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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
  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: 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 250
Study Start Date: August 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420055

Contacts
Contact: Novartis Pharmaceuticals +41-61-324-1111

  Show 55 Study Locations
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: December 7, 2012
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:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013