Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

Centre Hospitalier Universitaire de Nīmes3 enrolled

Overview

The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

CLIPPERS

Interventions

Data entryOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (11)

CHU de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, France

CH de Dax - Côte d'Argent

Dax, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Outcomes

Primary Outcomes

Presence/absence of cortico-sparing treatments

Time frame: baseline to 3 years

Secondary Outcomes

Presence/absence of allergies

\+ description

Time frame: Baseline (day 0)

Complete description of all treatments being taken

Time frame: Baseline (day 0)

CLIPPERS relapse severity

The rhythm and severity of relapses.

Time frame: Baseline (day 0)

Relapse-free interval rhythm

Time frame: Baseline (day 0)

Weight (kg)

Time frame: Baseline (day 0)

Presence/absence of vascular risk factors

Time frame: Baseline (Day 0)

Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids

Time frame: Baseline (day 0)

Presence/absence of allergies

\+ description

Time frame: 6 months

Presence/absence of allergies

\+ description

Time frame: 12 months

Presence/absence of allergies

\+ description

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.