DRKS00020132
Recruiting
Not Applicable
Explorative study of emerging blood biomarkers in progressive multiple sclerosis - EmBioProMS
Reha- und Universitätsklinikum Ulm0 sites240 target enrollmentDecember 19, 2019
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- G35
- Sponsor
- Reha- und Universitätsklinikum Ulm
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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