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Clinical Disease Activity With Long Term Natalizumab Treatment

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ClinicalTrials.gov Identifier: NCT02677077
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

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.

Condition or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis Drug: natalizumab

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.

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Study Type : Observational
Actual Enrollment : 277 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
Actual Study Start Date : December 31, 2015
Actual Primary Completion Date : August 18, 2016
Actual Study Completion Date : August 18, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Group/Cohort Intervention/treatment
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
Drug: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
  • BG00002
  • Tysabri

Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
Drug: natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
  • BG00002
  • Tysabri




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants who have been receiving treatment with natalizumab for ≥24 months.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677077


Locations
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Belgium
Research Site 1
Brussels, Belgium
Research Site 2
Brussels, Belgium
Research Site
Overpelt, Belgium
Czechia
Research Site
Prague, Czechia
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02677077    
Other Study ID Numbers: BEL-TYS-14-10727
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: December 2018
Keywords provided by Biogen:
RRMS
MRI
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs