Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

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

Detailed Description
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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.

Official Title
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Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort

Conditions
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CLIPPERS

Intervention / Treatment
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* Other: Data entry


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CLIPPERS patients<br>The population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria). Intervention: Data entry | Other: Data entry<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of cortico-sparing treatments |  | baseline to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence/absence of allergies | + description | Baseline (day 0) | 
| Complete description of all treatments being taken |  | Baseline (day 0) | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | Baseline (day 0) | 
| Relapse-free interval rhythm |  | Baseline (day 0) | 
| Weight (kg) |  | 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) | 
| Presence/absence of allergies | + description | 6 months | 
| Presence/absence of allergies | + description | 12 months | 
| Presence/absence of allergies | + description | 18 months | 
| Presence/absence of allergies | + description | 21 months | 
| Presence/absence of allergies | + description | 24 months | 
| Presence/absence of allergies | + description | 30 months | 
| Presence/absence of allergies | + description | 36 months | 
| Complete description of all treatments being taken |  | 6 months | 
| Complete description of all treatments being taken |  | 12 months | 
| Complete description of all treatments being taken |  | 18 months | 
| Complete description of all treatments being taken |  | 21 months | 
| Complete description of all treatments being taken |  | 24 months | 
| Complete description of all treatments being taken |  | 30 months | 
| Complete description of all treatments being taken |  | 36 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 6 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 12 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 18 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 21 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 24 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 30 months | 
| CLIPPERS relapse severity | The rhythm and severity of relapses. | 36 months | 
| Relapse-free interval rhythm |  | 6 months | 
| Relapse-free interval rhythm |  | 12 months | 
| Relapse-free interval rhythm |  | 18 months | 
| Relapse-free interval rhythm |  | 21 months | 
| Relapse-free interval rhythm |  | 24 months | 
| Relapse-free interval rhythm |  | 30 months | 
| Relapse-free interval rhythm |  | 36 months | 
| Weight (kg) |  | 6 months | 
| Weight (kg) |  | 12 months | 
| Weight (kg) |  | 18 months | 
| Weight (kg) |  | 21 months | 
| Weight (kg) |  | 24 months | 
| Weight (kg) |  | 30 months | 
| Weight (kg) |  | 36 months | 
| Presence/absence of vascular risk factors |  | 6 months | 
| Presence/absence of vascular risk factors |  | 12 months | 
| Presence/absence of vascular risk factors |  | 18 months | 
| Presence/absence of vascular risk factors |  | 21 months | 
| Presence/absence of vascular risk factors |  | 24 months | 
| Presence/absence of vascular risk factors |  | 30 months | 
| Presence/absence of vascular risk factors |  | 36 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 6 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 12 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 18 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 21 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 24 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 30 months | 
| Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids |  | 36 months |