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
  Purpose

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.


Condition
Clinically Isolated Syndrome

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Longitudinal Study in Clinical Isolated Syndrome Patients Treated With Interferon Beta. Correlation With Cognitive Disorders and Quality of Life.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 37
Study Start Date: June 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with CIS and temporo spatial dissemination for less than one year without prior immunomodulatory treatment

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819897

Locations
France
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
University hospital of Côte de Nacre
Caen, France
Hôpital Gabriel Montpied
Clermont-ferrand, France
Hôpital Général de DIJON
Dijon, France
Hôpital Roger Salengro
Lille, France
Hôpital de Saint Philibert
Lomme, France
Centre Hospitalier de la Timone
Marseille, France
Hôpital Gui de Chauliac
Montpellier, France
CHU de Nancy
Nancy, France
CHU de Nantes
Nantes, France
CHU Nice
Nice, France, 06000
CHU de Montpellier-Nîmes - Hôpital Caremeau
Nîmes, France
Hôpital de Poissy
Poissy, France
CHU de Reims
Reims, France
Hôpital Pontchaillon
Rennes, France
CHRU de Strasbourg
Strasbourg, France
Hôpital Purpan
Toulouse, France
Sponsors and Collaborators
Department of Clinical Research and Innovation
Investigators
Principal Investigator: Christine LEBRUN-FRENAY, MDPH University hospital of Nice
  More Information

No publications provided

Responsible Party: Department of Clinical Research and Innovation, LEBRUN-FRENAY, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00819897     History of Changes
Other Study ID Numbers: 08-PP-05
Study First Received: January 8, 2009
Last Updated: December 6, 2011
Health Authority: France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire de Nice:
MS
CIS
IFN
MRI
OCT
QOL

Additional relevant MeSH terms:
Interferon-beta
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 22, 2014