Overview

This trial is active, not recruiting.

Condition relapsing-remitting multiple sclerosis (rrms)
Treatment natalizumab
Sponsor Biogen
Start date December 2015
End date June 2017
Trial size 277 participants
Trial identifier NCT02677077, BEL-TYS-14-10727

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
natalizumab BG00002
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
natalizumab BG00002
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Primary Outcomes

Measure
Change over time in the number of participants free of new or enlarging FLAIR lesions
time frame: Treatment years 3 and 4

Secondary Outcomes

Measure
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
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
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
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Biogen.