CLIPPERS Clinical Trial
Official title:
Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
| Verified date | January 2018 |
| Source | Centre Hospitalier Universitaire de Nimes |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | March 25, 2016 |
| Est. primary completion date | March 25, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | |
| France | CH de Dax - Côte d'Argent | Dax | |
| France | CHU de Limoges - Hôpital Dupuytren | Limoges | |
| France | APHM - Hôpital La Timone Adultes | Marseille | |
| France | CHU de Montpellier - Hôpital Saint-Eloi | Montpellier | |
| France | CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes Cedex 9 | |
| France | CHU de Rouen - Hôpital Charles Nicolle | Rouen | |
| France | CHRU de Strasbourg - Hôpital Civil | Strasbourg Cedex | |
| France | CHRU de Toulouse - Hôpital de Rangueil | Toulouse Cedex 9 | |
| France | CHRU de Toulouse - Hôpital Purpan | Toulouse Cedex 9 | |
| France | CHRU de Tours - Hôpital Bretonneau | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Nimes |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Family history of auto-immune disease | Baseline | ||
| Other | Height (cm) | Baseline (day 0) | ||
| Primary | Presence/absence of cortico-sparing treatments | baseline to 3 years | ||
| Secondary | Presence/absence of allergies | + description | Baseline (day 0) | |
| Secondary | Complete description of all treatments being taken | Baseline (day 0) | ||
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | Baseline (day 0) | |
| Secondary | Relapse-free interval rhythm | Baseline (day 0) | ||
| Secondary | Weight (kg) | Baseline (day 0) | ||
| Secondary | Presence/absence of vascular risk factors | Baseline (Day 0) | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | Baseline (day 0) | ||
| Secondary | Presence/absence of allergies | + description | 6 months | |
| Secondary | Presence/absence of allergies | + description | 12 months | |
| Secondary | Presence/absence of allergies | + description | 18 months | |
| Secondary | Presence/absence of allergies | + description | 21 months | |
| Secondary | Presence/absence of allergies | + description | 24 months | |
| Secondary | Presence/absence of allergies | + description | 30 months | |
| Secondary | Presence/absence of allergies | + description | 36 months | |
| Secondary | Complete description of all treatments being taken | 6 months | ||
| Secondary | Complete description of all treatments being taken | 12 months | ||
| Secondary | Complete description of all treatments being taken | 18 months | ||
| Secondary | Complete description of all treatments being taken | 21 months | ||
| Secondary | Complete description of all treatments being taken | 24 months | ||
| Secondary | Complete description of all treatments being taken | 30 months | ||
| Secondary | Complete description of all treatments being taken | 36 months | ||
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 6 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 12 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 18 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 21 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 24 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 30 months | |
| Secondary | CLIPPERS relapse severity | The rhythm and severity of relapses. | 36 months | |
| Secondary | Relapse-free interval rhythm | 6 months | ||
| Secondary | Relapse-free interval rhythm | 12 months | ||
| Secondary | Relapse-free interval rhythm | 18 months | ||
| Secondary | Relapse-free interval rhythm | 21 months | ||
| Secondary | Relapse-free interval rhythm | 24 months | ||
| Secondary | Relapse-free interval rhythm | 30 months | ||
| Secondary | Relapse-free interval rhythm | 36 months | ||
| Secondary | Weight (kg) | 6 months | ||
| Secondary | Weight (kg) | 12 months | ||
| Secondary | Weight (kg) | 18 months | ||
| Secondary | Weight (kg) | 21 months | ||
| Secondary | Weight (kg) | 24 months | ||
| Secondary | Weight (kg) | 30 months | ||
| Secondary | Weight (kg) | 36 months | ||
| Secondary | Presence/absence of vascular risk factors | 6 months | ||
| Secondary | Presence/absence of vascular risk factors | 12 months | ||
| Secondary | Presence/absence of vascular risk factors | 18 months | ||
| Secondary | Presence/absence of vascular risk factors | 21 months | ||
| Secondary | Presence/absence of vascular risk factors | 24 months | ||
| Secondary | Presence/absence of vascular risk factors | 30 months | ||
| Secondary | Presence/absence of vascular risk factors | 36 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 6 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 12 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 18 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 21 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 24 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 30 months | ||
| Secondary | Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids | 36 months |