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SNCTP000004148 | EUCTR2019-001341-40 | BASEC2020-01678

Studie zur Beurteilung von Ofatumumab bei Patienten mit schubförmiger Multipler Sklerose

Data source: BASEC (Imported from 21.01.2021), WHO (Imported from 17.01.2021)
Changed: 12.01.2021
Disease category: Nervous System diseases, Brain diseases (non cancer)

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: Arzerra
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)

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)
• Subject transitioning from either fingolimod or dimethyl fumarate 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 fingolimod or dimethyl fumarate 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
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 550
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 12 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, viral or fungal infections, 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
• Subjects at risk of developing or having reactivation of hepatitis: positive results at screening for serological markers for hepatitis A, B, C and E indicating acute or chronic infection
• Have received any live or live-attenuated vaccines within 2 months 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, cyclophosphamide, etc.)
• Any other disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the subjects to cooperate or comply with the study procedures

Further information on the trial in WHO primary registry

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001341-40

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2019-001341-40-CZ

Further information on trial

Date trial registered

11.02.2020

Incorporation of the first participant

07.05.2020

Recruitment status

Authorised-recruitment may be ongoing or finished

Academic title (Data source: WHO)

A 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

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 dimethyl fumarate 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 dimethyl fumarate 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 in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy

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, France, Germany, Greece, Hungary, Italy, Lebanon, Mexico, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Turkey, 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)

Informacní služba – klin. hodnocení
Na Pankráci 1724/129
Novartis s.r.o.
+420 2 25775 111
dotazy.klinickehodnoceni@novartis.com

Contact for scientific information (Data source: WHO)

Informacní služba – klin. hodnocení
Na Pankráci 1724/129
Novartis s.r.o.
+420 2 25775 111
dotazy.klinickehodnoceni@novartis.com

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novartis Pharma AG

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