- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740180
Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort
Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Investigators
- Principal Investigator: Guillaume Taieb, MD, Centre Hospitalier Universitaire de Nīmes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Data entry
-
Intermountain Health Care, Inc.Savvysherpa, Inc.Completed
-
Umraniye Education and Research HospitalUnknownObesity, MorbidTurkey
-
Zeynep Kamil Maternity and Pediatric Research and...UnknownGastrointestinal Disorder PostoperativeTurkey
-
Inter-American Development BankCompleted
-
Cedars-Sinai Medical CenterNot yet recruiting
-
Shirley Ryan AbilityLabRecruitingStroke | Parkinson Disease | Lower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury)United States
-
Institut Universitari DexeusWithdrawnLaparoscopic Gynecological SurgerySpain
-
Johns Hopkins UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Zagazig UniversityUnknownGynecologic DiseaseEgypt
-
University of South FloridaTampa General HospitalCompletedLaparoscopic Surgery | Laparoscopy | Insufflation | Gynecologic Surgical ProceduresUnited States