A PHASE III, MULTICENTRE, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS

Not Applicable

• Conditions: -G35 Multiple sclerosis; Multiple sclerosis; G35

• Registration Number: PER-098-10
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Study Completion: 2022-12-22
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

• Ability to provide written informed consent and to follow the protocol evaluation program.
• PPMS diagnosis according to McDonald´s revised criteria (2005)
• Age 18-55 years, inclusive
• EDSS in the selection of 3.0 to 6.5 points
• Rating of> 2.0 on the Functional Systems (ES) scale for the pyramid system due to the lower limb results.
• urination of the disease from the onset of MS symptoms
• Documented history or presence in the selection of at least one of the following laboratory results in a CSF sample [source documentation of laboratory results and method must be verified)]
• For sexually active patients of both sexes with reproductive potential, use of reliable means of contraception as described below as a minimum (compliance with local requirements is necessary if they are more stringent)

Exclusion Criteria

• History of recurrent remitting multiple sclerosis, secondary progressive, or progressive recurrent multiple sclerosis in the selection.
• Inability to complete a MRL (contraindications for MRI include but are not restricted to weight> 140 kg, pacemakers, cochlear implants, intracranial vascular clips, surgery within 6 weeks prior to study entry, coronary stent implant within 8 weeks prior to the time of the planned MRI, etc.). Patients with gadolinium contraindication may be included in the study, but may not receive gadolinium contrast media during their MRI studies.
• Contraindications to or intolerance to oral corticosteroids or IV, including methylprednisolone administered IV, according to the country´s technical data sheet
• Known presence of other neurological disorders
• Pregnancy or breastfeeding;
• Lack of peripheral venous access;
• History of severe allergic or anaphylactic reactions to murine or humanized monoclonal antibodies; 8. Significant uncontrolled disease, such as cardiovascular disease (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), kidney, liver, endocrine or gastrointestinal disease, or any other significant disease that could prevent the patient from participating in the study.
• Congestive heart failure (NYHA functional severity class III or IV);
• Known active bacterial, viral, fungal, mycobacterial or other infection [including tuberculosis [TB] or atypical mycobacterial disease (but excluding fungal infection of nail beds) or any major episode of infection that requires hospitalization or treatment with antibiotics i.v. within 4 weeks prior to the baseline visit (visit 2) or oral antibiotics during the 2 weeks prior to the baseline visit (visit 2);
• Istoria or known presence of chronic or recurrent infection (for example, HIV, syphilis, tuberculosis);
• History of recurrent aspiration pneumonia that requires antibiotic treatment.
• History of cancer, including solid tumors and hematologic malignancies (except basal cell and spinocellular carcinoma in situ of the skin, and carcinoma in situ of the cervix that have been removed and resolved, with clean margins documented in the pathology);
• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study;
• History of alcohol or other drug abuse within 24 weeks prior to randomization;
• History or active presence of primary or secondary immunodeficiency;
• History or laboratory evidence of coagulation disorders.
• Treatment with any investigational drug within 24 weeks prior to selection (visit 1) or five half-lives of the investigational medication (whichever is longer); or treatment with any experimental procedure for MS (for example, treatment for chronic cerebrospinal venous insufficiency).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The time to onset of CDP was defined as time from baseline to first disability progression, which is confirmed at next regularly scheduled visit >=12 weeks (>=84 days) after initial disability progression. Baseline for time to onset of CDP is the date of randomization, independent of the first day of dosing. Disability progression is defined as an increase of >= 1.0 point from baseline expanded disability status scale (EDSS) score, if baseline EDSS value is <=5.5 points (inclusive), or an increase of >=0.5 points, if baseline EDSS is >5.5 points. The total EDSS score ranges from 0 (normal) to 10 (death due to multiple sclerosis). The randomized participants who did not receive any treatment were censored at days 0 in each Arm.<br><br>Measure:Time to Onset of Clinical Disability Progression (CDP) Sustained for at Least 12 Weeks During the Double-Blind Treatment Period<br>Timepoints:Maximal follow up: 216 weeks for Placebo arm and 217 weeks for Ocrelizumab arm<br>