2023-505975-54-00CompletedPhase 3
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Apr 2025
Brief summary (registry, in English)
To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 2 May 2024
- Start date
- 28 Mar 2022
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Multiple sclerosis
- EU CT number
- 2023-505975-54-00
- EudraCT number
- 2020-005448-48
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 153
- 21 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
Other
- Immunocompromised state
- Inability to complete an MRI or contraindication to gadolinium administration
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fakultni Nemocnice U Sv Anny V Brne | Brno-Stred | Czechia | Completed |
| Nemocnice Jihlava prispevkova organizace | Jihlava 1 | Czechia | Completed |
| Fakultni Nemocnice Hradec Kralove | Novy Hradec Kralove | Czechia | Completed |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | Completed |
| Nemocnice Pardubickeho kraje a.s. | Pardubice | Czechia | Completed |
| Fakultni nemocnice v Motole | Prague | Czechia | Completed |
| Vseobecna Fakultni Nemocnice V Praze | Prague 2 | Czechia | Completed |
| Krajska zdravotni a.s. | Teplice | Czechia | Completed |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital Universitario Reina Sofia | Córdoba | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Completed |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Spain | Completed |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Completed |
| Istituto Neurologico Mediterraneo Neuromed S.p.A. | Pozzilli | Italy | Completed |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata | Rome | Italy | Completed |
| Azienda Ospedaliero-Universitaria Sant Andre | Rome | Italy | Completed |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | Poland | Completed |
| Care Clinic Sp. Z O.O. | Katowice | Poland | Completed |
| Centrum Neurologii Krzysztof Selmaj | Łódź | Poland | Completed |
| EMC Instytut Medyczny S.A. | Wroclaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.