Clinical trial NCT01420055: Fingolimod -Response According to Coping - Evaluation
Official title: A 4-month, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple sclerosis
Fingolimod
Coping
Anxiety
France
Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9)
Active
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To assess the mean change in Hospital Anxiety Depression Scale (HADS) anxiety sub-score between baseline and Month 4 in RRMS fingolimod treated patient total population, and according to coping profile (task, emotion or avoidance oriented).
timeFrame: 4 months
Secondary outcomes:
measure: To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
timeFrame: 4 months
measure: To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset)
timeFrame: 4 months
measure: To explore treatment satisfaction with fingolimod in patients with RRMS either naive (rapidly evolving severe RRMS) or who transitioned from previous treatment with Disease Modifying Therapy using the TSQM 9 and according to coping profile
timeFrame: 4 months
Other outcomes:
Locations:
city: Agen Cedex 9
country: France
facility: Novartis Investigative Site
city: Amiens Cedex 1
country: France
facility: Novartis Investigative Site
city: Angers Cedex 1
country: France
facility: Novartis Investigative Site
city: Auxerre
country: France
facility: Novartis Investigative Site
city: Avignon
country: France
facility: Novartis Investigative Site
city: Bayonne
country: France
facility: Novartis Investigative Site
city: Beziers
country: France
facility: Novartis Investigative Site
city: Bobigny Cedex
country: France
facility: Novartis Investigative Site
city: Brest
country: France
facility: Novartis Investigative Site
city: Calais
country: France
facility: Novartis Investigative Site
city: Castelnau-le-Lez
country: France
facility: Novartis Investigative Site
city: Chambray les Tours
country: France
facility: Novartis Investigative Site
city: Cherbourg
country: France
facility: Novartis Investigative Site
city: Clermont-Ferrand Cedex 1
country: France
facility: Novartis Investigative Site
city: Créteil
country: France
facility: Novartis Investigative Site
city: Dijon
country: France
facility: Novartis Investigative Site
city: Epinal
country: France
facility: Novartis Investigative Site
city: Grenoble Cedex 9
country: France
facility: Novartis Investigative Site
city: Hagueneau
country: France
facility: Novartis Investigative Site
city: La Rochelle cedex 1
country: France
facility: Novartis Investigative Site
city: La Seyne sur mer
country: France
facility: Novartis Investigative Site
city: Le Kremlin Bicetre
country: France
facility: Novartis Investigative Site
city: Le Mans Cedex 09
country: France
facility: Novartis Investigative Site
city: Limoges
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Metz
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nimes
country: France
facility: Novartis Investigative Site
city: Orsay
country: France
facility: Novartis Investigative Site
city: Paris
country: France
facility: Novartis Investigative Site
city: Poitiers
country: France
facility: Novartis Investigative Site
city: Pontoise
country: France
facility: Novartis Investigative Site
city: Reims
country: France
facility: Novartis Investigative Site
city: Rennes Cedex
country: France
facility: Novartis Investigative Site
city: Roanne
country: France
facility: Novartis Investigative Site
city: Saint Aubin sur Scie
country: France
facility: Novartis Investigative Site
city: Saint Jean
country: France
facility: Novartis Investigative Site
city: Sainte Foy les Lyon
country: France
facility: Novartis Investigative Site
city: Saumur
country: France
facility: Novartis Investigative Site
city: Strasbourg Cedex
country: France
facility: Novartis Investigative Site
city: Talant
country: France
facility: Novartis Investigative Site
city: Toulouse
country: France
facility: Novartis Investigative Site
city: Tourcoing
country: France
facility: Novartis Investigative Site
city: Tours Cedex
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: