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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 : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

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, 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Natalizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Arm Intervention/treatment
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.
Drug: Natalizumab
Natalizumab 300 mg IV infusion
Other Name: BG00002

Experimental: Extended Interval Dosing (EID)
Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.
Drug: Natalizumab
Natalizumab 300 mg IV infusion
Other Name: BG00002




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689972


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
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United States, Alabama
Research Site Recruiting
Cullman, Alabama, United States, 35058
United States, California
Research Site Recruiting
Newport Beach, California, United States, 92663
United States, Colorado
Research Site Recruiting
Fort Collins, Colorado, United States, 80528
United States, Florida
Research Site Recruiting
Sunrise, Florida, United States, 33351
Research Site Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30309
United States, Massachusetts
Research Site Recruiting
Wellesley, Massachusetts, United States, 02481
United States, Michigan
Research Site Recruiting
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Research Site Recruiting
Golden Valley, Minnesota, United States, 55422
United States, New Jersey
Research Centre Recruiting
Teaneck, New Jersey, United States, 07666
United States, New York
Research Site Recruiting
Patchogue, New York, United States, 11772
United States, Ohio
Research Site Recruiting
Cleveland, Ohio, United States, 44195
Research Site Recruiting
Dayton, Ohio, United States, 45417
United States, Texas
Research Site Recruiting
Round Rock, Texas, United States, 78681
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84103
Canada, Quebec
Research Site Recruiting
Gatineau, Quebec, Canada, J8Y 1W2
Research Site Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03689972     History of Changes
Other Study ID Numbers: 101MS329
2018-002145-11 ( EudraCT Number )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Please refer data queries to DataSharing@biogen.com.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs