ong term, prospective, observational cohort study evaluating the safety profile in patients with highly active relapsing multiple sclerosis (RMS) newly started on oral cladribine

• Conditions: G35.9

• Registration Number: DRKS00015267
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 1115

Inclusion Criteria

Newly initiating oral cladribine or fingolimod according to local label for MS, after the date of oral cladribine launch in the relevant country.
- Written informed consent is obtained:
- at the date of oral cladribine or fingolimod treatment initiation or, at the latest, 24 weeks after oral cladribine or fingolimod treatment initiation in all countries for which primary data is used.
- in those countries where secondary data collection is used and require an informed consent.

Exclusion Criteria

- Received fingolimod prior to initiating oral cladribine;
- Received oral cladribine prior to initiating fingolimod.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of AESIs (malignancies [all], (severe infections, herpes zoster, tuberculosis, PML, other opportunistic infections, and seizures) in patients with highly active R(R)MS newly initiating oral cladribine or fingolimod

Secondary Outcome Measures

Name	Time	Method
- Number of AESIs in patients with highly active R(R)MS newly initiating oral cladribine or<br>fingolimod by prior use of immunomodulatory/ immunosuppressive agents<br>- Number of severe lymphopenia events in patients with highly active R(R)MS newly initiating oral cladribine;<br>- Number of patients by DMT (immunosuppressive or immunomodulatory agents) after oral cladribine treatment in patients with highly active R(R)MS newly initiating oral cladribine;<br>- Number of AESIs in patients with highly active R(R)MS by first subsequent use of DMT (immunomodulatory / immunosuppressive agents) after oral cladribine treatment.