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A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
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 focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).
Study details:
The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 120 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks.
In the FU1 phase, all participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants who receive post-double progression ocrelizumab (PDP OCR) treatment, other immunomodulatory or immunosuppressive treatment(s) for MS, commercial ocrelizumab, or no treatment. The FU1 phase will run in parallel with the double-blind treatment phase until the primary analysis is performed. If the primary analysis is positive, an optional OLE phase is planned for eligible participants who either have remained in the double-blind treatment phase or are on PDP OCR treatment at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment.
The follow-up 2 (FU2) phase will begin after the primary analysis is performed. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 and not on PDP OCR treatment at the time of primary analysis; participants who are ongoing in the double-blind treatment phase or receiving PDP OCR at the time of the primary analysis and do not enter the OLE phase; participants who complete or withdraw from the OLE phase. At the end of the FU2, all participants will move into B-cell monitoring (BCM) phase until the end of the study.
This study will end when all participants who are not being treated with an alternative B-cell depleting therapy have repleted his or her B-cells.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2019-08-12
Primary completion: 2025-01-15
Study completion finish: 2028-01-19
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT04035005
Intervention or treatment
DRUG: Ocrelizumab
DRUG: Placebo
Conditions
- • Multiple Sclerosis, Primary Progressive
Find a site
Closest Location:
John Hunter Hospital
Research sites nearby
Select from list below to view details:
John Hunter Hospital
New Lambton, New South Wales, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Brain and Mind Research Institute
Camperdown, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Ocrelizumab
| DRUG: Ocrelizumab
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks | 20% increase from baseline in Nine-Hole Peg Test (9-HPT) confirmed for at least 12 weeks. | Baseline up to approximately 5.5 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Time to Upper Limb Disability Progression Confirmed For at Least 24 Weeks | 20% increases from baseline in 9-HPT confirmed for at least 24 weeks. | Baseline up to approximately 5.5 years |
Time to Disability Progression Confirmed For at Least 12 Weeks | Increase in EDSS Score is defined as an increase of \>= 1.0 point from baseline 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. | Baseline up to approximately 5.5 years |
Time to Disability Progression Confirmed For at Least 24 Weeks | Increase in EDSS Score is defined as an increase of \>= 1.0 point from baseline 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. | Baseline up to approximately 5.5 years |
Percent Change in Total Volume of T2 Lesions on MRI | Not Specified | Baseline up to week 120 |
Percent Change in Total Brain Volume on MRI Scans | Not Specified | Week 24 to Week 120 |
Percentage of Participants with Adverse Events | Not Specified | Baseline up to 8.5 years |
Percentage of Participants With Serious Adverse Events | Not Specified | Baseline up to 8.5 years |
Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab | Not Specified | Baseline, Weeks 2, 12, 24, 48, 60, 72, and every 12 weeks till the end of the double-blind period and Weeks 0 and 48 of the OLE period |
Evaluation of Ocrelizumab Pharmacodynamics, as measured by B-Cell Levels in Blood | Not Specified | Baseline, Weeks 2, 24, 48, 72 and every 12 weeks till the end of the double-blind period and Weeks 0, 22, 46, 70 and 96 of the OLE period |
Frequently Asked Questions
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