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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002145-11 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: IV Q4W | Experimental | Participants received natalizumab 300 mg intravenous (IV) infusion once Q4W up to Week 72. |
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| Part 1: IV Q6W | Experimental | Participants received natalizumab 300 mg IV infusion once Q6W up to Week 72. |
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| Part 2: Run-in Period: IV Q6W | Experimental | Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102. |
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| Part 2: Crossover Period: IV Q6W, then SC Q6W | Experimental | Participants 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. |
|
| Part 2: Crossover Period: SC Q6W, then IV Q6W | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | Natalizumab 300 mg IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 72 |
| Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Crossover Period of Part 2 | Week 150 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Key Inclusion Criteria:
For Part 1:
For Part 2:
Key Exclusion Criteria:
For Part 1:
For Part 2:
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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, P.C. | Cullman | Alabama | 35058 | United States | ||
| Alabama Neurology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39393045 | Derived | 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. | |
| 39046635 |
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Please refer data queries to DataSharing@biogen.com.
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585 participants were enrolled in the study, out of which 499 participants were randomized in Part 1. A total of 396 participants completed Part 1 of the study, out of which 67 participants entered Part 2 of the study. A total of 153 participants (including 86 new participants) entered Part 2 crossover period and 123 participants completed the study.
Participants were enrolled at the investigative sites in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, the United Kingdom, and the United States from 27 November 2018 to 20 June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Standard Interval Dosing (SID) (Every 4 Weeks [Q4W]) IV | Participants received natalizumab 300 mg intravenous (IV) infusion Q4W up to Week 72. |
| FG001 | Part 1: Extended Interval Dosing (EID) (Every 6 Weeks [Q6W]) IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 (Day 1 up to Week 72) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 20, 2020 | Jan 30, 2024 |
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|
| Natalizumab | Drug | Natalizumab 300 mg SC injection or IV infusion. |
|
|
| Up to Week 72 |
| 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. | Week 72 |
| 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. | Up to Week 72 |
| 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. | Weeks 24, 48, and 72 |
| 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. | Weeks 24 and 48 |
| 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. | Weeks 24, 48, and 72 |
| 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. | Baseline up to Week 84 |
| 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. | Part 2 Baseline (Week 108) up to Week 156 |
| Part 2: Mean Time for Drug Preparation and Drug Administration During the Crossover Period | Week 108 up to Week 156 |
| 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. | Part 2: Baseline (Week 108) up to Week 180 |
| Part 2: Percentage of Participants With Anti-Natalizumab Antibodies During the Crossover Period | Part 2 Baseline (Week 108) up to Week 156 |
| 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. | Part 2 Baseline (Week 108) up to Week 156 |
| 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. | Part 2 Baseline (Week 108) up to Week 156 |
| 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. | Part 2 Baseline (Week 108) up to Week 156 |
| 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. | Part 2 Baseline (Week 108) up to Week 156 |
| 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. | Week 108 up to Week 156 |
| 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. | Week 108 up to Week 156 |
| Part 2: Mean Percentage Change From Baseline in Brain Volume During the Crossover Period | Part 2 Baseline (Week 108) up to Week 156 |
| Part 2: Change From Baseline in Cortical and Thalamic Brain Region Volume During the Crossover Period | Part 2 Baseline (Week 108) up to Week 156 |
| Part 2: Trough Serum Concentration of Natalizumab (Ctrough) During the Crossover Period | Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156 |
| Part 2: Mean Trough α4 Integrin Saturation During the Crossover Period | Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156 |
| 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 | 80010-0510 | United States |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | United States |
| Yale University | Fairfield | Connecticut | 06824 | United States |
| Georgetown University Hospital-Medstar | Washington D.C. | District of Columbia | 20007-2113 | 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. | Foxborough | Massachusetts | 02035 | United States |
| Beth Israel Deaconess Medical Center, Inc. | Jamaica Plain | Massachusetts | 02130-2075 | 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 | St 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 | 27607-6010 | 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 | Brussels | 1070 | Belgium |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UZA | Edegem | 2650 | Belgium |
| CHU de Tivoli | La Louvière | 7100 | Belgium |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Clinique Neuro-Outaouais | Gatineau | Quebec | J8Y 1W2 | Canada |
| Recherche SEPMUS | Greenfield Park | Quebec | J4V 2J2 | Canada |
| CHUM Centre de Recherche | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institute Clinical Research Unit | Montreal | Quebec | H3A 3B4 | 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 im Odenwald | 64711 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Marburg | Marburg | 35043 | Germany |
| Klinikum rechts der Isar der TU Muenchen | Munich | 81675 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | 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 | Milan | 20133 | Italy |
| Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" | Naples | 80131 | Italy |
| I.R.C.C.S. Neuromed-Istituto Neurologico Mediterraneo | Pozzilli | 86077 | Italy |
| Amphia Ziekenhuis, Molengracht | Breda | 4818 CK | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Zuyderland Medisch Centrum - Sittard-Geleen | Sittard | 6162 BG | 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 | Málaga | 29010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| King's College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| The National Hospital for Neurology & Neurosurgery | London | Greater London | WC1N 3BG | United Kingdom |
| Walton Centre for Neurology & Neurosurgery. | Liverpool | Merseyside | L9 7LJ | United Kingdom |
| Queen Elizabeth University Hospital Campus | Glasgow | Strathclyde | G51 4TF | United Kingdom |
| Newcastle University- Clinical Ageing Research Unit | Newcastle upon Tyne | Tyne & Wear | NE4 5PL | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Nottingham University Hospital, Queen's Medical Centre | Nottingham | NG7 2UH | United Kingdom |
| Salford Care Organisation | Salford | M6 8HD | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Morriston Hospital | Swansea | SA6 6NL | United Kingdom |
| Derived |
| 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. |
| 35483387 | Derived | 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. |
Participants received natalizumab 300 mg IV infusion Q6W up to Week 72.
| FG002 | Part 2: Run-in Period: IV Q6W | Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102. |
| FG003 | Part 2: Crossover Period: IV Q6W Then SC Q6W | Participants 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. |
| FG004 | Part 2: Crossover Period: SC Q6W Then IV Q6W | Participants 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. |
| COMPLETED | Completed denotes the participants that completed the study treatment. |
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| NOT COMPLETED |
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| Part 2:Run-in Period (Week73uptoWeek107) |
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| Part2CrossoverPeriod(Week108uptoWeek156) |
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Part 1: All randomized population included all the randomized participants in Part 1 of the study. Part 2: Included all the newly enrolled randomized participants in the crossover period of Part 2 of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: IV Q4W | Participants received natalizumab 300 mg IV infusion Q4W up to Week 72. |
| BG001 | Part 1: IV Q6W | Participants received natalizumab 300 mg IV infusion Q6W up to Week 72. |
| BG002 | Part 2: Crossover Period | Participants who were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 108 through Week 126 followed by natalizumab 300 mg SC injection Q6W from Week 132 through Week 150, or 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | Modified intent to treat (mITT) population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Mean | 95% Confidence Interval | number of T2 lesions | Week 72 |
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| Primary | Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Crossover Period of Part 2 | mITT population included all randomized participants who received at least one dose of SC natalizumab after randomization in Part 2 and who completed at least the first question in the Patient Preference Questionnaire (PPQ) on one occasion. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. (Confidence interval=CI) | Posted | Number | percentage of participants | Week 150 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. | Posted | Median | Inter-Quartile Range | weeks | Up to Week 72 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. | Posted | Number | 95% Confidence Interval | relapses per participant-year | Week 72 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. | Posted | Median | Inter-Quartile Range | weeks | Up to Week 72 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. Here, 'number analyzed' signifies the number of participants with data available for analysis at specified time-point. | Posted | Mean | Standard Deviation | number of T1 lesions | Weeks 24, 48, and 72 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. Here, 'number analyzed' signifies the number of participants with data available for analysis at specified time point. | Posted | Mean | Standard Deviation | number of T2 lesions | Weeks 24 and 48 |
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| Secondary | 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. | mITT population included all randomized participants who received at least one dose of study treatment and had at least one postbaseline result in Part 1. 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. Here, 'number analyzed' signifies the number of participants with data available for analysis at specified time-point. | Posted | Mean | Standard Deviation | number of Gd lesions | Weeks 24, 48, and 72 |
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| Secondary | 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. | Safety population included all randomized participants who received at least one dose of study treatment in Part 1. | Posted | Number | percentage of participants | Baseline up to Week 84 |
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| Secondary | 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. | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Least Squares Mean | Standard Error | Score on a scale | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | Part 2: Mean Time for Drug Preparation and Drug Administration During the Crossover Period | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. | Posted | Mean | Standard Deviation | minutes | Week 108 up to Week 156 |
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| Secondary | 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. | Safety population included all randomized participants who received at least one dose of study treatment during the crossover period of Part 2. | Posted | Number | percentage of participants | Part 2: Baseline (Week 108) up to Week 180 |
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| Secondary | Part 2: Percentage of Participants With Anti-Natalizumab Antibodies During the Crossover Period | Immunogenicity population included all participants who received at least one dose of SC or IV natalizumab and had at least one assessment for anti-drug antibody during crossover period of Part 2. | Posted | Number | percentage of participants | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | 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. | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Mean | Standard Deviation | number of T2 lesions | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | 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. | FAS: all randomized participants receiving ≥1 dose of study treatment during at least one study period and had ≥1 baseline assessment in Part 2. Overall number analyzed: participants without any relapse at beginning of crossover period of Part 2. As pre-specified in the Statistical Analysis Plan(SAP), time to event analyses was planned 'per treatment sequence' rather than 'per intervention' in Part 2 as protocol-specified analysis does not account for correlation of within participant effect. | Posted | Median | Inter-Quartile Range | weeks | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | 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. | Data was not analyzed for this outcome measure as only one relapse was observed in the Part 2 crossover period. | Posted | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | 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. | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Least Squares Mean | Standard Error | Score on a scale | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | 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. | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Mean | Standard Deviation | number of Gd lesions | Week 108 up to Week 156 |
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| Secondary | 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. | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Mean | Standard Deviation | number of T1 lesions | Week 108 up to Week 156 |
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| Secondary | Part 2: Mean Percentage Change From Baseline in Brain Volume During the Crossover Period | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. Here, 'overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. | Posted | Least Squares Mean | Standard Error | percent change | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | Part 2: Change From Baseline in Cortical and Thalamic Brain Region Volume During the Crossover Period | Full analysis set included all randomized participants who received at least one dose of study treatment during at least one study period and had at least one baseline assessment in Part 2. 'Overall number of participants analyzed' signifies the number of participants with data available for outcome measure analysis. Here "number analyzed" signifies the number of participants with data available for analysis at specified categories. | Posted | Least Squares Mean | Standard Error | cubic centimeters (cm^3) | Part 2 Baseline (Week 108) up to Week 156 |
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| Secondary | Part 2: Trough Serum Concentration of Natalizumab (Ctrough) During the Crossover Period | Pharmacokinetic (PK) population included all participants who received at least one dose of SC or IV natalizumab and had at least one assessment for the concentration of natalizumab in serum during the crossover period of Part 2. | Posted | Mean | Standard Deviation | micrograms per milliliter (µg/mL) | Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156 |
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| Secondary | Part 2: Mean Trough α4 Integrin Saturation During the Crossover Period | Pharmacodynamic (PD) population included all participants who received at least one dose of SC or IV natalizumab after randomization in Part 2 and had at least one post-baseline assessment of the PD parameter. Here 'overall number of participants analyzed' indicates the number of participants without any relapse at the beginning of the crossover period of Part 2. | Posted | Mean | Standard Deviation | percentage | Pre-dose at Weeks 108, 114, 120, 126, 132, 138, 144, 150, and 156 |
|
|
From first dose of study drug up to Week 180
Safety population included all randomized participants who received at least one dose of study treatment. MedDRA version 24.0 applied for Part 1 and MedDRA version 26.0 applied for Part 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: IV Q4W | Participants received natalizumab 300 mg IV infusion Q4W up to Week 72. | 0 | 247 | 17 | 247 | 104 | 247 |
| EG001 | Part 1: IV Q6W | Participants received natalizumab 300 mg IV infusion Q6W up to Week 72. | 0 | 250 | 17 | 250 | 105 | 250 |
| EG002 | Part 2: Run-in Period: IV Q6W | Participants who completed Part 1 or were newly enrolled in Part 2 received natalizumab 300 mg IV infusion Q6W from Week 72 through Week 102. | 0 | 158 | 3 | 158 | 42 | 158 |
| EG003 | Part 2: Crossover Period: IV Q6W | Participants received natalizumab 300 mg IV infusion Q6W for 24 weeks. | 0 | 136 | 2 | 136 | 48 | 136 |
| EG004 | Part 2: Crossover Period: SC Q6W | Participants received natalizumab 300 mg SC injection Q6W for 24 weeks. | 0 | 132 | 4 | 132 | 56 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coronary artery dissection | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholangitis infective | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Covid-19 pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract procedural complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple sclerosis pseudo relapse | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adnexal torsion | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0, 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0, 26.0 | Systematic Assessment |
|
Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| US Biogen Clinical Trial Center | Biogen | 866-633-4636 | clinicaltrials@biogen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2023 | Jan 30, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Pregnancy |
|
| Reason not Specified |
|
| Consent Withdrawn |
|
| Investigator Decision |
|
| Pregnancy |
|
| Reason not Specified |
|
| Randomized but not Dosed |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Not Reported |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
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Participants received natalizumab 300 mg SC injection Q6W for 24 weeks. |
|
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| Units |
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| Counts |
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| Participants |
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Participants 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.
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| Units |
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| Counts |
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| Participants |
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