Status:
COMPLETED
Fingolimod -Response According to Coping - Evaluation
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT01420055
Start Date
August 1 2011
End Date
June 1 2013
Last Update
November 18 2016
Active Locations (47)
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1
Novartis Investigative Site
Angers, France, France, 49033
2
Novartis Investigative Site
Agen, France, 47923
3
Novartis Investigative Site
Amiens, France, 80054
4
Novartis Investigative Site
Auxerre, France, 89000