Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Ocrelizumab
CAS Number: 637334-45-3
Current Sponsor code: RO496
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Able to comply with the study protocol, in the investigator’s judgment - Age 18 - 55 years, inclusive - Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria - Have a length of disease duration, from first documented clinical attack consistent with multiple sclerosis (MS) disease of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS - Inability to complete a Magnetic resonance imaging (MRI) - Known presence of other neurological disorders, including but not limited to, the following: • History of ischemic cerebrovascular disorders or ischemia of 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 or lactation - Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug - Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study - History or currently active primary or secondary immunodeficiency - Lack of peripheral venous access - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies - Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study - Congestive heart failure [NYHA] III or IV functional severity) - Known active bacterial, viral, fungal, mycobacterial infection or other infection, or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening - History of major opportunistic infections - History or known presence of recurrent or chronic infection - History of malignancy, including solid tumors and hematological malignancies - History of alcohol or drug abuse within 24 weeks prior to baseline - History or laboratory evidence of coagulation disorders Exclusions Related to Medications - Received any prior approved Disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate - Received a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit - Treatment with any investigational agent within 24 weeks of screening or five half-lives of the investigational drug or treatment with any experimental procedures for MS - Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label - Previous treatment with B-cell targeted therapies - Systemic corticosteroid therapy within 4 weeks prior to screening. - Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies - Treatment with IV Immunoglobulin within 12 weeks prior to baseline - Treatment with investigational DMT - History of recurrent aspiration pneumonia requiring antibiotic therapy - Treatment with fampridine/dalfamipridine unless on stable dose for = 30 days prior to screening. Wherever possible, patients should remain on stable doses throughout the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of ocrelizumab in early stage of RRMS;Secondary Objective: - To evaluate different clinical measures related to disease progression in early stage of RRMS disease - To evaluate the safety and tolerability of ocrelizumab in early stage of RRMS ;Primary end point(s): Disease progression;Timepoint(s) of evaluation of this end point: Up to 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to onset of confirmed disability progression (CDP) sustained for at least 24 weeks and 48 weeks 2. Proportion of patients who have confirmed disability improvement (CDI), CDP for at least 24 weeks and 48 weeks at Years 1, 2 and 4 3. Proportion of patients who have improved, stable or worsened disability compared with baseline measured by EDSS annually 4. Mean change from baseline in EDSS score over the course of the study 5. Time to first protocol-defined event of disease activity 6. Time to first relapse 7. Annualized relapse rate 8. Proportion of patient relapse free by Weeks 48, 96, 144 and 192 9. Proportion of patients with no evidence of protocol-defined disease activity (NEDA) over Week 96, Week 144 and Week 192 10. Proportion of patients with no evidence of progression sustained for at least 24 weeks on all the following three components (CDP; 20% increase in timed 25 Foot Walk Test [T25FWT]; 20% increase in timed 9 hole peg test [9HPT]) between baseline and Week 96/192 11. Proportion of patients with no active disease between Baseline and Week 96/192 12. Change from baseline of multiple sclerosis functional composite (MSFC) and its composites (T25FW, 9HP, and Paced Auditory Serial Addition Test [PASAT]) over time 13. Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) performed annually 14. Total number of T1 Gd-enhancing lesions; and new and/or enlarging T2 lesion as detected by brain MRI over time 15. Change in T1 volume over time 16. Total number of fluid-attenuated inversion-recovery (FLAIR) lesion counts as detected by brain MRI over time 17. Change in brain volume (including white and grey matter fractions) as detected by brain MRI over time 18. Time to treatment discontinuation/switch 19. Employment status score (Work Productivity and Activity Impairment Questionnaire [WPAI]) 20. SymptoMScreen score 21. Quality of life | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Denmark, France, Germany, Hungary, Italy, Kuwait, Lebanon, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed