Phase 3
Completed N=732
A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis
Multiple Sclerosis, Primary Progressive
Source: ClinicalTrials.gov NCT01194570 ↗
Enrolled (actual)
732
Serious AEs
31.0%
Results posted
Dec 2017
Primary outcomePrimary: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period — NA; NA weeks
◆ Published Evidence
Established
62citations · ~21 / year
Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis.
Summary
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.
Linked Publications (5)
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Association of Higher Ocrelizumab Exposure With Reduced Disability Progression in Multiple Sclerosis.
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Estimating individual treatment effect on disability progression in multiple sclerosis using deep learning.
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Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials.
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Evolution of atrophied T2 lesion volume in primary-progressive multiple sclerosis: results from the phase 3 ORATORIO study.
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Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period |
NA; NA | — |
| SECONDARY Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 24 Weeks During the Double-Blind Treatment Period |
NA; NA | — |
| SECONDARY Percent Change From Baseline in Timed 25-Foot Walk (T25-FW) at Week 120 |
55.097; 38.933 | 0.0404 sig |
| SECONDARY Percent Change From Baseline in Total Volume of T2 Lesions at Week 120 |
7.426; -3.366 | < 0.0001 sig |
| SECONDARY Percent Change in Total Brain Volume From Week 24 to Week 120 |
-1.093; -0.902 | 0.0206 sig |
| SECONDARY Change in From Baseline Physical Component Summary Score (PCS) SF- 36 Health Survey (SF-36) at Week 120 |
-1.108; -0.731 | 0.6034 |
| SECONDARY Number of Participants With at Least One Adverse Event (AE) |
53; 99; 59; 167; 215; 462 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)
- EDSS at screening from 3 to 6.5 points
- Disease duration from onset of MS symptoms less than ( ) 5.0; /=) 5.0
- Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Exclusion Criteria
- History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening
- Inability to complete an MRI (contraindications for MRI)
- Known presence of other neurologic disorders
- Known active infection or history of or presence of recurrent or chronic infection
- History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
- Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
- Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Data sourced from ClinicalTrials.gov (NCT01194570) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.