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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03689972
Registration number
NCT03689972
Ethics application status
Date submitted
27/09/2018
Date registered
1/10/2018
Titles & IDs
Public title
A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
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Scientific title
A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration
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Secondary ID [1]
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2018-002145-11
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Secondary ID [2]
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101MS329
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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
Treatment: Drugs - Natalizumab
Treatment: Drugs - Natalizumab
Experimental: Part 1: IV Q4W - Participants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72.
Experimental: Part 1: IV Q6W - Participants received natalizumab 300 mg IV infusion once Q6W up to Week 72.
Experimental: Part 2: Run-in Period: IV Q6W - Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102.
Experimental: Part 2: Crossover Period: IV Q6W, then SC Q6W - Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg IV infusion Q6W from Week 108 through Week 126 followed by natalizumab 300 mg subcutaneous (SC) injection Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.
Experimental: Part 2: Crossover Period: SC Q6W, then IV Q6W - Participants who completed run-in period of Part 2 were randomized to receive natalizumab 300 mg SC injection Q6W from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion Q6W from Week 132 through Week 150 along with a single dose of natalizumab 300 mg SC injection or IV infusion as per participant's choice at Week 156.
Treatment: Drugs: Natalizumab
Natalizumab 300 mg IV infusion.
Treatment: Drugs: Natalizumab
Natalizumab 300 mg SC injection or IV infusion.
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Intervention code [1]
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Treatment: Drugs
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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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Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72
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Assessment method [1]
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T2 hyperintense lesions were analyzed by magnetic resonance imaging (MRI) scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new or newly enlarging T2 hyperintense lesions at Week 72 relative to baseline.
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Timepoint [1]
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Week 72
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Primary outcome [2]
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Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Crossover Period of Part 2
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Assessment method [2]
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Timepoint [2]
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Week 150
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Secondary outcome [1]
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Part 1: Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)
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Assessment method [1]
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Relapse is defined as the onset of new or recurrent neurological symptoms, not associated with fever, infection, severe stress, or drug toxicity, lasting at least 24 hours, accompanied by new objective abnormalities on a neurological examination. Only relapses confirmed by an INEC were included in the analysis. Time to First Relapse was estimated by Kaplan-Meier method.
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Timepoint [1]
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Up to Week 72
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Secondary outcome [2]
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Part 1: Annualized Relapse Rate at Week 72
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Assessment method [2]
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Annualized relapse rate is calculated as the total number of INEC-confirmed relapses that occurred during the treatment period divided by the total number of participant-years followed in the period.
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Timepoint [2]
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Week 72
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Secondary outcome [3]
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Part 1: Time to Expanded Disability Status Scale (EDSS) Worsening
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Assessment method [3]
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Confirmed EDSS worsening is defined as an increase of at least 1.0 point from a baseline EDSS score = 1.0 or an increase of at least 1.5 points from a baseline EDSS score of 0 that is confirmed after at least 24 weeks. Time to EDSS worsening is estimated by Kaplan-Meier method.
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Timepoint [3]
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Up to Week 72
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Secondary outcome [4]
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Part 1: Mean Number of New T1 Hypointense Lesions at Weeks 24, 48, and 72
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Assessment method [4]
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T1 hypointense lesions on brain were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new T1 hypointense lesions at Weeks 24, 48, and 72 relative to baseline.
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Timepoint [4]
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Weeks 24, 48, and 72
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Secondary outcome [5]
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Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48
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Assessment method [5]
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T2 hyperintense lesions were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new or newly enlarging T2 hyperintense lesions at Weeks 24 and 48 relative to baseline.
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Timepoint [5]
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Weeks 24 and 48
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Secondary outcome [6]
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Part 1: Mean Number of New Gadolinium (Gd) Enhancing Lesions at Weeks 24, 48, and 72
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Assessment method [6]
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Gd enhancing lesions on brain were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new Gd enhancing lesions at Weeks 24, 48, and 72 relative to baseline.
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Timepoint [6]
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Weeks 24, 48, and 72
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Secondary outcome [7]
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Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [7]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any event occurring on or after first dose after randomization up to 12 weeks (or 24 weeks for PML \[progressive multifocal leukoencephalopathy\] events) following the last dose on the study.An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, is a medically important event.
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Timepoint [7]
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Baseline up to Week 84
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Secondary outcome [8]
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Part 2: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores During the Crossover Period
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Assessment method [8]
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The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100 for effectiveness. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.
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Timepoint [8]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [9]
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Part 2: Mean Time for Drug Preparation and Drug Administration During the Crossover Period
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Assessment method [9]
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Timepoint [9]
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Week 108 up to Week 156
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Secondary outcome [10]
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Part 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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Assessment method [10]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is any event occurring on or after first dose after randomization up to and including 12 weeks (or 24 weeks for PML events) following the last dose on the study.
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Timepoint [10]
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Part 2: Baseline (Week 108) up to Week 180
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Secondary outcome [11]
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Part 2: Percentage of Participants With Anti-Natalizumab Antibodies During the Crossover Period
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Assessment method [11]
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Timepoint [11]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [12]
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Part 2: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions During the Crossover Period
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Assessment method [12]
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T2 hyperintense lesions were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new or newly enlarging T2 hyperintense lesions during the crossover period of Part 2 relative to baseline.
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Timepoint [12]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [13]
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Part 2: Time to First Relapse During the Crossover Period
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Assessment method [13]
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Relapse is defined as the onset of new or recurrent neurological symptoms, not associated with fever, infection, severe stress, or drug toxicity, lasting at least 24 hours. The time to first relapse is defined as the time from the first randomized dose in Part 2 up to the first relapse. Time to First Relapse is estimated by Kaplan-Meier method.
