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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00306592
Registration number
NCT00306592
Ethics application status
Date submitted
31/01/2006
Date registered
24/03/2006
Date last updated
21/03/2017
Titles & IDs
Public title
Natalizumab 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, or C-1803 and a Dosing Suspension Safety Evaluation
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Secondary ID [1]
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101-MS-322
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BG00002 (natalizumab)
Experimental: Natalizumab - All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
Other interventions: BG00002 (natalizumab)
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Intervention code [1]
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Other interventions
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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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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs (SAEs)
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Assessment method [1]
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AEs: any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. Any other medically important event that, in the opinion of the investigator, may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. Treatment-emergent AEs: events in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
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Timepoint [1]
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Baseline through Week 48
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Primary outcome [2]
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Number of Participants With Hypersensitivity-related Adverse Events
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Assessment method [2]
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For purposes of this analysis, the terms 'hypersensitivity' and 'drug hypersensitivity' were categorized by their temporal relationship to study drug infusion (within 2 hours of the start of the infusion), and were considered equivalent. Hypersensitivity reactions are defined as infusion reactions with the following preferred terms: hypersensitivity not otherwise specified (NOS), anaphylactic reaction, anaphylactoid reaction, dermatitis allergic, drug hypersensitivity, urticaria NOS, vasoconstriction, urticaria generalised, hypersensitivity, urticaria.
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Timepoint [2]
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Baseline through Week 48
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Primary outcome [3]
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Number of Participants With Antibodies to Natalizumab
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Assessment method [3]
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'Positive with unknown persistence' is defined as a positive result (=0.5 micrograms/mL) at one timepoint only with no confirmatory re-test available at least 42 days later. 'Transient positive' is defined as a positive at one timepoint but negative upon re-test at least 42 days later. 'Persistent positive' is defined as positive at 2 or more timepoints separated by at least 42 days. The threshold for classifying a sample as 'antibody positive' was set at the lowest level of reactivity that had a measurable impact on drug serum concentrations.
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Timepoint [3]
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Baseline (Week 0), Week 4, Week 24 (test was repeated after 8 weeks if positive, to confirm persistence)
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Eligibility
Key inclusion criteria
- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803
(NCT00097760) and completed a Dosing Suspension Safety Evaluation (neurological
examination and magnetic resonance imaging [MRI] scan)
- Considered by the investigator to be free of signs and symptoms suggestive of
progressive multifocal leukoencephalopathy (PML) based on medical history, physical
examination, or laboratory testing (results from the Dosing Suspension Safety
Evaluation from Study C-1808 [NCT000276172] may be used)
- Other protocol-defined inclusion criteria may apply
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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
- Considered by the investigator to be immunocompromised, based on medical history,
physical examination, or laboratory testing (results from the Dosing Suspension Safety
Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment
- History of persistent anti-natalizumab antibodies, based upon testing from prior
natalizumab studies
- Other protocol-defined exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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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Who is / are masked / blinded?
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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
Completed
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Data analysis
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Reason for early stopping/withdrawal
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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
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2008
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Sample size
Target
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Accrual to date
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Final
404
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Recruitment in Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Commercial sector/Industry
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Elan Pharmaceuticals
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Ethics approval
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Summary
Brief summary
The primary objectives of this study are to further evaluate the safety of natalizumab
(Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity
following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab
from interferon beta (IFN-ß), glatiramer acetate (GA), or other multiple sclerosis (MS)
therapies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00306592
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Trial related presentations / publications
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
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Medical Director
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Biogen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00306592
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