Fingolimod -Response According to Coping - Evaluation (GRACE)

This study is currently recruiting participants.

Verified December 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01420055

First received: August 17, 2011

Last updated: December 7, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 17, 2011

Last Updated Date

December 7, 2012

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01420055 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fingolimod -Response According to Coping - Evaluation

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Multiple Sclerosis, Relapsing-Remitting

Intervention ^ICMJE

Drug: fingolimod

Study Arm (s)

Experimental: fingolimod

Intervention: Drug: fingolimod

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

May 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+41-61-324-1111

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01420055

Other Study ID Numbers ^ICMJE

CFTY720DFR03, 2011-001280-49

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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