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Completed

NCT Number: NCT02677077

Clinical Disease Activity With Long Term Natalizumab Treatment

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.

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site 1, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Other names: BG00002, Tysabri

Primary outcomes

  1. Change over time in the number of participants free of new or enlarging FLAIR lesions

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

  4. Cumulative number of new ≥6-month confirmed T1-hypointense lesions

    Time frame: Post long term treatment with natalizumab (>2 years) through Year 4

  5. Annualized T1-hypointense and FLAIR lesion volume change

    Time frame: Post long term treatment with natalizumab (>2 years) through Year 4

  6. Cumulative percent change in T1-hypointense and FLAIR lesion volume

    Time frame: Post long term treatment with natalizumab (>2 years) through Year 4

  7. 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

    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

  8. 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

    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

  9. 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

    No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions

  10. 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

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2016
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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