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Fingolimod -Response According to Coping - Evaluation (GRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420055
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
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 : August 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: fingolimod Drug: fingolimod

Primary Outcome Measures :
  1. 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). [ Time Frame: 4 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01420055

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Novartis Investigative Site
Agen Cedex 9, France, 47923
Novartis Investigative Site
Amiens Cedex 1, France, 80054
Novartis Investigative Site
Angers Cedex 1, France, 49033
Novartis Investigative Site
Auxerre, France, 89000
Novartis Investigative Site
Avignon, France, 84000
Novartis Investigative Site
Bayonne, France, 64109
Novartis Investigative Site
Beziers, France, 34525
Novartis Investigative Site
Bobigny Cedex, France, 93009
Novartis Investigative Site
Brest, France, 29240
Novartis Investigative Site
Calais, France, 62107
Novartis Investigative Site
Castelnau-le-Lez, France, 34170
Novartis Investigative Site
Chambray les Tours, France, 37175
Novartis Investigative Site
Cherbourg, France, 50100
Novartis Investigative Site
Clermont-Ferrand Cedex 1, France, 63003
Novartis Investigative Site
Créteil, France, 94010
Novartis Investigative Site
Dijon, France, 21034
Novartis Investigative Site
Epinal, France, 88021
Novartis Investigative Site
Grenoble Cedex 9, France, 38042
Novartis Investigative Site
Hagueneau, France, 67500
Novartis Investigative Site
La Rochelle cedex 1, France, 17019
Novartis Investigative Site
La Seyne sur mer, France, 83500
Novartis Investigative Site
Le Kremlin Bicetre, France, 94275
Novartis Investigative Site
Le Mans Cedex 09, France, 72037
Novartis Investigative Site
Limoges, France
Novartis Investigative Site
Lyon, France, 69275
Novartis Investigative Site
Marseille, France, 13008
Novartis Investigative Site
Marseille, France, 13012
Novartis Investigative Site
Metz, France, 57085
Novartis Investigative Site
Montpellier, France, 34000
Novartis Investigative Site
Montpellier, France, 34295
Novartis Investigative Site
Nimes, France, 32900
Novartis Investigative Site
Orsay, France, 91401
Novartis Investigative Site
Paris, France, 75005
Novartis Investigative Site
Poitiers, France, 86021
Novartis Investigative Site
Pontoise, France, F-95300
Novartis Investigative Site
Reims, France, 51092
Novartis Investigative Site
Rennes Cedex, France, 35033
Novartis Investigative Site
Roanne, France, 42328
Novartis Investigative Site
Saint Aubin sur Scie, France, 76550
Novartis Investigative Site
Saint Jean, France, 31243
Novartis Investigative Site
Sainte Foy les Lyon, France, 69110
Novartis Investigative Site
Saumur, France, 49400
Novartis Investigative Site
Strasbourg Cedex, France, 67091
Novartis Investigative Site
Talant, France, 21240
Novartis Investigative Site
Toulouse, France, 31059
Novartis Investigative Site
Tourcoing, France, 59200
Novartis Investigative Site
Tours Cedex, France, 37044
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01420055    
Other Study ID Numbers: CFTY720DFR03
2011-001280-49 ( EudraCT Number )
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple sclerosis
Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9)
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs