DRKS00020132RecruitingNot Applicable
Explorative study of emerging blood biomarkers in progressive multiple sclerosis - EmBioProMS
Reha- und Universitätsklinikum Ulm0 sites240 target enrollmentStarted: December 19, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
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)
Investigators
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