Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— IQUALYSEP  

Official title:

Study Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01065727
• Other study ID #: PHRC/09-06
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2010
• Last updated: November 30, 2012
• Start date: February 2010
• Est. completion date: February 2019

Study information

• Verified date: November 2012
• Source: Rennes University Hospital
• Contact: Le Page Emmanuelle, MD
• Phone: 33-2-9928-5296
• Email: emmanuelle.lepage[@]chu-rennes.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Cost-effectiveness study of 2 disease-modifying therapies (natalizumab versus mitoxantrone followed by immunomodulator) in the management of aggressive remitting multiple sclerosis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 2019
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with remitting multiple sclerosis according to mac Donald criteria

• aggressive remitting multiple sclerosis according to following criteria:

• 2 or less disabling relapse during the 12 months before inclusion

• 1 or more

• EDSS between 2 and 5

• aged less or equal to 40 years old for the women

• effective contraception

Exclusion Criteria:

• patients less than 18 years old

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• mitoxantrone - immunomodulator
mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
• natalizumab
monthly natalizumab during 3 years

Locations

Country	Name	City	State
France	CHU Cavale Blanche	Brest
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cost effectiveness		30 years	No
Secondary	progressive neurological disability		3 years	No