TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Natalizumab Cohort The cohort will include participants with MS who are newly treated with natalizumab (administered as a standard of care/routine clinical practice) from 1st January 2019 including those participants who terminate or discontinue the treatment during the observational period. |
Drug: Natalizumab
Administered as specified in the treatment arm.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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 who are John Cunningham Virus (JCV) Positive and Taking Natalizumab [Up to 6 years]
- Number of Pregnant and Breastfeeding Participants who Were Previously Exposed to Natalizumab [Up to 6 years]
Eligibility Criteria
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/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fakultní nemocnice Brno | Brno | Czechia | ||
| 2 | Fakultní nemocnice u sv. Anny v Brně | Brno | Czechia | ||
| 3 | Fakultní nemocnice Hradec Králové | Hradec Králové | Czechia | ||
| 4 | Nemocnice Jihlava | Jihlava | Czechia | ||
| 5 | Fakultní nemocnice Olomouc | Olomouc | Czechia | ||
| 6 | Fakultní nemocnice v Ostravě | Ostrava | Czechia | ||
| 7 | Nemocnice Pardubického kraje | Pardubice | Czechia | ||
| 8 | Fakultní nemocnice v Plzni | Pilsen | Czechia | ||
| 9 | Fakultní nemocnice Královské Vinohrady v Praze | Prague | Czechia | ||
| 10 | Fakultní nemocniceMotol v Praze | Prague | Czechia | ||
| 11 | Fakultní Thomayerova nemocnice v Praze v Krči | Prague | Czechia | ||
| 12 | Všeobecná fakultní nemocnice v Praze | Prague | Czechia | ||
| 13 | Nemocnice Teplice | Teplice | Czechia | ||
| 14 | Krajská nemocnice T. Bati ve Zlíně | Zlín | Czechia | ||
| 15 | Nemocnice České Budějovice | České Budějovice | Czechia |
Sponsors and Collaborators
- Biogen
- Association for Functional Rehabilitation, Recreation and Applied Kinesiology Impulse
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CZ-TYS-12155