Explorative study of emerging blood biomarkers in progressive multiple sclerosis

Recruiting

• Conditions: G35; Multiple sclerosis

• Registration Number: DRKS00020132
• Lead Sponsor: Reha- und Universitätsklinikum Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

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

- 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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
• examine serum NfL as a marker of disease progression by comparing PMS patients with progressive vs non-progressive disease course. <br>• examine serum GFAP as a marker of disease activity by comparing PMS Patients with active vs non-active disease course.<br>• examine serum NfL as a marker of disease activity by comparing PMS Patients with active vs non-active disease course.<br>• examine the ability of GFAP to distinguish between RRMS and PMS. <br>• examine the ability of NfL to distinguish between RRMS and PMS. <br>• 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.<br>• 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.