Adults 18 to 55, any sex, with Multiple Sclerosis, Primary Progressive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment PeriodPrimary· Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an increase of \>=0.5 points, if baseline EDSS is \>5.5 points. The total EDSS score ranges from 0 (norma
Group
Value
95% CI
Placebo
NA
0 – NA
Ocrelizumab 600 mg
NA
0 – NA
Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment PeriodSecondary· Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm
The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit \>=12 weeks (\>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of \>= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is \<=5.5 points (inclusive), or an increase of \>=0.5 points, if baseline EDSS is \>5.5 points. The total EDSS score ranges from 0 (norma
Group
Value
95% CI
Placebo
NA
0 – NA
Ocrelizumab 600 mg
NA
0 – NA
Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120Secondary· Baseline, Week 120
Group
Value
95% CI
Placebo
55.097
39.855 – 71.999
Ocrelizumab 600 mg
38.933
29.222 – 49.374
Percent Change From Baseline in Total Volume of T2 Lesions at Week 120Secondary· From Baseline to Week 120
Group
Value
95% CI
Placebo
7.426
4.967 – 9.942
Ocrelizumab 600 mg
-3.366
-4.987 – -1.718
Percent Change in Total Brain Volume From Week 24 to Week 120Secondary· From Week 24 to Week 120
Group
Value
95% CI
Placebo
-1.093
-1.236 – -0.951
Ocrelizumab 600 mg
-0.902
-1.004 – -0.799
Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120Secondary· From Baseline to Week 120
The SF-36v2 is a 36-item, self- reported, generic measure of quality of life that has been widely used in multiple disease areas. It is composed of 8 health domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The PCS score was derived based on the SF-36 V2 User's Manual. Scoring for PCS involves (a) recoding item response values, (b) summing recoded response values for all items in a given scale to obtain the scale raw score, (c) transforming scale raw score to a 0-100 score. The PCS score was computed by (
Group
Value
95% CI
Placebo
-1.108
-2.394 – 0.177
Ocrelizumab 600 mg
-0.731
-1.655 – 0.193
Number of Participants With at Least One Adverse Event (AE)Secondary· From baseline to 9 years
AEs included infusion related reactions (IRRs) and serious multiple sclerosis (MS) relapses, but excluded non-serious MS relapses.
Serious Adverse Events
Group
Value
95% CI
Placebo
53
Ocrelizumab 600 mg
99
Placebo (Open Label Extension)
59
Ocrelizumab (Open Label Extension)
167
Adverse Events
Group
Value
95% CI
Placebo
215
Ocrelizumab 600 mg
462
Placebo (Open Label Extension)
148
Ocrelizumab (Open Label Extension)
354
Adverse events — posted to ClinicalTrials.gov
Time frame: Baseline up to 615 weeks.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06677710 — IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis
· Phase 1
· suspended
NCT07282574 — A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrel
· Phase 2
· recruiting
NCT06846281 — Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Scle
· Phase 3
· recruiting
NCT07483450 — A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Rel
· Phase 4
· recruiting
NCT06495593 — Effects of Ocrelizumab Treatment on Immune Cells in Lymph Nodes in Multiple Sclerosis
· Phase 4
· enrolling by invitation
Other recruiting trials for Multiple Sclerosis, Primary Progressive
Currently open trials in the same condition.
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NCT04035005 — A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 10 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01194570.