Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS (ALITHIOS)

April 17, 2024 updated by: Novartis Pharmaceuticals

An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study.

Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2060

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1424BYD
        • Active, not recruiting
        • Novartis Investigative Site
      • Cordoba, Argentina, X5004CDT
        • Active, not recruiting
        • Novartis Investigative Site
      • Tucuman, Argentina, 4000
        • Active, not recruiting
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000BZL
        • Active, not recruiting
        • Novartis Investigative Site
      • Rosario, Santa Fe, Argentina, S2000DSW
        • Active, not recruiting
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Completed
        • Novartis Investigative Site
      • New Lambton Heights, New South Wales, Australia, 2305
        • Active, not recruiting
        • Novartis Investigative Site
      • St Leonards, New South Wales, Australia, 2065
        • Active, not recruiting
        • Novartis Investigative Site
  • Austria
      • Vienna, Austria, 1090
        • Active, not recruiting
        • Novartis Investigative Site
      • Wien, Austria, 1010
        • Completed
        • Novartis Investigative Site
  • Belgium
      • Brasschaat, Belgium, 2930
        • Active, not recruiting
        • Novartis Investigative Site
      • Brugge, Belgium, 8000
        • Active, not recruiting
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1200
        • Active, not recruiting
        • Novartis Investigative Site
      • Gent, Belgium, 9000
        • Active, not recruiting
        • Novartis Investigative Site
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Active, not recruiting
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Active, not recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1113
        • Active, not recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Active, not recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1413
        • Recruiting
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1309
        • Active, not recruiting
        • Novartis Investigative Site
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Active, not recruiting
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Completed
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Active, not recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Active, not recruiting
        • Novartis Investigative Site
    • Quebec
      • Gatineau, Quebec, Canada, J9J 0A5
        • Active, not recruiting
        • Novartis Investigative Site
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Completed
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3A 2B4
        • Active, not recruiting
        • Novartis Investigative Site
  • Croatia
      • Osijek, Croatia, 31000
        • Active, not recruiting
        • Novartis Investigative Site
      • Zagreb, Croatia, 10000
        • Active, not recruiting
        • Novartis Investigative Site
    • HRV
      • Rijeka, HRV, Croatia, 51000
        • Active, not recruiting
        • Novartis Investigative Site
  • Czechia
      • JIhlava, Czechia, 586 01
        • Active, not recruiting
        • Novartis Investigative Site
      • Ostrava Poruba, Czechia, 708 52
        • Active, not recruiting
        • Novartis Investigative Site
      • Pardubice, Czechia, 532 03
        • Active, not recruiting
        • Novartis Investigative Site
      • Praha 10, Czechia, 100 34
        • Active, not recruiting
        • Novartis Investigative Site
      • Praha 4, Czechia, 140 59
        • Active, not recruiting
        • Novartis Investigative Site
      • Praha 5, Czechia, 150 06
        • Completed
        • Novartis Investigative Site
    • CZE
      • Hradec Kralove, CZE, Czechia, 500 05
        • Active, not recruiting
        • Novartis Investigative Site
      • Olomouc, CZE, Czechia, 779 00
        • Active, not recruiting
        • Novartis Investigative Site
    • Czech Republic
      • Brno, Czech Republic, Czechia, 656 91
        • Active, not recruiting
        • Novartis Investigative Site
      • Havirov, Czech Republic, Czechia, 736 01
        • Active, not recruiting
        • Novartis Investigative Site
      • Teplice, Czech Republic, Czechia, 415 01
        • Active, not recruiting
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Active, not recruiting
        • Novartis Investigative Site
      • Odense C, Denmark, 5000
        • Active, not recruiting
        • Novartis Investigative Site
  • Estonia
      • Tallinn, Estonia, 10617
        • Active, not recruiting
        • Novartis Investigative Site
      • Tartu, Estonia, 50406
        • Active, not recruiting
        • Novartis Investigative Site
  • Finland
      • Tampere, Finland, 33100
        • Active, not recruiting
        • Novartis Investigative Site
      • Turku, Finland, 20520
        • Active, not recruiting
        • Novartis Investigative Site
  • France
      • Lille Cedex, France, 59037
        • Active, not recruiting
