GRACE: Fingolimod -Response According to Coping - Evaluation

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01420055

Collaborator

(none)

189

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Relapsing-Remitting	Drug: fingolimod	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

189 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fingolimod	Drug: fingolimod

Arm

Intervention/Treatment

Experimental: fingolimod

Drug: fingolimod

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile. [4 months]
To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset) [4 months]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Agen Cedex 9	France	47923
2	Novartis Investigative Site	Amiens Cedex 1	France	80054
3	Novartis Investigative Site	Angers Cedex 1	France	49033
4	Novartis Investigative Site	Auxerre	France	89000
5	Novartis Investigative Site	Avignon	France	84000
6	Novartis Investigative Site	Bayonne	France	64109
7	Novartis Investigative Site	Beziers	France	34525
8	Novartis Investigative Site	Bobigny Cedex	France	93009
9	Novartis Investigative Site	Brest	France	29240
10	Novartis Investigative Site	Calais	France	62107
11	Novartis Investigative Site	Castelnau-le-Lez	France	34170
12	Novartis Investigative Site	Chambray les Tours	France	37175
13	Novartis Investigative Site	Cherbourg	France	50100
14	Novartis Investigative Site	Clermont-Ferrand Cedex 1	France	63003
15	Novartis Investigative Site	Créteil	France	94010
16	Novartis Investigative Site	Dijon	France	21034
17	Novartis Investigative Site	Epinal	France	88021
18	Novartis Investigative Site	Grenoble Cedex 9	France	38042
19	Novartis Investigative Site	Hagueneau	France	67500
20	Novartis Investigative Site	La Rochelle cedex 1	France	17019
21	Novartis Investigative Site	La Seyne sur mer	France	83500
22	Novartis Investigative Site	Le Kremlin Bicetre	France	94275
23	Novartis Investigative Site	Le Mans Cedex 09	France	72037
24	Novartis Investigative Site	Limoges	France
25	Novartis Investigative Site	Lyon	France	69275
26	Novartis Investigative Site	Marseille	France	13008
27	Novartis Investigative Site	Marseille	France	13012
28	Novartis Investigative Site	Metz	France	57085
29	Novartis Investigative Site	Montpellier	France	34000
30	Novartis Investigative Site	Montpellier	France	34295
31	Novartis Investigative Site	Nimes	France	32900
32	Novartis Investigative Site	Orsay	France	91401
33	Novartis Investigative Site	Paris	France	75005
34	Novartis Investigative Site	Poitiers	France	86021
35	Novartis Investigative Site	Pontoise	France	F-95300
36	Novartis Investigative Site	Reims	France	51092
37	Novartis Investigative Site	Rennes Cedex	France	35033
38	Novartis Investigative Site	Roanne	France	42328
39	Novartis Investigative Site	Saint Aubin sur Scie	France	76550
40	Novartis Investigative Site	Saint Jean	France	31243
41	Novartis Investigative Site	Sainte Foy les Lyon	France	69110
42	Novartis Investigative Site	Saumur	France	49400
43	Novartis Investigative Site	Strasbourg Cedex	France	67091
44	Novartis Investigative Site	Talant	France	21240
45	Novartis Investigative Site	Toulouse	France	31059
46	Novartis Investigative Site	Tourcoing	France	59200
47	Novartis Investigative Site	Tours Cedex	France	37044