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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

August 17, 2011
January 17, 2014
August 2011
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01420055 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Fingolimod -Response According to Coping - Evaluation
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Drug: fingolimod
Experimental: fingolimod
Intervention: Drug: fingolimod
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
189
June 2013
June 2013   (final data collection date for primary outcome measure)

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

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01420055
CFTY720DFR03, 2011-001280-49
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2014

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