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Fingolimod -Response According to Coping - Evaluation (GRACE)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
fingolimod
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Multiple sclerosis, Fingolimod, Coping, Anxiety, France, Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9), Active

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

fingolimod

Arm Description

Outcomes

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).

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2011
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01420055
Brief Title
Fingolimod -Response According to Coping - Evaluation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Multiple sclerosis, Fingolimod, Coping, Anxiety, France, Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9), Active

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fingolimod
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fingolimod
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
Time Frame
4 months
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Agen Cedex 9
ZIP/Postal Code
47923
Country
France
Facility Name
Novartis Investigative Site
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Novartis Investigative Site
City
Angers Cedex 1
ZIP/Postal Code
49033
Country
France
Facility Name
Novartis Investigative Site
City
Auxerre
ZIP/Postal Code
89000
Country
France
Facility Name
Novartis Investigative Site
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Novartis Investigative Site
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Novartis Investigative Site
City
Beziers
ZIP/Postal Code
34525
Country
France
Facility Name
Novartis Investigative Site
City
Bobigny Cedex
ZIP/Postal Code
93009
Country
France
Facility Name
Novartis Investigative Site
City
Brest
ZIP/Postal Code
29240
Country
France
Facility Name
Novartis Investigative Site
City
Calais
ZIP/Postal Code
62107
Country
France
Facility Name
Novartis Investigative Site
City
Castelnau-le-Lez
ZIP/Postal Code
34170
Country
France
Facility Name
Novartis Investigative Site
City
Chambray les Tours
ZIP/Postal Code
37175
Country
France
Facility Name
Novartis Investigative Site
City
Cherbourg
ZIP/Postal Code
50100
Country
France
Facility Name
Novartis Investigative Site
City
Clermont-Ferrand Cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Novartis Investigative Site
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Novartis Investigative Site
City
Epinal
ZIP/Postal Code
88021
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble Cedex 9
ZIP/Postal Code
38042
Country
France
Facility Name
Novartis Investigative Site
City
Hagueneau
ZIP/Postal Code
67500
Country
France
Facility Name
Novartis Investigative Site
City
La Rochelle cedex 1
ZIP/Postal Code
17019
Country
France
Facility Name
Novartis Investigative Site
City
La Seyne sur mer
ZIP/Postal Code
83500
Country
France
Facility Name
Novartis Investigative Site
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novartis Investigative Site
City
Le Mans Cedex 09
ZIP/Postal Code
72037
Country
France
Facility Name
Novartis Investigative Site
City
Limoges
Country
France
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69275
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13012
Country
France
Facility Name
Novartis Investigative Site
City
Metz
ZIP/Postal Code
57085
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Novartis Investigative Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Novartis Investigative Site
City
Nimes
ZIP/Postal Code
32900
Country
France
Facility Name
Novartis Investigative Site
City
Orsay
ZIP/Postal Code
91401
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Novartis Investigative Site
City
Pontoise
ZIP/Postal Code
F-95300
Country
France
Facility Name
Novartis Investigative Site
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Novartis Investigative Site
City
Rennes Cedex
ZIP/Postal Code
35033
Country
France
Facility Name
Novartis Investigative Site
City
Roanne
ZIP/Postal Code
42328
Country
France
Facility Name
Novartis Investigative Site
City
Saint Aubin sur Scie
ZIP/Postal Code
76550
Country
France
Facility Name
Novartis Investigative Site
City
Saint Jean
ZIP/Postal Code
31243
Country
France
Facility Name
Novartis Investigative Site
City
Sainte Foy les Lyon
ZIP/Postal Code
69110
Country
France
Facility Name
Novartis Investigative Site
City
Saumur
ZIP/Postal Code
49400
Country
France
Facility Name
Novartis Investigative Site
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Novartis Investigative Site
City
Talant
ZIP/Postal Code
21240
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Novartis Investigative Site
City
Tourcoing
ZIP/Postal Code
59200
Country
France
Facility Name
Novartis Investigative Site
City
Tours Cedex
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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Fingolimod -Response According to Coping - Evaluation

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