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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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Natalizumab

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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 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

Sites / Locations

North Central Neurology Associates, P.C.
Alabama Neurology Associates
UCI MIND
UC San Diego Movement Disorder Center
MS Center of California
Stanford Hospital and Clinics
University of Colorado Hospital Anschutz Outpatient Pavillion
Advanced Neurosciences Research
Yale University
Georgetown University Hospital-Medstar
University of Miami Miller School of Medicine
Infinity Clinical Research, LLC
University of South Florida
Shepherd Center, Inc.
Atlanta Neuroscience Institute
NorthShore University HealthSystem
Northwestern University
College Park Family Care Center
Lahey Clinic Inc. - PARENT ACCOUNT
Neurology Center of New England P.C.
Beth Israel Deaconess Medical Center, Inc.
Dragonfly Research, LLC
South Shore Neurology Associates
Michigan Institute for Neurological Disorders
Michigan State University
Memorial Healthcare
Minneapolis Clinic of Neurology
Washington University, School of Medicine
Cleveland Clinic Lou Ruvo Center for Brain Health
RWJ Barnabas Health
Holy Name Medical Center
NYU Langone Clinical Cancer Center
Mount Sinai Medical Center
Columbia University Hervert Irving Comprehensive Cancer Center
Island Neurological Associates, P.C.
Raleigh Neurology Associates
Wake Forest University Health Sciences
University of Cincinnati
The Cleveland Clinic Foundation
OhioHealth Riverside Methodist Hospital
Dayton Center for Neurological Disorders
Providence Neurological Specialties
Thomas Jefferson University
Magee-Womens Hospital of UPMC
Sibyl Wray, MD Neurology, PC
Vanderbilt University Medical Center
Central Texas Neurology Consultants
Rocky Mountain MS Research Group LLC
University Of Virginia
Multiple Sclerosis Center of Greater Washington
Virginia Mason Medical Center
Wheaton Franciscan Healthcare
Royal North Shore Hospital
Brain and Mind Centre
Lyell McEwin Hospital
Box Hill Hospital
The Alfred Hospital
Royal Melbourne Hospital
Cliniques Universitaires de Bruxelles Hopital Erasme
Cliniques Universitaires Saint-Luc
UZA
CHU de Tivoli
St. Michael's Hospital
Clinique Neuro-Outaouais
Recherche SEPMUS
CHUM Centre de Recherche
Montreal Neurological Institute Clinical Research Unit
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
CHU CAEN - Hôpital de la Côte de Nacre
Hopital Roger Salengro - CHU Lille
CHU Nice - Hôpital Pasteur
CHU Nantes - Hopital Nord Laënnec
CHU Strasbourg - Nouvel Hôpital Civil
Neurologie im Alphamed
Charité - Campus Charité Mitte
Katholisches Klinikum Bochum gGmbH
Neuro Centrum Science GmbH
Universitaetsklinikum Essen
Universitaetsklinikum Freiburg
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Universitaetsklinikum Muenster
Klinikum rechts der Isar der TU Muenchen
Synconcept GmbH - Neuro MVZ
Chaim Sheba Medical Center
Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)
Fondazione Istituto G.Giglio di Cefalù
Fondazione IRCCS Istituto Neurologico Carlo Besta
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Amphia Ziekenhuis, Molengracht
St. Antonius Ziekenhuis
Zuyderland Medisch Centrum - Sittard-Geleen
Hospital Universitari Arnau de Vilanova
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario Ramon y Cajal
Hospital Regional Universitario de Malaga
Hospital Universitario Virgen Macarena
King's College Hospital
The National Hospital for Neurology & Neurosurgery
Walton Centre for Neurology & Neurosurgery.
Queen Elizabeth University Hospital Campus
Newcastle University- Clinical Ageing Research Unit
Charing Cross Hospital
Nottingham University Hospital, Queen's Medical Centre
Salford Care Organisation
Royal Hallamshire Hospital
Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Part 1: Standard Interval Dosing (SID) IV

Part 1: Extended Interval Dosing (EID) IV

Part 2: EID SC, then EID IV

Part 2: EID IV, then EID SC

Arm Description

Participants will receive natalizumab 300 milligram (mg) intravenous (IV) infusion every 4 weeks (-2/+5 days) up to Week 72.

Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.

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.

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.

Outcomes

Primary Outcome Measures

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at 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.

Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Part 2

Secondary Outcome Measures

Part1: Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)

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.

Part 1: Number of New Gadolinium (Gd) Enhancing and New T1 Hypointense Lesions at 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.

Part 1: Annualized Relapse Rate at 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.

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at 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.

Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Part 1: Time to Expanded Disability Status Scale (EDSS) Worsening as Confirmed After at Least 24 Weeks

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.

Part 2: Total Score on Treatment Satisfaction Questionnaire for Medication (TSQM)

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.

Part 2: Mean Time for Drug Preparation and Administration

Part 2: Number of Participants with Treatment Emergent AEs (TEAEs)

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.

Part 2: Percentage of Participants With Anti-Natalizumab Antibodies

Part 2: Number of New or Newly Enlarging T2 Hyperintense Lesions

Part 2: Time to First Relapse

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.

Part 2: Annualized Relapse Rate

Annualized relapse rate included relapses reported prior to the end of each period.

Part 2: Change in Expanded Disability Status Scale (EDSS) Score

The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability.

Part 2: Number of New Gadolinium (Gd) Enhancing Lesions

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.

Part 2: Number of New T1 Hypointense Lesions

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.

Part 2: Percentage of Brain Volume Change

Part 2: Change in Cortical and Thalamic Brain Region Volume

Part 2: Trough Serum Concentration of Natalizumab (Ctrough)

Part 2: Trough α4 Integrin Saturation

Full Information

NCT ID

NCT03689972

First Posted

September 27, 2018

Last Updated

August 17, 2023

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT03689972

Brief 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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 27, 2018 (Actual)

Primary Completion Date

January 31, 2023 (Actual)

Study Completion Date

July 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study will be conducted in 2 parts. At the end of part 1, participants who provide consent and are eligible, and newly enrolled participants, will enter part 2, an Open Label Extension comprising a crossover analysis. Those participants who completed part 1 and cannot participate, or elect not to participate, in Part 2 (Open label extension) will enter a 12-week follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: Standard Interval Dosing (SID) IV

Arm Type

Experimental

Arm Description

Participants will receive natalizumab 300 milligram (mg) intravenous (IV) infusion every 4 weeks (-2/+5 days) up to Week 72.

Arm Title

Part 1: Extended Interval Dosing (EID) IV

Arm Type

Experimental

Arm Description

Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.

Arm Title

Part 2: EID SC, then EID IV

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 2: EID IV, then EID SC

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Natalizumab

Other Intervention Name(s)

BG00002

Intervention Description

Natalizumab 300 mg SC injection or IV infusion.

Primary Outcome Measure Information:

Title

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72

Description

Time Frame

Week 72

Title

Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Part 2

Time Frame

Week 156

Secondary Outcome Measure Information:

Title

Part1: Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)

Description

Time Frame

Up to Week 72

Title

Part 1: Number of New Gadolinium (Gd) Enhancing and New T1 Hypointense Lesions at Weeks 24, 48 and 72

Description

Time Frame

Weeks 24, 48 and 72

Title

Part 1: Annualized Relapse Rate at Week 72

Description

Time Frame

Week 72

Title

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48

Description

Time Frame

Weeks 24 and 48

Title

Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Up to Week 96

Title

Part 1: Time to Expanded Disability Status Scale (EDSS) Worsening as Confirmed After at Least 24 Weeks

Description

Time Frame

Week 24, 48, 72 and 84

Title

Part 2: Total Score on Treatment Satisfaction Questionnaire for Medication (TSQM)

Description

Time Frame

Up to Week 156

Title

Part 2: Mean Time for Drug Preparation and Administration

Time Frame

Up to Week 156

Title

Part 2: Number of Participants with Treatment Emergent AEs (TEAEs)

Description

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.

Time Frame

From Week 132 to Week 156

Title

Part 2: Percentage of Participants With Anti-Natalizumab Antibodies

Time Frame

From Week 132 to Week 156

Title

Part 2: Number of New or Newly Enlarging T2 Hyperintense Lesions

Description

Time Frame

From Week 132 to Week 156

Title

Part 2: Time to First Relapse

Description

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.

Time Frame

From Week 132 to Week 156

Title

Part 2: Annualized Relapse Rate

Description

Annualized relapse rate included relapses reported prior to the end of each period.

Time Frame

From Week 132 to Week 156

Title

Part 2: Change in Expanded Disability Status Scale (EDSS) Score

Description

The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability.

Time Frame

From Week 132 to Week 156

Title

Part 2: Number of New Gadolinium (Gd) Enhancing Lesions

Description

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.

Time Frame

From Week 132 to Week 156

Title

Part 2: Number of New T1 Hypointense Lesions

Description

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.

Time Frame

From Week 132 to Week 156

Title

Part 2: Percentage of Brain Volume Change

Time Frame

From Week 132 to Week 156

Title

Part 2: Change in Cortical and Thalamic Brain Region Volume

Time Frame

From Week 132 to Week 156

Title

Part 2: Trough Serum Concentration of Natalizumab (Ctrough)

Time Frame

From Week 132 to Week 156

Title

Part 2: Trough α4 Integrin Saturation

Time Frame

From Week 132 to Week 156

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

North Central Neurology Associates, P.C.

City

Cullman

State/Province

Alabama

ZIP/Postal Code

35058

Country

United States

Facility Name

Alabama Neurology Associates

City

Homewood

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

UCI MIND

City

Irvine

State/Province

California

ZIP/Postal Code

92607

Country

United States

Facility Name

UC San Diego Movement Disorder Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

MS Center of California

City

Laguna Hills

State/Province

California

ZIP/Postal Code

92653

Country

United States

Facility Name

Stanford Hospital and Clinics

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

University of Colorado Hospital Anschutz Outpatient Pavillion

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80010-0510

Country

United States

Facility Name

Advanced Neurosciences Research

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Yale University

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Georgetown University Hospital-Medstar

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007-2113

Country

United States

Facility Name

University of Miami Miller School of Medicine

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Facility Name

Infinity Clinical Research, LLC

City

Sunrise

State/Province

Florida

ZIP/Postal Code

33351

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Shepherd Center, Inc.

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Atlanta Neuroscience Institute

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30327

Country

United States

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Northwestern University

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60208

Country

United States

Facility Name

College Park Family Care Center

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66212

Country

United States

Facility Name

Lahey Clinic Inc. - PARENT ACCOUNT

City

Burlington

State/Province

Massachusetts

ZIP/Postal Code

01805

Country

United States

Facility Name

Neurology Center of New England P.C.

City

Foxboro

State/Province

Massachusetts

ZIP/Postal Code

02035

Country

United States

Facility Name

Beth Israel Deaconess Medical Center, Inc.

City

Jamaica Plain

State/Province

Massachusetts

ZIP/Postal Code

02130-2075

Country

United States

Facility Name

Dragonfly Research, LLC

City

Wellesley

State/Province

Massachusetts

ZIP/Postal Code

02481

Country

United States

Facility Name

South Shore Neurology Associates

City

Weymouth

State/Province

Massachusetts

ZIP/Postal Code

02190

Country

United States

Facility Name

Michigan Institute for Neurological Disorders

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Michigan State University

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49506

Country

United States

Facility Name

Memorial Healthcare

City

Owosso

State/Province

Michigan

ZIP/Postal Code

48867

Country

United States

Facility Name

Minneapolis Clinic of Neurology

City

Golden Valley

State/Province

Minnesota

ZIP/Postal Code

55422

Country

United States

Facility Name

Washington University, School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Cleveland Clinic Lou Ruvo Center for Brain Health

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

RWJ Barnabas Health

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Holy Name Medical Center

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

NYU Langone Clinical Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University Hervert Irving Comprehensive Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Island Neurological Associates, P.C.

