Relapsing-Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
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.
Interventions
DRUGNatalizumab
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6 | Month 6 | The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. Are you satisfied with the route of administration of natalizumab? (yes/no) and indicate main reason. 2. For SC participants only- Have you experienced adverse events related to a subcutaneous injection. (1= mild to 5 = severe), and 3. If you had to choose between subcutaneous or intravenous route again, which route would you choose?. |
| Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12 | Month 12 | The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. Are you satisfied with the route of administration of natalizumab? (yes/no) and indicate main reason. 2. For SC participants only- Have you experienced adverse events related to a subcutaneous injection. (1= mild to 5 = severe), and 3. If you had to choose between subcutaneous or intravenous route again, which route would you choose?. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual Relapse Rate | Baseline, Months 3, 6, 9, and 12 | An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years. |
| Number of Participants Positive for Anti-Natalizumab-Antibody | Baseline, Month 6 and 12 | — |
| Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab | Baseline, Months 3, 6, 9, and 12 | Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score \>0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease. |
| Time to Relapse | Baseline, Months 3, 6, 9, and 12 | An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. |
| Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody | Baseline, Month 6 and 12 | — |
Countries
Germany
Outcome results
None listed