G35 Multiple Sclerosis Multiple Sclerosis
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - 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 - A sustained increase of =20% from baseline in T25FWT score, or - A sustained increase of =20% from baseline in time to complete the 9-HPT score. NAME OF THE RESULT: Risk reduction in cCDP sustained for at least 12 weeks. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 12 weeks/ Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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: - 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 - A sustained increase of =20% from baseline in T25FWT score, or - A sustained increase of =20% from baseline in time to complete the 9-HPT score. NAME OF THE RESULT: Risk reduction in cCDP sustained for at least 12 weeks. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 12 weeks/ Throughout study.;Time to onset of 24-week cCDP (cCDP24), according to scales: EDSS, T25FWT y 9-HPT NAME OF THE RESULT: Time to onset of 24-week cCDP (cCDP24) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 24 weeks/ Throughout study.;Time to onset of 12-week CDP (CDP12) according to scale EDSS. NAME OF THE RESULT: Time to onset of 12-week CDP (CDP12) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 12 weeks/ Throughout study.;Time to onset of 24-week CDP (CDP24) according to scale EDSS. NAME OF THE RESULT: Time to onset of 24-week CDP (CDP24) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 24 weeks/ Throughout study.;T25FWT (timed 25-foot walk test) NAME OF THE RESULT: Time to = 20% increase in 12-week confirmed T25FWT PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: For at least 12 weeks/ Throughout study.;T25FWT (timed 25-foot walk test) NAME OF THE RESULT: Time to = 20% increase in 24-week confirmed T25FWT PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY R | — |
Countries
Belgium, Canada, Croatia, Finland, Hungary, India, Israel, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Spain, United Kindgdom, United States
Outcome results
None listed