13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240

  
126 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05266469
(ClinicalTrials.gov)
May 1, 202223/2/2022Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the GulfExploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf RegionRelapsing Multiple SclerosisOther: Ofatumumab;Other: OcrelizumabNovartis PharmaceuticalsNULLNot yet recruiting18 Years100 YearsAll240NULL
2NCT05090033
(ClinicalTrials.gov)
April 30, 202222/9/2021Characterizing the Use of Ofatumumab in a Real World SettingSecondary Use of Data Study Characterizing Kesimpta (Ofatumumab) Onboarding and Utilization in RMS Patients Using MSGo, With a Non-interventional Primary Use of Data Sub-study Comparing Patient Reported Outcomes Relative to Clinical Outcomes (EAFToS)Relapsing Multiple SclerosisOther: ofatumumabNovartis PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll3500NULL
3NCT05285904
(ClinicalTrials.gov)
March 30, 20228/3/2022Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational StudyKesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study (KOSMOS)Multiple SclerosisOther: OfatumumabNovartis PharmaceuticalsNULLNot yet recruiting18 Years99 YearsAll149NULL
4NCT05090371
(ClinicalTrials.gov)
March 2, 202212/10/2021A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) ElevationA Randomized, Open Label, Multi-center, Active-comparator Study to Assess Efficacy, Safety & Tolerability of Ofatumumab 20mg sc Monthly Versus Continued Current Therapy in Relapsing-remitting Multiple Sclerosis After Elevation of Serum Neurofilament Light Levels (SOSTOS)Relapsing-Remitting Multiple SclerosisDrug: Ofatumumab;Drug: Disease modifying treatment (DMT)Novartis PharmaceuticalsNULLRecruiting18 Years50 YearsAll150Phase 4United States
5NCT05171972
(ClinicalTrials.gov)
January 29, 202210/12/2021Reduced Oligodendrocyte-specific Cytotoxicity and Ofatumumab TreatmentAssessing Reduced Oligodendrocyte-specific Cytotoxicity of Peripheral Blood Leukocytes in Patients With Multiple Sclerosis Following Treatment With OfatumumabRelapsing Remitting Multiple SclerosisDrug: OfatumumabUniversity of Southern CaliforniaNovartis PharmaceuticalsRecruiting18 Years65 YearsAll40United States
6NCT05084638
(ClinicalTrials.gov)
January 25, 20227/10/2021Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.AGNOS: An 18-month, Open-label, Multi-Center Study to Assess the Effect of Ofatumumab 20mg SC Monthly in Treatment Naïve, Very Early Relapsing Remitting Multiple Sclerosis Patients Benchmarked Against Healthy Controls on Select Outcomes.Relapse Remitting Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years35 YearsAll168Phase 4United States
7EUCTR2020-002700-39-HR
(EUCTR)
29/11/202106/12/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
8NCT04926818
(ClinicalTrials.gov)
October 5, 202114/6/2021Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple SclerosisA 2-year Randomized, 3-arm, Double-blind, Non-inferiority Study Comparing the Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Patients With Multiple Sclerosis Followed by an Open-label ExtensionMultiple Sclerosis (MS)Drug: Fingolimod;Drug: Ofatumumab;Drug: Siponimod;Other: Fingolimod placebo;Other: Siponimod placebo;Other: Ofatumumab placeboNovartis PharmaceuticalsNULLRecruiting10 Years17 YearsAll180Phase 3United States;Australia;Austria;Belgium;France;Germany;India;Latvia;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Turkey
9EUCTR2020-002700-39-SK
(EUCTR)
04/10/202116/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Portugal;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
10EUCTR2020-002700-39-PL
(EUCTR)
29/09/202110/08/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany
11EUCTR2020-004505-32-IT
(EUCTR)
24/09/202112/10/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE
Product Name: COPAXONE
Product Code: [-]
INN or Proposed INN: glatiramer acetato
Trade Name: Rebif
Product Name: Rebif
Product Code: [-]
INN or Proposed INN: interferone beta-1a
Trade Name: Rebif
Product Name: rebif
Product Code: [-]
INN or Proposed INN: interferone beta-1a
Trade Name: plegridy
Product Name: plegridy
Product Code: [-]
INN or Proposed INN: peginterferone beta 1a
Trade Name: Avonex
Product Name: Avonex
Product Code: [-]
INN or Proposed INN: Interferone beta 1a
Trade Name: Extavia
Product Name: Extavia
Product Code: [-]
INN or Proposed INN: interferone beta-1b
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Spain;Germany;Italy
12EUCTR2020-002700-39-IT
(EUCTR)
15/09/202117/08/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-labelextension (NEOS). - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: siponimob
Product Code: [BAF312]
