Fingolimod -Response According to Coping - Evaluation (GRACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01420055
First received: August 17, 2011
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Drug: fingolimod
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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). [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 189
Study Start Date: August 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fingolimod Drug: fingolimod

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420055

Locations
France
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, 13012
Novartis Investigative Site
Marseille, France, 13008
Novartis Investigative Site
Metz, France, 57085
Novartis Investigative Site
Montpellier, France, 34295
Novartis Investigative Site
Montpellier, France, 34000
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01420055     History of Changes
Other Study ID Numbers: CFTY720DFR03, 2011-001280-49
Study First Received: August 17, 2011
Last Updated: January 17, 2014
Health Authority: United States: Food and Drug Administration
France: French Health Authorities (Afssaps)

Keywords provided by Novartis:
Multiple sclerosis
Fingolimod
Coping
Anxiety
France
Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9)
Active

Additional relevant MeSH terms:
Sclerosis
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014