EUCTR2012-004040-30-AT
Active, not recruiting
Not Applicable
atalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study
Ospedale Regionale di Lugano0 sites72 target enrollmentMarch 12, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ospedale Regionale di Lugano
- Enrollment
- 72
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •· Female or male patients with relapsing\-remitting forms of multiple
- •sclerosis (according to McDonald's criteria);
- •· Age between 18 and 70 years;
- •· Natalizumab\-treatment for at least 12 months following the current Swiss guidelines for treatment initiation;
- •· Treated with a disease\-modifying therapy other than interferon beta\-1b for at least 12 months before natalizumab was initiated;
- •· Never treated with interferon beta\-1b;
- •· Eligible patients are clinically stable (free from relapses and 6\-month confirmed disability progression for at least 6 months) while on natalizumab\-treatment and do not show any Gd\-enhancement on their last MRI performed while on Tysabri;
- •· In eligible patients MRI were performed in the past as following
- •a) 6\-18 months prior to natalizumab\-treatment
- •b) at natalizumab start
Exclusion Criteria
- •· Patients who have previously entered this study;
- •· Natalizumab\-treatment for less than 12 months following the current Swiss guidelines for treatment initiation;
- •· Prior treatment with interferon beta\-1b (ever interferon beta\-1b);
- •· Sign of clinical disease activity within the 6 months;
- •· One or more relapses and/or 6\-month confirmed disability
- •progression during the 6 months prior to the study;
- •· Secondary progressive MS;
- •· Primary progressive MS;
- •· Pregnancy \- Serum pregnancy test at screening visit positive\- or
- •breast feeding;
Outcomes
Primary Outcomes
Not specified
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