Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

January 2, 2018 updated by: Centre Hospitalier Universitaire de Nīmes

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33076
        • CHU de Bordeaux - Groupe hospitalier Pellegrin
      • Dax, France, 40100
        • CH de Dax - Côte d'Argent
      • Limoges, France, 87042
        • CHU de Limoges - Hôpital Dupuytren
      • Marseille, France, 13385
        • APHM - Hôpital La Timone Adultes
      • Montpellier, France, 34295
        • CHU de Montpellier - Hopital Saint-Eloi
      • Nîmes Cedex 9, France, 30029
        • CHU de Nimes - Hopital Universitaire Caremeau
      • Rouen, France, 76031
        • CHU de Rouen - Hôpital Charles Nicolle
      • Strasbourg Cedex, France, 67091
        • CHRU de Strasbourg - Hôpital Civil
      • Toulouse Cedex 9, France, 31059
        • CHRU de Toulouse - Hôpital Purpan
      • Toulouse Cedex 9, France, 31059
        • CHRU de Toulouse - Hôpital de Rangueil
      • Tours, France, 37044
        • CHRU de Tours - Hôpital Bretonneau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLIPPERS patients

The population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria).

Intervention: Data 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Height (cm)
Time Frame: Baseline (day 0)
Baseline (day 0)
Family history of auto-immune disease
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Guillaume Taieb, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2015

Primary Completion (Actual)

March 25, 2016

Study Completion (Actual)

March 25, 2016

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • LOCAL/2012/GT
  • Taieb Cohorte CLIPPERS (Other Identifier: BESPIM, Nîmes University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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