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Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740180
Recruitment Status : Terminated (No recruitment)
First Posted : December 4, 2012
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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

Condition or disease Intervention/treatment
CLIPPERS Other: Data entry

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
Actual Study Start Date : March 25, 2015
Actual Primary Completion Date : March 25, 2016
Actual Study Completion Date : March 25, 2016

Resource links provided by the National Library of Medicine


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

Other: 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.





Primary Outcome Measures :
  1. Presence/absence of cortico-sparing treatments [ Time Frame: baseline to 3 years ]

Secondary Outcome Measures :
  1. Presence/absence of allergies [ Time Frame: Baseline (day 0) ]
    + description

  2. Complete description of all treatments being taken [ Time Frame: Baseline (day 0) ]
  3. CLIPPERS relapse severity [ Time Frame: Baseline (day 0) ]
    The rhythm and severity of relapses.

  4. Relapse-free interval rhythm [ Time Frame: Baseline (day 0) ]
  5. Weight (kg) [ Time Frame: Baseline (day 0) ]
  6. Presence/absence of vascular risk factors [ Time Frame: Baseline (Day 0) ]
  7. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: Baseline (day 0) ]
  8. Presence/absence of allergies [ Time Frame: 6 months ]
    + description

  9. Presence/absence of allergies [ Time Frame: 12 months ]
    + description

  10. Presence/absence of allergies [ Time Frame: 18 months ]
    + description

  11. Presence/absence of allergies [ Time Frame: 21 months ]
    + description

  12. Presence/absence of allergies [ Time Frame: 24 months ]
    + description

  13. Presence/absence of allergies [ Time Frame: 30 months ]
    + description

  14. Presence/absence of allergies [ Time Frame: 36 months ]
    + description

  15. Complete description of all treatments being taken [ Time Frame: 6 months ]
  16. Complete description of all treatments being taken [ Time Frame: 12 months ]
  17. Complete description of all treatments being taken [ Time Frame: 18 months ]
  18. Complete description of all treatments being taken [ Time Frame: 21 months ]
  19. Complete description of all treatments being taken [ Time Frame: 24 months ]
  20. Complete description of all treatments being taken [ Time Frame: 30 months ]
  21. Complete description of all treatments being taken [ Time Frame: 36 months ]
  22. CLIPPERS relapse severity [ Time Frame: 6 months ]
    The rhythm and severity of relapses.

  23. CLIPPERS relapse severity [ Time Frame: 12 months ]
    The rhythm and severity of relapses.

  24. CLIPPERS relapse severity [ Time Frame: 18 months ]
    The rhythm and severity of relapses.

  25. CLIPPERS relapse severity [ Time Frame: 21 months ]
    The rhythm and severity of relapses.

  26. CLIPPERS relapse severity [ Time Frame: 24 months ]
    The rhythm and severity of relapses.

  27. CLIPPERS relapse severity [ Time Frame: 30 months ]
    The rhythm and severity of relapses.

  28. CLIPPERS relapse severity [ Time Frame: 36 months ]
    The rhythm and severity of relapses.

  29. Relapse-free interval rhythm [ Time Frame: 6 months ]
  30. Relapse-free interval rhythm [ Time Frame: 12 months ]
  31. Relapse-free interval rhythm [ Time Frame: 18 months ]
  32. Relapse-free interval rhythm [ Time Frame: 21 months ]
  33. Relapse-free interval rhythm [ Time Frame: 24 months ]
  34. Relapse-free interval rhythm [ Time Frame: 30 months ]
  35. Relapse-free interval rhythm [ Time Frame: 36 months ]
  36. Weight (kg) [ Time Frame: 6 months ]
  37. Weight (kg) [ Time Frame: 12 months ]
  38. Weight (kg) [ Time Frame: 18 months ]
  39. Weight (kg) [ Time Frame: 21 months ]
  40. Weight (kg) [ Time Frame: 24 months ]
  41. Weight (kg) [ Time Frame: 30 months ]
  42. Weight (kg) [ Time Frame: 36 months ]
  43. Presence/absence of vascular risk factors [ Time Frame: 6 months ]
  44. Presence/absence of vascular risk factors [ Time Frame: 12 months ]
  45. Presence/absence of vascular risk factors [ Time Frame: 18 months ]
  46. Presence/absence of vascular risk factors [ Time Frame: 21 months ]
  47. Presence/absence of vascular risk factors [ Time Frame: 24 months ]
  48. Presence/absence of vascular risk factors [ Time Frame: 30 months ]
  49. Presence/absence of vascular risk factors [ Time Frame: 36 months ]
  50. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 6 months ]
  51. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 12 months ]
  52. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 18 months ]
  53. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 21 months ]
  54. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 24 months ]
  55. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 30 months ]
  56. Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 36 months ]

Other Outcome Measures:
  1. Family history of auto-immune disease [ Time Frame: Baseline ]
  2. Height (cm) [ Time Frame: Baseline (day 0) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740180


Locations
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France
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
CH de Dax - Côte d'Argent
Dax, France, 40100
CHU de Limoges - Hôpital Dupuytren
Limoges, France, 87042
APHM - Hôpital La Timone Adultes
Marseille, France, 13385
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, France, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
CHU de Rouen - Hôpital Charles Nicolle
Rouen, France, 76031
CHRU de Strasbourg - Hôpital Civil
Strasbourg Cedex, France, 67091
CHRU de Toulouse - Hôpital de Rangueil
Toulouse Cedex 9, France, 31059
CHRU de Toulouse - Hôpital Purpan
Toulouse Cedex 9, France, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Guillaume Taieb, MD Centre Hospitalier Universitaire de Nîmes
Additional Information:

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01740180    
Other Study ID Numbers: LOCAL/2012/GT
Taieb Cohorte CLIPPERS ( Other Identifier: BESPIM, Nîmes University Hospital )
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018