Fingolimod -Response According to Coping - Evaluation
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
What it found
We found no results in the registry or in papers.
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
What it measured
Main 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).
4 months
Bladder, bowel and sexual functionMood and sleepSous-score d’anxiété de l’HADS
Mood and sleep
Other measures (4)
To assess patient Clinical Global Impression (CGI) and clinician CGI at M4 in total population, and according to coping profile.
4 months
To evaluate the safety and tolerability of fingolimod 0.5 mg/day (especially initial cardiac effects, liver function and macular edema onset)
4 months
SafetyTo 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
4 months
Quality of life (reported by participants)Score CGI-I (impression clinique globale-amélioration)patient et clinicien
Who could take part
Relapsing MS · 18 to 65 · EDSS 0 to 5.5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Aug 2011
Main results due
Jun 2013
Finished
Jun 2013