Multiple Sclerosis Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT03689972

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 107 Locations for this study

See Locations Near You

North Central Neurology Associates, P.C.
Cullman Alabama, 35058, United States
Alabama Neurology Associates
Homewood Alabama, 35209, United States
UCI MIND
Irvine California, 92607, United States
UC San Diego Movement Disorder Center
La Jolla California, 92037, United States
MS Center of California
Laguna Hills California, 92653, United States
Stanford Hospital and Clinics
Palo Alto California, 94304, United States
University of Colorado Hospital Anschutz Outpatient Pavillion
Aurora Colorado, 80010, United States
Advanced Neurosciences Research
Fort Collins Colorado, 80528, United States
Yale University
Fairfield Connecticut, 06824, United States
Georgetown University Hospital-Medstar
Washington District of Columbia, 20007, United States
University of Miami Miller School of Medicine
Miami Florida, 33125, United States
Infinity Clinical Research, LLC
Sunrise Florida, 33351, United States
University of South Florida
Tampa Florida, 33612, United States
Shepherd Center, Inc.
Atlanta Georgia, 30309, United States
Atlanta Neuroscience Institute
Atlanta Georgia, 30327, United States
NorthShore University HealthSystem
Evanston Illinois, 60201, United States
Northwestern University
Evanston Illinois, 60208, United States
College Park Family Care Center
Overland Park Kansas, 66212, United States
Lahey Clinic Inc. - PARENT ACCOUNT
Burlington Massachusetts, 01805, United States
Neurology Center of New England P.C.
Foxboro Massachusetts, 02035, United States
Beth Israel Deaconess Medical Center, Inc.
Jamaica Plain Massachusetts, 02130, United States
Dragonfly Research, LLC
Wellesley Massachusetts, 02481, United States
South Shore Neurology Associates
Weymouth Massachusetts, 02190, United States
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States
Michigan State University
Grand Rapids Michigan, 49506, United States
Memorial Healthcare
Owosso Michigan, 48867, United States
Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Washington University, School of Medicine
Saint Louis Missouri, 63110, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada, 89106, United States
RWJ Barnabas Health
Newark New Jersey, 07102, United States
Holy Name Medical Center
Teaneck New Jersey, 07666, United States
NYU Langone Clinical Cancer Center
New York New York, 10016, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Columbia University Hervert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Island Neurological Associates, P.C.
Plainview New York, 11803, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
OhioHealth Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Dayton Center for Neurological Disorders
Dayton Ohio, 45459, United States
Providence Neurological Specialties
Portland Oregon, 97225, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Magee-Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
Sibyl Wray, MD Neurology, PC
Knoxville Tennessee, 37922, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37215, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Rocky Mountain MS Research Group LLC
Salt Lake City Utah, 84103, United States
University Of Virginia
Charlottesville Virginia, 22908, United States
Multiple Sclerosis Center of Greater Washington
Vienna Virginia, 22182, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Wheaton Franciscan Healthcare
Milwaukee Wisconsin, 53227, United States
Royal North Shore Hospital
St Leonards New South Wales, 2065, Australia
Brain and Mind Centre
Sydney New South Wales, 2050, Australia
Lyell McEwin Hospital
Elizabeth Vale South Australia, 5112, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Cliniques Universitaires de Bruxelles Hopital Erasme
Bruxelles , 1070, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
UZA
Edegem , 2650, Belgium
CHU de Tivoli
La Louvière , 7100, Belgium
St. Michael's Hospital
Toronto Ontario, M5B 1, Canada
Clinique Neuro-Outaouais
Gatineau Quebec, J8Y 1, Canada
Recherche SEPMUS
Greenfield Park Quebec, J4V 2, Canada
CHUM Centre de Recherche
Montreal Quebec, H2X 0, Canada
Montreal Neurological Institute Clinical Research Unit
Montreal Quebec, H3A 3, Canada
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux , 33076, France
CHU CAEN - Hôpital de la Côte de Nacre
Caen , 14033, France
Hopital Roger Salengro - CHU Lille
Lille , 59037, France
CHU Nice - Hôpital Pasteur
Nice , 6001, France
CHU Nantes - Hopital Nord Laënnec
Saint Herblain , 44800, France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg , 67091, France
Neurologie im Alphamed
Bamberg , 96052, Germany
Charité - Campus Charité Mitte
Berlin , 10117, Germany
Katholisches Klinikum Bochum gGmbH
Bochum , 44791, Germany
Neuro Centrum Science GmbH
Erbach , 64711, Germany
Universitaetsklinikum Essen
Essen , 45147, Germany
Universitaetsklinikum Freiburg
Freiburg , 79106, Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg
Marburg , 35043, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Klinikum rechts der Isar der TU Muenchen
Munich , 81675, Germany
Synconcept GmbH - Neuro MVZ
Stuttgart , 70182, Germany
Chaim Sheba Medical Center
Ramat Gan , 52363, Israel
Azienda Ospedaliero Universitaria Policlinico "Gaspare Rodolico - San Marco" (Presidio G. Rodolico)
Catania , 95123, Italy
Fondazione Istituto G.Giglio di Cefalù
Cefalù , 90015, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano , 20133, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli , 80131, Italy
I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo
Pozzilli , 86077, Italy
Amphia Ziekenhuis, Molengracht
Breda , 4818 , Netherlands
St. Antonius Ziekenhuis
Nieuwegein , 3435 , Netherlands
Zuyderland Medisch Centrum - Sittard-Geleen
Sittard , 6162 , Netherlands
Hospital Universitari Arnau de Vilanova
Lleida Catalonia, 25198, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar Murcia, 30120, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
King's College Hospital
London Greater London, SE5 9, United Kingdom
The National Hospital for Neurology & Neurosurgery
London Greater London, WC1N , United Kingdom
Walton Centre for Neurology & Neurosurgery.
Liverpool Merseyside, L9 7L, United Kingdom
Queen Elizabeth University Hospital Campus
Glasgow Strathclyde, G51 4, United Kingdom
Newcastle University- Clinical Ageing Research Unit
Newcastle upon Tyne Tyne & Wear, NE4 5, United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
Nottingham University Hospital, Queen's Medical Centre
Nottingham , NG7 2, United Kingdom
Salford Care Organisation
Salford , M6 8H, United Kingdom
Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom
Morriston Hospital
Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

499

Study ID:

NCT03689972

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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