        • Novartis Investigative Site
      • Montpellier, France, 34295
        • Completed
        • Novartis Investigative Site
      • Nantes Cedex 1, France, 44093
        • Active, not recruiting
        • Novartis Investigative Site
      • Nimes, France, 30029
        • Completed
        • Novartis Investigative Site
      • Paris 13, France, 75651
        • Completed
        • Novartis Investigative Site
      • Strasbourg, France, 67000
        • Active, not recruiting
        • Novartis Investigative Site
    • Cedex1
      • Nice, Cedex1, France, 06001
        • Active, not recruiting
        • Novartis Investigative Site
  • Germany
      • Barsinghausen, Germany, 30890
        • Completed
        • Novartis Investigative Site
      • Bayreuth, Germany, 95445
        • Active, not recruiting
        • Novartis Investigative Site
      • Bielefeld, Germany, D 33647
        • Active, not recruiting
        • Novartis Investigative Site
      • Bochum, Germany, 44791
        • Active, not recruiting
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Active, not recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Active, not recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 22179
        • Active, not recruiting
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Completed
        • Novartis Investigative Site
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • Novartis Investigative Site
      • Koln, Germany, 50935
        • Active, not recruiting
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Active, not recruiting
        • Novartis Investigative Site
      • Marburg, Germany, 35043
        • Active, not recruiting
        • Novartis Investigative Site
      • Minden, Germany, 32429
        • Completed
        • Novartis Investigative Site
      • Muenchen, Germany, 81377
        • Active, not recruiting
        • Novartis Investigative Site
      • Muenchen, Germany, 80377
        • Completed
        • Novartis Investigative Site
      • Neuburg an der Donau, Germany, 86633
        • Completed
        • Novartis Investigative Site
      • Potsdam, Germany, 14471
        • Active, not recruiting
        • Novartis Investigative Site
      • Siegen, Germany, 57076
        • Active, not recruiting
        • Novartis Investigative Site
      • Ulm, Germany, 89073
        • Active, not recruiting
        • Novartis Investigative Site
      • Unterhaching, Germany, 82008
        • Completed
        • Novartis Investigative Site
  • Greece
      • Thessaloniki, Greece, GR 54636
        • Active, not recruiting
        • Novartis Investigative Site
    • GR
      • Athens, GR, Greece, 115 25
        • Active, not recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1106
        • Active, not recruiting
        • Novartis Investigative Site
      • Budapest, Hungary, 1138
        • Recruiting
        • Novartis Investigative Site
      • Budapest, Hungary, 1204
        • Recruiting
        • Novartis Investigative Site
      • Kistarcsa, Hungary, 2143
        • Active, not recruiting
        • Novartis Investigative Site
      • Pecs, Hungary, 7623
        • Recruiting
        • Novartis Investigative Site
      • Szeged, Hungary, 6725
        • Active, not recruiting
        • Novartis Investigative Site
    • HUN
      • Budapest, HUN, Hungary, 1135
        • Recruiting
        • Novartis Investigative Site
  • India
      • Mangalore, India, 575018
        • Active, not recruiting
        • Novartis Investigative Site
    • Delhi
      • New Delhi, Delhi, India, 110 060
        • Active, not recruiting
        • Novartis Investigative Site
      • New Delhi, Delhi, India, 110017
        • Active, not recruiting
        • Novartis Investigative Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Active, not recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Active, not recruiting
        • Novartis Investigative Site
      • Pune, Maharashtra, India, 411004
        • Active, not recruiting
        • Novartis Investigative Site
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Active, not recruiting
        • Novartis Investigative Site
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Active, not recruiting
        • Novartis Investigative Site
    • West Bengal
      • Howrah, West Bengal, India, 711103
        • Active, not recruiting
        • Novartis Investigative Site
  • Israel
      • Ashkelon, Israel, 78278
        • Active, not recruiting
        • Novartis Investigative Site
      • Haifa, Israel, 3109601
        • Completed
        • Novartis Investigative Site
      • Sefad, Israel, 13100
        • Active, not recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Completed
        • Novartis Investigative Site
  • Japan
      • Chiba, Japan, 2608677
        • Active, not recruiting
        • Novartis Investigative Site
      • Niigata, Japan, 951 8520
        • Active, not recruiting
        • Novartis Investigative Site
      • Osaka, Japan, 556-0016
        • Active, not recruiting
        • Novartis Investigative Site
    • Ehime
      • Toon city, Ehime, Japan, 791-0295
        • Active, not recruiting
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo city, Hokkaido, Japan, 063-0005
        • Completed
        • Novartis Investigative Site
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Active, not recruiting
        • Novartis Investigative Site
    • Miyagi
      • Sendai city, Miyagi, Japan, 980 8574
        • Active, not recruiting
        • Novartis Investigative Site
      • Sendai city, Miyagi, Japan, 983 8512
        • Active, not recruiting
        • Novartis Investigative Site
    • Saitama
      • Kawagoe, Saitama, Japan, 350 8550
        • Active, not recruiting
        • Novartis Investigative Site
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8551
        • Active, not recruiting
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160 8582
        • Active, not recruiting
        • Novartis Investigative Site
  • Latvia
      • Riga, Latvia, LV 1002
        • Active, not recruiting
        • Novartis Investigative Site
      • Riga, Latvia, LV-1038
        • Active, not recruiting
        • Novartis Investigative Site
    • LV
      • Riga, LV, Latvia, LV-1005
        • Active, not recruiting
        • Novartis Investigative Site
  • Lithuania
      • Vilnius, Lithuania, LT-08661
        • Active, not recruiting
        • Novartis Investigative Site
    • LTU
      • Kaunas, LTU, Lithuania, LT 50161
        • Active, not recruiting
        • Novartis Investigative Site
  • Mexico
      • Chihuahua, Mexico, 31238
        • Active, not recruiting
        • Novartis Investigative Site
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 06700
        • Active, not recruiting
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 03100
        • Active, not recruiting
        • Novartis Investigative Site
    • Michoacan
      • Morelia, Michoacan, Mexico, 58260
        • Withdrawn
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Active, not recruiting
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3015 CE
        • Completed
        • Novartis Investigative Site
      • Sittard-Geleen, Netherlands, 6162 BG
        • Active, not recruiting
        • Novartis Investigative Site
  • Norway
      • Drammen, Norway, 1086
        • Active, not recruiting
        • Novartis Investigative Site
  • Peru
      • Lima, Peru, LIMA 13
        • Active, not recruiting
        • Novartis Investigative Site
    • Lima
      • Cercado De Lima, Lima, Peru, 01
        • Active, not recruiting
        • Novartis Investigative Site
      • San Isidro, Lima, Peru, 27
        • Active, not recruiting
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland, 80 952
        • Active, not recruiting
        • Novartis Investigative Site
      • Gdansk, Poland, 80-462
        • Active, not recruiting
        • Novartis Investigative Site
      • Gdansk, Poland, 80-803
        • Active, not recruiting
        • Novartis Investigative Site
      • Glogow, Poland, 36-060
        • Active, not recruiting
        • Novartis Investigative Site
      • Katowice, Poland, 40 571
        • Active, not recruiting
        • Novartis Investigative Site
      • Kielce, Poland, 25 726
        • Active, not recruiting
        • Novartis Investigative Site
      • Lodz, Poland, 90 324
        • Active, not recruiting
        • Novartis Investigative Site
      • Rzeszow, Poland, 35 055
        • Active, not recruiting
        • Novartis Investigative Site
      • Warszawa, Poland, 02 957
        • Active, not recruiting
        • Novartis Investigative Site
      • Wroclaw, Poland, 51-685
        • Active, not recruiting
        • Novartis Investigative Site
      • Zabrze, Poland, 41-800
        • Active, not recruiting
        • Novartis Investigative Site
    • Woj Kujawsko-pomorskie
      • Bydgoszcz, Woj Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Active, not recruiting
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000 075
        • Active, not recruiting
        • Novartis Investigative Site
      • Lisboa, Portugal, 1500 650
        • Active, not recruiting
        • Novartis Investigative Site
      • Lisboa, Portugal, 1169-050
        • Completed
        • Novartis Investigative Site
      • Loures, Portugal, 2674514
        • Active, not recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Completed
        • Novartis Investigative Site
      • Santa Maria da Feira, Portugal, 4520 211
        • Active, not recruiting
        • Novartis Investigative Site
    • Porto
      • Matosinhos, Porto, Portugal, 4454509
        • Active, not recruiting
        • Novartis Investigative Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • Active, not recruiting
        • Novartis Investigative Site
      • Kazan, Russian Federation, 420043
        • Active, not recruiting
        • Novartis Investigative Site
      • Kemerovo, Russian Federation, 650066
        • Active, not recruiting
        • Novartis Investigative Site
      • Krasnoyarsk, Russian Federation, 660049
        • Active, not recruiting
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127015
        • Active, not recruiting
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125367
