Brief description of trial (Data source: BASEC)
Dies ist eine internationale Studie. Ungefähr 550 Patienten weltweit werden an dieser Studie teilnehmen. Das Ziel dieser Studie ist es, die Sicherheit und Wirksamkeit der Behandlung mit Ofatumumab bei Patienten zu untersuchen, die von ihrer aktuellen Multiple-Sklerose(MS)-Behandlung (Dimethylfumarat, auch bekannt als DMF, oder Fingolimod) zu Ofatumumab wechseln. Darüber hinaus wird die Studie den Nutzen von Biomarkern und digitalen Hilfsmitteln bei der Beurteilung und Behandlung von Menschen mit MS untersuchen.
Die Studie ist in drei Teile unterteilt: ein Voruntersuchungsabschnitt, ein Behandlungsabschnitt und entweder eine Sicherheitsnachbeobachtung oder die Verlängerungsstudie. Nach dem Voruntersuchungsabschnitt von bis zu 60 Tagen wird die Studienbehandlung von geeigneten Patienten etwa 96 Wochen dauern. Alle geeigneten Teilnehmer dieser Studie werden mit einer subkutanen Injektion unter Verwendung eines Autoinjektors (Pen) mit 20 mg/0,4 ml Ofatumumab behandelt. Zu Beginn der Behandlung werden die Patienten, oder auf Wunsch auch ein Angehöriger, trainiert um im weiteren Verlauf die Injektion unbeaufsichtigt zuhause vornehmen zu können.
Patienten, die den Behandlungsabschnitt abschliessen, können für die Teilnahme an der Verlängerungsstudie in Frage kommen, in der sie bis zu 5 Jahre lang weiterbehandelt werden können. Wenn sie nicht an der Verlängerungsstudie teilnehmen werden, treten sie in den Sicherheits-Nachbeobachtungsabschnitt ein, der bis zu 9 Monate dauern wird.
Health conditions investigated(Data source: BASEC)
Diese Studie wird an erwachsenen Patienten mit schubförmiger Multipler Sklerose im Alter von 18 bis 60 Jahren durchgeführt, die unter ihrer aktuellen MS-Behandlung (Dimethylfumarat oder Fingolimod) weiterhin eine Krankheitsaktivität haben.
Health conditions
(Data source: WHO)
Multiple sclerosis
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Alle Teilnehmer dieser Studie werden mit Ofatumumab behandelt. 20 mg/0,4 ml Ofatumumab, wird mit einem Autoinjektor (Pen) als subkutane Injektion verabreicht. Zu Beginn werden 3 wöchentliche Injektionen über 14 Tage verabreicht, danach erfolgen die Injektionen alle 4 Wochen.
Interventions
(Data source: WHO)
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: OFATUMUMAB
CAS Number: 679818-59-8
Current Sponsor code: OMB157
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Criteria for participation in trial
(Data source: BASEC)
- Frauen und Männer zwischen 18 und 60 Jahren
- schubförmige Multiple Sklerose
- frühere Behandlung mit höchstens 3 krankheitsmodifizierenden Therapien
Exclusion criteria
(Data source: BASEC)
- Patienten mit primär progressiver oder sekundär progressiver Multipler Sklerose
- Patienten, welche die Kriterien für Neuromyelitis optica erfüllen
- Schwangere oder stillende Frauen, sowie gebärfähige Frauen, die keine hochwirksame Verhütung anwenden.
