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 trial
Date trial registered
Jun 2, 2016
Incorporation of the first participant
Aug 26, 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
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
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
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
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