ms multiple sclerosis
Conditions
Interventions
Patients that will be eligible for participation in this study will be treated
with ocrelizumab, according to the study-specific form set out in Appendix 1
(schedule of assessments) of the study pro
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Able to comply with the study protocol, in the investigator's judgement - Age 18-65 years, inclusive - Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS) - Expanded Disability Status Scale (EDSS)
Exclusion criteria
Exclusion criteria: - Relapsing-remitting multiple sclerosis (RRMS) at screening. - Inability to complete an MRI - Gadolinium (Gd) intolerance - Known presence of other neurological disorders, including but not limited to, the following: History of ischemic or hemorrhagic disorders of the brain or the spinal cord. History or known presence of Central nervous system (CNS) or spinal cord tumor. History or known presence of potential metabolic causes of myelopathy. History or known presence of infectious causes of myelopathy. History of genetically inherited progressive CNS degenerative disorder. Neuromyelitis optica. History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease. History of severe, clinically significant brain or spinal cord trauma. Exclusions Related to General Health - Pregnancy - Lactation - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressant*s during the course of the study - History of or currently active primary or secondary immunodeficiency. - Lack of peripheral venous access. - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study. - Active infections must be treated and resolved prior to the first infusion of ocrelizumab - Patients in a severely immunocompromised state until the condition resolves - Patients with known active malignancies or being actively monitored for recurrence of malignancy - Patients who have or have had confirmed progressive multifocal leukoencephalopathy (PML) Exclusions Related to Laboratory Findings Any abnormal screening laboratory value that is clinically relevant should be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before randomisation must meet study criteria. • Positive screening tests for hepatitis B: All patients must be tested for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (total HBcAb). o If HBsAg is positive, the patient is not eligible o If HBsAg is negative and HBcAb is positive, hepatitis B virus (HBV) DNA must be measured by polymerase chain reaction (PCR) * If HBV DNA is positive, the patient is not eligible * If HBV DNA is negative, the patient is eligible and HBV DNA (by PCR) must be repeated every 24 weeks. o If HBsAg and HBcAb are both negative, the patient is eligible. Note: Hepatitis B virus serologies measured using biotin-based immunoassays should be interpreted with caution in MS patients using high-dose biotin, as false positives have been reported in these patients. A biotin-free immunoassay is recommended in these patients; if unavailable, an appropriate correction technique should be applied. • CD4 count =3.0 × the upper limit of normal (ULN) Please note: based on local Ethics Committees or National Competent Authority requirements, additional diagnostic testing may be required for selected patients or selected centres to exclude tuberculosis, Lyme disease, HTLV-1 associated myelopat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to evaluate the effectiveness of ocrelizumab treatment in patients with PMS disease course. See section 2 of the protocol for more information (table 1). | — |
Secondary
| Measure | Time frame |
|---|---|
| -To evaluate the effectiveness of ocrelizumab treatment in PMS patients using a range of patient-relevant measures and imaging outcomes. -To evaluate the safety and tolerability of ocrelizumab in PMS patients. See section 2 of the protocol for more information (table 1). | — |
Countries
Netherlands
Outcome results
None listed