        • Active, not recruiting
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603137
        • Active, not recruiting
        • Novartis Investigative Site
      • Nizhny Novgorod, Russian Federation, 603155
        • Active, not recruiting
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation, 630087
        • Active, not recruiting
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation, 630007
        • Active, not recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 197022
        • Active, not recruiting
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 194044
        • Active, not recruiting
        • Novartis Investigative Site
      • Saransk, Russian Federation, 430032
        • Active, not recruiting
        • Novartis Investigative Site
      • Sestroretsk, Russian Federation, 197706
        • Active, not recruiting
        • Novartis Investigative Site
      • St Petersburg, Russian Federation, 190000
        • Active, not recruiting
        • Novartis Investigative Site
      • St. Petersburg, Russian Federation, 197376
        • Active, not recruiting
        • Novartis Investigative Site
      • Tyumen, Russian Federation, 625000
        • Active, not recruiting
        • Novartis Investigative Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Active, not recruiting
        • Novartis Investigative Site
      • Bratislava, Slovakia, 813 69
        • Active, not recruiting
        • Novartis Investigative Site
      • Bratislava, Slovakia, 82606
        • Active, not recruiting
        • Novartis Investigative Site
      • Bratislava, Slovakia, 83305
        • Active, not recruiting
        • Novartis Investigative Site
      • Martin, Slovakia, 036 59
        • Active, not recruiting
        • Novartis Investigative Site
      • Nitra, Slovakia, 94901
        • Active, not recruiting
        • Novartis Investigative Site
      • Trnava, Slovakia, 917 75
        • Completed
        • Novartis Investigative Site
  • South Africa
      • Pretoria, South Africa, 0041
        • Active, not recruiting
        • Novartis Investigative Site
      • Rosebank, South Africa, 2196
        • Active, not recruiting
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28040
        • Active, not recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Active, not recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28006
        • Active, not recruiting
        • Novartis Investigative Site
      • Madrid, Spain, 28222
        • Active, not recruiting
        • Novartis Investigative Site
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Novartis Investigative Site
    • Andalucia
      • Cadiz, Andalucia, Spain, 11009
        • Active, not recruiting
        • Novartis Investigative Site
      • Malaga, Andalucia, Spain, 29010
        • Active, not recruiting
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41009
        • Active, not recruiting
        • Novartis Investigative Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Active, not recruiting
        • Novartis Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08026
        • Active, not recruiting
        • Novartis Investigative Site
      • Salt, Cataluna, Spain, 17190
        • Active, not recruiting
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08003
        • Completed
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08035
        • Active, not recruiting
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08036
        • Active, not recruiting
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Active, not recruiting
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Active, not recruiting
        • Novartis Investigative Site
    • Pais Vasco
      • San Sebastian, Pais Vasco, Spain, 20080
        • Active, not recruiting
        • Novartis Investigative Site
    • Sevilla
      • Castilleja De La Cuesta, Sevilla, Spain, 41950
        • Active, not recruiting
        • Novartis Investigative Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Active, not recruiting
        • Novartis Investigative Site
  • Sweden
      • Goeteborg, Sweden, 413 45
        • Active, not recruiting
        • Novartis Investigative Site
      • Stockholm, Sweden, 102 35
        • Active, not recruiting
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Active, not recruiting
        • Novartis Investigative Site
      • Lugano, Switzerland, 6900
        • Active, not recruiting
        • Novartis Investigative Site
  • Taiwan
      • Tainan, Taiwan, 70403
        • Active, not recruiting
        • Novartis Investigative Site
  • Thailand
    • THA
      • Khon Kaen, THA, Thailand, 40002
        • Active, not recruiting
        • Novartis Investigative Site
  • Turkey
      • Haseki Istanbul, Turkey, 34096
        • Active, not recruiting
        • Novartis Investigative Site
      • Istanbul, Turkey, 34147
        • Active, not recruiting
        • Novartis Investigative Site
      • Izmir, Turkey, 35040
        • Recruiting
        • Novartis Investigative Site
      • Izmir, Turkey, 35340
        • Completed
        • Novartis Investigative Site
      • Izmir, Turkey, 35575
        • Recruiting
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Active, not recruiting
        • Novartis Investigative Site
      • Mersin, Turkey, 33079
        • Completed
        • Novartis Investigative Site
      • Samsun, Turkey, 55139
        • Recruiting
        • Novartis Investigative Site
      • Trabzon, Turkey, 61080
        • Recruiting
        • Novartis Investigative Site
    • Istanbul
      • Sancaktepe, Istanbul, Turkey, 34785
        • Recruiting
        • Novartis Investigative Site
    • TUR
      • Istanbul, TUR, Turkey, 34098
        • Recruiting
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, SW17 0QT
        • Active, not recruiting
        • Novartis Investigative Site
      • London, United Kingdom, E1 1BB
        • Completed
        • Novartis Investigative Site
    • Beds
      • Luton, Beds, United Kingdom, LU4 0DZ
        • Active, not recruiting
        • Novartis Investigative Site
    • Oxfordshire
      • Headington, Oxfordshire, United Kingdom, OX3 9DU
        • Active, not recruiting
        • Novartis Investigative Site
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
        • Active, not recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-0271
        • Recruiting
        • University of Alabama At Birmingham
        • Contact:
        • Principal Investigator:
          • Khurram Bashir
      • Cullman, Alabama, United States, 35058
        • Recruiting
        • North Cntrl Neurology Associates PC
        • Contact:
        • Principal Investigator:
          • Christopher LaGanke
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • Barrow Neurological Clinics at St Josephs Hospital and MC
        • Contact:
        • Principal Investigator:
          • Aimee Borazanci
    • California
      • Fullerton, California, United States, 92835
        • Recruiting
        • Fullerton Neuro and Headache Ctr
        • Principal Investigator:
          • Jack H Florin
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
        • Principal Investigator:
          • Michelle Apperson
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • CU Anschutz Med Campus
        • Principal Investigator:
          • Enrique Alvarez
        • Contact:
      • Basalt, Colorado, United States, 81621
        • Active, not recruiting
        • Mountain Neuro Research Center PC .
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center
        • Contact:
          • Phone Number: 303-443-7229
        • Principal Investigator:
          • Paul Brownstone
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Colorado Springs Neurological Associates .
        • Contact:
        • Principal Investigator:
          • Kimberly Wagner
      • Denver, Colorado, United States, 80210
        • Completed
        • Novartis Investigative Site
      • Fort Collins, Colorado, United States, 80528
        • Withdrawn
        • Novartis Investigative Site
      • Fort Collins, Colorado, United States, 80528
        • Active, not recruiting
        • University of Colorado Health Neuro
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Christiana Care Health Services
        • Contact:
        • Principal Investigator:
          • Jason M Silversteen
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Withdrawn
        • Novartis Investigative Site
    • Florida
      • Atlantis, Florida, United States, 33462-6608
        • Recruiting
        • Jem Research Institute
        • Principal Investigator:
          • Mark Goldstein
        • Contact:
          • Phone Number: +1 561 968 2933 302
      • Bradenton, Florida, United States, 34205
      • Delray Beach, Florida, United States, 33445
        • Recruiting
        • Neurology Offices of South Florida PLLC CBAF312A2304
        • Contact:
          • Phone Number: 561-482-1027
        • Principal Investigator:
          • Brian Costell
      • Hollywood, Florida, United States, 33024
      • Maitland, Florida, United States, 32751
        • Recruiting
        • Neurology Associates, PA
        • Contact:
        • Principal Investigator:
          • William David Honeycutt
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine
        • Contact:
        • Principal Investigator:
          • Silvia R Delgado
      • Miami, Florida, United States, 33032
        • Recruiting
        • Homestead Associates in Research Inc
        • Contact:
        • Principal Investigator:
          • Angel Carrasco
      • Naples, Florida, United States, 34102
        • Recruiting
        • Aqualane Clinical Research
        • Contact:
        • Principal Investigator:
          • Matthew J Baker
      • Oldsmar, Florida, United States, 34677
        • Recruiting
        • MS and Neuromuscular Center of Excellence
        • Contact:
        • Principal Investigator:
          • Jean-Raphael Schneider
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Neurology Associates of Ormond Beach
        • Contact:
        • Principal Investigator:
          • James Scott
      • Pensacola, Florida, United States, 32514
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Neurostudies Inc
