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Fingolimod -Response According to Coping - Evaluation

NCT ID: NCT01420055

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-06-30

Brief Summary

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This is a prospective, open-label, multi-center phase IV study to assess response to fingolimod initiation according to coping profile in adult patients with highly active relapsing remitting multiple sclerosis in France.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Keywords

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Multiple sclerosis Fingolimod Coping Anxiety France Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9) Active

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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fingolimod

Group Type EXPERIMENTAL

fingolimod

Intervention Type DRUG

Interventions

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fingolimod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 year-old male \& female with RRMS (2005 revised McDonald criteria) corresponding to fingolimod indication (in Europe) and EDSS score 0 - 5.5 inclusive

Exclusion Criteria

* History of immune system chronic disease other than MS or known immunodeficiency syndrome; increased risk for opportunistic infections, including immunocompromised patients; severe active infections, active chronic infections; negative for varicella-zoster virus IgG antibodies; live or live attenuated vaccines;
* Active malignancies; Macular edema; Cardiac disease or medicines decreasing heart rate; severe liver impairment; lymphocyte count \<800/mm3;
* Pregnant or nursing (lactating) women /child-bearing potential UNLESS they are using an effective contraceptive method;
* Hypersensitivity; participation in any clinical research study within 6 months prior to baseline; prior participation in a trial with fingolimod
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Angers, France, France

Site Status

Novartis Investigative Site

Agen, , France

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Novartis Investigative Site

Amiens, , France

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Auxerre, , France

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Avignon, , France

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Bayonne, , France

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Béziers, , France

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Bobigny, , France

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Brest, , France

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Calais, , France

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Castelnau-le-Lez, , France

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Chambray-lès-Tours, , France

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Cherbourg, , France

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Clermont-Ferrand, , France

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Créteil, , France

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Dijon, , France

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Épinal, , France

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Grenoble, , France

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Hagueneau, , France

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La Rochelle, , France

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La Seyne-sur-Mer, , France

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Le Kremlin-Bicêtre, , France

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Le Mans, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Marseille, , France

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Metz, , France

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Montpellier, , France

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Montpellier, , France

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Nîmes, , France

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Orsay, , France

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Paris, , France

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Poitiers, , France

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Pontoise, , France

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Reims, , France

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Rennes, , France

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Roanne, , France

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Saint-Aubin-sur-Scie, , France

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Saint-Jean, , France

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Sainte-Foy-lès-Lyon, , France

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Saumur, , France

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Strasbourg, , France

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Talant, , France

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Toulouse, , France

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Novartis Investigative Site

Tourcoing, , France

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Novartis Investigative Site

Tours, , France

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Countries

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France

Other Identifiers

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2011-001280-49

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFTY720DFR03

Identifier Type: -

Identifier Source: org_study_id