A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
Condition(s) studied
Investigational drug(s) / intervention(s)
Ocrelizumab: The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total)
Ocrelizumab: Ocrelizumab will be administered at a dose of 600 mg Q24W. The first dose of ocrelizumab will be administered as two 300 mg, IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion Q24W.
Antihistamine: Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Methylprednisolone: Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Study summary
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with PPMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Eligibility
Primary outcome measure(s)
- Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) — Up to approximately 4.5 years
Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of \>5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disability scale that ranges in 0.5-point steps from 0 \[normal\]-10.0 \[death\]. In T25FWT test participants walked to a 25 foot course as quickly \& safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place \& remove pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the amount of time (in seconds) required was recorded. In T25FWT \& 9-HPT the longer it took complete test= higher scores, indicating deterioration.
Trial sites (147)
| Facility | City | Region | Status |
|---|---|---|---|
| Alabama Neurology Associates | Homewood | Alabama | |
| 21st Century Neurology | Phoenix | Arizona | |
| University of California Irvine | Irvine | California | |
| Stanford University Medical Center | Stanford | California | |
| University of Colorado Denver | Aurora | Colorado | |
| Advanced Neurosciences Research LLC | Fort Collins | Colorado | |
| MS and Neuromuscular Center of Excellence | Clearwater | Florida | |
| University of South Florida | Tampa | Florida | |
| Baptist Health Lexington | Nicholasville | Kentucky | |
| International Neurorehabilitation Institute | Lutherville | Maryland | |
| Massachusetts General Hospital. | Boston | Massachusetts | |
| University of Massachusetts Medical School | Worcester | Massachusetts | |
| Michigan Institute for Neurological Disorders | Farmington Hills | Michigan | |
| Washington University School of Medicine | St Louis | Missouri | |
| Jersey Shore University Medical Centre | Neptune City | New Jersey | |
| Northwell Health | Great Neck | New York | |
| Lenox Hill Hospital | New York | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| Neurology Clinic PC | Cordova | Tennessee | |
| Advanced Neurosciences Institute | Nashville | Tennessee | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| Lone Star Neurology of San Antonio | San Antonio | Texas | |
| Texas Institute for Neurological Disorders | Sherman | Texas | |
| Wheaton Franciscan Healthcare - St. Francis Outpatient Center | Milwaukee | Wisconsin | |
| CEMIC Saavedra | Buenos Aires | Argentina | |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR | Buenos Aires | Argentina | |
| INECO | Rosario | Argentina | |
| Revalidatie en MS Centrum | Overpelt | Belgium | |
| L2 Ip Instituto de Pesquisas Clinicas Ltda ME | Brasília | Federal District | |
| Hospital das Clinicas - UFG | Goiânia | Goiás | |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | |
| Instituto Méderi de Pesquisa e Saúde | Passo Fundo | Rio Grande do Sul | |
| Hospital Moinhos de Vento | Porto Alegre | Rio Grande do Sul | |
| IMV Pesquisa Neurológica | Porto Alegre | Rio Grande do Sul | |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | |
| Clinica Neurologica | Joinville | Santa Catarina | |
| Hospital das Clinicas - UNICAMP | Campinas | São Paulo | |
| Praxis Pesquisa Médica | Santo André | São Paulo | |
| CPQuali Pesquisa Clinica Ltda | São Paulo | São Paulo | |
| UMHAT Dr. Georgi Stranski | Pleven | Bulgaria |
+ 107 more sites — see the full list on the official registry below.
On this site
📄 Ocrevus (ocrelizumab) drug profile →More Hoffmann-La Roche trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04548999 on ClinicalTrials.gov ↗ ← All trials in Italy