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A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

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ClinicalTrials.gov Identifier: NCT03689972
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 1, 2018
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE November 28, 2018
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72 [ Time Frame: Week 72 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 48 [ Time Frame: Week 48 ]
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.
Change History Complete list of historical versions of study NCT03689972 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
  • Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC) [ Time Frame: Up to Week 72 ]
    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.
  • Number of new Gadolinium (Gd) Enhancing and new T1 Hypointense Lesions at Weeks 24, 48 and 72 [ Time Frame: Weeks 24, 48 and 72 ]
    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.
  • Annualized Relapse Rate at Week 72 [ Time Frame: Week 72 ]
    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.
  • Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48 [ Time Frame: Weeks 24 and 48 ]
    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.
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ]
    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.
  • Time to Expanded Disability Status Scale (EDSS) Worsening as Confirmed After at Least 24 Weeks [ Time Frame: Week 24, 48, 72 and 84 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC) [ Time Frame: Up to Week 72 ]
    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.
  • Number of new Gadolinium (Gd) Enhancing and new T1 Hypointense Lesions at Weeks 24, 48 and 72 [ Time Frame: Weeks 24, 48 and 72 ]
    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.
  • Annualized Relapse Rate at Weeks 48 and 72 [ Time Frame: Weeks 48 and 72 ]
    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.
  • Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 72 [ Time Frame: Weeks 24 and 72 ]
    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.
  • Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
Official Title  ICMJE A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing 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
Brief Summary

The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in subjects 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 are to evaluate additional clinical and MRI based efficacy endpoints, disability worsening and safety of EID in subjects who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE Drug: Natalizumab
Natalizumab 300 mg IV infusion
Other Name: BG00002
Study Arms  ICMJE
  • Experimental: Standard Interval Dosing (SID)
    Participants will receive natalizumab 300 milligram (mg) intravenous (IV) infusion every 4 weeks (-2/+5 days) up to Week 72.
    Intervention: Drug: Natalizumab
  • Experimental: Extended Interval Dosing (EID)
    Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.
    Intervention: Drug: Natalizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2018)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • 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) <=5.5 at screening.
  • No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator.

Key Exclusion Criteria:

  • 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE Australia,   Canada,   Germany,   Israel,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689972
Other Study ID Numbers  ICMJE 101MS329
2018-002145-11 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Please refer data queries to DataSharing@biogen.com.
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP