A PHASE IIIB MULTICENTER, RANDOMIZED,DOUBLE-BLIND, CONTROLLED STUDY TOEVALUATE THE EFFICACY, SAFETY ANDPHARMACOKINETICS OF A HIGHER DOSE OFOCRELIZUMAB IN ADULTS WITH PRIMARYPROGRESSIVE MULTIPLE SCLEROSIS
- Conditions
- -G35 Multiple sclerosisMultiple sclerosisG35
- Registration Number
- PER-068-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
Patients must meet the following criteria for study entry:
- Signed ICF
- Ages 18- 55 years at time of screening
- Ability to comply with the study protocol
- Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017 (Thompson
et al. 2018)
- EDSS score at screening and baseline
- Score of 2.0 on the Functional Systems (FS) scale for the pyramidal system
- Patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or
physiotherapy must be treated at a stable dose during the screening period prior to the
initiation of study drug on Day 1 and must have a plan to remain at a stable dose for the
duration of study treatment
- Patients must be neurologically stable for at least 30 days prior to randomization and
baseline assessments
- Disease duration from the onset of MS
- Documented evidence of the presence of cerebrospinal fluid-specific oligoclonal bands
(established by a historical lumbar puncture or presence at screening in a newly obtained
CSF specimen (source documentation of historical laboratory results and method must be
verified)
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use adequate contraceptive methods during the treatment
period and for 6 or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after
the final dose of ocrelizumab.
- For female patients without reproductive potential. Females may be enrolled if post-menopausal (i.e., spontaneous amenorrhea for the past year confirmed by a follicle-stimulating hormone [FSH] level 40 mIU/mL) unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).
For more details, review the protocol.
Patients who meet any of the following criteria will be excluded from study entry:
- History of relapsing remitting or secondary progressive MS at screening
- Any known or suspected active infection at screening or baseline (except nailbed
infections), or any major episode of infection requiring hospitalization or treatment with IV
anti microbials within 8 weeks prior to and during screening or treatment with oral anti
microbials within 2 weeks prior to and during screening
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- History of cancer
- Immunocompromised state
- Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
- Inability to complete an MRI
- Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) for
IRRs, including uncontrolled psychosis for corticosteroids or closed-angle glaucoma for
antihistamines
- Known presence of other neurologic disorders
- Any concomitant disease that may require chronic treatment with systemic corticosteroids
or immunosuppressants during the course of the study
- Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia),
pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or
gastrointestinal, or any other significant disease that may preclude patient from participating
in the study.
For more details, review the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Time to onset of cCDP, defined as the first occurrence of a confirmed progression event according to at least one of the following three criteria:<br>- CDP, defined as a sustained increase from baseline in EDSS score of ≥1.0 point in patients with a baseline EDSS score of ≤5.5 or a sustained increase ≥0.5 points in patients with a baseline EDSS score of >5.5, or<br>- A sustained increase of ≥20% from baseline in T25FWT score, or<br>- A sustained increase of ≥20% from baseline in time to complete the 9-HPT score.<br>Measure:Risk reduction in<br>cCDP sustained for at least 12 weeks.<br>Timepoints:For at least 12 weeks/ Throughout study.<br>
- Secondary Outcome Measures
Name Time Method