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SNCTP000003284 | NCT03650114 | BASEC2018-02102

Offenarmige Studie zur Langzeit-Sicherheit, -Verträglichkeit und Effektivität von Ofatumumab in Patienten mit schubförmiger multipler Sklerose

Data source: BASEC (Imported from 29.11.2021), WHO (Imported from 18.04.2021)
Changed: 25.11.2021
Disease category: Nervous System diseases, Brain diseases (non cancer)

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)


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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03650114

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03650114

Further information on trial

Date trial registered

17.08.2018

Incorporation of the first participant

22.11.2018

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 neurofilament light change serum concentration;Changes in the Magnetic Resonance Image (MRI) related to Gd-enhancing lesions

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

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

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