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Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta (QUALICIS)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00819897
First received: January 8, 2009
Last updated: December 6, 2011
Last verified: December 2011
History of Changes

January 8, 2009
December 6, 2011
June 2008
June 2014   (final data collection date for primary outcome measure)
Clinical exams performed at Baseline and every year during 3 years Neurological examination: relapses recording and EDSS. Quality of life: SEP-59, MusiQOL. Neuropsychological screening [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819897 on ClinicalTrials.gov Archive Site
Fatigue test: MS Fatigue, MRI (T1 gadolinium, T2, sagittale T1, acquisition volumique 3D T1), Optical coherence tomography (OCT) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Longitudinal Study in Clinically Isolated Syndrome (CIS) Patients Treated With Interferon Beta
Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.

The aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with CIS, considered as high risk to develop an MS, treated with interferon Beta. This prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (OCT, OF, VEP, VF), auto questionnaire about fatigue (musicol, ELIF), quality of life (SEP-59), and conventional MRI.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment
Clinically Isolated Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
37
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients older than 18 years,
  • Patients with CIS and temporo spatial dissemination for less than one year
  • Patient without prior immunomodulatory treatment
  • Patient informed of CIS diagnosis and MS according to McDonald criteria,
  • Patients with EDSS inferior or egal to 5,5
  • Patients usually french-reader and with MMS >24
  • Patients informed of study protocol
  • Patients agree to sign informed consent
  • Patients with affiliation number from social French département.

Exclusion Criteria:

  • Secondary progressive MS
  • Patient with acute relapse
  • Patient already treated with IFN
  • corticosteroids less than 15 days
  • Patient with severe dépressive disorders
  • Patient already included in clinical study
  • Patient < 18 years
  • Patient with known contra indications for beta interféron
  • Every reason with can provoke an interruption of the study, regarding a patient empechment
  • Contre indications for MRI or other tests required in the study
  • pregnancy or lactation
  • patient Under juridic protection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00819897
08-PP-05
No
Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
Department of Clinical Research and Innovation
Not Provided
Principal Investigator: Christine LEBRUN-FRENAY, MDPH University hospital of Nice
Centre Hospitalier Universitaire de Nice
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP