A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS
- Conditions
- G35-G35 Multiple sclerosisMultiple sclerosis
- Registration Number
- PER-056-20
- Lead Sponsor
- F. HOFFMANN-LA ROCHE LTD.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Patients must meet the following criteria for study entry:
• Signed ICF
• Ages 1855 years at time of signing ICF
• Ability to comply with the study protocol
• Diagnosis of RMS in accordance with the revised McDonald Criteria 2017
(Thompson et al. 2018)
• At least two documented clinical attacks within the last 2 years prior to screening, or
one clinical attack in the year prior to screening (with no relapse 30 days prior to
screening and at baseline)
• Patients must be neurologically stable for at least 30 days prior to randomization
and baseline assessments
• EDSS, at screening and baseline, from 0 to 5.5 inclusive
• Documented MRI of brain with abnormalities consistent with MS prior to screening
• 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 not initiate symptomatic treatment for MS or physiotherapy
within 4 weeks of randomization.
For more details, review the protocol.
Patients who meet any of the following criteria will be excluded from study entry:
•History of primary 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, including hematologic malignancy and solid tumors, within
10 years of screening
Basal or squamous cell carcinoma of the skin that has been excised and is
considered cured and in situ carcinoma of the cervix treated with apparent
success by curative therapy >1year prior to screening is not exclusionary.
For more details, review the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The primary efficacy objective will be assessed by risk reduction in cCDP sustained for at least 12 weeks.<br>Time to onset of cCDP is defined as the first occurrence of a confirmed progression<br>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:composite confirmed disability progression (cCDP)<br>Timepoints:Throughout the study.<br>The primary efficacy analysis will be performed after at least 205 events of cCDP12 have occurred in the study.<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:The time to onset of 12-week CDP (CDP12) is measure assesing an increase in a patient’s EDSS score.<br>For more detail, review the protocol.<br>Measure:Time to onset of 12-week CDP (CDP12)<br>Timepoints:Throughout the estudy.<br>For more details, review the protocol<br>;<br>Outcome name:Time to onset of 24-week cCDP (cCDP24).<br>Composite CDP include time to progression measured by the expanded disability status scale (EDSS), Timed 25-Foot Walk (T25FWT) or 9-<br>Hole Peg Test (9-HPT).<br><br>Measure:24-week composite confirmed disability progression (cCDP24)<br>Timepoints:Throughout the study.<br>