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Timepoint [13]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [14]
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Part 2: Annualized Relapse Rate During the Crossover Period
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Assessment method [14]
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Annualized relapse rate is calculated as the total number of relapses that occurred during the treatment period divided by the total number of participant-years followed in the period.
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Timepoint [14]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [15]
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Part 2: Change From Baseline in EDSS Score During the Crossover Period
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Assessment method [15]
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The EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory and cerebral functions, as well as walking ability. It measures the MS disability status on a scale ranging from 0 (normal) to 10 (death due to MS), with higher scores indicating more disability.
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Timepoint [15]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [16]
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Part 2: Mean Number of New Gd Enhancing Lesions During the Crossover Period
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Assessment method [16]
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Gd enhancing lesions on brain were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new Gd enhancing lesions during the crossover period of Part 2 relative to baseline.
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Timepoint [16]
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Week 108 up to Week 156
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Secondary outcome [17]
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Part 2: Mean Number of New T1 Hypointense Lesions During the Crossover Period
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Assessment method [17]
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T1 hypointense lesions on brain were analyzed by MRI scans of brain. New MRI scans were compared with the prior MRI scans to analyze the number of new T1 hypointense lesions during the crossover period of Part 2 relative to baseline.
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Timepoint [17]
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Week 108 up to Week 156
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Secondary outcome [18]
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Part 2: Mean Percentage Change From Baseline in Brain Volume During the Crossover Period
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Assessment method [18]
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Timepoint [18]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [19]
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Part 2: Change From Baseline in Cortical and Thalamic Brain Region Volume During the Crossover Period
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Assessment method [19]
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Timepoint [19]
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Part 2 Baseline (Week 108) up to Week 156
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Secondary outcome [20]
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Part 2: Trough Serum Concentration of Natalizumab (Ctrough) During the Crossover Period
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Assessment method [20]
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Timepoint [20]
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Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156
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Secondary outcome [21]
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Part 2: Mean Trough a4 Integrin Saturation During the Crossover Period
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Assessment method [21]
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Timepoint [21]
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Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156
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Eligibility
Key inclusion criteria
Key
For Part 1:
* Ability of the participant to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
* Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to the McDonald criteria [Thompson 2018].
* Treatment with natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing for a minimum of 12 months prior to randomization. The participant must have received at least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization.
* Expanded Disability Status Scale (EDSS) score <=5.5 at screening.
* No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator.
For Part 2:
* Ability of the participants to understand the purpose and risks of the study and provide signed and dated informed consent for Part 2 and authorization to use confidential health information in accordance with national and local participant privacy regulations.
* Completed Part 1 Week 72 visit while remaining on their randomized treatment assignment of Q4W or Q6W.
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Minimum age
18
Years
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Maximum age
60
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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
For Part 1:
* Primary and secondary progressive multiple sclerosis (MS).
* MRI positive for Gd-enhancing lesions at screening.
* Participants for whom MRI is contraindicated (e.g., have a contraindicated pacemaker or other contraindicated implanted metal device, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed).
* History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study, in the opinion of the Investigator.
* Presence of anti-natalizumab antibodies at screening.
For Part 2:
* Participants treated with natalizumab Q6W was reverted to natalizumab Q4W by choice or as rescue treatment in Part 1.
* Participant received treatment with any MS disease-modifying therapy other than natalizumab in Part 1 or in the period between Part 1 and Part 2.
* History of human immunodeficiency virus or history of other immunodeficient conditions.
* Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 30 days (or 5 half-lives of the agent, whichever is longer) prior to the Baseline Visit or at any time during this study.
* Inability to comply with study requirements.
* Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for enrollment.
The inclusion and exclusion criteria for new participants who did not participate in Part 1 of the study are the same as those for participants who did participate in Part 1.
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
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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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
27/11/2018
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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
24/07/2023
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Sample size
Target
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Accrual to date
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Final
585
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
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Brain and Mind Centre - Sydney
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Recruitment hospital [3]
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Lyell McEwin Hospital - Elizabeth Vale
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Box Hill Hospital - Box Hill
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The Alfred Hospital - Melbourne
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2065 - St Leonards
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2050 - Sydney
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5112 - Elizabeth Vale
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Recruitment postcode(s) [4]
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3128 - Box Hill
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Kansas
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Massachusetts
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Missouri
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Belgium
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Bruxelles
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Edegem
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Nice
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France
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France
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Berlin
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Erbach
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Essen
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Stuttgart
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Israel
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Ramat Gan
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Italy
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Catania
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Italy
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Cefalù
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Italy
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Milano
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Sittard
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Spain
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Catalonia
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Spain
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Murcia
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Sevilla
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Greater London
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Merseyside
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Strathclyde
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United Kingdom
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Tyne & Wear
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Salford
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United Kingdom
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Sheffield
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United Kingdom
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Swansea
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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
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks \[Q6W\]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks \[Q4W\]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.
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Trial website
https://clinicaltrials.gov/study/NCT03689972
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Trial related presentations / publications
Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter G, Giovannoni G, Killestein J, Wiendl H, Smirnakis K, Xiao S, Kong G, Kuhelj R, Campbell N; NOVA study investigators. Comparison of switching to 6-week dosing of natalizumab versus continuing with 4-week dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):608-619. doi: 10.1016/S1474-4422(22)00143-0. Epub 2022 Apr 25.
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Public notes
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Please refer data queries to
[email protected]
.
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/72/NCT03689972/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/72/NCT03689972/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03689972