A rollover study to evaluate the long-term safety and efficacy of Ocrelizumab in patients with Multiple Sclerosis
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
• 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)
Lieu de l’étude
Bâle, Lugano
(BASEC)
Sponsor
F. Hoffmann-La Roche Ltd.
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Tobias Derfuss
+41 61 328 67 26
Tobias.Derfuss@clutterusb.chUniversitätsspital Basel
(BASEC)
Informations générales
Hoffmann-La Roche
(ICTRP)
Informations scientifiques
Hoffmann-La Roche
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
23.06.2022
(BASEC)
Identifiant de l'essai ICTRP
NCT05269004 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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)
Titre public
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis (ICTRP)
Maladie en cours d'investigation
Multiple Sclerosis (ICTRP)
Intervention étudiée
Drug: Ocrelizumab (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Clinical Trials, Hoffmann-La Roche (ICTRP)
ID secondaires
2021-005746-15, MN43964 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT05269004 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible