A Phase 3 interventional study of Ocrelizumab and Placebo in Multiple Sclerosis, Primary Progressive, sponsored by Hoffmann-La Roche. Active, not recruiting at 155 sites in 23 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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).
The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 144 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. All participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants receiving 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 for 144 weeks or until the primary analysis is performed, whichever occurs first. An optional OLE phase is planned for eligible participants who either have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 at 144 weeks from randomization or at the time of the primary analysis; participants who have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and will not enter the OLE phase; participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase.
244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.
This study's enrollment of 1,013 is above the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.
Browse Multiple Sclerosis, Chronic Progressive studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening \<= 5.0
Exclusion Criteria:
uncontrolled psychosis for and closed-angle glaucoma for antihistamines
Eligibility Criteria for OLE Phase:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks.
Drug: Ocrelizumab
Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.
Drug: Placebo
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.
Also known as: Ocrevus
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.
Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS
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 frame: Up to approximately 243 weeks
Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set
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.
Time frame: Up to approximately 243 weeks
Time to 12-week CDP in 9-HPT
12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Time frame: Up to approximately 243 weeks
Time to 12-week CDP in EDSS
12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated \& then scored as a functional system scores (FSS), \& ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, \& ambulation score that is rated from 0 to 16. These ratings along with observations \& assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
Time frame: Up to approximately 243 weeks
Time to 24-week CDP in 9-HPT
24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
Time frame: Up to approximately 243 weeks
Time to 24-week CDP in EDSS
24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
Time frame: Up to approximately 243 weeks
Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions
Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change.
Time frame: Up to approximately 120 weeks
Annual Rate of Percent Change From Week 24 in Total Brain Volume
Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change.
Time frame: From Week 24 up to approximately 120 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment.
Time frame: From initiation of study drug up to approximately 10.5 years
Serum Concentration of Ocrelizumab
Time frame: Up to approximately 10.5 years
B-cell Levels in Blood
Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Change From Baseline in B-cell Levels
Time frame: Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Percentage of Participants With B-cell Counts ≤5 Cells/μL
Percentages have been rounded off.
Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Percentage of Participants With B-cell Counts ≤10 Cells/μL
Percentages have been rounded off.
Time frame: Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228
Number of Participants With ADAs to Ocrelizumab
Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result.
Time frame: Baseline up to approximately 10.5 years
A total of 1013 participants with primary progressive multiple sclerosis (PPMS) took part in the study at 148 investigative sites across 23 countries. Participants were randomized in a 1:1 ratio to receive double-blinded treatment (DBT) with either ocrelizumab or placebo followed by an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), \& follow-up 2 (FU2).
| Milestone | Ocrelizumab | Placebo |
|---|---|---|
| Started | 505 | 508 |
| Safety analysis set (sas) | 506 | 506 |
| Completed | 321 | 273 |
| Not completed | 184 | 235 |
| Withdrew: Ongoing in dbt | 108 | 109 |
| Withdrew: Adverse event | 8 | 6 |
| Withdrew: Death | 11 | 9 |
| Withdrew: Lack of efficacy | 1 | 2 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Withdrew: Reason not specified | 0 | 1 |
| Withdrew: Physician decision | 0 | 5 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Switch to commercial ocrelizumab | 1 | 4 |
| Withdrew: Withdrawal by subject | 35 | 55 |
| Withdrew: Discontinued and entered pdp ocr treatment phase | 9 | 31 |
| Withdrew: Discontinued and entered fu1 phase | 8 | 7 |
| Milestone | Ocrelizumab | Placebo |
|---|---|---|
| Started | 9 | 31 |
| Completed | 0 | 0 |
| Not completed | 9 | 31 |
| Withdrew: Ongoing in pdp ocr phase | 6 | 26 |
| Withdrew: Discontinued and entered fu2 | 0 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 4 |
| Withdrew: Physician decision | 1 | 0 |
| Milestone | Ocrelizumab | Placebo |
|---|---|---|
| Started | 8 | 7 |
| Completed | 2 | 1 |
| Not completed | 6 | 6 |
| Withdrew: Ongoing in fu1 phase | 2 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Milestone | Ocrelizumab | Placebo |
|---|---|---|
| Started | 321 | 273 |
| Completed | 0 | 0 |
| Not completed | 321 | 273 |
| Withdrew: Ongoing in ole phase | 309 | 261 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Death | 3 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 6 | 5 |
| Withdrew: Discontinued and entered fu2 | 2 | 1 |
| Milestone | Ocrelizumab | Placebo |
|---|---|---|
| Started | 4 | 3 |
| Completed | 0 | 1 |
| Not completed | 4 | 2 |
| Withdrew: Ongoing in fu2 phase | 2 | 2 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
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.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS | 204.9 (141.1 to NA) | 133.6 (121.9 to 168.1) |
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.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set | NA (NA to NA) | 124.9 (103.3 to NA) |
12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to 12-week CDP in 9-HPT | 204.9 (NA to NA) | 203.3 (168.1 to NA) |
12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated \& then scored as a functional system scores (FSS), \& ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, \& ambulation score that is rated from 0 to 16. These ratings along with observations \& assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to 12-week CDP in EDSS | NA (NA to NA) | 155.7 (146.0 to NA) |
24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to 24-week CDP in 9-HPT | 180.1 (180.1 to NA) | 203.3 (168.1 to NA) |
24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of \<5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel \& bladder, \& cerebral \[or mental\]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps.
| weeks | Ocrelizumab | Placebo |
|---|---|---|
| Time to 24-week CDP in EDSS | NA (NA to NA) | 155.7 (146.0 to NA) |
Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change.
| centimeter (cm) per year | Ocrelizumab | Placebo |
|---|---|---|
| Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions | -0.016 (-0.021 to -0.010) | 0.021 (0.013 to 0.029) |
Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change.
| percent change per year | Ocrelizumab | Placebo |
|---|---|---|
| Annual Rate of Percent Change From Week 24 in Total Brain Volume | -0.566 (-0.654 to -0.477) | -0.564 (-0.660 to -0.468) |
AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
| cells/microliters (cells/μL) | Ocrelizumab | Placebo |
|---|---|---|
| Baseline | 221.20 ± 122.80 | 212.09 ± 117.06 |
| Week 2 | 0.98 ± 7.78 | 207.07 ± 114.54 |
| Week 12 | 14.57 ± 53.95 | 252.58 ± 83.48 |
| Week 24 | 9.31 ± 26.22 | 206.19 ± 117.72 |
| Week 36 | 35.73 ± 50.79 | 232.94 ± 156.34 |
| Week 48 | 7.59 ± 22.66 | 200.35 ± 108.76 |
| Week 60 | 36.08 ± 61.01 | 217.64 ± 150.79 |
| Week 72 | 7.55 ± 26.75 | 196.81 ± 110.00 |
| Week 84 | 15.04 ± 30.10 | 219.46 ± 135.10 |
| Week 96 | 8.03 ± 26.25 | 197.81 ± 112.76 |
| Week 108 | 27.66 ± 57.90 | 205.44 ± 90.71 |
| Week 120 | 9.36 ± 42.94 | 202.21 ± 126.00 |
| Week 132 | 13.93 ± 39.57 | 200.75 ± 105.92 |
| Week 144 | 3.48 ± 8.38 | 192.82 ± 80.97 |
| Week 156 | 4.50 ± 0.71 | 215.00 ± 59.40 |
| Week 168 | 0.00 ± NA | 152.67 ± 94.65 |
| Week 180 | 36.00 ± NA | — |
| Week 192 | — | 135.00 ± NA |
| Week 204 | 259.00 ± NA | — |
| Week 228 | 0.00 ± NA | — |
| cells/μL | Ocrelizumab | Placebo |
|---|---|---|
| Change at Week 2 | -218.56 ± 121.25 | -3.18 ± 74.88 |
| Change at Week 12 | -208.29 ± 124.70 | 9.33 ± 60.64 |
| Change at Week 24 | -210.92 ± 118.65 | -2.12 ± 91.17 |
| Change at Week 36 | -206.70 ± 101.74 | -9.65 ± 100.67 |
| Change at Week 48 | -216.97 ± 118.30 | -10.11 ± 78.67 |
| Change at Week 60 | -209.92 ± 109.68 | -7.19 ± 146.55 |
| Change at Week 72 | -220.87 ± 122.14 | -7.43 ± 83.34 |
| Change at Week 84 | -206.36 ± 98.52 | -19.54 ± 83.21 |
| Change at Week 96 | -223.86 ± 124.29 | -9.29 ± 94.36 |
| Change at Week 108 | -197.66 ± 122.00 | -44.65 ± 130.97 |
| Change at Week 120 | -216.28 ± 126.33 | -1.99 ± 90.39 |
| Change at Week 132 | -243.00 ± 144.23 | -18.23 ± 117.14 |
| Change at Week 144 | -227.07 ± 106.36 | -24.94 ± 55.75 |
| Change at Week 156 | -206.50 ± 161.93 | -60.00 ± 76.37 |
| Change at Week 168 | -282.00 ± NA | -127.67 ± 68.54 |
| Change at Week 180 | -60.00 ± NA | — |
| Change at Week 192 | — | -104.00 ± NA |
| Change at Week 204 | -278.00 ± NA | — |
| Change at Week 228 | -537.00 ± NA | — |
Percentages have been rounded off.
| percentage of participants | Ocrelizumab | Placebo |
|---|---|---|
| Baseline | 0.8 | 0 |
| Week 2 | 98.9 | 0.4 |
| Week 12 | 92.9 | 0 |
| Week 24 | 78.4 | 0 |
| Week 36 | 42.4 | 0 |
| Week 48 | 84.2 | 0.5 |
| Week 60 | 50.0 | 0 |
| Week 72 | 84.0 | 1.2 |
| Week 84 | 66.7 | 3.6 |
| Week 96 | 83.7 | 0 |
| Week 108 | 61.5 | 1.8 |
| Week 120 | 84.3 | 0.4 |
| Week 132 | 79.7 | 1.9 |
| Week 144 | 89.7 | 0 |
| Week 156 | 100 | 0 |
| Week 168 | 100 | 0 |
| Week 180 | 0 | — |
| Week 192 | — | 0 |
| Week 204 | 0 | — |
| Week 228 | 100 | — |
Percentages have been rounded off.
| percentage of participants | Ocrelizumab | Placebo |
|---|---|---|
| Baseline | 1.0 | 0 |
| Week 2 | 99.6 | 0.4 |
| Week 12 | 92.9 | 0 |
| Week 24 | 85.5 | 0 |
| Week 36 | 51.5 | 0 |
| Week 48 | 87.3 | 0.5 |
| Week 60 | 58.3 | 0 |
| Week 72 | 89.4 | 1.2 |
| Week 84 | 75.6 | 3.6 |
| Week 96 | 88.5 | 0.4 |
| Week 108 | 69.2 | 1.8 |
| Week 120 | 88.8 | 1.3 |
| Week 132 | 83.1 | 1.9 |
| Week 144 | 89.7 | 0 |
| Week 156 | 100 | 0 |
| Week 168 | 100 | 0 |
| Week 180 | 0 | — |
| Week 192 | — | 0 |
| Week 204 | 0 | — |
| Week 228 | 100 | — |
Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result.
Results for this outcome have not been posted.
Collected over AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ocrelizumab | 16/506 (3.2%) | 65/506 (12.8%) | 257/506 (50.8%) |
| Placebo | 14/506 (2.8%) | 68/506 (13.4%) | 201/506 (39.7%) |
| Event | Ocrelizumab | Placebo |
|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 13/506 | 8/506 |
| COVID-19Infections and infestations | 7/506 | 1/506 |
| PneumoniaInfections and infestations | 4/506 | 3/506 |
| Urinary tract infectionInfections and infestations | 4/506 | 4/506 |
| UrosepsisInfections and infestations | 3/506 | 4/506 |
| Myocardial infarctionCardiac disorders | 1/506 | 3/506 |
| Femoral neck fractureInjury, poisoning and procedural complications | 3/506 | 2/506 |
| Femur fractureInjury, poisoning and procedural complications | 0/506 | 3/506 |
| Multiple sclerosisNervous system disorders | 2/506 | 3/506 |
| Multiple sclerosis relapseNervous system disorders | 0/506 | 3/506 |
| Event | Ocrelizumab | Placebo |
|---|---|---|
| Infusion related reactionInjury, poisoning and procedural complications | 99/506 | 21/506 |
| COVID-19Infections and infestations | 75/506 | 56/506 |
| Urinary tract infectionInfections and infestations | 54/506 | 59/506 |
| HeadacheNervous system disorders | 48/506 | 44/506 |
| NasopharyngitisInfections and infestations | 37/506 | 46/506 |
| Upper respiratory tract infectionInfections and infestations | 30/506 | 21/506 |
| Back painMusculoskeletal and connective tissue disorders | 27/506 | 25/506 |
Full analysis set (FAS) included all randomized participants.
| Age, Continuous(years) | Ocrelizumab | Placebo | Total |
|---|---|---|---|
| Mean | 47.7 ± 10.5 | 47.1 ± 10.6 | 47.4 ± 10.6 |
| Sex: Female, Male(Participants) | Ocrelizumab | Placebo | Total |
|---|---|---|---|
| Female | 290 | 278 | 568 |
| Male | 215 | 230 | 445 |
| Ethnicity (NIH/OMB)(Participants) | Ocrelizumab | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 22 | 53 |
| Not Hispanic or Latino | 457 | 476 | 933 |
| Unknown or Not Reported | 17 | 10 | 27 |
| Race (NIH/OMB)(Participants) | Ocrelizumab | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 18 | 14 | 32 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Black or African American | 2 | 1 | 3 |
| White | 464 | 480 | 944 |
| More than one race | 4 | 4 | 8 |
| Unknown or Not Reported | 15 | 7 | 22 |
Showing the first 100 of 155 sites across 23 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Studies of the drug tested here: Ocrelizumab
Multiple Sclerosis, Chronic Progressive →