INN or Proposed INN: siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: ofatumumab
Product Name: fingolimod
Product Code: [FTY720]
INN or Proposed INN: fingolimob
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Product Name: Siponimob
Product Code: [BAF312]
INN or Proposed INN: Siponimob
NOVARTIS PHARMA SERVICES AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
13EUCTR2020-002700-39-DE
(EUCTR)
10/09/202120/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany
14EUCTR2020-002700-39-LV
(EUCTR)
09/09/202128/07/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
95Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
15EUCTR2020-002700-39-PT
(EUCTR)
03/09/202124/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta 20 mg solution for injection in pre-filled pen
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent 2 mg film-coated tablets
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent 0.25 mg fi
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;Portugal;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
16EUCTR2019-001341-40-LV
(EUCTR)
02/09/202128/07/2021An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
17EUCTR2019-001341-40-SI
(EUCTR)
20/08/202112/07/2021An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA 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 Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Saudi Arabia;Estonia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
18EUCTR2020-002700-39-AT
(EUCTR)
17/08/202107/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
19EUCTR2020-002700-39-LT
(EUCTR)
10/08/202107/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
20NCT04788615
(ClinicalTrials.gov)
July 23, 20218/3/2021Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMSOpen-Label Rater-Blind Randomized Multi-Center Parallel-Arm Active- Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC Monthly vs. First Line DMT - Physician's Choice in the Treatment of Newly Diagnosed RMSMultiple SclerosisDrug: Ofatumumab;Drug: First line DMTNovartis PharmaceuticalsNULLRecruiting18 Years45 YearsAll236Phase 3France;Germany;Spain;United Kingdom
21EUCTR2020-002700-39-ES
(EUCTR)
14/07/202123/06/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala
22EUCTR2020-004505-32-DE
(EUCTR)
06/07/202125/05/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Spain;Germany;Italy
23EUCTR2020-002700-39-FR
(EUCTR)
05/07/202127/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN:
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
24NCT04878211
(ClinicalTrials.gov)
June 10, 20213/5/2021A Open-label Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Study to Assess Response to COVID-19 Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple Sclerosis (RMS)Drug: Ofatumumab;Biological: mRNA COVID-19 vaccine;Drug: interferon or glatiramer acetateNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll66Phase 4United States
25EUCTR2020-004505-32-FR
(EUCTR)
09/06/202126/04/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Germany
26NCT04869358
(ClinicalTrials.gov)
May 27, 202129/4/2021Exploring the Immune Response to SARS-CoV-2 COVID-19 Vaccines in Patients With Relapsing Multiple Sclerosis (RMS) Treated With OfatumumabTracking the Immune Response to SARS-CoV-2 modRNA Vaccines in an Open-label Multicenter Study in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab s.c. (KYRIOS)Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years100 YearsAll40Phase 4Germany
27NCT04847596
(ClinicalTrials.gov)
May 21, 202114/4/2021A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple SclerosisOther: Ofatumumab;Other: Covid-19 vaccineNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll22United States;Puerto Rico
28NCT04676555
(ClinicalTrials.gov)
May 11, 202116/12/2020Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple SclerosisTime and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple SclerosisRelapsing Forms of Multiple SclerosisDrug: Ocrelizumab;Drug: OfatumumabNovartis PharmaceuticalsNULLTerminated18 Years100 YearsAll2United States;Australia;United Kingdom
29EUCTR2021-000307-20-DE
(EUCTR)
28/04/202112/02/2021Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS)Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: Kesimpta 20 mg Injektionslösung im Fertigpen
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Comirnaty Konzentrat zur Herstellung einer Injektionsdispersion
INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Trade Name: Spikevax
INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Novartis Pharma Vertriebs GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 4Germany
30EUCTR2019-001341-40-PL
(EUCTR)
20/01/202117/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
31NCT04667117
(ClinicalTrials.gov)
January 14, 20218/12/2020A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple SclerosisBiological: Quadrivalent influenza vaccine;Drug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years55 YearsAll66Phase 4United States
32NCT04486716
(ClinicalTrials.gov)
October 19, 202023/7/2020A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple SclerosisA Single-arm, Prospective, Multi-center Study to Explore Maintained Efficacy With Ofatumumab Therapy in Patients With Relapsing Multiple Sclerosis Who Discontinue Intravenously Delivered Anti-CD20 Monoclonal Antibody (aCD20 mAb) Therapy (OLIKOS)Relapsing Multiple SclerosisDrug: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years60 YearsAll100Phase 3United States;Puerto Rico
33NCT04510220
(ClinicalTrials.gov)
September 21, 202031/7/20209-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisOpen-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab;Drug: [F-18]PBR06Brigham and Women's HospitalNovartisRecruiting18 Years60 YearsAll10Phase 3United States
34EUCTR2019-001341-40-AT
(EUCTR)
10/09/202007/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
35EUCTR2019-001341-40-IT
(EUCTR)
09/09/202019/05/2021An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
36NCT04353492
(ClinicalTrials.gov)
July 14, 202016/4/2020An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to OfatumumabA Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod TherapyRelapsing Multiple SclerosisBiological: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years60 YearsAll550Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Estonia;Germany;Greece;Hungary;Italy;Latvia;Lebanon;Mexico;Norway;Poland;Portugal;Russian Federation;Saudi Arabia;Slovakia;Slovenia;Spain;Switzerland;Turkey;United Kingdom
37EUCTR2019-001341-40-PT
(EUCTR)
15/06/202031/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
38EUCTR2019-001341-40-BG
(EUCTR)
12/06/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
39EUCTR2019-001341-40-GR
(EUCTR)
20/05/202010/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
40EUCTR2019-001341-40-DE
(EUCTR)
08/05/202005/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from fumarate-based RMS approved therapies or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis (RMS) transitioning from fumarate-based RMS approved therapies or fingolimod. Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
41EUCTR2019-001341-40-CZ
(EUCTR)
07/05/202011/02/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom
42EUCTR2019-001341-40-BE
(EUCTR)
29/04/202017/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
43EUCTR2019-001341-40-HU
(EUCTR)
29/04/202011/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Latvia;Czechia;Slovenia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
44EUCTR2019-001341-40-ES
(EUCTR)
24/04/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
45EUCTR2017-004703-51-GB
(EUCTR)
18/06/201915/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden;Austria;Turkey;Lithuania;Finland;Latvia;Netherlands;South Africa;Denmark;Australia;Peru;France;India;Switzerland;Italy;Israel;Russian Federation;Spain;Thailand;Greece;Slovakia;Estonia;Taiwan;United States;Portugal
46EUCTR2017-004703-51-BE
(EUCTR)
17/06/201915/01/2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
47EUCTR2017-004703-51-HR
(EUCTR)
06/05/201903/06/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
48EUCTR2017-004703-51-GR
(EUCTR)
24/04/201927/03/2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
49EUCTR2017-004703-51-NL
(EUCTR)
29/03/201916/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Japan;Sweden;Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Bulgaria;Norway;Germany;Croatia;Belgium;Poland;Argentina;Canada;Mexico;Hungary;United Kingdom;Austria;Turkey;Lithuania;Finland;Czechia;Netherlands;Latvia;South Africa;Denmark;Australia;Peru;France;India;Italy;Switzerland;Israel
50EUCTR2017-004703-51-LV
(EUCTR)
28/03/201924/01/2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
51EUCTR2017-004703-51-PT
(EUCTR)
18/03/201924/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
52EUCTR2017-004703-51-LT
(EUCTR)
19/02/201903/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
53EUCTR2017-004703-51-ES
(EUCTR)
31/01/201925/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
54EUCTR2017-004702-17-PL
(EUCTR)
25/01/201917/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
55EUCTR2017-004703-51-FR
(EUCTR)
18/01/201922/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
56EUCTR2017-004703-51-DK
(EUCTR)
18/01/201911/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Peru;South Africa;Latvia;Netherlands;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
57EUCTR2017-004703-51-DE
(EUCTR)
10/01/201927/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: Ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
58EUCTR2017-004703-51-CZ
(EUCTR)
10/01/201908/11/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
59EUCTR2017-004703-51-FI
(EUCTR)
02/01/201911/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
60EUCTR2017-004703-51-SE
(EUCTR)
17/12/201815/11/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
61EUCTR2017-004702-17-ES
(EUCTR)
12/12/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Farmacéutica, S.A.NULLNot Recruiting Female: yes
Male: yes
284 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
62EUCTR2017-004702-17-BG
(EUCTR)
03/12/201823/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
63EUCTR2017-004703-51-HU
(EUCTR)
29/11/201811/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
64EUCTR2017-004703-51-AT
(EUCTR)
28/11/201817/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
65NCT03650114
(ClinicalTrials.gov)
November 22, 201817/8/2018Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MSAn Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisBiological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigenNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll2010Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
66EUCTR2017-004703-51-SK
(EUCTR)
21/11/201828/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: Ofatumumab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2328Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Switzerland;Italy;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
67EUCTR2017-004702-17-IT
(EUCTR)
07/11/201804/11/2020A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND Multiple sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE
Product Name: Formistin 10 mg
Product Code: [Formistin 10 mg]
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [Tachipirina CPR 500mg]
Other descriptive name: paracetamolo 500 mg
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Solumedrol IM 125mg/2ml
Product Code: [Metilprednisolone]
Other descriptive name: Metilprednisolone sodio succinato
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: Ofatumumab
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: OFATUMUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia
68EUCTR2017-004702-17-LV
(EUCTR)
02/11/201803/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy
69EUCTR2017-004702-17-LT
(EUCTR)
31/10/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
70EUCTR2017-004702-17-CZ
(EUCTR)
23/10/201816/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
71EUCTR2017-004702-17-EE
(EUCTR)
17/09/201828/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
72NCT03560739
(ClinicalTrials.gov)
September 11, 201815/5/2018A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsA 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsMultiple SclerosisCombination Product: ofatumumab with PRF;Combination Product: ofatumumab with AINovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll284Phase 2United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
73EUCTR2017-004702-17-AT
(EUCTR)
01/09/201810/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
74NCT03249714
(ClinicalTrials.gov)
March 15, 201811/8/2017Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label OfatumumabA 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label OfatumumabRelapsing Multiple SclerosisDrug: Ofatumumab;Drug: Matching placebo of ofatumumabNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll64Phase 2Japan;Russian Federation
75JPRN-JapicCTI-173711
15/3/201814/09/2017Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label OfatumumabA 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab Relapsing Multiple SclerosisIntervention name : Ofatumumab
INN of the intervention : -
Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks
Novartis Pharma K.K.NULLcomplete1855BOTH30Phase 2Japan, Russia
76EUCTR2015-005418-31-IT
(EUCTR)
09/05/201709/11/2020Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ARZERRA - 1000 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 50 ML (20 MG/ML) 1 FLACONCINO + 2 KIT DI PROLUNGA
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA
Product Name: Teriflunomide
Product Code: [NA]
INN or Proposed INN: Teriflunomide
NOVARTIS PHARMA SERVICES AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
77EUCTR2015-005419-33-IT
(EUCTR)
09/05/201725/05/2021Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis - Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing form multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ARZERRA - 100 MG - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONE(VETRO) - 5 ML(20MG/ML) 3 FLACONI
Product Name: ofatumumab
Product Code: [OMB 157]
INN or Proposed INN: Ofatumumab
Trade Name: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BISTER (ALU/ALU) PERFORATO MONODOSE - 10 X 1 COMPRESSA
Product Name: Teriflunomide
Product Code: [NA]
INN or Proposed INN: Teriflunomide
Other descriptive name: Aubagio
NOVARTIS PHARMA SERVICES AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
78EUCTR2015-005418-31-FR
(EUCTR)
07/03/201712/01/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
79EUCTR2015-005419-33-HR
(EUCTR)
10/02/201705/06/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
80EUCTR2015-005419-33-CZ
(EUCTR)
31/01/201720/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
81EUCTR2015-005418-31-CZ
(EUCTR)
31/01/201714/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;Australia;Denmark;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
82EUCTR2015-005419-33-BG
(EUCTR)
19/01/201725/11/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United States;Portugal
83EUCTR2015-005418-31-NL
(EUCTR)
04/01/201708/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
84EUCTR2015-005418-31-HR
(EUCTR)
13/12/201615/12/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
85EUCTR2015-005418-31-BG
(EUCTR)
01/12/201612/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
86EUCTR2015-005418-31-PL
(EUCTR)
11/11/201620/09/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
87EUCTR2015-005419-33-LV
(EUCTR)
03/11/201611/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
88EUCTR2015-005419-33-DE
(EUCTR)
21/10/201607/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United Kingdom;Austria;Lithuania;Turkey;Finland;Latvia;South Africa;Australia;Peru;France;India;Switzerland;Russian Federation;Spain;Slovakia;Taiwan;Portugal;United States
89EUCTR2015-005418-31-GR
(EUCTR)
21/10/201605/09/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
90EUCTR2015-005418-31-BE
(EUCTR)
17/10/201607/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
91EUCTR2015-005419-33-FR
(EUCTR)
14/10/201612/01/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
92EUCTR2015-005419-33-GB
(EUCTR)
11/10/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
93EUCTR2015-005418-31-GB
(EUCTR)
11/10/201611/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
94EUCTR2015-005419-33-PT
(EUCTR)
06/10/201628/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Italy;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
95EUCTR2015-005419-33-LT
(EUCTR)
03/10/201623/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Bulgaria;United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Germany
96EUCTR2015-005419-33-BE
(EUCTR)
26/09/201611/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
97EUCTR2015-005418-31-DK
(EUCTR)
23/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
98EUCTR2015-005418-31-HU
(EUCTR)
21/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
99EUCTR2015-005419-33-HU
(EUCTR)
21/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
100EUCTR2015-005419-33-FI
(EUCTR)
20/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
101NCT02792218
(ClinicalTrials.gov)
September 20, 20162/6/2016Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple SclerosisA Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll930Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom
102EUCTR2015-005418-31-SK
(EUCTR)
19/09/201629/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
103EUCTR2015-005419-33-SK
(EUCTR)
19/09/201603/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
104EUCTR2015-005418-31-DE
(EUCTR)
13/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
105EUCTR2015-005418-31-EE
(EUCTR)
12/09/201610/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
106EUCTR2015-005418-31-SE
(EUCTR)
06/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden
107EUCTR2015-005419-33-ES
(EUCTR)
03/09/201605/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United Arab Emirates;Portugal;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany
108EUCTR2015-005418-31-ES
(EUCTR)
03/09/201605/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden
109NCT02792231
(ClinicalTrials.gov)
August 26, 20162/6/2016Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.Relapsing Multiple ScelrosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll957Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom
110EUCTR2015-005419-33-AT
(EUCTR)
16/08/201615/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157G
INN or Proposed INN: OFATUMUMAB
Trade Name: Aubagio
Product Name: Teriflunomide
INN or Proposed INN: TERIFLUNOMIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany
111EUCTR2011-002333-19-IT
(EUCTR)
19/03/201214/03/2012Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS).
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Arzerra
INN or Proposed INN: OFATUMUMAB
Other descriptive name: NA
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Russian Federation;Netherlands;Germany;Italy
112EUCTR2011-002333-19-CZ
(EUCTR)
27/02/201231/10/2011Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Arzerra®
Product Name: Ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Germany;Norway;Italy
113EUCTR2011-002333-19-DE
(EUCTR)
29/11/201109/09/2011Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 15.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Netherlands;Norway;Germany;Italy
114EUCTR2011-002333-19-DK
(EUCTR)
25/11/201118/10/2011Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 17.1;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Arzerra®
Product Name: Ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
196Phase 2United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy
115EUCTR2011-002333-19-NL
(EUCTR)
23/11/201105/10/2011Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Arzerra®
Product Name: Ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
196United States;Czech Republic;Canada;Spain;Denmark;Bulgaria;Russian Federation;Germany;Norway;Netherlands;Italy
116NCT01457924
(ClinicalTrials.gov)
November 1, 201120/10/2011Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple SclerosisA Randomized, Double-blind, Placebo-controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months' Administration of Ofatumumab in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple SclerosisDrug: Ofatumumab 3mg;Drug: Ofatumumab 30mg;Drug: Ofatumumab 60mg;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll232Phase 2United States;Bulgaria;Canada;Czechia;Denmark;Germany;Italy;Netherlands;Norway;Russian Federation;Spain;Czech Republic
117EUCTR2011-002333-19-ES
(EUCTR)
21/10/201128/09/2011Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: LLT;Classification code 10070716;Term: Multiple sclerosis pseudo relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Arzerra®
Product Name: Ofatumumab
Product Code: GSK1841157
INN or Proposed INN: OFATUMUMAB
GlaxoSmithKline SANULLNot RecruitingFemale: yes
Male: yes
196Phase 2United States;Czech Republic;Canada;Spain;Denmark;Russian Federation;Bulgaria;Norway;Netherlands;Germany;Italy
118EUCTR2007-004223-38-GB
(EUCTR)
05/01/200926/11/2007A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline UKNULLNot Recruiting Female: yes
Male: yes
57 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden
119EUCTR2007-004223-38-DE
(EUCTR)
02/06/200824/01/2008A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
Genmab A/SNULLNot RecruitingFemale: yes
Male: yes
324Phase 2Czech Republic;Belgium;Denmark;Germany;United Kingdom;Sweden
120EUCTR2007-004223-38-SE
(EUCTR)
05/05/200813/03/2008A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline ABNULLNot RecruitingFemale: yes
Male: yes
57Germany;Czech Republic;United Kingdom;Denmark;Sweden
121NCT00640328
(ClinicalTrials.gov)
May 200818/3/2008Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsA Double-blind, Randomized, Placebo Controlled, Multicenter, Dose-finding Trial of Ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) PatientsMultiple SclerosisDrug: Ofatumumab 100;Drug: Ofatumumab 300;Drug: Ofatumumab 700;Drug: PlaceboGlaxoSmithKlineNULLCompleted18 Years55 YearsAll38Phase 2Belgium;Czech Republic;Denmark;Former Serbia and Montenegro;Germany;Poland;Serbia;Sweden;United Kingdom
122EUCTR2007-004223-38-BE
(EUCTR)
16/04/200806/05/2008A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
Genmab A/SNULLNot RecruitingFemale: yes
Male: yes
324Sweden;Czech Republic;Belgium;Denmark;Germany;United Kingdom
123EUCTR2007-004223-38-DK
(EUCTR)
04/04/200823/01/2008A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
57Czech Republic;Denmark;Germany;United Kingdom;Sweden
124EUCTR2007-004223-38-CZ
(EUCTR)
27/02/200802/01/2008A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patientsA double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Ofatumumab
Product Code: HuMax-CD20
INN or Proposed INN: Ofatumumab
GlaxoSmithKline s.r.o.NULLNot RecruitingFemale: yes
Male: yes
57Germany;United Kingdom;Czech Republic;Denmark;Sweden
125EUCTR2020-002700-39-BE
(EUCTR)
31/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLNAFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany
126EUCTR2020-002700-39-EE
(EUCTR)
27/05/2021Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis.A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followed by an open-label extension. Additional PIP decision number: P/014/2021 - NEOS Multiple Sclerosis in pediatric patients
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Product Name: Siponimod
Product Code: BAF312
INN or Proposed INN: Siponimod
Other descriptive name: SIPONIMOD FUMARIC ACID
Trade Name: Mayzent
Product Code: BAF312
INN or Proposed INN: Siponimod
Novartis Pharma AGNULLNAFemale: yes
Male: yes
180Phase 3Serbia;United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;India;France;Australia;Latvia;Czechia;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany