Clinical Disease Activity With Long Term Natalizumab Treatment
- Registration Number
- NCT02677077
- Lead Sponsor
- Biogen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- 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 ≤ 6.5.
Key
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Belgium natalizumab Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium Czech Republic natalizumab Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
- Primary Outcome Measures
Name Time Method 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
Name Time Method Annualized T1-hypointense and FLAIR lesion volume change 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 % 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 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
Trial Locations
- Locations (3)
Research Site
🇨🇿Prague, Czechia
Research Site 2
🇧🇪Brussels, Belgium
Research Site 1
🇧🇪Brussels, Belgium