An observational study in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 4 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by Biogen · Observational
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.
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.
615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.
This study's enrollment of 277 is above the median of 115 across 154 observational studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have been receiving treatment with natalizumab for ≥24 months.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
Drug: natalizumab
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
Drug: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Also known as: BG00002, Tysabri
Change over time in the number of participants free of new or enlarging FLAIR lesions
Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).
Time frame: Treatment years 3 and 4
Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
Time frame: 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)
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative number of new ≥6-month confirmed T1-hypointense lesions
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Annualized T1-hypointense and FLAIR lesion volume change
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Cumulative percent change in T1-hypointense and FLAIR lesion volume
Time frame: 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
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
Time frame: 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
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
Time frame: 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
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Number of participants with brain volume loss ≤0.2% and ≤0.4%
Time frame: Post long term treatment with natalizumab (>2 years) through Year 4
Ran from Dec 2015 to primary completion in Aug 2016, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Relapsing-Remitting →