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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00015267

Enrollment

8000

Registered

2018-08-29

Start date

2018-09-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G35.9

Interventions

Group 1: Patients newly starting with oral cladribine - no investigations outside of clinical routine Group 2: Patients newly starting with fingolimod - no investigations outside of clinical routin

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Received fingolimod prior to initiating oral cladribine; - Received oral cladribine prior to initiating fingolimod.

Design outcomes

Primary

Measure	Time frame
Number 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

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

Measure

Time frame

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

—

Countries

Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Netherlands, Norway, Sweden, Switzerland, Turkey, United States

Contacts

Public ContactMeritxell Sabidó

Merck KGaA

meritxell.sabido-espin@merckgroup.com+49 (0) 6151 72 26203

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026