The effect of Cladribine on iron rims around lesions, lesion expansion, brain atrophy and disease progression in multiple sclerosis patients - an observational exploratory study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023841

Enrollment

Registered

2021-01-11

Start date

2021-02-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G35

Interventions

Group 1: Effects of cladribine therapy on iron rings and brain atrophy on MRI, and levels of neurofilaments in serum in MS patients Group 2: Effects of treatments other than cladribine on iron rings,

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Patients diagnosed with MS according to the revised current McDonald's criteria. -treatment with cladribine -age > 18 years, - Expanded Disability Status Scale (EDSS) < 6.5 - No steroid therapy during the past 3 months

Exclusion criteria

Exclusion criteria: - Pregnancy, breast-feeding, - contraindications for 7T MRI (allergy against contrast agents, metallic implants, renal insufficiency, or claustrophobia) - Exclusion criteria for Cladribine therapy according to SmPC (applicable only to cladribine cohort)

Design outcomes

Primary

Measure	Time frame
Difference in number of iron rim lesions between pre-treatment scans and at 2 years in patients treated with cladribine.	—

Secondary

Measure	Time frame
- A reduction in T1 hypointensity in the lesion core over study duration (baseline vs. years 1 and 2) in cladribine patients with iron rings. - A reduction in the extent of T2 hyperintensity at the lesion margin (zone of secondary Wallerian degeneration, baseline vs. years 1 and 2) in cladribine patients - A reduction in lesion size and a prevention of fusion with adjacent lesions (baseline vs. year l and 2) in cladribine patients. - dissolution of iron rings (baseline vs. years 1 and 2) in cladribine patients - reduced neurodegeneration in cladribine patients, reflected by a reduction in serum NFL levels (baseline vs. years 1 and 2) - reduced atrophy development of the brain in cladribine patients (observation time > 2 years)	—

Measure

Time frame

- A reduction in T1 hypointensity in the lesion core over study duration (baseline vs. years 1 and 2) in cladribine patients with iron rings. - A reduction in the extent of T2 hyperintensity at the lesion margin (zone of secondary Wallerian degeneration, baseline vs. years 1 and 2) in cladribine patients - A reduction in lesion size and a prevention of fusion with adjacent lesions (baseline vs. year l and 2) in cladribine patients. - dissolution of iron rings (baseline vs. years 1 and 2) in cladribine patients - reduced neurodegeneration in cladribine patients, reflected by a reduction in serum NFL levels (baseline vs. years 1 and 2) - reduced atrophy development of the brain in cladribine patients (observation time > 2 years)

—

Countries

Austria

Contacts

Public ContactAssunta Dal-Bianco

Medizinische Universität Wien

assunta.dal-bianco@meduniwien.ac.at+43 1 40400 31170

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026