Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) (AttackMS)
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ClinicalTrials.gov Identifier: NCT05418010 |
Recruitment Status :
Recruiting
First Posted : June 14, 2022
Last Update Posted : May 22, 2023
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Tracking Information | ||||||||||
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First Submitted Date ICMJE | February 17, 2022 | |||||||||
First Posted Date ICMJE | June 14, 2022 | |||||||||
Last Update Posted Date | May 22, 2023 | |||||||||
Actual Study Start Date ICMJE | December 1, 2022 | |||||||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
To establish whether there is efficacy superiority of Tysabri® over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR). [ Time Frame: 12 weeks ] Mean magnetisation transfer ratio (MTR) change in FLAIR-hyper-intense lesions at 12 weeks compared to baseline
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Original Primary Outcome Measures ICMJE | Same as current | |||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS) | |||||||||
Official Title ICMJE | AttackMS: Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation | |||||||||
Brief Summary | Multiple Sclerosis (MS) is a chronic inflammatory & degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins. Evidence suggests that shutting down inflammation using highly effective DMTs early after diagnosis leads to better long term clinical outcomes The AttackMS trial will test the effect of starting a highly-effective DMT licensed for MS, Tysabri® (Natalizumab 300mg), within a short time - 14 days - after symptom onset. |
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Detailed Description | MS is a disease of the central nervous system affecting over 130,000 people in the UK and more than 2.8 million worldwide. Left untreated, MS leads to chronic disability in the large majority of cases. CIS is a common first manifestation of MS: There is a more than 80% chance of MS in somebody presenting with CIS provided one or more "lesions" characteristic of inflammatory demyelination can be detected on a magnetic resonance imaging (MRI) of the brain. The presence of at least two such lesions is an inclusion criterion for this study. Inflammatory demyelination is the process by which cells of your body's own immune system attack the insulation sheath (= myelin) of nerve fibres (= axons) in the central nervous system. Once a diagnosis of MS has been confirmed, many people with this disease will be eligible for what is called "disease-modifying treatment" (DMT) on the NHS. Such treatment targets the immune cells that are involved in the inflammatory attack against the myelin sheaths and nerve fibres. However, while in a small number of cases, a diagnosis of MS can be made instantaneously it regularly takes week, months and, sometimes even longer, to fulfil the formal diagnostic criteria of MS. This diagnostic delay inevitably leads to delays in starting disease-modifying treatment. Using a trial concept geared towards rapid assessment of eligibility, and a disease-modifying treatment that is both highly effective and generally well tolerated in people with MS, AttackMS will test whether: (i) It is feasible to recruit participants with a diagnosis of CIS at high risk of MS, or definite MS, at first presentation for treatment within 14 days of symptom onset and (ii) Such early treatment improves myelin repair at 3 months, as measured using a special MRI technology called magnetisation transfer ratio (MTR). Natalizumab (Tysabri®) is a medication currently approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a disease-modifying treatment for adults with rapidly evolving severe (RES) relapsing MS. We are looking to test safety and efficacy of treatment with Tysabri® 300mg, given through a needle in a vein (intravenous infusion), over 20 weeks and to advance mechanistic understanding in treating people with first presentation of CIS or MS. AttackMS will test the effect of starting a highly-effective DMT licensed for MS, Tysabri®, within a short time - 14 days - after symptom onset. The main objective is to test Tysabri®, given intravenously every 4 weeks over 20 weeks, for safety, efficacy, and to advance the mechanistic understanding of the earliest events in inflammatory demyelination/MS |
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Study Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: This is a randomized, double-blind, placebo-controlled efficacy trial of hyperacute disease modifying treatment using Tysabri® in people with a first manifestation of central nervous system inflammatory demyelination. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Recruiting | |||||||||
Estimated Enrollment ICMJE |
40 | |||||||||
Original Estimated Enrollment ICMJE | Same as current | |||||||||
Estimated Study Completion Date ICMJE | May 31, 2024 | |||||||||
Estimated Primary Completion Date | May 31, 2024 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United Kingdom | |||||||||
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Administrative Information | ||||||||||
NCT Number ICMJE | NCT05418010 | |||||||||
Other Study ID Numbers ICMJE | 1003822 2021-002255-11 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Queen Mary University of London | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Queen Mary University of London | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Queen Mary University of London | |||||||||
Verification Date | May 2023 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |