Fingolimod -Response According to Coping - Evaluation

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— GRACE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420055
• Other study ID #: CFTY720DFR03
• Secondary ID: 2011-001280-49
• Status: Completed
• Phase: Phase 4
• First received: August 17, 2011
• Last updated: November 16, 2016
• Start date: August 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: French Health Authorities (Afssaps)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• fingolimod

Locations

Country	Name	City	State
France	Novartis Investigative Site	Agen Cedex 9
France	Novartis Investigative Site	Amiens Cedex 1
France	Novartis Investigative Site	Angers Cedex 1
France	Novartis Investigative Site	Auxerre
France	Novartis Investigative Site	Avignon
France	Novartis Investigative Site	Bayonne
France	Novartis Investigative Site	Beziers
France	Novartis Investigative Site	Bobigny Cedex
France	Novartis Investigative Site	Brest
France	Novartis Investigative Site	Calais
France	Novartis Investigative Site	Castelnau-le-Lez
France	Novartis Investigative Site	Chambray les Tours
France	Novartis Investigative Site	Cherbourg
France	Novartis Investigative Site	Clermont-Ferrand Cedex 1
France	Novartis Investigative Site	Créteil
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Epinal
France	Novartis Investigative Site	Grenoble Cedex 9
France	Novartis Investigative Site	Hagueneau
France	Novartis Investigative Site	La Rochelle cedex 1
France	Novartis Investigative Site	La Seyne sur mer
France	Novartis Investigative Site	Le Kremlin Bicetre
France	Novartis Investigative Site	Le Mans Cedex 09
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Metz
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nimes
France	Novartis Investigative Site	Orsay
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Pontoise
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Rennes Cedex
France	Novartis Investigative Site	Roanne
France	Novartis Investigative Site	Saint Aubin sur Scie
France	Novartis Investigative Site	Saint Jean
France	Novartis Investigative Site	Sainte Foy les Lyon
France	Novartis Investigative Site	Saumur
France	Novartis Investigative Site	Strasbourg Cedex
France	Novartis Investigative Site	Talant
France	Novartis Investigative Site	Toulouse
France	Novartis Investigative Site	Tourcoing
France	Novartis Investigative Site	Tours Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		4 months	No
Secondary	To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.		4 months	No
Secondary	To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset)		4 months	Yes
Secondary	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		4 months	No

External Links

•   Results for CFTY720DFR03 from the Novartis Clinical Trials website