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ARTIOS: An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod to Ofatumumab

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04353492
Collaborator
(none)
555
Enrollment
164
Locations
1
Arm
57.6
Anticipated Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Open-label study to evaluate the effectiveness of treatment with ofatumumab in subjects transitioning from any fumarate-based RMS approved therapy or fingolimod due to breakthrough disease.

Condition or Disease Intervention/Treatment Phase
  • Biological: Ofatumumab
 Phase 3

Detailed Description

This is a single arm, prospective, multicentre and open-label, 96-week study to evaluate the treatment effectiveness of ofatumumab (OMB) in subjects with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF), diroximel fumarate (DRF), and monomethyl fumarate (MMF), or fingolimod due to breakthrough disease activity.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
555 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient-reported Outcomes (PRO) in Patients With Relapsing Multiple Sclerosis (RMS) Transitioning From Fumarate-based RMS Approved Therapies or Fingolimod
Actual Study Start Date :
Jul 14, 2020
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ofatumumab

Ofatumumab 20 mg subcutaneous injections every 4 weeks, following loading of 3 doses in the first 14 days

Biological: Ofatumumab
Subjects will receive ofatumumab injections in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
Other Names:
  • OMB157

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Annual Relapse Rate (ARR) [Up to 96 weeks from baseline]

      ARR is the number of confirmed relapses in a year calculated based on cumulative number of relapses by patient adjusted for time-in-study by patient

    Secondary Outcome Measures

    1. Safety evaluation [96 weeks]

      Proportion of patients with adverse events, including injection related reactions, abnormal laboratory results or vital signs, as well as proportion of patients discontinuing treatment due to insufficient effectiveness or tolerability/safety reasons

    Eligibility Criteria

    Criteria

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

    • Diagnosis of MS according to the 2017 Revised McDonald criteria

    • Relapsing MS: relapsing forms of MS (RMS) including RMS and secondary progressive MS (SPMS)

    • Disability status at screening defined by Expanded Disability Status Scale (EDSS) score of 0 to 4 (inclusive)

    • MS treatment history with a maximum of 3 Disease Modifying Therapies (DMTs), where all fumarates are considered as one DMT

    • Subject transitioning from either any fumarate-based RMS approved therapies, such as dimethyl fumarate (DMF) or diroximel fumarate (DRF), or fingolimod which was administered for a period of at least 6 months, as their last DMT before first study drug administration

    • Breakthrough disease activity while the participant was adequately using fumarates or fingolimod prior to transitioning for a minimum of 6 months as evidenced by one or more clinically reported relapses or one or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+ enhancement, new or enlarging T2 lesions)

    • Neurologically stable within one month prior to first study drug administration

    Exclusion Criteria:

    • Subjects with primary progressive MS or SPMS without disease activity

    • Subjects meeting criteria for neuromyelitis optica

    • Disease duration of more than 10 years since diagnosis

    • Pregnant or nursing (lactating) women

    • Women of child-bearing potential unless they are using highly effective forms of contraception during dosing and for at least 6 months after stopping study medication

    • Subjects with active chronic disease of the immune system other than MS or with immunodeficiency syndrome

    • Subjects with active systemic bacterial, fungal or viral infections (such as hepatitis, HIV, COVID-19), or known to have Acquired Immunodeficiency Syndrome (AIDS)

    • Subjects with neurological symptoms consistent with Progressive Multifocal Leukoencephalopathy (PML) or with confirmed PML

    • Subjects at risk of developing or having reactivation of syphilis or tuberculosis (e.g. subjects with known exposure to, or history of syphilis, or active or latent tuberculosis, even if previously treated), as confirmed by medical history or per local practice

    • Subjects with active hepatitis B and C disease, assessed locally

    • Have received any live or live-attenuated vaccines within 4 weeks prior to first study drug administration

    • Have been treated with medications as specified or within timeframes specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab, alemtuzumab, natalizumab, daclizumab, cyclophosphamide, teriflunomide etc.)

    • Subjects suspected of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the investigator

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Cullman Alabama United States 35058
    2 Novartis Investigative Site Tucson Arizona United States 85718
    3 Novartis Investigative Site Fullerton California United States 92835
    4 Novartis Investigative Site Loma Linda California United States 92354
    5 Novartis Investigative Site Los Angeles California United States 90033
    6 Novartis Investigative Site Mountain View California United States 94040
    7 Novartis Investigative Site San Diego California United States 92103
    8 Novartis Investigative Site Aurora Colorado United States 80045
    9 Novartis Investigative Site Colorado Springs Colorado United States 80907
    10 Novartis Investigative Site Newark Delaware United States 19713
    11 Novartis Investigative Site Hollywood Florida United States 33021
    12 Novartis Investigative Site Maitland Florida United States 32751
    13 Novartis Investigative Site Miami Florida United States 33032
    14 Novartis Investigative Site Miami Florida United States 33136
    15 Novartis Investigative Site Sarasota Florida United States 34233
    16 Novartis Investigative Site Sunrise Florida United States 33351
    17 Novartis Investigative Site Tampa Florida United States 33609
    18 Novartis Investigative Site Tampa Florida United States 33612
    19 Novartis Investigative Site West Palm Beach Florida United States 33407
    20 Novartis Investigative Site Atlanta Georgia United States 30327
    21 Novartis Investigative Site Suwanee Georgia United States 30024
    22 Novartis Investigative Site Honolulu Hawaii United States 96817
    23 Novartis Investigative Site Indianapolis Indiana United States 46256
    24 Novartis Investigative Site Baltimore Maryland United States 21287
    25 Novartis Investigative Site Boston Massachusetts United States 02114
    26 Novartis Investigative Site Foxboro Massachusetts United States 02035
    27 Novartis Investigative Site Chesaning Michigan United States 48616
    28 Novartis Investigative Site Detroit Michigan United States 48202
    29 Novartis Investigative Site Golden Valley Minnesota United States 55422
    30 Novartis Investigative Site Lincoln Nebraska United States 68510
    31 Novartis Investigative Site Omaha Nebraska United States 68130
    32 Novartis Investigative Site Las Vegas Nevada United States 89106
    33 Novartis Investigative Site Albuquerque New Mexico United States 87131-0001
    34 Novartis Investigative Site Amherst New York United States 14226
    35 Novartis Investigative Site Woodmere New York United States 11598
    36 Novartis Investigative Site Cincinnati Ohio United States 45219
    37 Novartis Investigative Site Cleveland Ohio United States 44195
    38 Novartis Investigative Site Westerville Ohio United States 43082
    39 Novartis Investigative Site Oklahoma City Oklahoma United States 73104
    40 Novartis Investigative Site Portland Oregon United States 97225
    41 Novartis Investigative Site Philadelphia Pennsylvania United States 19107-5098
    42 Novartis Investigative Site Pittsburgh Pennsylvania United States 15240
    43 Novartis Investigative Site Houston Texas United States 77030
    44 Novartis Investigative Site Fairfax Virginia United States 22030
    45 Novartis Investigative Site Milwaukee Wisconsin United States 53215
    46 Novartis Investigative Site Rosario Santa Fe Argentina S2000BZL
    47 Novartis Investigative Site Rosario Santa Fe Argentina S2000DSW
    48 Novartis Investigative Site Buenos Aires Argentina 1061
    49 Novartis Investigative Site Tucuman Argentina 4000
    50 Novartis Investigative Site Liverpool New South Wales Australia 2170
    51 Novartis Investigative Site New Lambton Heights New South Wales Australia 2305
    52 Novartis Investigative Site Woolloongabba Queensland Australia 4102
    53 Novartis Investigative Site Heidelberg Victoria Australia 3084
    54 Novartis Investigative Site Melbourne Victoria Australia 3004
    55 Novartis Investigative Site Parkville Victoria Australia 3050
    56 Novartis Investigative Site Nedlands Western Australia Australia 6009
    57 Novartis Investigative Site Linz Oberoesterreich Austria A 4020
    58 Novartis Investigative Site Linz Austria 4020
    59 Novartis Investigative Site Vienna Austria 1090
    60 Novartis Investigative Site Wien Austria 1010
    61 Novartis Investigative Site Edegem Antwerpen Belgium 2650
    62 Novartis Investigative Site Bonheiden Belgium 2820
    63 Novartis Investigative Site Brugge Belgium 8000
    64 Novartis Investigative Site Bruxelles Belgium 1200
    65 Novartis Investigative Site Esneux Belgium 4130
    66 Novartis Investigative Site Pleven Bulgaria 5800
    67 Novartis Investigative Site Sofia Bulgaria 1113
    68 Novartis Investigative Site Sofia Bulgaria 1413
    69 Novartis Investigative Site Sofia Bulgaria 1431
    70 Novartis Investigative Site Burnaby British Columbia Canada V5G 2X6
    71 Novartis Investigative Site Toronto Ontario Canada M4N 3M5
    72 Novartis Investigative Site Toronto Ontario Canada M5B 1W8
    73 Novartis Investigative Site Brno Czech Republic Czechia 656 91
    74 Novartis Investigative Site Havirov Czech Republic Czechia 736 01
    75 Novartis Investigative Site Teplice Czech Republic Czechia 415 01
    76 Novartis Investigative Site Hradec Kralove CZE Czechia 500 05
    77 Novartis Investigative Site Praha Czechia 12808
    78 Novartis Investigative Site Tallinn Estonia 11315
    79 Novartis Investigative Site Tartu Estonia 51014
    80 Novartis Investigative Site Regensburg Bavaria Germany 93053
    81 Novartis Investigative Site Alzenau Germany 63755
    82 Novartis Investigative Site Berlin Germany 10713
    83 Novartis Investigative Site Bielefeld Germany D 33647
    84 Novartis Investigative Site Cottbus Germany 03048
    85 Novartis Investigative Site Erlangen Germany 91054
    86 Novartis Investigative Site Heidelberg Germany 69120
    87 Novartis Investigative Site Koln Germany 50935
    88 Novartis Investigative Site Leipzig Germany 04275
    89 Novartis Investigative Site Minden Germany 32429
    90 Novartis Investigative Site Muenchen Germany 81377
    91 Novartis Investigative Site Osnabrück Germany 49076
    92 Novartis Investigative Site Potsdam Germany 14471
    93 Novartis Investigative Site Siegen Germany 57076
    94 Novartis Investigative Site Ulm Germany 89073
    95 Novartis Investigative Site Ulm Germany 89081
    96 Novartis Investigative Site Unterhaching Germany 82008
    97 Novartis Investigative Site Westerstede/Oldenburg Germany 26655
    98 Novartis Investigative Site Larissa GR Greece 411 10
    99 Novartis Investigative Site Thessaloniki GR Greece 54645
    100 Novartis Investigative Site Thessaloniki Greece 53246
    101 Novartis Investigative Site Thessaloniki Greece GR 54636
    102 Novartis Investigative Site Budapest HUN Hungary 1135
    103 Novartis Investigative Site Budapest HUN Hungary 1204
    104 Novartis Investigative Site Tatabanya Komarom Esztergom Hungary 2800
    105 Novartis Investigative Site Pecs Hungary 7623
    106 Novartis Investigative Site Firenze FI Italy 50134
    107 Novartis Investigative Site Pavia PV Italy 27100
    108 Novartis Investigative Site Roma RM Italy 00152
    109 Novartis Investigative Site Verona VR Italy 37134
    110 Novartis Investigative Site Riga LV Latvia LV-1005
    111 Novartis Investigative Site Riga Latvia LV 1002
    112 Novartis Investigative Site Ashrafieh Lebanon 166830
    113 Novartis Investigative Site Beirut Lebanon 1107 2020
    114 Novartis Investigative Site Beirut Lebanon
    115 Novartis Investigative Site Ciudad de Mexico Distrito Federal Mexico 06700
    116 Novartis Investigative Site Mexico Distrito Federal Mexico 03100
    117 Novartis Investigative Site Morelia Michoacan Mexico 58260
    118 Novartis Investigative Site Chihuahua Mexico 31203
    119 Novartis Investigative Site Bergen Norway 5021
    120 Novartis Investigative Site Drammen Norway 1086
    121 Novartis Investigative Site Oslo Norway NO 0450
    122 Novartis Investigative Site Bydgoszcz Woj Kujawsko-pomorskie Poland 85-796
    123 Novartis Investigative Site Katowice Poland 40 571
    124 Novartis Investigative Site Kielce Poland 25 726
    125 Novartis Investigative Site Lodz Poland 90-153
    126 Novartis Investigative Site Wroclaw Poland 51-685
    127 Novartis Investigative Site Braga Portugal 4710243
    128 Novartis Investigative Site Lisboa Portugal 1349-019
    129 Novartis Investigative Site Loures Portugal 2674514
    130 Novartis Investigative Site Porto Portugal 4099-001
    131 Novartis Investigative Site Moscow Russian Federation 115516
    132 Novartis Investigative Site Moscow Russian Federation 127015
    133 Novartis Investigative Site St Petersburg Russian Federation 190000
    134 Novartis Investigative Site Riyadh SAU Saudi Arabia 11525
    135 Novartis Investigative Site Jeddah Saudi Arabia 21499
    136 Novartis Investigative Site Kosice Slovak Republic Slovakia 04066
    137 Novartis Investigative Site Banska Bystrica Slovakia 975 17
    138 Novartis Investigative Site Bratislava Slovakia 813 69
    139 Novartis Investigative Site Bratislava Slovakia 82606
    140 Novartis Investigative Site Bratislava Slovakia 83305
    141 Novartis Investigative Site Nitra Slovakia 94901
    142 Novartis Investigative Site Trnava Slovakia 917 75
    143 Novartis Investigative Site Ljubljana Slovenia 1000
    144 Novartis Investigative Site Maribor Slovenia 2000
    145 Novartis Investigative Site Sevilla Andalucia Spain 41009
    146 Novartis Investigative Site Barcelona Cataluna Spain 08026
    147 Novartis Investigative Site Valencia Comunidad Valenciana Spain 46010
    148 Novartis Investigative Site El Palmar Murcia Spain 30120
    149 Novartis Investigative Site Vigo Pontevedra Spain 36212
    150 Novartis Investigative Site Baracaldo Vizcaya Spain 48903
    151 Novartis Investigative Site Madrid Spain 28040
    152 Novartis Investigative Site Santa Cruz de Tenerife Spain 38009
    153 Novartis Investigative Site Valencia Spain 46026
    154 Novartis Investigative Site Basel Switzerland 4031
    155 Novartis Investigative Site Lugano Switzerland 6900
    156 Novartis Investigative Site St Gallen Switzerland 9007
    157 Novartis Investigative Site Sancaktepe Istanbul Turkey 34785
    158 Novartis Investigative Site Istanbul TUR Turkey 34098
    159 Novartis Investigative Site Izmir Turkey 35040
    160 Novartis Investigative Site Samsun Turkey 55139
    161 Novartis Investigative Site Trabzon Turkey 61080
    162 Novartis Investigative Site Plymouth Devon United Kingdom PL6 8BT
    163 Novartis Investigative Site Cardiff United Kingdom CF14 4XW
    164 Novartis Investigative Site Swansea United Kingdom

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04353492
    Other Study ID Numbers:
    • COMB157G23101
    • 2019-001341-40
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    Aug 10, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    RMS
    MS
    multiple sclerosis
    relapsing multiple sclerosis
    OMB157
    adult
    secondary progressive MS
    SPMS
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Ofatumumab

    Study Results

    No Results Posted as of Aug 10, 2022