EUCTR2013-004622-29-ITActive, not recruitingNot Applicable
A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Biogen Idec Research Limited
- Enrollment
- 540
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion Criteria for MS Patients:
- •- Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria [Polman 2011]) at study screening.
- •- If the subject is on BRACE at study screening:
- •He/she must have been on therapy for at least 12 months, and
- •Experienced =1 relapse within the last 6 months prior to study screening with =1 new T1-Gd+ lesion or =2 new T2 lesions on a brain MRI scan performed =6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening.
- •- If the subject is DMT naïve at study screening, he/she must have experienced =2 relapses in the 12 months prior to study screening. In addition, they must have had =1 new T1-Gd+ lesion or =2 new T2 lesions on a brain MRI scan performed =6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months prior to study screening.
- •- Willing to take natalizumab or fingolimod as the only DMTs for the duration of the study.
- •- Must have an EDSS score from 0 to 5.5 inclusive at study screening.
- •Inclusion Criteria for Healthy Volunteers:
- •- Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.
- •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 540
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •Exclusion Criteria for MS Patients:
- •- History of or positive test result at study screening for human immunodeficiency virus (HIV).
- •- History or positive test result at study screening for hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and positive HBcAb) are eligible to participate in the study (definitions are based on the United States (US) Centers for Disease Control and Prevention [CDC]’s interpretation of the hepatitis B serology panel).
- •- Prior treatment with natalizumab or fingolimod
- •- Diagnosis of Primary Progressive Multiple Sclerosis [PPMS] and/or Secondary Progressive Multiple Sclerosis [SPMS]
- •-Exclusion Criteria for Healthy Volunteers:
- •- Claustrophobia sufficient to interfere with generating reliable MRI scans
- •- History of other major illness including neurological disorders as determined by the Investigator
- •- Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects), which would be a contraindication for MRI
Investigators
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