A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis
Key facts
- Where
- Brno-Stred, Jihlava 1, Novy Hradec Kralove, Ostrava, Pardubice, Prague, Prague 2 és Teplice, CsehországSee 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 Csehország
- Fakultni Nemocnice U Sv Anny V BrneBrno-Stred, CsehországNo longer taking part
- Nemocnice Jihlava prispevkova organizaceJihlava 1, CsehországNo longer taking part
- Fakultni Nemocnice Hradec KraloveNovy Hradec Kralove, CsehországNo longer taking part
- Fakultni nemocnice OstravaOstrava, CsehországNo longer taking part
- Nemocnice Pardubickeho kraje a.s.Pardubice, CsehországNo longer taking part
- Fakultni nemocnice v MotolePrague, CsehországNo longer taking part
- Vseobecna Fakultni Nemocnice V PrazePrague 2, CsehországNo longer taking part
- Krajska zdravotni a.s.Teplice, CsehországNo 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 2023-505975-54-00
- Record updated
- 2025. április 1.
- Original description
To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MSRead full original descriptionShow less
A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab in Patients with Multiple Sclerosis
To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS
Inclusion: Diagnosis of primary progressive MS (PPMS) or relapsing forms of MS (RMS) according to the revised McDonald 2017 criteria; Age 18-65 years, inclusive, at time of signing Informed Consent Form; Expanded disability status scale (EDSS) score, 0-6.5, inclusive, at screening; Neurological stability for ≥30 days prior to both screening and baseline; Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening; Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months or 12 months (as applicable by the ocrelizumab IV [Ocrevus] local label) after the final dose of ocrelizumab.
Exclusion: Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening; Receipt of a live attenuated vaccine within 6 weeks prior to randomization; History of confirmed or suspected progressive multifocal leukoencephalopathy (PML); History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening; Immunocompromised state; Inability to complete an MRI or contraindication to gadolinium administration.