AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 3NCT03689972

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

A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 107 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Natalizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
585 participants
Where
107 sitesin 11 countries
Study dates
27 Nov 2018to 24 Jul 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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

Trial locations and contacts

107 sites in 11 countries.

107 sites in 11 countries

United States52 sites

  • Shepherd Center, Inc.

    Atlanta, Georgia, 30309

  • Atlanta Neuroscience Institute

    Atlanta, Georgia, 30327

  • University of Colorado Hospital Anschutz Outpatient Pavillion

    Aurora, Colorado, 80010-0510

  • Lahey Clinic Inc. - PARENT ACCOUNT

    Burlington, Massachusetts, 01805

  • University Of Virginia

    Charlottesville, Virginia, 22908

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • North Central Neurology Associates, P.C.

    Cullman, Alabama, 35058

  • Dayton Center for Neurological Disorders

    Dayton, Ohio, 45459

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Northwestern University

    Evanston, Illinois, 60208

  • Yale University

    Fairfield, Connecticut, 06824

  • Michigan Institute for Neurological Disorders

    Farmington Hills, Michigan, 48334

  • Advanced Neurosciences Research

    Fort Collins, Colorado, 80528

  • Neurology Center of New England P.C.

    Foxborough, Massachusetts, 02035

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • Michigan State University

    Grand Rapids, Michigan, 49506

  • Alabama Neurology Associates

    Homewood, Alabama, 35209

  • UCI MIND

    Irvine, California, 92607

  • Beth Israel Deaconess Medical Center, Inc.

    Jamaica Plain, Massachusetts, 02130-2075

  • Sibyl Wray, MD Neurology, PC

    Knoxville, Tennessee, 37922

  • UC San Diego Movement Disorder Center

    La Jolla, California, 92037

  • MS Center of California

    Laguna Hills, California, 92653

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • University of Miami Miller School of Medicine

    Miami, Florida, 33125

  • Wheaton Franciscan Healthcare

    Milwaukee, Wisconsin, 53227

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37215

  • NYU Langone Clinical Cancer Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Hervert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • RWJ Barnabas Health

    Newark, New Jersey, 07102

  • College Park Family Care Center

    Overland Park, Kansas, 66212

  • Memorial Healthcare

    Owosso, Michigan, 48867

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Island Neurological Associates, P.C.

    Plainview, New York, 11803

  • Providence Neurological Specialties

    Portland, Oregon, 97225

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6010

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681

  • Rocky Mountain MS Research Group LLC

    Salt Lake City, Utah, 84103

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • University of South Florida

    Tampa, Florida, 33612

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Multiple Sclerosis Center of Greater Washington

    Vienna, Virginia, 22182

  • Georgetown University Hospital-Medstar

    Washington D.C., District of Columbia, 20007-2113

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481

  • South Shore Neurology Associates

    Weymouth, Massachusetts, 02190

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany10 sites

  • Neurologie im Alphamed

    Bamberg, 96052

  • Charité - Campus Charité Mitte

    Berlin, 10117

  • Katholisches Klinikum Bochum gGmbH

    Bochum, 44791

  • Neuro Centrum Science GmbH

    Erbach im Odenwald, 64711

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg

    Marburg, 35043

  • Klinikum rechts der Isar der TU Muenchen

    Munich, 81675

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Synconcept GmbH - Neuro MVZ

    Stuttgart, 70182

Other trials in Germany

United Kingdom10 sites

  • Queen Elizabeth University Hospital Campus

    Glasgow, Strathclyde, G51 4TF

  • Walton Centre for Neurology & Neurosurgery.

    Liverpool, Merseyside, L9 7LJ

  • King's College Hospital

    London, Greater London, SE5 9RS

  • The National Hospital for Neurology & Neurosurgery

    London, Greater London, WC1N 3BG

  • Charing Cross Hospital

    London, W6 8RF

  • Newcastle University- Clinical Ageing Research Unit

    Newcastle upon Tyne, Tyne & Wear, NE4 5PL

  • Nottingham University Hospital, Queen's Medical Centre

    Nottingham, NG7 2UH

  • Salford Care Organisation

    Salford, M6 8HD

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

Australia6 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Brain and Mind Centre

    Sydney, New South Wales, 2050

Other trials in Australia

France6 sites

  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin

    Bordeaux, 33076

  • CHU CAEN - Hôpital de la Côte de Nacre

    Caen, 14033

  • Hopital Roger Salengro - CHU Lille

    Lille, 59037

  • CHU Nice - Hôpital Pasteur

    Nice, 6001

  • CHU Nantes - Hopital Nord Laënnec

    Saint-Herblain, 44800

  • CHU Strasbourg - Nouvel Hôpital Civil

    Strasbourg, 67091

Other trials in France

Canada5 sites

  • Clinique Neuro-Outaouais

    Gatineau, Quebec, J8Y 1W2

  • Recherche SEPMUS

    Greenfield Park, Quebec, J4V 2J2

  • CHUM Centre de Recherche

    Montreal, Quebec, H2X 0A9

  • Montreal Neurological Institute Clinical Research Unit

    Montreal, Quebec, H3A 3B4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Italy5 sites

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

    Catania, 95123

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, 90015

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

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

    Naples, 80131

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

    Pozzilli, 86077

Other trials in Italy

Spain5 sites

  • Hospital Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitari Arnau de Vilanova

    Lleida, Catalonia, 25198

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

Other trials in Spain

Belgium4 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • UZA

    Edegem, 2650

  • CHU de Tivoli

    La Louvière, 7100

Other trials in Belgium

Netherlands3 sites

  • Amphia Ziekenhuis, Molengracht

    Breda, 4818 CK

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435 CM

  • Zuyderland Medisch Centrum - Sittard-Geleen

    Sittard, 6162 BG

Other trials in Netherlands

Israel1 site

  • Chaim Sheba Medical Center

    Ramat Gan, 52363

Other trials in Israel

About this study

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

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.

Read the 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.

Being tested
Natalizumab
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NatalizumabDrug

    Also called BG00002

    Natalizumab 300 mg IV infusion.

  • NatalizumabDrug

    Also called BG00002

    Natalizumab 300 mg SC injection or IV infusion.

Study groups in NCT03689972
Study groupRoleWhat they receive
Part 1: IV Q4WExperimentalParticipants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72.
Receives: Drug: Natalizumab
Part 1: IV Q6WExperimentalParticipants received natalizumab 300 mg IV infusion once Q6W up to Week 72.
Receives: Drug: Natalizumab
Part 2: Run-in Period: IV Q6WExperimentalParticipants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102.
Receives: Drug: Natalizumab
Part 2: Crossover Period: IV Q6W, then SC Q6WExperimentalParticipants 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.
Receives: Drug: Natalizumab
Part 2: Crossover Period: SC Q6W, then IV Q6WExperimentalParticipants 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.
Receives: Drug: Natalizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Week 72

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

    Measured: Week 150

Secondary outcomes (21)

  1. Part 1: Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC)

    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.

    Measured: Up to Week 72

  2. Part 1: Annualized Relapse Rate at Week 72

    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.

    Measured: Week 72

  3. Part 1: Time to Expanded Disability Status Scale (EDSS) Worsening

    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.

    Measured: Up to Week 72

  4. Part 1: Mean Number of New T1 Hypointense Lesions at Weeks 24, 48, and 72

    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.

    Measured: Weeks 24, 48, and 72

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

    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.

    Measured: Weeks 24 and 48

  6. Part 1: Mean Number of New Gadolinium (Gd) Enhancing Lesions at Weeks 24, 48, and 72

    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.

    Measured: Weeks 24, 48, and 72

  7. Part 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) 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 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.

    Measured: Baseline up to Week 84

  8. Part 2: Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores During the Crossover Period

    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.

    Measured: Part 2 Baseline (Week 108) up to Week 156

  9. Part 2: Mean Time for Drug Preparation and Drug Administration During the Crossover Period

    Measured: Week 108 up to Week 156

  10. Part 2: Percentage of Participants With Treatment-Emergent Adverse Events (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 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.

    Measured: Part 2: Baseline (Week 108) up to Week 180

  11. Part 2: Percentage of Participants With Anti-Natalizumab Antibodies During the Crossover Period

    Measured: Part 2 Baseline (Week 108) up to Week 156

  12. Part 2: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions During the Crossover Period

    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.

    Measured: Part 2 Baseline (Week 108) up to Week 156

  13. Part 2: Time to First Relapse During the Crossover Period

    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.

    Measured: Part 2 Baseline (Week 108) up to Week 156

  14. Part 2: Annualized Relapse Rate During the Crossover Period

    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.

    Measured: Part 2 Baseline (Week 108) up to Week 156

  15. Part 2: Change From Baseline in EDSS Score During the Crossover Period

    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.

    Measured: Part 2 Baseline (Week 108) up to Week 156

  16. Part 2: Mean Number of New Gd Enhancing Lesions During the Crossover Period

    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.

    Measured: Week 108 up to Week 156

  17. Part 2: Mean Number of New T1 Hypointense Lesions During the Crossover Period

    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.

    Measured: Week 108 up to Week 156

  18. Part 2: Mean Percentage Change From Baseline in Brain Volume During the Crossover Period

    Measured: Part 2 Baseline (Week 108) up to Week 156

  19. Part 2: Change From Baseline in Cortical and Thalamic Brain Region Volume During the Crossover Period

    Measured: Part 2 Baseline (Week 108) up to Week 156

  20. Part 2: Trough Serum Concentration of Natalizumab (Ctrough) During the Crossover Period

    Measured: Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156

  21. Part 2: Mean Trough α4 Integrin Saturation During the Crossover Period

    Measured: Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2018
  2. Study start27 Nov 2018
  3. Primary completion31 Jan 2023
  4. Study completion24 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
585 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03689972
Sponsor's protocol ID
101MS329
Other IDs
2018-002145-11, 2018
Status last verified
May 2024
First submitted
27 Sep 2018
Last updated
12 Jun 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Please refer data queries to DataSharing@biogen.com.

Publications

  • Foley JF, Defer G, Ryerson LZ, Cohen JA, Arnold DL, Butzkueven H, Cutter GR, Giovannoni G, Killestein J, Wiendl H, Li K, Dsilva L, Toukam M, Ferber K, Sohn J, Engelman H, Lasky T. Pharmacokinetics and Pharmacodynamics of Natalizumab 6-Week Dosing vs Continued 4-Week Dosing for Relapsing-Remitting Multiple Sclerosis. Neurol Neuroimmunol Neuroinflamm. 2024 Dec;11(6):e200321. doi: 10.1212/NXI.0000000000200321. Epub 2024 Oct 11.

    PubMed 39393045

  • Wiendl H, Foley J, Defer G, Zhovtis Ryerson L, Cohen JA, Arnold DL, Butzkueven H, Cutter GR, Giovannoni G, Killestein J, Domingo-Horne R, Toukam M, Nunn A, Maghzi AH, Kuhelj R, Lasky T. Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (Tysabri(R)) Dosing: NOVA Phase IIIb Extension Study (Part 2). Neurol Ther. 2024 Oct;13(5):1385-1401. doi: 10.1007/s40120-024-00647-0. Epub 2024 Jul 24.

    PubMed 39046635

  • 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.

    PubMed 35483387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Natalizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Biogen at 107 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Germany, United Kingdom, Australia, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Mean Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72 (time frame: Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689972, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.

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