Clinical trial NCT01740180: Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort
Official title: Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: CLIPPERS
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria).

Patients will be recruited from referral centers throughout France. We also intend to communicate with all multiple sclerosis networks (French League against Multiple Sclerosis) to facilitate the detection of new cases.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of cortico-sparing treatments
timeFrame: baseline to 3 years
Secondary outcomes:
measure: Presence/absence of allergies
timeFrame: Baseline (day 0)
measure: Complete description of all treatments being taken
timeFrame: Baseline (day 0)
measure: CLIPPERS relapse severity
timeFrame: Baseline (day 0)
measure: Relapse-free interval rhythm
timeFrame: Baseline (day 0)
measure: Weight (kg)
timeFrame: Baseline (day 0)
measure: Presence/absence of vascular risk factors
timeFrame: Baseline (Day 0)
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: Baseline (day 0)
measure: Presence/absence of allergies
timeFrame: 6 months
measure: Presence/absence of allergies
timeFrame: 12 months
measure: Presence/absence of allergies
timeFrame: 18 months
measure: Presence/absence of allergies
timeFrame: 21 months
measure: Presence/absence of allergies
timeFrame: 24 months
measure: Presence/absence of allergies
timeFrame: 30 months
measure: Presence/absence of allergies
timeFrame: 36 months
measure: Complete description of all treatments being taken
timeFrame: 6 months
measure: Complete description of all treatments being taken
timeFrame: 12 months
measure: Complete description of all treatments being taken
timeFrame: 18 months
measure: Complete description of all treatments being taken
timeFrame: 21 months
measure: Complete description of all treatments being taken
timeFrame: 24 months
measure: Complete description of all treatments being taken
timeFrame: 30 months
measure: Complete description of all treatments being taken
timeFrame: 36 months
measure: CLIPPERS relapse severity
timeFrame: 6 months
measure: CLIPPERS relapse severity
timeFrame: 12 months
measure: CLIPPERS relapse severity
timeFrame: 18 months
measure: CLIPPERS relapse severity
timeFrame: 21 months
measure: CLIPPERS relapse severity
timeFrame: 24 months
measure: CLIPPERS relapse severity
timeFrame: 30 months
measure: CLIPPERS relapse severity
timeFrame: 36 months
measure: Relapse-free interval rhythm
timeFrame: 6 months
measure: Relapse-free interval rhythm
timeFrame: 12 months
measure: Relapse-free interval rhythm
timeFrame: 18 months
measure: Relapse-free interval rhythm
timeFrame: 21 months
measure: Relapse-free interval rhythm
timeFrame: 24 months
measure: Relapse-free interval rhythm
timeFrame: 30 months
measure: Relapse-free interval rhythm
timeFrame: 36 months
measure: Weight (kg)
timeFrame: 6 months
measure: Weight (kg)
timeFrame: 12 months
measure: Weight (kg)
timeFrame: 18 months
measure: Weight (kg)
timeFrame: 21 months
measure: Weight (kg)
timeFrame: 24 months
measure: Weight (kg)
timeFrame: 30 months
measure: Weight (kg)
timeFrame: 36 months
measure: Presence/absence of vascular risk factors
timeFrame: 6 months
measure: Presence/absence of vascular risk factors
timeFrame: 12 months
measure: Presence/absence of vascular risk factors
timeFrame: 18 months
measure: Presence/absence of vascular risk factors
timeFrame: 21 months
measure: Presence/absence of vascular risk factors
timeFrame: 24 months
measure: Presence/absence of vascular risk factors
timeFrame: 30 months
measure: Presence/absence of vascular risk factors
timeFrame: 36 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 6 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 12 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 18 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 21 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 24 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 30 months
measure: Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
timeFrame: 36 months
Other outcomes:
measure: Family history of auto-immune disease
timeFrame: Baseline
measure: Height (cm)
timeFrame: Baseline (day 0)
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Groupe Hospitalier Pellegrin
city: Dax
country: France
facility: CH de Dax - Côte d'Argent
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
city: Marseille
country: France
facility: APHM - Hôpital La Timone Adultes
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Saint-Eloi
city: Nîmes Cedex 9
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
city: Strasbourg Cedex
country: France
facility: CHRU de Strasbourg - Hôpital Civil
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital de Rangueil
city: Toulouse Cedex 9
country: France
facility: CHRU de Toulouse - Hôpital Purpan
city: Tours
country: France
facility: CHRU de Tours - Hôpital Bretonneau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Guillaume Taieb, MD
role: PRINCIPAL_INVESTIGATOR
References: