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.
Study Type
OBSERVATIONAL
Enrollment
675
Administered as specified in the treatment arm.
Fakultní nemocnice Brno
Brno, Czechia
Fakultní nemocnice u sv. Anny v Brně
Brno, Czechia
Nemocnice České Budějovice
České Budějovice, Czechia
Fakultní nemocnice Hradec Králové
Hradec Králové, Czechia
Nemocnice Jihlava
Jihlava, Czechia
Fakultní nemocnice Olomouc
Olomouc, Czechia
Fakultní nemocnice v Ostravě
Ostrava, Czechia
Nemocnice Pardubického kraje
Pardubice, Czechia
Fakultní nemocnice v Plzni
Pilsen, Czechia
Fakultní nemocnice Královské Vinohrady v Praze
Prague, Czechia
...and 5 more locations
Number of Participants With Progressive Multifocal Leukoencephalopathy (PML) who are Taking Natalizumab
Time frame: Up to 6 years
Number of Participants with Serious Adverse Events (SAEs) of Other Opportunistic Infections (OIs) who are Taking Natalizumab
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.
Time frame: Up to 6 years
Number of Participants With SAEs
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.
Time frame: Up to 6 years
Number of Participants With SAEs Among Participant Subgroups Defined by Demographic and Clinical Factors
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.
Time frame: Up to 6 years
Number of Participants With Malignancies who are Taking Natalizumab
Time frame: Up to 6 years
Number of Participants With Hypersensitivity Reactions who are Taking Natalizumab
Time frame: Up to 6 years
Number of Participants who are John Cunningham Virus (JCV) Positive and Taking Natalizumab
Time frame: Up to 6 years
Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab
Time frame: Up to 6 years
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