Clinical Disease Activity With Long Term Natalizumab Treatment
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Czech Republic Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic |
Drug: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
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| Belgium Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium |
Drug: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change over time in the number of participants free of new or enlarging FLAIR lesions [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 Outcome Measures
- 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 percent brain volume change [PBVC] [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]
- 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]
No relapse and no ≥6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
- 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]
No relapse and no ≥6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC
- 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]
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
- Number of participants with brain volume loss ≤0.2% and ≤0.4% [Post long term treatment with natalizumab (>2 years) through Year 4]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Diagnosis of RRMS.
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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.
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≥1 MRI scan of sufficient quality for reliable measurement.
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Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
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≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
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EDSS ≤ 6.5.
Key Exclusion Criteria:
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Anti-natalizumab antibody detection.
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Prior treatment with alemtuzumab.
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Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site 1 | Brussels | Belgium | ||
| 2 | Research Site 2 | Brussels | Belgium | ||
| 3 | Research Site | Overpelt | Belgium | ||
| 4 | Research Site | Prague | Czechia |
Sponsors and Collaborators
- Biogen
Investigators
- Study Director: Medical Director, Biogen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BEL-TYS-14-10727