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

Country

United States

Facility Name

Raleigh Neurology Associates

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607-6010

Country

United States

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

The Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

OhioHealth Riverside Methodist Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Dayton Center for Neurological Disorders

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Providence Neurological Specialties

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Magee-Womens Hospital of UPMC

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Sibyl Wray, MD Neurology, PC

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37215

Country

United States

Facility Name

Central Texas Neurology Consultants

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

Rocky Mountain MS Research Group LLC

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84103

Country

United States

Facility Name

University Of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Multiple Sclerosis Center of Greater Washington

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22182

Country

United States

Facility Name

Virginia Mason Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Wheaton Franciscan Healthcare

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

Royal North Shore Hospital

City

St Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Brain and Mind Centre

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

Lyell McEwin Hospital

City

Elizabeth Vale

State/Province

South Australia

ZIP/Postal Code

5112

Country

Australia

Facility Name

Box Hill Hospital

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

The Alfred Hospital

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

Royal Melbourne Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

Cliniques Universitaires de Bruxelles Hopital Erasme

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Cliniques Universitaires Saint-Luc

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

UZA

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

CHU de Tivoli

City

La Louvière

ZIP/Postal Code

7100

Country

Belgium

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Clinique Neuro-Outaouais

City

Gatineau

State/Province

Quebec

ZIP/Postal Code

J8Y 1W2

Country

Canada

Facility Name

Recherche SEPMUS

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

CHUM Centre de Recherche

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Montreal Neurological Institute Clinical Research Unit

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 3B4

Country

Canada

Facility Name

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

CHU CAEN - Hôpital de la Côte de Nacre

City

Caen

ZIP/Postal Code

14033

Country

France

Facility Name

Hopital Roger Salengro - CHU Lille

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

CHU Nice - Hôpital Pasteur

City

Nice

ZIP/Postal Code

6001

Country

France

Facility Name

CHU Nantes - Hopital Nord Laënnec

City

Saint Herblain

ZIP/Postal Code

44800

Country

France

Facility Name

CHU Strasbourg - Nouvel Hôpital Civil

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Facility Name

Neurologie im Alphamed

City

Bamberg

ZIP/Postal Code

96052

Country

Germany

Facility Name

Charité - Campus Charité Mitte

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Katholisches Klinikum Bochum gGmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Neuro Centrum Science GmbH

City

Erbach

ZIP/Postal Code

64711

Country

Germany

Facility Name

Universitaetsklinikum Essen

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Universitaetsklinikum Muenster

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinikum rechts der Isar der TU Muenchen

City

Munich

ZIP/Postal Code

81675

Country

Germany

Facility Name

Synconcept GmbH - Neuro MVZ

City

Stuttgart

ZIP/Postal Code

70182

Country

Germany

Facility Name

Chaim Sheba Medical Center

City

Ramat Gan

ZIP/Postal Code

52363

Country

Israel

Facility Name

Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)

City

Catania

ZIP/Postal Code

95123

Country

Italy

Facility Name

Fondazione Istituto G.Giglio di Cefalù

City

Cefalù

ZIP/Postal Code

90015

Country

Italy

Facility Name

Fondazione IRCCS Istituto Neurologico Carlo Besta

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo

City

Pozzilli

ZIP/Postal Code

86077

Country

Italy

Facility Name

Amphia Ziekenhuis, Molengracht

City

Breda

ZIP/Postal Code

4818 CK

Country

Netherlands

Facility Name

St. Antonius Ziekenhuis

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Zuyderland Medisch Centrum - Sittard-Geleen

City

Sittard

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

Hospital Universitari Arnau de Vilanova

City

Lleida

State/Province

Catalonia

ZIP/Postal Code

25198

Country

Spain

Facility Name

Hospital Universitario Virgen de la Arrixaca

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Hospital Universitario Ramon y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

King's College Hospital

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

The National Hospital for Neurology & Neurosurgery

City

London

State/Province

Greater London

ZIP/Postal Code

WC1N 3BG

Country

United Kingdom

Facility Name

Walton Centre for Neurology & Neurosurgery.

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

Queen Elizabeth University Hospital Campus

City

Glasgow

State/Province

Strathclyde

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

Newcastle University- Clinical Ageing Research Unit

City

Newcastle upon Tyne

State/Province

Tyne & Wear

ZIP/Postal Code

NE4 5PL

Country

United Kingdom

Facility Name

Charing Cross Hospital

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Nottingham University Hospital, Queen's Medical Centre

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Salford Care Organisation

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Royal Hallamshire Hospital

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Morriston Hospital

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Please refer data queries to DataSharing@biogen.com.

Citations:

PubMed Identifier

35483387

Citation

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.

Results Reference

derived

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