Phase 3 N=732 Randomized Double-blind Treatment

A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

Multiple Sclerosis, Primary Progressive

Bottom Line

View on ClinicalTrials.gov: NCT01194570 ↗

Enrolled (actual)

732

Serious AEs

31.0%

Results posted

Dec 2017

Primary outcome: Primary: Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period — NA; NA weeks

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ocrelizumab (Drug); Placebo (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Jul 2015

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	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT01194570). 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.