Research Study to Evaluate the Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis
Brief description of study
The purpose of this study is to evaluate the effectiveness of ocrelizumab to alter the course of the complete spectrum of progressive Multiple Sclerosis (PMS) disease. Ocrelizumab is a type of drug called a monoclonal antibody.
Monoclonal antibodies act like your body’s immune system and attach to certain cells in order to attack germs and other illnesses in your body. Ocrelizumab attaches to certain types of white blood cells (B cells) that are thought to play a
role in MS. Ocrelizumab can be utilized as treatment for all forms of Multiple Sclerosis, this included Relapse-Remitting, Secondary Progressive, and Primary Progressive.
Detailed description of study
This study has three parts:
1. Screening (to see if you are eligible for the study)
2. Treatment
3. Follow-up (to check on you after treatment is finished)
During the treatment period, you will receive 8 doses of ocrelizumab. The first dose of ocrelizumab will be delivered as 2 separate infusions that will be spaced 14 days apart- Day 1 and day 15. After your first ocrelizumab dose is completed, you will receive the total dose of ocrelizumab as single infusionevery 6 months for up to 168 weeks (a total of 8 complete doses split into 9 infusions).
The study doctor will also ask you to return to the clinic 6 months after your last dose ofocrelizumab. During this study, you will have eleven visits, including the screening visit. You will need to remain at the clinic at every infusion visit for at least 1 hour after the completion of the infusion for observation.
At your final study visit (Week 192 visit), if you and your doctor decide to continue your treatment, you will be able to transition to another Roche clinical study or continue with commercially available ocrelizumab. If you decide to continue ocrelizumab treatment after week 192, you will have to discontinue from this study. If you decide not to continue with the ocrelizumab medication your doctor will contact you by telephone every 12 weeks and will ask you to return to the clinic every 6 months for safety monitoring for at least 12 months after the last dose of ocrelizumab.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
multiple sclerosis
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
27 Jun 2023.
Study ID: 832076
