multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial

• Conditions: patients with relapsing remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2006-004937-13-IT
• Lead Sponsor: niversita di Firenze

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

age 18-55 years; diagnosis of multiple sclerosis McDonald criteria 2001 with relapsin remitting course; at least 2 exacerbation in the preceding 2 years;Baseline EDSS score of 1 to 5,5; no clinical relapses within 30 days of study entry;effective method of contraception if women with childbearing potential; signed informed patient consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

immunomodulatory or immunosoppressive tratments in the preceding 6 mounths; steroid therapy in the last 30 days before study entry; concomitant diseases precluding interferon beta or azathioprine treatment; pregnancy or breastfeeding; inability to give the informed consent; pathological conditions interfering with multiple sclerosis evolution; allergy to paracetamol or known intolerance to azathioprine or interferon beta.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to directly compare in patients with relapsing remitting multiple sclerosis azathioprine to Interferon beta efficacy in modifying disease activity.;Secondary Objective: safety profile of azathioprina and interferon beta and their impact on quality of life;Primary end point(s): cumulative relapse count per patient over 2 years.