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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00297232
Registration number
NCT00297232
Ethics application status
Date submitted
27/02/2006
Date registered
28/02/2006
Date last updated
15/07/2016
Titles & IDs
Public title
Natalizumab (Tysabri) Re-Initiation of Dosing
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Scientific title
An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation
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Secondary ID [1]
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101-MS-321
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Universal Trial Number (UTN)
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Trial acronym
STRATA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Natalizumab - 300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
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Assessment method [1]
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Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as = 0.5 point increase from a baseline EDSS = 6.0, or = 1.0 point increase from a baseline EDSS = 1.0 and \< 6.0, or = 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
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Timepoint [1]
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up to 480 weeks
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Primary outcome [2]
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Time to 48-week Confirmed EDSS Progression
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Assessment method [2]
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Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as = 0.5 point increase from a baseline EDSS = 6.0, or = 1.0 point increase from a baseline EDSS = 1.0 and \< 6.0, or = 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.
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Timepoint [2]
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up to 480 weeks
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Primary outcome [3]
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Time to 24-week Confirmed EDSS Improvement Where Baseline = 2.0
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Assessment method [3]
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Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as = 1.0 point decrease from baseline sustained for 24 weeks.
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Timepoint [3]
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Up to 480 weeks
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Eligibility
Key inclusion criteria
Key Inclusion Criteria
* MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study
* Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study.
* In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* Considered by the Investigator to be immunocompromised
* History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
* History of any major disease or malignancy
* Discontinued natalizumab in a previous study due to allergic reaction
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
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Date of last data collection
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Actual
1/04/2014
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Sample size
Target
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Accrual to date
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Final
1094
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Recruitment in Australia
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - Heidelberg
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Research Site - Parkville
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2050 - Camperdown
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3084 - Heidelberg
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Ethics approval
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Summary
Brief summary
The primary objectives for the initial treatment period of this study are to further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity reactions and immunogenicity following re-exposure to natalizumab and confirming the safety of switching from interferon (IFN), glatiramer acetate, or other multiple sclerosis (MS) therapies to natalizumab. The primary objective for the long-term treatment period of this study is to evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by Expanded Disability Status Scale (EDSS) changes over time.
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Trial website
https://clinicaltrials.gov/study/NCT00297232
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Trial related presentations / publications
Gorelik L, Lerner M, Bixler S, Crossman M, Schlain B, Simon K, Pace A, Cheung A, Chen LL, Berman M, Zein F, Wilson E, Yednock T, Sandrock A, Goelz SE, Subramanyam M. Anti-JC virus antibodies: implications for PML risk stratification. Ann Neurol. 2010 Sep;68(3):295-303. doi: 10.1002/ana.22128. Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray SS, Griffith NM, Jurgensen SA, Gorelik L, Forrestal F, Sandrock AW, Goelz SE. Assessment of JC virus DNA in blood and urine from natalizumab-treated patients. Ann Neurol. 2010 Sep;68(3):304-10. doi: 10.1002/ana.22107. O'Connor P, Goodman A, Kappos L, Lublin F, Polman C, Rudick RA, Hauswirth K, Cristiano LM, Forrestal F, Duda P. Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study. Neurology. 2014 Jul 1;83(1):78-86. doi: 10.1212/WNL.0000000000000541. Epub 2014 Jun 4. Erratum In: Neurology. 2014 Aug 19;83(8):773.
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Public notes
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Contacts
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Biogen
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Gorelik L, Lerner M, Bixler S, Crossman M, Schlain...
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Journal
Rudick RA, O'Connor PW, Polman CH, Goodman AD, Ray...
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O'Connor P, Goodman A, Kappos L, Lublin F, Polman ...
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Results are available at
https://clinicaltrials.gov/study/NCT00297232
Download to PDF