Trial record 8 of 21 for:    Tysabri | Open Studies

Clinical Disease Activity With Long Term Natalizumab Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Biogen
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT02677077
First received: December 3, 2015
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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 Intervention
Relapsing-Remitting Multiple Sclerosis (RRMS)
Drug: natalizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Change over time in the number of participants free of new or enlarging FLAIR lesions [ Time Frame: Treatment years 3 and 4 ] [ Designated as safety issue: No ]
    Lesions that are ≥5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cumulative number of new ≥6-month confirmed T1-hypointense lesions [ Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4 ] [ Designated as safety issue: No ]
  • Annualized T1-hypointense and FLAIR lesion volume change [ Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4 ] [ Designated as safety issue: No ]
  • Cumulative percent change in T1-hypointense and FLAIR lesion volume [ Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions

  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02677077

Contacts
Contact: Biogen clinicaltrials@biogen.com

Locations
Belgium
Research Site Completed
Brussels, Belgium
Research Site Recruiting
Overpelt, Belgium
Czech Republic
Research Site Completed
Prague, Czech Republic
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02677077     History of Changes
Other Study ID Numbers: BEL-TYS-14-10727 
Study First Received: December 3, 2015
Last Updated: April 7, 2016
Health Authority: Belgium: Ethics Committee
Czech Republic: Ethics Committee

Keywords provided by Biogen:
RRMS
MRI

Additional relevant MeSH terms:
Natalizumab
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
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2016