Clinically Isolated Syndrome and Newly Diagnosed Multiple Sclerosis: Diagnostic, Prognostic and Therapy - Response Markers - a Prospective Observational Study (Berlin CIS-COHORT)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- time (in days) until relapse during the observation period of four years
Study Overview
Brief Summary
A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age > 18 years
- •signed informed consent
- •clinically isolated syndrome within the last 6 months
- •diagnosis of multiple sclerosis within the last two years
Exclusion Criteria
- •eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy)
- •secondary progressive multiple sclerosis
- •pregnancy
- •contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
- •alcohol or drug abuse
Outcomes
Primary Outcomes
time (in days) until relapse during the observation period of four years
Time Frame: 48 months
Secondary Outcomes
- MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)(48 months)
- biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF(48 months)
- Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)(48 months)