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender:
Female: yes
Male: yes
Inclusion criteria:
? Diagnosis of MS according to the 2017 Revised McDonald criteria
? Relapsing MS: relapsing forms of MS (RMS) including RMS and
secondary progressive MS (SPMS) (Lublin et al 2014)
? Disability status at screening defined by Expanded Disability Status
Scale (EDSS) score of 0 to 4 (inclusive)
? MS treatment history with a maximum of 3 Disease Modifying
Therapies (DMTs), where all fumarates are considered as one DMT
? Subject transitioning from either any fumarate-based RMS approved
therapies, such as dimethyl fumarate (DMF) or diroximel fumarate
(DRF), or fingolimod which was administered for a period of at least 6
months, as their last DMT before first study drug administration
? Breakthrough disease activity while the participant was adequately
using fumarates or fingolimod prior to transitioning for a minimum of 6
months as evidenced by one or more clinically reported relapses or one
or more signs of Magnetic Resonance Imaging (MRI) activity (e.g. Gd+
enhancement, new or enlarging T2 lesions)
? Neurologically stable within one month prior to first study drug
administration
Please see protocol for complete detailed list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
? Subjects with primary progressive MS (Polman et al 2011) or SPMS
without disease activity (Lublin et al 2014)
? Subjects meeting criteria for neuromyelitis optica (Wingerchuk et al
2015)
? Disease duration of more than 10 years since diagnosis
? Pregnant or nursing(lactating) women
? Women of child-bearing potential unless they are using highly effective
forms of contraception during dosing and for at least 6 months after
stopping study medication
? Subjects with active chronic disease of the immune system other than
MS or with immunodeficiency syndrome
? Subjects with active systemic bacterial, fungal or viral infections (such
as hepatitis, HIV, COVID-19), or known to have Acquired
Immunodeficiency Syndrome (AIDS)
? Subjects with neurological symptoms consistent with Progressive
Multifocal Leukoencephalopathy (PML) or with confirmed PML
? Subjects at risk of developing or having reactivation of syphilis or
tuberculosis (e.g. subjects with known exposure to, or history of
syphilis, or active or latent tuberculosis, even if previously treated), as
confirmed by medical history or per local practice
? Subjects with active hepatitis B and C disease, assessed locally
? Have received any live or live-attenuated vaccines within 4 weeks prior
to first study drug administration
? Have been treated with medications as specified or within timeframes
specified (e.g. corticosteroids, ofatumumab, rituximab, ocrelizumab,
alemtuzumab, natalizumab, daclizumab, cyclophosphamide,
teriflunomide etc.)
? Subjects suspected of not being able or willing to cooperate or comply
with study protocol requirements in the opinion of the investigator
Please see protocol for complete detailed list of exclusion criteria.
-
Further information on trial
Date trial registered
Mar 16, 2020
Incorporation of the first participant
Jul 20, 2020
Recruitment status
Authorised-recruitment may be ongoing or finished
Academic title
(Data source: WHO)
A single-arm, prospective, multicentre, open-label study to evaluateofatumumab treatment effectiveness and patient-reported outcomes (PRO)in patients with relapsing multiple sclerosis (RMS) transitioning fromfumarate-based RMS approved therapies or fingolimod
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: Demonstrate the effectiveness of ofatumumab 20 mg s.c. administered
every 4 weeks in subjects with relapsing forms of MS who had
breakthrough disease on fumarates or fingolimod;Secondary Objective: Evaluate the safety of ofatumumab 20 mg s.c. administrated every 4
weeks in subjects with relapsing forms of MS who had breakthrough
disease on fumarates or fingolimod;Primary end point(s): Annual relapse rate (ARR, based on confirmed relapses) measured over the 96 weeks;Timepoint(s) of evaluation of this end point: 96 weeks
Secundary end point
(Data source: WHO)
Secondary end point(s): ? Proportion of subjects with adverse events, including injection related reactions
? Proportion of patients with laboratory or vital signs results meeting abnormal criteria
? The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons;Timepoint(s) of evaluation of this end point: 96 weeks
Contact information
(Data source: WHO)
Novartis Pharma AG
Trial results
(Data source: WHO)
Results summary
A single-arm, prospective, multicentre, open-label study to evaluate
ofatumumab treatment effectiveness and patient-reported outcomes (PRO)
in patients with relapsing multiple sclerosis (RMS) transitioning from
fumarate-based RMS approved therapies or fingolimod
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, St. Gallen
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Czechia, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Switzerland, T?rkiye, United Kingdom, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dimitri Cloetta
+41 79 753 16 46
dimitri.cloetta@novartis.com
Contact for general information
(Data source: WHO)
DRA information desk
?i?kova 22/B
Novartis Slovakia s.r.o.
+421 2 50706116
dra.slovakia@novartis.com
Contact for scientific information
(Data source: WHO)
DRA information desk
?i?kova 22/B
Novartis Slovakia s.r.o.
+421 2 50706116
dra.slovakia@novartis.com
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
17.11.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2020-01678
Secondary ID (Data source: WHO)
COMB157G23101
2019-001341-40-CZ
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