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German Tysabri-Data-Register

German Tysabri-Data-Register

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00007127
Enrollment
1830
Registered
2014-12-01
Start date
2014-10-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35

Interventions

Group 1: Every six month the physician fills the medical data into a database. Patients will be asked to additionally complete a paper-based questionnaire. A follow-up of the medical and patient-based

Sponsors

Krankheitsbezogene Kompetenznetz Multiple Sklerose e.V.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: MS patients 18 years and older who are receiving Tysabri therapy (de novo or ongoing treatment with Tysabri).

Exclusion criteria

Exclusion criteria: Patients without a diagnosis of MS expect of Patients with CIS, other therapies than Tysabri or younger than 18 years.

Design outcomes

Primary

MeasureTime frame
The primary outcome the incidence, type and characteristics of adverse events in MS patients treated with Tysabri in routine clinical care.

Secondary

MeasureTime frame
For the secondary objective the following factors will be evaluated: a) EDSS progression b) Annual relapse rate. The Expanded Disability Status Scale (EDSS by Kurtzke) will be recorded every six month.

Countries

Germany

Contacts

Public ContactTysabri-Daten-Register REGIMS Team

Institut für Epidemiologie und SozialmedizinWestfälische Wilhelms-Universität Münster

regims@uni-muenster.de0251-83-55398

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026