daten Register (DRKS 0007127).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The immune therapy register REGIMS primary aims at assessing and characterizing the incidence, type and consequences of adverse events of current and future immune therapies in the routine clinical setting, except for tysabri. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives of the immune therapy register REGIMS are the analysis of a) factors associated with adverse events and b) with therapy adherence, c) health-related quality of life under therapy, assessed with the SF-36 health questionnaire, and d) the assessement of therapy effectiveness of recently approved agents in the long-term | — |
Countries
Germany
Contacts
Public ContactREGIMS Team
Institut für Epidemiologie und SozialmedizinWestfälische Wilhelms-Universität Münster
Outcome results
None listed