Fingolimod -Response According to Coping - Evaluation (GRACE)
This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
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
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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:
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
Hide Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | +41-61-324-1111 |
Hide Study LocationsLocations
| France | |
| Novartis Investigative Site | Not yet recruiting |
| Agen Cedex 9, France, 47923 | |
| Novartis Investigative Site | Not yet recruiting |
| Aix en Provence Cedex 1, France, 13616 | |
| Novartis Investigative Site | Not yet recruiting |
| Amiens Cedex 1, France, 80054 | |
| Novartis Investigative Site | Recruiting |
| Angers, France, 49 033 | |
| Novartis Investigative Site | Not yet recruiting |
| Auxerre, France, 89000 | |
| Novartis Investigative Site | Not yet recruiting |
| Avignon, France, 84000 | |
| Novartis Investigative Site | Not yet recruiting |
| Bayonne, France, 64109 | |
| Novartis Investigative Site | Not yet recruiting |
| Beziers, France, 34525 | |
| Novartis Investigative Site | Not yet recruiting |
| Bobigny Cedex, France, 93009 | |
| Novartis Investigative Site | Not yet recruiting |
| Boulogne-sur-Mer, France, 62321 | |
| Novartis Investigative Site | Not yet recruiting |
| Brest, France, 29240 | |
| Novartis Investigative Site | Not yet recruiting |
| Calais, France, 62107 | |
| Novartis Investigative Site | Not yet recruiting |
| Castelnau-le-Lez, France, 34170 | |
| Novartis Investigative Site | Not yet recruiting |
| Chambray les Tours, France, 37175 | |
| Novartis Investigative Site | Not yet recruiting |
| Cherbourg, France, 50100 | |
| Novartis Investigative Site | Not yet recruiting |
| Clermont-Ferrand Cedex 1, France, 63003 | |
| Novartis Investigative Site | Not yet recruiting |
| Créteil, France, 94010 | |
| Novartis Investigative Site | Not yet recruiting |
| Dijon, France, 21034 | |
| Novartis Investigative Site | Not yet recruiting |
| Epinal, France, 88021 | |
| Novartis Investigative Site | Not yet recruiting |
| Grenoble Cedex 9, France, 38042 | |
| Novartis Investigative Site | Not yet recruiting |
| Hagueneau, France, 67500 | |
| Novartis Investigative Site | Not yet recruiting |
| La Rochelle cedex 1, France, 17019 | |
| Novartis Investigative Site | Not yet recruiting |
| La Seyne sur mer, France, 83500 | |
| Novartis Investigative Site | Not yet recruiting |
| Le Kremlin Bicetre, France, 94275 | |
| Novartis Investigative Site | Not yet recruiting |
| Le Mans Cedex 09, France, 72037 | |
| Novartis Investigative Site | Not yet recruiting |
| Limoges, France, 87100 | |
| Novartis Investigative Site | Not yet recruiting |
| Limoges, France | |
| Novartis Investigative Site | Not yet recruiting |
| Lyon, France, 69275 | |
| Novartis Investigative Site | Not yet recruiting |
| Marseille, France, 13008 | |
| Novartis Investigative Site | Not yet recruiting |
| Marseille, France, 13012 | |
| Novartis Investigative Site | Not yet recruiting |
| Metz, France, 57085 | |
| Novartis Investigative Site | Not yet recruiting |
| Montpellier, France, 34295 | |
| Novartis Investigative Site | Not yet recruiting |
| Montpellier, France, 34000 | |
| Novartis Investigative Site | Not yet recruiting |
| Nimes, France, 32900 | |
| Novartis Investigative Site | Not yet recruiting |
| Orleans, France, 45100 | |
| Novartis Investigative Site | Not yet recruiting |
| Orsay, France, 91401 | |
| Novartis Investigative Site | Not yet recruiting |
| Paris, France, 75005 | |
| Novartis Investigative Site | Not yet recruiting |
| Paris, France, 75013 | |
| Novartis Investigative Site | Not yet recruiting |
| Pau, France, 64046 | |
| Novartis Investigative Site | Not yet recruiting |
| Poissy, France, 78303 | |
| Novartis Investigative Site | Not yet recruiting |
| Poitiers, France, 86021 | |
| Novartis Investigative Site | Not yet recruiting |
| Pontoise, France, F-95300 | |
| Novartis Investigative Site | Not yet recruiting |
| Reims, France, 51092 | |
| Novartis Investigative Site | Not yet recruiting |
| Rennes Cedex, France, 35033 | |
| Novartis Investigative Site | Not yet recruiting |
| Roanne, France, 42328 | |
| Novartis Investigative Site | Not yet recruiting |
| Saint Aubin sur Scie, France, 76550 | |
| Novartis Investigative Site | Not yet recruiting |
| Saint Jean, France, 31243 | |
| Novartis Investigative Site | Not yet recruiting |
| Sainte Foy les Lyon, France, 69110 | |
| Novartis Investigative Site | Not yet recruiting |
| Saumur, France, 49400 | |
| Novartis Investigative Site | Not yet recruiting |
| Strasbourg Cedex, France, 67091 | |
| Novartis Investigative Site | Not yet recruiting |
| Talant, France, 21240 | |
| Novartis Investigative Site | Not yet recruiting |
| Toulouse, France, 31059 | |
| Novartis Investigative Site | Not yet recruiting |
| Tourcoing, France, 59200 | |
| Novartis Investigative Site | Not yet recruiting |
| Tours Cedex, France, 37044 | |
| Novartis Investigative Site | Not yet recruiting |
| Vichy, France, 03201 | |
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 June 18, 2013