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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01420055

Acronym

GRACE

Enrollment

189

Registered

2011-08-19

Start date

2011-08-31

Completion date

2013-06-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple sclerosis, Fingolimod, Coping, Anxiety, France, Treatment Satisfaction Questionnaire for Medication-9 items (TSQM 9), Active

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 sclerosis in France.

Interventions

DRUGfingolimod

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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
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	4 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026