Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Phase 4

Terminated

Conditions: Relapsing-Remitting Multiple Sclerosis

Interventions: Drug: natalizumab
Drug: fingolimod

Registration Number: NCT02342704

Lead Sponsor: Biogen

Brief Summary: The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).

Detailed Description: This study also includes a Diffusion Tensor Imaging (DTI) sub-study that includes healthy volunteers. Healthy volunteers will not receive any study medication.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
natalizumab	natalizumab	Open-label natalizumab 300 mg IV every 4 weeks (Q4W)
fingolimod	fingolimod	Open-label fingolimod 0.5 mg once daily orally

Primary Outcome Measures

Name	Time	Method
Cumulative Number of ≥ 6-Month Confirmed T1-Hypointense Lesions Arising From New On-Treatment T1-Gadolinium-Enhancing (Gd+) Lesions	Up to Week 52

Secondary Outcome Measures

Name	Time	Method
Cumulative Number of New T1-Gd+ Lesions	Baseline, Week 4, Week 12, Week 24
Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 24	Baseline, Week 24	As assessed by magnetic resonance imaging (MRI).
Change From Baseline in Total T1-Hypointense and Total T2-Hyperintense Lesion Volumes at Week 52	Baseline, Week 52	As assessed by MRI.
Cumulative Number of New or Enlarging T2 Lesions	Baseline, Week 24
Proportion of Participants With No Evidence of Disease Activity (NEDA)	Up to Week 52	NEDA was defined as all of the following: no relapses; no 12-week confirmed disability progression based on Expanded Disability Status Scale (EDSS; defined as an increase of 1.0 or more on the EDSS from baseline of 1.0 or more, or an increase of 1.5 or more from a baseline score of 0) that was sustained for 12 weeks; no new T1-Gd+ lesions on brain MRI. No new or enlarging T2-hyperintense lesions.
Time to First Relapse	Up to Week 52	A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.
Cumulative Risk of Relapse	Up to Week 52	A clinical relapse was defined as new or recurrent neurological symptoms, not associated with fever, lasting for at least 24 hours, and followed by a period of 30 days of stability or improvement.
Time to Complete Recovery From First Relapse	Up to Week 52	12-week confirmed complete EDSS recovery from first on-treatment relapse is defined as an EDSS score that is equal to or lower than the last pre-relapse EDSS score and sustained for at least 12 weeks.
Change From Baseline in Symbol Digit Modalities Test (SDMT) at Week 24	Baseline, Week 24	The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.
Change From Baseline in SDMT at Week 52	Baseline, Week 52	The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution.