A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
Who is this study for? Patients with multiple sclerosis
What treatments are being studied? Ocrelizumab
Status: Completed
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Diagnosis of PPMS or RMS according to the revised McDonald 2017 criteria (Thompson et al. 2018)
• 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
• For females participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for menopause or if surgically sterile
• For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods
Locations
United States
Florida
Neurology Associates PA
Maitland
University of South Florida
Tampa
Maryland
Johns Hopkins Hospital
Baltimore
Michigan
Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis
Owosso
Ohio
UC Health Neurology
Dayton
South Carolina
Premier Neurology
Greenville
Tennessee
Neurology Clinic PC
Cordova
Other Locations
Brazil
Clinica Amo - Assistencia Medica Em Oncologia
Salvador
CEDOES - Diagnóstico e Pesquisa
Vitória
Italy
Ospedale Civile di Montichiari
Montichiari
IRCCS Istituto Neurologico Neuromed
Pozzilli
Azienda Ospedaliera Sant'Andrea
Rome
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome
New Zealand
Optimal Clinical Trials
Auckland
Hawkes Bay Hospital
Hastings
Poland
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz
Care Clinic
Katowice
Centrum Neurologii Krzysztof Selmaj
Lodz
Przychodnia EuroMediCare
Wroc?aw
Spain
Hospital Universitari Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda
Complejo Hospitalario Nuestra Señora de la Candelaria
Santa Cruz De Tenerife
Hospital Universitario Virgen Macarena
Seville
Turkey
Bakirkoy State Mental Hospital
Istanbul
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
Istanbul
Katip Celebi University Ataturk Training and Research Hospital
Izmir
Kocaeli University Hospital
Kocaeli
Namik Kemal Universitesi Sagli Uygulama ve Arastirma Hastanesi
Participants will receive the first dose of ocrelizumab IV as two IV infusions given 14 days apart. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between SC doses. Participants will undergo 96 weeks of study treatment.
Participants will receive the first dose of ocrelizumab SC as one SC injection at a dose which is expected to result in non-inferior exposure to ocrelizumab IV. The subsequent doses of study drug will be administered as SC injections. A minimum of 22 weeks should be kept between the first and second SC doses, and between subsequent SC doses. Participants will undergo 96 weeks of study treatment.