Study of an On-Body Injection System for Home Use of Ocrelizumab in People with Multiple Sclerosis
Key facts
- Where
- Bydgoszcz, Cracow, Katowice, Kielce, Łódź, Lublin, Rzeszów és Zabrze, LengyelországSee the 8 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Lengyelország
- Neurocentrum Bydgoszcz sp. z o.oBydgoszcz, LengyelországNo longer taking part
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, LengyelországNo longer taking part
- Care Clinic Sp. Z O.O.Katowice, LengyelországNo longer taking part
- Resmedica Sp. z o.o.Kielce, LengyelországNo longer taking part
- Centrum Neurologii Krzysztof SelmajŁódź, LengyelországNo longer taking part
- Indywidualna Praktyka Lekarska Prof. Dr hab Konrad RejdakLublin, LengyelországNo longer taking part
- Nmedis sp. z o.o.Rzeszów, LengyelországNo longer taking part
- IBISMED Wielospecjalistyczne Centrum MedyczneZabrze, LengyelországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2025-523726-40-00
- Record updated
- 2026. augusztus 14.
- Original description
To evaluate the suitability of the on-body delivery system (OBDS) for high concentration (HC) subcutaneous (SC) ocrelizumab administration by the participant or their lay caregiverRead full original descriptionShow less
A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
To evaluate the suitability of the on-body delivery system (OBDS) for high concentration (HC) subcutaneous (SC) ocrelizumab administration by the participant or their lay caregiver
Inclusion: Age 18-65 years at the time of signing Informed Consent Form; Willing and able to receive injections using the OBDS, as either a self-injection or administered by a lay caregiver For participants who are willing to complete self-injection: deemed by the healthcare provider to be able to do the injection based on motor and cognitive function; For female participants of childbearing potential, agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months after the final dose of ocrelizumab; For female participants without childbearing potential: Female participants may be enrolled if postmenopausal; Currently being treated with ocrelizumab: At least one prior dose of ocrelizumab 600 mg IV or 920 mg SC Note: The first dose of ocrelizumab in this study will be administered approximately 6 months (± 1 month) after a previous (pre-study) ocrelizumab dose (and may not be administered earlier than 5 months after the last pre-study ocrelizumab dose); Diagnosis of MS according to the revised McDonald 2024 criteria (Montalban et al. 2025) or the most current published revision of the McDonald criteria at the time of study start.
Exclusion: History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies; Participant does not have reliable and consistent access to communication (e.g., telephone/mobile phone); Participant resides in a location that, in the investigator's opinion, does not allow for timely access to an emergency medical facility; Pregnant or breastfeeding, or intending to become pregnant during the study or within the time frame in which contraception is required; Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab; Sensitivity or intolerance to acrylic.