Fingolimod -Response According to Coping - Evaluation (GRACE)

Novartis

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: fingolimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT01420055

CFTY720DFR03

2011-001280-49 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

189 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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