A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Ocrelizumab: The first dose of ocrelizumab will be administered as two 300 milligrams (mg), IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusion, should be maintained between each infusion.
Placebo: The first dose of placebo will be administered as two IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusions, maintained between each infusion.
Study summary
This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).
Eligibility
Primary outcome measure(s)
- Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS — Up to approximately 243 weeks
Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (EDSS) score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. - Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set — Up to approximately 243 weeks
Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in EDSS score in participants with a baseline EDSS score ≤5.5 or an increase of ≥ 0.5 point in participants with a baseline EDSS score of \>5.5 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems \& ambulation, that ranges in 0.5-point steps from 0 \[normal\] to 10.0 \[death\]. 9-HPT is a quantitative measure of arm \& hand function, where participants placed \& removed pegs 1 by 1 into 9 holes arranged in a board \& complete 2 successful trials for each hand \& the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Trial sites (155)
| Facility | City | Region | Status |
|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | |
| MS and Neuromuscular Center of Excellence | Clearwater | Florida | |
| Neurological Services of Orlando | Orlando | Florida | |
| Vero Neurology | Vero Beach | Florida | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company | Columbus | Ohio | |
| Columbus Neuroscience | Westerville | Ohio | |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | |
| Brain and Mind Research Institute | Camperdown | New South Wales | |
| Austin Hospital | Heidelberg | Victoria | |
| Royal Melbourne Hospital | Parkville | Victoria | |
| UZ Antwerpen | Edegem | Antwerpen | |
| Cliniques Universitaires St-Luc | Brussels | Belgium | |
| MS & Neurologisch Revalidatie Centrum | Overpelt | Belgium | |
| Military Medical Academy HBAT | Pleven | Bulgaria | |
| Multiprofile Hospital For Active Treatment Avis Medica | Pleven | Bulgaria | |
| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD | Sofia | Bulgaria | |
| University of Alberta | Edmonton | Alberta | |
| Dalhousie Multiple Sclerosis Research Unit | Halifax | Nova Scotia | |
| St. Michael's Hospital | Toronto | Ontario | |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | |
| Instituto Neurologico de Colombia INDEC | Medellín | Antioquia | |
| Clinica Colsanitas S.A. sede Clinica Universitaria Colombia | Bogotá | Colombia | |
| General Hospital Varazdin | Varaždin | Croatia | |
| Clinical Hospital Sestre Milosrdnice | Zagreb | Croatia | |
| University Hospital Center Zagreb | Zagreb | Croatia | |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | France | |
| Centre Hospitalier Universitaire de Clermont Ferrand | Clermont-Ferrand | France | |
| CHRU Nancy | Nancy | France | |
| Hopital Guillaume Et Rene Laennec | Nantes | France | |
| CHU de Nimes - Hopital Universitaire Caremeau | Nîmes | France | |
| Hopital Civil | Strasbourg | France | |
| Pineo Medical Ecosystem LTD | Tbilisi | Georgia | |
| The First University Clinic of Tbilisi State Medical University | Tbilisi | Georgia | |
| Khechinashvili University Hospital | Tbilisi | Georgia | |
| AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2 | Naples | Campania | |
| Fondazione PTV Policlinico Tor Vergata | Rome | Lazio | |
| Azienda Ospedaliera Sant'andrea | Rome | Lazio | |
| IRCCS AOM Azienda Ospedaliera Metropolitana | Genoa | Liguria | |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | Lombardy |
+ 115 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 NCT04035005 on ClinicalTrials.gov ↗ ← All trials in Italy