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Friday, June 16, 2017

Ocrevus Phase 3 Trial Will Explore How Treatment Works by Viewing Changes in Spinal Fluid


                                                                  
  
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Already an approved treatment for relapsing and primary progressive multiple sclerosis (MS), Ocrevus (ocrelizumab) is still undergoing scrutiny in several clinical trials. Most focus on the drug’s effects in specific patient groups, but one study aims to advance understanding of how Ocrevus works to harness disease.
To do so, the open-label Phase 3 trial (NCT02688985) will analyze participants’ cerebrospinal fluid, which bathes the brain and spinal cord.
Aiming to recruit 104 people with both relapsing and primary progressive disease — across 19 locations in North America, Germany, and Sweden — the study is open both to those new to disease-modifying treatment and those previously treated with interferons or Copaxone (glatiramer acetate).

Patients taking other therapies will need to stop treatment before starting Ocrevus infusions.
As in other Ocrevus trials, patients will be treated according to the drug’s prescription label. This means that the first 600-mg dose will be split into two infusions, two weeks apart. Two additional infusions, each 600-mg, will be given on weeks 24 and 48.

Brain biomarkers

Researchers will — for the first time — analyze levels of a factor called Neurofilament Light (NFL), as well as CD19+ B-cells and CD3+ T-cells, in the spinal fluid of Ocrevus-treated participants.
Changes in the fluid levels of these biomarkers will be the trial’s primary outcome measure, bringing new insights into how Ocrevus impacts MS disease processes.
For a disease involving the central nervous system, such as MS, measures of various factors in the blood do not necessarily mirror processes taking place in the brain. By analyzing factors in the cerebrospinal fluid, researchers may be better able to assess what is going on in the brain.
“This is a hypothesis-generating study to elucidate the effect of Ocrevus on biomarkers of inflammation and neurodegeneration in the CSF [cerebrospinal fluid] and peripheral blood of patients with relapsing MS and primary progressive MS, in correlation with clinical and MRI [magnetic resonance imaging] outcome measures,” Hideki Garren, Genentech’s Group Medical Director of Ocrevus, told Multiple Sclerosis News Today when asked about this company-supported trial.
But what will the factors under scrutiny tell researchers about MS disease processes and Ocrevus’ effects?
“Specifically, NFL is a marker of axonal injury,” Garren said. “And the aim of the study is to assess the potential impact of Ocrevus on this process, as well as on the inflammation,” he added, referring to measurements of B- and T-cells, which are immune system components.
Genentech scientists, in an earlier interview, said they believe that Ocrevus, through its interaction with B-cells, also has an impact on T-cells. Measuring T-cell changes in the brain can, for this reason, deepen understanding of a treatment like Ocrevus, which primarily acts to deplete CD20-type B-cells.
The study will also look for the presence of -- click here to continue reading 

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