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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
189
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
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
Time frame: 4 months
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
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
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Angers, France, France
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Agen, France
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Amiens, France
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Auxerre, France
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Avignon, France
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Bayonne, France
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Béziers, France
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Bobigny, France
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Brest, France
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Calais, France
...and 37 more locations