A Study for Tysabri Participant Preference

Biogen

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS)

Treatments: Drug: Natalizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05304520

DE-TYS-11923

Details and patient eligibility

About

The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

Enrollment: 318 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
• In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC

Key Exclusion Criteria:

• Progressive forms of MS
• Contraindication to natalizumab treatment according to natalizumab SmPC
• Concomitant treatment with other drugs for treating RRMS
• Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

318 participants in 3 patient groups

On Natalizumab: Switcher IV to SC Cohort

Description:

Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.

Treatment:

Drug: Natalizumab

Natalizumab-Naive IV Cohort

Description:

Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months

Treatment:

Drug: Natalizumab

Natalizumab-Naive SC Cohort

Description:

Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.

Treatment:

Drug: Natalizumab