Brief description of trial (Data source: BASEC)
Diese Studie untersucht Patienten aus vorangegangenen Ofatumumab-Studien (ASCLEPIOS). Zunächst wird Ihre Eignung für diese Studie überprüft. Anschliessend wird eine Auswasch-Phase durchgeführt, um allfälliges Teriflunomid aus der ASCLEPIOS-Studie aus Ihrem Körper zu entfernen. Danach erhalten alle Patienten einmal monatlich Ofatumumab als Injektion unter die Haut gespritzt. Nach einer Einführung können Sie Ofatumumab selbst zu Hause injizieren oder diese durch eine Vertrauensperson oder den Studienarzt injizieren lassen. Während der Behandlungsphase werden etwa alle drei Monate ähnliche Untersuchung wie während der ASCLEPIOS-Studie durchgeführt, einschliesslich Magnetresonanz-Tomographie (MRT), Blutuntersuchungen und verschiedener Fragebögen.
Health conditions investigated(Data source: BASEC)
Schubförmige multiple Sklerose
Health conditions
(Data source: WHO)
Relapsing Multiple Sclerosis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Alle Patienten erhalten 20 mg Ofatumumab als Spritze unter die Haut (subkutan) alle vier Wochen. Es gibt in dieser Studie keine Placebo- oder Teriflunomid-Kontrolle.
Interventions
(Data source: WHO)
Biological: 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-antigen
Criteria for participation in trial
(Data source: BASEC)
- Sie müssen an einer Novartis-Studie mit Ofatumumab in Multipler Sklerose teilgenommen haben.
- Sie müssen die Einverständniserklärung zur Teilnahme unterschreiben.
Exclusion criteria
(Data source: BASEC)
- Vorzeitiges Beenden einer vorherigen Ofatumumab-Studie
- Studienende der vorherigen Ofatumumab-Studie mehr als 6 Monate vor Eintritt in diese Studie oder andere MS-Therapeutika seit Studienende
- Weniger als 3.5 Monate Auswaschen für Teriflunomid, sofern das beschleunigte Auswasch-Verfahren nicht genutzt wird
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 100 Years
Minimum age: 18 Years
Inclusion Criteria:
1. Must have completed a selected Novartis MS study which dosed ofatumumab 20 mg sc every
4 weeks
2. Written informed consent
Exclusion Criteria:
- Emergence of any clinically significant condition/disease during the previous
ofatumumab study in which study participation might result in safety risk for the
subject
- Subjects with active systemic bacterial, viral or fingal infections, or chronic
infection (e.g. AIDS)
- Subjects taking medications prohibited by the protocol
- Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion
criteria may apply
Vaccination sub-study:
Inclusion criteria
1. Informed consent
2. Actively enrolled in the COMB157G2399 Study
3. 12 weeks of continuous treatment within the COMB157G2399 Study
4. prior vaccination history as per protocol-defined
Exclusion criteria
- known hypersensitivity or history of systemic allergic, neurologic or other reactions
to vaccines
- allergies to egg or shellfish
- any safety findings including low IgG/IgM requiring ofatumumab interruption within 12
weeks prior to vaccination sub-study start
- any major episode of infection requiring hospitalization or treatment with intravenous
antibiotics within 2 weeks of the first vaccination sub-study visit
Other protocol-defined inclusion/exclusion criteria may apply
-
Further information on trial
Recruitment status
Recruiting
Academic title
(Data source: WHO)
An Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple Sclerosis
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Number of patients that experience an adverse event or abnormal laboratory, vital and/or ECG results and positive suicidiality outcomes
Secundary end point
(Data source: WHO)
Number of relapse rates per year;Patients with confirmed 3 and 6 month disability worsening;Patients with confirmed 6, 12 and 24 month disability improvement and improvement until end of study;Patients with changes in Expanded Disability Status Scale (EDSS) scores;Changes in and time to 6 month confirmed worsening of Symbol Digit Modalities Test Scores;Changes in the Magnetic Resonance Image (MRI) related to brain volume loss;Changes in the Magnetic Resonance Image (MRI) related to T2 lesions;Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions;Changes in neurofilament light change serum concentration
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
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, Lugano
Countries
(Data source: WHO)
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, 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
1-888-669-6682
Novartis.email@novartis.com
Contact for scientific information
(Data source: WHO)
Novartis Pharmaceuticals
1-888-669-6682
Novartis.email@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
08.03.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2018-02102
Secondary ID (Data source: WHO)
COMB157G2399
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