Multiple Sclerosis G35
Conditions
Interventions
Group 1: Patients starting Tysabri therapy (infusion)
Group 2: Patients starting Tysabri therapy (injection)
Group 3: Patients switching from Tysabri infusions to Tysabri injections
Sponsors
Biogen GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Ability of the patient to understand the purpose of the data collection and to provide signed and dated informed consent in participation and collection and processing of personal data (health information) in a pseudonymous form. • At least 18 years of age at enrollment. • Diagnosis of highly active RRMS (RRMS diagnosis according to McDonald criteria (2018) and initiating natalizumab treatment (new starters) is indicated based on current SmPC. • In RRMS patients who are already on intravenous natalizumab therapy, continued treatment must be indicated based on current SmPC. • Natalizumab treatment and administration in accordance with the current SmPC. • Patients who start natalizumab therapy (IV starters or SC starters) are allowed a maximum of three applications of natalizumab prior to study inclusion. Patients who switch from IV to SC administration route (Switchers) are allowed a maximum of three subcutaneous applications of natalizumab prior to study inclusion (the interval between the last IV and the first SC application must not exceed 8 weeks). • Decision to start/continue natalizumab treatment and choice of administration route has been made prior to and independently of patient’s study participation. The special warnings and precautions for use listed in the current SmPC of Tysabri® (natalizumab) should be considered for patient selection and treatment.
Exclusion criteria
Exclusion criteria: Patients with any of the following characteristics will be excluded from the data collection within this non-interventional study: • Progressive forms of MS • Contraindication to natalizumab treatment according to current Tysabri (natalizumab) SmPC • Participation in any interventional clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To collect, evaluate and compare data on patient preference between subcutaneous and intravenous natalizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the immunogenicity of subcotaneous natalizumab for natalizumab naive patients. To collect and evaluate data on the MS disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months in patients with natalizumab therapy starting subcutaneous natalizumab or switching from intravenous natalizumab. | — |
Countries
Austria, Germany
Contacts
Public ContactAnna Hammer
Winicker Norimed GmbH
Outcome results
None listed