NCT02677077

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

December 31, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2016

Completed
Last Updated

January 4, 2019

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

December 3, 2015

Last Update Submit

January 3, 2019

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

RRMSMRI

Outcome Measures

Primary Outcomes (1)

  • 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).

    Treatment years 3 and 4

Secondary Outcomes (10)

  • 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 percent brain volume change [PBVC]

    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

  • Annualized T1-hypointense and FLAIR lesion volume change

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

  • +5 more secondary outcomes

Study Arms (2)

Czech Republic

Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic

Drug: natalizumab

Belgium

Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium

Drug: natalizumab

Interventions

natalizumabDRUG

Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Also known as: BG00002, Tysabri
BelgiumCzech Republic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants who have been receiving treatment with natalizumab for ≥24 months.

You may qualify if:

  • 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.

You may not qualify if:

  • Anti-natalizumab antibody detection.
  • Prior treatment with alemtuzumab.
  • Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site 1

Brussels, Belgium

Location

Research Site 2

Brussels, Belgium

Location

Research Site

Overpelt, Belgium

Location

Research Site

Prague, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2015

First Posted

February 9, 2016

Study Start

December 31, 2015

Primary Completion

August 18, 2016

Study Completion

August 18, 2016

Last Updated

January 4, 2019

Record last verified: 2018-12

Locations

CZ(1)BE(3)