Fingolimod -Response According to Coping - Evaluation

NCT01420055 | Completed Phase 4

• 2 other identifiers: CFTY720DFR032011-001280-49
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 47

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

fingolimod

EXPERIMENTAL

Drug: fingolimod

Interventions

fingolimod DRUG

fingolimod

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old male \& female with RRMS (2005 revised McDonald criteria) corresponding to fingolimod indication (in Europe) and EDSS score 0 - 5.5 inclusive

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (47)

Novartis Investigative Site

Angers, France, 49033, France

Location

Novartis Investigative Site

Agen, 47923, France

Location

Novartis Investigative Site

Amiens, 80054, France

Location

Novartis Investigative Site

Auxerre, 89000, France

Location

Novartis Investigative Site

Avignon, 84000, France

Location

Novartis Investigative Site

Bayonne, 64109, France

Location

Novartis Investigative Site

Béziers, 34525, France

Location

Novartis Investigative Site

Bobigny, 93009, France

Location

Novartis Investigative Site

Brest, 29240, France

Location

Novartis Investigative Site

Calais, 62107, France

Location

Novartis Investigative Site

Castelnau-le-Lez, 34170, France

Location

Novartis Investigative Site

Chambray-lès-Tours, 37175, France

Location

Novartis Investigative Site

Cherbourg, 50100, France

Location

Novartis Investigative Site

Clermont-Ferrand, 63003, France

Location

Novartis Investigative Site

Créteil, 94010, France

Location

Novartis Investigative Site

Dijon, 21034, France

Location

Novartis Investigative Site

Épinal, 88021, France

Location

Novartis Investigative Site

Grenoble, 38042, France

Location

Novartis Investigative Site

Hagueneau, 67500, France

Location

Novartis Investigative Site

La Rochelle, 17019, France

Location

Novartis Investigative Site

La Seyne-sur-Mer, 83500, France

Location

Novartis Investigative Site

Le Kremlin-Bicêtre, 94275, France

Location

Novartis Investigative Site

Le Mans, 72037, France

Location

Novartis Investigative Site

Limoges, France

Location

Novartis Investigative Site

Lyon, 69275, France

Location

Novartis Investigative Site

Marseille, 13008, France

Location

Novartis Investigative Site

Marseille, 13012, France

Location

Novartis Investigative Site

Metz, 57085, France

Location

Novartis Investigative Site

Montpellier, 34000, France

Location

Novartis Investigative Site

Montpellier, 34295, France

Location

Novartis Investigative Site

Nîmes, 32900, France

Location

Novartis Investigative Site

Orsay, 91401, France

Location

Novartis Investigative Site

Paris, 75005, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Pontoise, F-95300, France

Location

Novartis Investigative Site

Reims, 51092, France

Location

Novartis Investigative Site

Rennes, 35033, France

Location

Novartis Investigative Site

Roanne, 42328, France

Location

Novartis Investigative Site

Saint-Aubin-sur-Scie, 76550, France

Location

Novartis Investigative Site

Saint-Jean, 31243, France

Location

Novartis Investigative Site

Sainte-Foy-lès-Lyon, 69110, France

Location

Novartis Investigative Site

Saumur, 49400, France

Location

Novartis Investigative Site

Strasbourg, 67091, France

Location

Novartis Investigative Site

Talant, 21240, France

Location

Novartis Investigative Site

Toulouse, 31059, France

Location

Novartis Investigative Site

Tourcoing, 59200, France

Location

Novartis Investigative Site

Tours, 37044, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Anxiety Disorders; Motor Activity

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 18, 2016

Record last verified: 2016-11

Locations

FR (47)