A rollover study to evaluate the long-term safety and efficacy of Ocrelizumab in patients with Multiple Sclerosis
Zusammenfassung der Studie
This extension study includes participants with relapsing Multiple Sclerosis and primary progressive Multiple Sclerosis from the main studies WA21092 (OPERA I), WA21093 (OPERA II), and WA25046 (ORATORIO) to ensure continuity of Ocrelizumab treatment or safety monitoring without interruption and to continue the collection of valuable long-term data on the safety and efficacy of treatment with Ocrelizumab. The investigational product Ocrelizumab is approved in Switzerland. Approximately 1300 study participants from the main studies will participate in this study. In Switzerland, about 7 patients will participate.
(BASEC)
Untersuchte Intervention
This study consists of three parts:
1. Screening (to see if participants are eligible for the study). This can occur at a scheduled visit as part of the main study, but in some cases, a separate visit may take place.
2. Treatment (not applicable if participants are already in the safety monitoring phase of the main study)
3. Safety monitoring (for further observation of participants after treatment completion)
Participants will continue to receive Ocrelizumab at the same dose and frequency as during their participation in the main studies, i.e., an intravenous infusion of 600 mg every 24 weeks. This also aligns with the current instructions on the Ocrelizumab label and thus represents the current standard of care.
During this study, participants will have a total of about 6-8 visits. After screening, visits will occur every 24 weeks and may last approximately between 4.5 and 7 hours, depending on the duration of the Ocrelizumab infusion.
The study duration from screening to the end of safety monitoring is approximately 3.5 years.
When participants are enrolled in this study to complete the 48-week safety monitoring phase of the main study, they will have 1-3 visits, depending on how many safety monitoring visits they have already completed in the main study. A total of 48 weeks of safety monitoring is required.
(BASEC)
Untersuchte Krankheit(en)
Relapsing Multiple Sclerosis (RMS) Primary Progressive Multiple Sclerosis (PPMS)
(BASEC)
• Signed informed consent • Previous eligibility and prior participation in one of the Roche-sponsored main studies WA21092, WA21093, or WA25046, where participants either received Ocrelizumab as an investigational medicinal product (IMP) or are in safety monitoring after treatment discontinuation • For female participants of childbearing potential: Consent to the use of contraceptive methods deemed effective by the investigator during the treatment period and for at least 6 months or longer, if stricter local guidelines apply, after the last dose of Ocrelizumab, as stated in the Ocrelizumab package insert. (BASEC)
Ausschlusskriterien
• Simultaneous participation in another clinical study (other than the main study) • Lack of willingness or inability to meet the requirements of the study protocol (BASEC)
Studienstandort
Basel, Lugano
(BASEC)
Sponsor
F. Hoffmann-La Roche Ltd.
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Tobias Derfuss
+41 61 328 67 26
Tobias.Derfuss@clutterusb.chUniversitätsspital Basel
(BASEC)
Allgemeine Auskünfte
Hoffmann-La Roche
(ICTRP)
Wissenschaftliche Auskünfte
Hoffmann-La Roche
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.06.2022
(BASEC)
ICTRP Studien-ID
NCT05269004 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Multicenter, Single-arm, Open-label, Extension, Rollover Study to Evaluate the Long-term Safety and Efficacy Of Ocrelizumab in Patients with Multiple Sclerosis. (BASEC)
Wissenschaftlicher Titel
A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis (ICTRP)
Öffentlicher Titel
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis (ICTRP)
Untersuchte Krankheit(en)
Multiple Sclerosis (ICTRP)
Untersuchte Intervention
Drug: Ocrelizumab (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria
- Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent
Studies WA21092, WA21093, or WA25046 with the participant either receiving
ocrelizumab as an investigational medicinal product (IMP) or being in safety
follow-up after treatment discontinuation
- For female participants of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use adequate acceptable contraception
during the treatment period and for at least 6 months or longer if the local label
is more stringent after the final dose of ocrelizumab, as applicable in the
ocrelizumab package leaflet
Exclusion criteria
- Concurrent participation in any clinical trial (other than the Parent study)
- Unable or unwilling to comply with the requirements of the protocol (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 (ICTRP)
Change in Expanded Disability Status Scale (EDSS) score over time;Change in 9-Hole Peg Test (9HPT) over time;Change in Timed 25-Foot Walk Test (T25FWT) over time;The number of T1 lesions and number of new or enlarging T2 lesions;The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Clinical Trials, Hoffmann-La Roche (ICTRP)
Sekundäre IDs
2021-005746-15, MN43964 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05269004 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar