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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/NCT03689972
Registration number
NCT03689972
Ethics application status
Date submitted
27/09/2018
Date registered
1/10/2018
Date last updated
25/01/2024
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
Experimental: Part 1: Standard Interval Dosing (SID) IV - Participants will receive natalizumab 300 milligram (mg) intravenous (IV) infusion every 4 weeks (-2/+5 days) up to Week 72.
Experimental: Part 1: Extended Interval Dosing (EID) IV - Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.
Experimental: Part 2: EID SC, then EID IV - Participants will receive natalizumab 300 mg SC injection every 6 weeks from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion every 6 weeks from Week 132 through Week 150.
Experimental: Part 2: EID IV, then EID SC - Participants will receive natalizumab 300 mg IV infusion every 6 weeks from Week 108 through Week 126 followed by natalizumab 300 mg SC injection every 6 weeks from Week 132 through Week 150.
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: Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72
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Assessment method [1]
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Number of new or newly enlarging T2 hyperintense lesions will be analysed by magnetic resonance imaging (MRI) scans of brain. New MRI scans will be compared with the prior MRI scans to analyse the number of new or newly enlarging T2 hyperintense lesions.
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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 Part 2
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Assessment method [2]
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Timepoint [2]
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Week 156
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Secondary outcome [1]
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Part1: Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)
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Assessment method [1]
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A multiple sclerosis (MS) relapse will be 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 will be included in the analysis.
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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: Number of New Gadolinium (Gd) Enhancing and New T1 Hypointense Lesions at Weeks 24, 48 and 72
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Assessment method [2]
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Number of new Gd enhancing and new T1 hypointense lesions on brain will be analysed by MRI scans of brain. New MRI scans will be compared with the prior MRI scans to analyse number of new Gd enhancing and new T1 hypointense lesions.
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Timepoint [2]
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Weeks 24, 48 and 72
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Secondary outcome [3]
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Part 1: Annualized Relapse Rate at Week 72
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Assessment method [3]
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An MS relapse will be 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 will be included in the analysis.
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Timepoint [3]
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Week 72
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Secondary outcome [4]
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Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48
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Assessment method [4]
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Number of new or newly enlarging T2 hyperintense lesions will be analysed by MRI scans of brain. New MRI scans will be compared with the prior MRI scans to analyse the number of new or newly enlarging T2 hyperintense lesions.
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Timepoint [4]
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Weeks 24 and 48
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Secondary outcome [5]
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Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [5]
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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 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 [5]
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Up to Week 96
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Secondary outcome [6]
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Part 1: Time to Expanded Disability Status Scale (EDSS) Worsening as Confirmed After at Least 24 Weeks
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Assessment method [6]
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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.
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Timepoint [6]
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Week 24, 48, 72 and 84
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Secondary outcome [7]
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Part 2: Total Score on Treatment Satisfaction Questionnaire for Medication (TSQM)
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Assessment method [7]
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The TSQM assessed participants' global satisfaction with treatment and captured information on treatment side effects, effectiveness, and convenience using transformed scores between 0 and 100 for effectiveness. Higher scores indicates greater satisfaction.
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Timepoint [7]
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Up to Week 156
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Secondary outcome [8]
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Part 2: Mean Time for Drug Preparation and Administration
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Assessment method [8]
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Timepoint [8]
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Up to Week 156
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Secondary outcome [9]
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Part 2: Number of Participants with Treatment Emergent AEs (TEAEs)
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Assessment method [9]
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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 in participants who had received at least 1 dose of study drug, regardless of relationship to study drug.
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Timepoint [9]
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From Week 132 to Week 156
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Secondary outcome [10]
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Part 2: Percentage of Participants With Anti-Natalizumab Antibodies
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Assessment method [10]
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Timepoint [10]
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From Week 132 to Week 156
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Secondary outcome [11]
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Part 2: Number of New or Newly Enlarging T2 Hyperintense Lesions
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Assessment method [11]
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Number of new or newly enlarging T2 hyperintense lesions will be analysed by magnetic resonance imaging (MRI) scans of brain. New MRI scans will be compared with the prior MRI scans to analyse the number of new or newly enlarging T2 hyperintense lesions.
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Timepoint [11]
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From Week 132 to Week 156
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Secondary outcome [12]
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Part 2: Time to First Relapse
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Assessment method [12]
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A MS relapse will be 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.
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Timepoint [12]
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From Week 132 to Week 156
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Secondary outcome [13]
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Part 2: Annualized Relapse Rate
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Assessment method [13]
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Annualized relapse rate included relapses reported prior to the end of each period.
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Timepoint [13]
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From Week 132 to Week 156
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Secondary outcome [14]
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Part 2: Change in Expanded Disability Status Scale (EDSS) Score
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Assessment method [14]
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The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability.
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Timepoint [14]
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From Week 132 to Week 156
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Secondary outcome [15]
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Part 2: Number of New Gadolinium (Gd) Enhancing Lesions
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Assessment method [15]
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Number of new Gd enhancing lesions on brain will be analysed by MRI scans of brain. New MRI scans will be compared with the prior MRI scans to analyse number of new Gd enhancing lesions.
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Timepoint [15]
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From Week 132 to Week 156
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Secondary outcome [16]
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Part 2: Number of New T1 Hypointense Lesions
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Assessment method [16]
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Number of new T1 hypointense lesions on brain will be analysed by MRI scans of brain. New MRI scans will be compared with the prior MRI scans to analyse number new T1 hypointense lesions.
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Timepoint [16]
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From Week 132 to Week 156
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Secondary outcome [17]
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Part 2: Percentage of Brain Volume Change
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Assessment method [17]
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Timepoint [17]
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From Week 132 to Week 156
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Secondary outcome [18]
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Part 2: Change in Cortical and Thalamic Brain Region Volume
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Assessment method [18]
0
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Timepoint [18]
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From Week 132 to Week 156
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Secondary outcome [19]
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Part 2: Trough Serum Concentration of Natalizumab (Ctrough)
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Assessment method [19]
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Timepoint [19]
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From Week 132 to Week 156
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Secondary outcome [20]
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Part 2: Trough a4 Integrin Saturation
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Assessment method [20]
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Timepoint [20]
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From Week 132 to Week 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 SID or EID.
Key
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Minimum age
18
Years
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Maximum age
60
Years
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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 EID was reverted to natalizumab SID 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
499
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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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Recruitment hospital [6]
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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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Recruitment postcode(s) [5]
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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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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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Ramat Gan
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Catania
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London
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Nottingham
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Sheffield
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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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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval
dosing (EID) in participants who have previously been treated with natalizumab standard
interval dosing (SID) for at least 12 months, in relation to continued SID 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
EID in participants who have previously been treated with natalizumab SID for at least 12
months, in relation to continued SID 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/ct2/show/NCT03689972
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Contacts
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Biogen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03689972
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