Clinical trial NCT02677077: Clinical Disease Activity With Long Term Natalizumab Treatment
Official title: MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: RRMS
MRI
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-02-09
Enrollment: 277
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who have been receiving treatment with natalizumab for ≥24 months.

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.

Eligibility criteria: Key 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 ≤ 6.5.

Key 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.

Primary outcomes:
measure: Change over time in the number of participants free of new or enlarging FLAIR lesions
timeFrame: Treatment years 3 and 4
Secondary outcomes:
measure: Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Annualized brain volume change rate as assessed by percent brain volume change [PBVC]
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Cumulative number of new ≥6-month confirmed T1-hypointense lesions
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Annualized T1-hypointense and FLAIR lesion volume change
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Cumulative percent change in T1-hypointense and FLAIR lesion volume
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Cumulative number of ≥6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Number of total participants and 4-year completers with NEDA as measured by clinical measures
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Number of total participants and 4-year completers with NEDA as measured by radiological measures
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
measure: Number of participants with brain volume loss ≤0.2% and ≤0.4%
timeFrame: Post long term treatment with natalizumab (>2 years) through Year 4
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Research Site 1
city: Brussels
country: Belgium
facility: Research Site 2
city: Overpelt
country: Belgium
facility: Research Site
city: Prague
country: Czechia
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: