IQUALYSEP: Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple Sclerosis

• Sponsor: Rennes University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01065727
• Collaborator: (none)
• Enrollment: 250
• Locations: 2
• Arms: 2
• Duration (Months): 108
• Patients Per Site: 125
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: mitoxantrone - immunomodulator; Other: natalizumab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Health Services Research
• 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
• Study Start Date: Feb 1, 2010
• Anticipated Primary Completion Date: Feb 1, 2016
• Anticipated Study Completion Date: Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mitoxantrone followed by immunomodulator	Other: mitoxantrone - immunomodulator; mitoxantrone during 6 months and followed by immunomodulator during 2 years and half
Active Comparator: natalizumab	Other: natalizumab; monthly natalizumab during 3 years

Outcome Measures

Primary Outcome Measures

1. cost effectiveness [30 years]

Secondary Outcome Measures

1. progressive neurological disability [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Cavale Blanche	Brest		France	29609
2	CHU Rennes	Rennes		France	35033

Sponsors and Collaborators

• Rennes University Hospital

Investigators

• Principal Investigator: Edan Gilles, MD PhD, Rennes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rennes University Hospital
• ClinicalTrials.gov Identifier: NCT01065727
• Other Study ID Numbers: PHRC/09-06
• First Posted: Feb 9, 2010
• Last Update Posted: Dec 3, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Rennes University Hospital: Reemitting aggressive multiple sclerosis
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis; Aggression; Mitoxantrone; Natalizumab; Immunologic Factors; Adjuvants, Immunologic

Study Results

No Results Posted as of Dec 3, 2012