- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677077
Clinical Disease Activity With Long Term Natalizumab Treatment
January 3, 2019 updated by: Biogen
MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
277
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants who have been receiving treatment with natalizumab for ≥24 months.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Czech Republic
Approximately 230 participants with RRMS receiving commercial natalizumab in Czech Republic
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
|
Belgium
Approximately 70 participants with RRMS receiving commercial natalizumab in Belgium
|
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Treatment years 3 and 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions
|
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
|
Post long term treatment with natalizumab (>2 years) through Year 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2015
Primary Completion (Actual)
August 18, 2016
Study Completion (Actual)
August 18, 2016
Study Registration Dates
First Submitted
December 3, 2015
First Submitted That Met QC Criteria
February 4, 2016
First Posted (Estimate)
February 9, 2016
Study Record Updates
Last Update Posted (Actual)
January 4, 2019
Last Update Submitted That Met QC Criteria
January 3, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BEL-TYS-14-10727
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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