Display again
SNCTP000002058 | NCT02792231 | BASEC2016-01600

Studie welche in Patienten mit schubförmig verlaufender Multipler Sklerose (MS) die Wirksamkeit und Sicherheit von Ofatumumab im Vergleich zu Teriflunomid untersucht

Data source: BASEC (Imported from 21.06.2021), WHO (Imported from 18.04.2021)
Changed: 04.06.2021
Disease category: Nervous System diseases, Musculoskeletal deseases (non cancer)

Brief description of trial (Data source: BASEC)

Der Wirkstoff Ofatumumab (OMB157) soll gegenüber dem Wirkstoff Teriflunomid (Aubagio©) in erwachsenen Patienten, welche an schubförmiger Multiplen Sklerose (MS) leiden, in einer klinischen Studie hinsichtlich seiner Wirksamkeit und Sicherheit untersucht werden. Das Design der Studie ist randomisiert, doppelt verblindet und beinhaltet zwei parallele Studiengruppen, in welchen der entsprechende Wirkstoff (also OMB157 oder Aubagio©) und das Placebo des jeweils anderen Präparates dazu verabreicht werden wird (sogenanntes „double-dummy“-Design). Ofatumumab (20 mg) wird unter die Haut gespritzt, während Teriflunomid als Tablette (14 mg) über den Mund eingenommen wird.
Hauptinteresse ist dabei, ob Patienten die mit Ofatumumab behandelt werden, weniger häufig an MS-Schüben leiden, als Patienten, die Teriflunome (Aubagio®) erhalten.

Health conditions investigated (Data source: BASEC)

schubförmig verlaufende Multiple Sklerose

Health conditions (Data source: WHO)

Relapsing Multiple Scelrosis

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Ofatumumab 20mg subkutane (unter die Haut) Injektion einmal alle 4 Wochen
Teriflunomid 14mg Kapsel (über den Mund) einmal täglich jeweils Placebo dazu

Interventions (Data source: WHO)

Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections

Criteria for participation in trial (Data source: BASEC)

erwachsene Patienten mit schubförmiger MS, welche eine vordefinierte Krankheitsaktivität vor Einschluss der Studie aufweisen

Exclusion criteria (Data source: BASEC)

- Patienten mit primär fortgeschrittener MS oder schubförmiger MS ohne Krankheitsaktivität
- Patienten mit aktiven Infektionen
- Schwangere und stillende Frauen

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- 18 to 55 years of age

- Diagnosis of multiple sclerosis (MS)

- Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)

- At least 1 relapse during the previous 1 year or 2 relapses during the previous 2
years or a positive gadolinium-enhancing MRI scan in previous year

- Expanded disability status scale (EDSS) score of 0 to 5.5

Exclusion Criteria:

- Primary progressive MS

- Disease duration of more than 10 years in patients with an EDSS score of 2 or less

- Patients with an active chronic disease of the immune system other than MS

- Patients at risk of developing or having reactivation of hepatitis

- Patients with active systemic infections or with neurological findings consistent with
PML

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02792231

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02792231

Further information on trial

Date trial registered

02.06.2016

Incorporation of the first participant

26.08.2016

Recruitment status

Completed

Academic title (Data source: WHO)

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

Annualized Relapse Rate (ARR) (Confirmed Relapses)

Secundary end point (Data source: WHO)

3-month Confirmed Disability Worsening) (3mCDW) Based on EDSS;6-month Confirmed Disability Worsening (6mCDW) Based on EDSS;6-month Confirmed Disability Improvement) (6mCDI ) Based on EDSS;Number of Gd-enhancing T1 Lesions Per MRI Scan;Number of New or Enlarging T2 Lesions on MRI Per Year (Annualized Lesion Rate);Neurofilament Light Chain (NfL) Concentration in Serum;Annualized Rate of Brain Volume Loss Based on Assessments of Percent Brain Volume Change From Baseline

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

https://clinicaltrials.gov/ct2/show/results/NCT02792231

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Lugano, Lugano

Countries (Data source: WHO)

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, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Michael E. Arzt
+41 79 561 93 35
michael.arzt@novartis.com

Contact for general information (Data source: WHO)

Novartis Pharmaceuticals
Novartis

Contact for scientific information (Data source: WHO)

Novartis Pharmaceuticals
Novartis

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Novartis Pharmaceuticals

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

23.12.2016

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2016-01600

Secondary ID (Data source: WHO)

2015-005419-33
COMB157G2302