        • Contact:
        • Principal Investigator:
          • Liliana Montoya
      • Sarasota, Florida, United States, 34233
        • Recruiting
        • Negroski Neurology
        • Contact:
          • Phone Number: 941-487-2160
        • Principal Investigator:
          • Donald Negroski
      • Sarasota, Florida, United States, 34243
        • Recruiting
        • Roskamp Institute, Inc.
        • Contact:
          • Phone Number: 941-256-8018
        • Principal Investigator:
          • Sanjay Yathiraj
      • Tallahassee, Florida, United States, 32312
        • Recruiting
        • AMO Corporation
        • Principal Investigator:
          • Ricardo Ayala
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Derrick Robertson
        • Contact:
      • Tampa, Florida, United States, 33609
        • Recruiting
        • Axiom Clinical Research of Florida
        • Principal Investigator:
          • Mark Cascione
        • Contact:
      • Tampa, Florida, United States, 33603
        • Recruiting
        • Clinical Research Of West FL Inc
        • Contact:
        • Principal Investigator:
          • Lon D. Lynn
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Premiere Research Institute
        • Contact:
          • Phone Number: 561-845-0500
        • Principal Investigator:
          • Paul K. Winner
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Velocity Clinical Research
        • Contact:
          • Phone Number: 912-790-4837
        • Principal Investigator:
          • J Michael Hemphill
      • Suwanee, Georgia, United States, 30024
        • Recruiting
        • Georgia Neurology and Sleep Medicine Assoc
        • Contact:
          • Phone Number: 770-814-9455
        • Principal Investigator:
          • David Lesch
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Pacific Neuroscience LLC
        • Principal Investigator:
          • Kore Liow
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas Shoemaker
      • Northbrook, Illinois, United States, 60062
        • Active, not recruiting
        • Consultants in Neurology
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Recruiting
        • Josephson Wallack Munshower Neurology P.C
        • Contact:
          • Phone Number: +1 (317) 537-6060
        • Principal Investigator:
          • Craig Edward Herrman
    • Iowa
      • Des Moines, Iowa, United States, 50314-2611
        • Completed
        • Mercy Ruan Neurology Clinic Res Ct.
    • Kansas
      • Kansas City, Kansas, United States, 66160-7330
        • Recruiting
        • University of Kansas Medical Center .
        • Contact:
        • Principal Investigator:
          • Sharon Lynch
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • College Park Family Care Center
        • Principal Investigator:
          • Jeffrey Kaplan
        • Contact:
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Recruiting
        • Neuro Medical Clinic of Cenla LLC COMB157G2301
        • Contact:
        • Principal Investigator:
          • Ariel Antezana-Antezana
      • Baton Rouge, Louisiana, United States, 70810
        • Recruiting
        • The Neuromedical Center
        • Contact:
        • Principal Investigator:
          • Jon Olson
    • Massachusetts
      • Wellesley, Massachusetts, United States, 02481
        • Completed
        • Dragonfly Research LLC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne Stat Uni Multi Sclerosis Clnc
        • Principal Investigator:
          • Evanthia Bernitsas
        • Contact:
      • Detroit, Michigan, United States, 48202 2689
        • Recruiting
        • Henry Ford Hospital Main Centre
        • Contact:
          • Phone Number: 313-556-8186
        • Principal Investigator:
          • Mirela Cerghet
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Active, not recruiting
        • Minnesota Center Multiple Sclerosis Main Centre
    • Missouri
      • Ozark, Missouri, United States, 65721
        • Completed
        • Sharlin Health and Neurology .
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Research
        • Contact:
        • Principal Investigator:
          • William Logan
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington Uni School of Med
        • Principal Investigator:
          • Robert Naismith
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic
        • Contact:
        • Principal Investigator:
          • Sara Qureshi
      • Great Falls, Montana, United States, 59405
        • Completed
        • Advanced Neurology Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
          • Phone Number: 702-483-6003
        • Principal Investigator:
          • Carrie M Hersh
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • Completed
        • University of New Mexico
    • New York
      • Latham, New York, United States, 12110
        • Completed
        • Ms Ctr Of Northeastern Ny
    • North Carolina
      • Asheville, North Carolina, United States, 28806
        • Recruiting
        • Asheville Neurology Specialists PA
        • Contact:
          • Phone Number: +1 828 210 9311
        • Principal Investigator:
          • Robert Fairborn Armstrong
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • The Neurological Institute PA
        • Contact:
        • Principal Investigator:
          • T Hemanth Hemanth Rao
      • Greensboro, North Carolina, United States, 27405
        • Completed
        • Novartis Investigative Site
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • Velocity Clinical Research
        • Contact:
        • Principal Investigator:
          • John Scagnelli
      • Winston-Salem, North Carolina, United States, 27103
        • Completed
        • Novartis Investigative Site
    • Ohio
      • Akron, Ohio, United States, 44320
        • Completed
        • Neurology and Neuroscience Assos
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation .
        • Contact:
        • Principal Investigator:
          • Jeffrey Cohen
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Ohio Health Research Institute
        • Contact:
        • Principal Investigator:
          • Jacqueline Nicholas
      • Westerville, Ohio, United States, 43082
        • Completed
        • Columbus Neuroscience
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Multiple Sclerosis Center of Excellence of OMRF
        • Principal Investigator:
          • Gabriel Pardo
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Neurological Services West
        • Contact:
        • Principal Investigator:
          • Stanley Cohan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107-5098
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Leist
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Abington Neurological Associates Ltd
        • Contact:
          • Phone Number: 215-957-9250
        • Principal Investigator:
          • David Weisman
    • South Carolina
      • Greenville, South Carolina, United States, 29650
        • Recruiting
        • Premier Neurology
        • Contact:
        • Principal Investigator:
          • Mary Denise Hughes
      • Spartanburg, South Carolina, United States, 29303
        • Completed
        • Novartis Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Completed
        • Upstate Clinical Trials LLC
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Wesley Neurology Clinic
        • Contact:
        • Principal Investigator:
          • Kendrick K Henderson
      • Johnson, Tennessee, United States, 37604
        • Completed
        • Tri State Mountain Neurology
      • Knoxville, Tennessee, United States, 37922
        • Recruiting
        • Hope Neurology
        • Principal Investigator:
          • Sibyl Wray
        • Contact:
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center COMB157G2301
        • Contact:
        • Principal Investigator:
          • Randall Trudell
    • Texas
      • El Paso, Texas, United States, 79935
        • Recruiting
        • Med Research Inc
        • Contact:
        • Principal Investigator:
          • Javier Alejandro Vasallo
      • Houston, Texas, United States, 77074
        • Withdrawn
        • Novartis Investigative Site
      • Lubbock, Texas, United States, 79410
        • Recruiting
        • Neurology and Sleep Center
        • Contact:
        • Principal Investigator:
          • Bhupesh Dihenia
      • Round Rock, Texas, United States, 78681
        • Completed
        • Novartis Investigative Site
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Neurology Center of San Antonio P.A.
        • Contact:
        • Principal Investigator:
          • Ann Bass
      • Sherman, Texas, United States, 75092
        • Recruiting
        • Texas Institute for Neurological Disorders
        • Contact:
          • Phone Number: +1 903 893 5141#4334
        • Principal Investigator:
          • Bharathy E. Sundaram
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Completed
        • Novartis Investigative Site
      • Salt Lake City, Utah, United States, 84132
        • Active, not recruiting
        • The University of Utah
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Recruiting
        • Sentara Neuroscience Institute
        • Contact:
          • Phone Number: 757-507-0642
        • Principal Investigator:
          • Michelle B Betz
    • Washington
      • Kirkland, Washington, United States, 98034
        • Recruiting
        • Evergreen Health Multiple Sclerosis Center
        • Contact:
        • Principal Investigator:
          • Theodore Brown
      • Tacoma, Washington, United States, 98405
        • Completed
        • Novartis Investigative Site
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Active, not recruiting
        • Aurora BayCare Medical Center
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Madison
        • Contact:
        • Principal Investigator:
          • Christopher Luzzio
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Ascension St Francis Center
        • Contact:
        • Principal Investigator:
          • Bhupendra Khatri
      • Milwaukee, Wisconsin, United States, 53215
        • Completed
        • St Luke s Medical Center Aurora COMB157G2301

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every 4 weeks
  2. Written informed consent

Exclusion Criteria:

  • Emergence of any clinically significant condition/disease during the previous ofatumumab study in which study participation might result in safety risk for the subject
  • Subjects with active systemic bacterial, viral or fingal infections, or chronic infection (e.g. AIDS)
  • Subjects taking medications prohibited by the protocol
  • Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply

Vaccination sub-study:

Inclusion criteria

  1. Informed consent
  2. Actively enrolled in the COMB157G2399 Study
  3. 12 weeks of continuous treatment within the COMB157G2399 Study
  4. prior vaccination history as per protocol-defined

Exclusion criteria

  • known hypersensitivity or history of systemic allergic, neurologic or other reactions to vaccines
  • allergies to egg or shellfish
  • any safety findings including low IgG/IgM requiring ofatumumab interruption within 12 weeks prior to vaccination sub-study start
  • any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 2 weeks of the first vaccination sub-study visit

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ofatumumab
Subcutaneous injection
Biological: Ofatumumab
subcutaneous injection of 20 mg ofatumumab every 4 weeks
Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap)
0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
Biological: 13-valent pneumococcal conjugate vaccine (13-PCV)
0.5mL Vial/Syringe
Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV)
0.5mL Vial/Syringe
Biological: Seasonal Quadrivalent influenza vaccine
Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
Biological: Keyhole limpet hemocyanin (KLH) neo-antigen
1mg Vial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of relapse rates per year
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Annual Relapse Rate (ARR) time calculated as number of confirmed relapses divided by time in study per year and will also be presented for the entire duration
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Patients with confirmed 3 and 6 month disability worsening
Time Frame: Duration of the study, approximately 5 years
A confirmed disability worsening is an increase from baseline in Expanded Disability Status Scale (EDSS) score sustained for at last 3, or 6 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
Duration of the study, approximately 5 years
Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study
Time Frame: Duration of the study, approximately 5 years
Confirmed disability improvement is a decrease from baseline in Expanded Disability Status Scale (EDSS) score sustained for at least 6, 12 or 24 months EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
Duration of the study, approximately 5 years
Patients with changes in Expanded Disability Status Scale (EDSS) scores
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Score changes in Expanded Disability Status Scale (EDSS) over time EDSS consists of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, and Cerebral functions (Fatigue contributes).
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores
Time Frame: Duration of the study, approximately 5 years
Score changes and confirmed 4-point worsening sustained for 6 months in Symbol Digit Modalities Test (SDMT) scores The Symbol Digit Modalities Test is a neuropsychological, timed test for sustained attention and concentration. 3 versions will be used, alternating at each visit where done. The number of correct responses will be counted for the score.
Duration of the study, approximately 5 years
Changes in the Magnetic Resonance Image (MRI) related to brain volume loss
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Percent change from baseline in brain volume loss (BVL)
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Changes in the Magnetic Resonance Image (MRI) related to T2 lesions
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Number of new or enlarging T2 lesions
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Total number of Gd-enhancing lesions on all MRI scans adjusted for different time of scan versus follow up time in study
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Changes in neurofilament light change serum concentration
Time Frame: Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)
Extent of neurofilament light change concentration in blood NfL is a component of the neuronal cytoskeleton and is released into the cerebrospinal fluid and into subsequently blood following neuro-axonal damage
Core studies up to 5 years from first dose of ofatumumab (depending on if first dose was in the core or in this extension study or comparator randomization)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hummoral immune response to TT vaccine
Time Frame: Pre-vaccination, 4 and 8 weeks post-vaccination

Proportion of subjects with a positive antibody response to TT vaccine measured 4 and 8 weeks after vaccination while treated with ofatumumab

  • 2-fold increase in titer level
  • Tetanus anti-bodies ≥ 0.2 IU/mL
  • Mean titers of anti-tetanus antibody
Pre-vaccination, 4 and 8 weeks post-vaccination
Hummoral immune response to 13-valent pneumococcal conjugate vaccine (13-PCV)
Time Frame: 4 and 8 weeks

Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes while treated with ofatumumab

  • 2-fold increase in titer level or a > 1 microgram/mL rise in titer compared with pre-immunization titer
  • Positive anti-body response against at least 2 of the 13 pneumococcal antibody serotypes
  • Positive anti-body response against at least 50% of serotypes
  • Mean titers of anti-pneumococcal antibody
4 and 8 weeks
Hummoral immune response to 13-PCV boosted eight weeks later by 23-valent pneumococcal polysaccharide vaccine (23-PPV)
Time Frame: Pre-vaccination, 4 and 8 weeks post-vaccination

Proportion of subjects with a positive antibody response against individual anti-pneumococcal antibody serotypes (23 serotypes to be tested individually) measured 4 and 8 weeks after the booster 23-PPV while the subject continues to be treated with ofatumumab

  • 2-fold increase in titer level or a > 1 microgram/mL rise in titer compared with pre-immunization titer
  • Positive anti-body response against at least 2 of the 23 pneumococcal antibody serotypes
  • Positive anti-body response against at least 50% of serotypes
  • Mean titers of anti-pneumococcal antibody
Pre-vaccination, 4 and 8 weeks post-vaccination
Humoral immune response to KLH neo-antigen
Time Frame: Pre-administration, 4, 8, 12 weeks after initial administration and 4 weeks after last administration
Mean titers of anti-KLH antibody measured immediately prior the first administration of KLH and measured immediately prior to the first administration, 4, 8 and 12 weeks after the first administration, and measured 4 weeks post last administration of KLH
Pre-administration, 4, 8, 12 weeks after initial administration and 4 weeks after last administration
Hummoral immune response to 2020-2021 seasonal quadrivalent influenza vaccine
Time Frame: Pre-vaccination and 4 weeks post-vaccination

Proportion of subjects fulfilling:

  1. Seroconversion: The pre-vaccination HI antibody titer is < 1:10 and the postvaccination measurement is ≥ 1:40 (this applies to subjects with a pre-vaccination HI titer < 1:10), or
  2. Significant increase in HI antibody titer: The pre-vaccination HI antibody titer is ≥ 1:10 and the increase from the pre- to the post-vaccination measurement is ≥ 4-fold (this applies to subjects with a pre-vaccination HI titer ≥ 1:10)
Pre-vaccination and 4 weeks post-vaccination
Antibody response rate to TT and influenza vaccination as a function of exposure to ofatumumab
Time Frame: 8 weeks
Immune response to TT and influenza vaccination
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2018

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

September 7, 2028

Study Registration Dates

First Submitted

August 17, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMB157G2399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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