MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
Overview
- Phase
- Not Applicable
- Intervention
- natalizumab
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Sponsor
- Biogen
- Enrollment
- 277
- Locations
- 3
- Primary Endpoint
- Change over time in the number of participants free of new or enlarging FLAIR lesions
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.
Detailed Description
Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of RRMS.
- •Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
- •≥1 MRI scan of sufficient quality for reliable measurement.
- •Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
- •≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
- •EDSS ≤ 6.
Exclusion Criteria
- •Anti-natalizumab antibody detection.
- •Prior treatment with alemtuzumab.
- •Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
Intervention: natalizumab
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
Intervention: natalizumab
Outcomes
Primary Outcomes
Change over time in the number of participants free of new or enlarging FLAIR lesions
Time Frame: Treatment years 3 and 4
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
Secondary Outcomes
- Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF](Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative number of new ≥6-month confirmed T1-hypointense lesions(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of participants with brain volume loss ≤0.2% and ≤0.4%(Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized brain volume change rate as assessed by percent brain volume change [PBVC](Post long term treatment with natalizumab (>2 years) through Year 4)
- Annualized T1-hypointense and FLAIR lesion volume change(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative percent change in T1-hypointense and FLAIR lesion volume(Post long term treatment with natalizumab (>2 years) through Year 4)
- Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of total participants and 4-year completers with NEDA as measured by clinical measures(Post long term treatment with natalizumab (>2 years) through Year 4)
- Number of total participants and 4-year completers with NEDA as measured by radiological measures(Post long term treatment with natalizumab (>2 years) through Year 4)