Fingolimod -Response According to Coping - Evaluation

Phase 4

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: fingolimod

• Registration Number: NCT01420055
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-17
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fingolimod	fingolimod	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇫🇷 Tours Cedex, France