Multiple Sclerosis
Conditions
Keywords
Progressive Multifocal Leukoencephalopathy (PML)
Brief summary
The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all participants taking natalizumab. The secondary objectives of the study are to estimate the incidence of SAEs, to estimate the incidence of SAEs among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and John Cunningham Virus (JCV) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.
Interventions
DRUGNatalizumab
Administered as specified in the treatment arm.
Sponsors
ReMuS Registry
Biogen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study Key
Exclusion criteria
* Not Applicable (NA) NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab | Up to 6 years | — |
| Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab | Up to 6 years | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Serious OI means such OI which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a birth defect in offspring. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Malignancies who are Taking Natalizumab | Up to 6 years | — |
| Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab | Up to 6 years | — |
| Number of Participants With SAEs | Up to 6 years | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. |
| Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab | Up to 6 years | — |
| Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab | Up to 6 years | — |
| Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors | Up to 6 years | SAE means such adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product. Demographic and clinical factors involve age, gender, duration of treatment, pregnancy, breastfeeding. |
Countries
Czechia
Outcome results
None listed