CLIPPERS
Conditions
Brief summary
The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.
Detailed description
This is an observational study. Data will be prospectively collected, starting with a detailed baseline description of disease and treatment status, followed by updates everything six months for the next three years.
Interventions
OTHERData entry
This cohort describes the basic information about the patients (age, sex, weight, height, background) as well as acts required, treatment and results of imaging studies. These data are extracted from patient records by each participating center and collected in an e-CRF.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient correctly informed about the study * Symptoms and/or clinical signs indicating that the brain stem is affected * MRI shows punctate gadolinium highlights and/or curvilinear bridge and/or middle cerebellar peduncles * Clinical and radiological cortico sensitivity * If a cerebral biopsy has been performed, presence of a lymphocytic, histiocytic or lympho-hysticytic infiltrate
Exclusion criteria
* symptoms and/or clinical signs indicating impairment other than the central nervous system * Cortical impairment present on MRI, microbleeds, stenosis on magnetic resonance angiography, or pacchymeningitis * Presence of other diseases that could explain such clinical and radiological signs (see inclusion criteria) * If a cerebral biopsy has been performed, presence of signs of malignancy (eg, clonal proliferation, cellular atypia), vasculitis, granuloma, or demyelination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence/absence of cortico-sparing treatments | baseline to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence/absence of allergies | Baseline (day 0) | \+ description |
| Complete description of all treatments being taken | Baseline (day 0) | — |
| CLIPPERS relapse severity | Baseline (day 0) | The rhythm and severity of relapses. |
| Relapse-free interval rhythm | Baseline (day 0) | — |
| Presence/absence of vascular risk factors | Baseline (Day 0) | — |
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | Baseline (day 0) | — |
| Weight (kg) | Baseline (day 0) | — |
Other
| Measure | Time frame |
|---|---|
| Family history of auto-immune disease | Baseline |
| Height (cm) | Baseline (day 0) |
Countries
France
Outcome results
None listed