Fingolimod -Response According to Coping - Evaluation (GRACE)

November 16, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

189

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fingolimod
Drug: fingolimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
Time Frame: 4 months
4 months
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
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
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

August 17, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFTY720DFR03
  • 2011-001280-49 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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