Explorative study of emerging blood biomarkers in progressive multiple sclerosis

Explorative study of emerging blood biomarkers in progressive multiple sclerosis - EmBioProMS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020132

Enrollment

240

Registered

2019-12-19

Start date

2018-06-01

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: Levels of serum NfL and GFAP will be assessed in patients with progressive MS over a follow-up period of 18 months

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with progressive multiple sclerosis (PMS) - Duration of the progressive phase of at least 12 months - Cranial MRI scan within the last three months of baseline-Visit* - EDSS between 1 and 6,5+ * not obligatory in 50% of the study population (100 patients) + a cap of 25% will be applied as the upper limit of patients with EDSS > 5.5

Exclusion criteria

Exclusion criteria: - Patients with relapsing-remitting multiple sclerosis. - Acute exacerbation in the last 3 months - Treatment with*: • Methylprednisolone in the last 30 days • Interferon, Glatiramer acetate, Natalizumab, Dimethyl fumarate, Fingolimod and Teriflunomide in the last 3 months • Ocrelizumab, Rituximab or Mitoxantrone in the last 12 months • With Cladribine or alemtuzumab in the last 24 months - Contraindication for MRI or for Gadolinium injection - Inflammatory diseases of the central nervous system * not obligatory in 50% of the study population (100 patients)

Design outcomes

Primary

Measure	Time frame
examine serum GFAP as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course.	—

Secondary

Measure	Time frame
• examine serum NfL as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course. • examine serum GFAP as a marker of disease activity by comparing PMS Patients with active vs non-active disease course. • examine serum NfL as a marker of disease activity by comparing PMS Patients with active vs non-active disease course. • examine the ability of GFAP to distinguish between RRMS and PMS. • examine the ability of NfL to distinguish between RRMS and PMS. • examine different OCT-parameters (whole retinal thickness, GCL, RNFL, INL) as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course. • examine different OCT-parameters (whole retinal thickness, GCL, RNFL, INL) as a marker of disease activity by comparing PMS Patients with active vs non-active disease course.	—

Measure

Time frame

• examine serum NfL as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course. • examine serum GFAP as a marker of disease activity by comparing PMS Patients with active vs non-active disease course. • examine serum NfL as a marker of disease activity by comparing PMS Patients with active vs non-active disease course. • examine the ability of GFAP to distinguish between RRMS and PMS. • examine the ability of NfL to distinguish between RRMS and PMS. • examine different OCT-parameters (whole retinal thickness, GCL, RNFL, INL) as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course. • examine different OCT-parameters (whole retinal thickness, GCL, RNFL, INL) as a marker of disease activity by comparing PMS Patients with active vs non-active disease course.

—

Countries

Germany

Contacts

Public ContactAhmed Abdelhak

Universitätsklinikum Ulm, Klinik für Neurologie

ahmed.abdelhak@uni-ulm.de07311770

Outcome results

None listed

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