Below is a step by step guide to participating in CELLO
If you’re interested in participating please contact one of our study locations
Step 1: Screening
For people who already know they have RIS
People who already know that they have RIS may be eligible to participate in this study.
Screening for CELLO includes 1-2 screening visits to determine whether you are eligible to participate. If you are eligible and decide to participate, you will undergo the following tests:
- a lumbar puncture (spinal tap) (for any participants who have not had this procedure done previously) Learn why studying immune cells from spinal fluid is important
- a blood draw
- MRIs of your brain and cervical spine
- surveys about your health.
For people who are at risk for RIS
People whose close relatives have MS may be at risk for RIS. If you have a parent, sibling or child with MS and otherwise qualify for the study, you can opt to be pre-screened for the CELLO study. You will undergo a brain MRI to see if you have RIS. If you do, you would undergo the additional testing outlined above. If the MRI is normal, study staff will follow up with you by phone once per year to assess your overall health throughout the duration of the study, which is expected to be 4-6 years.
Before choosing to be screened for RIS, we encourage everyone to consider the risks of uncovering this diagnosis. The uncertainty of not knowing whether you will develop symptoms in the future can be unsettling. Being diagnosed with RIS could also impact your ability to get life insurance in the future, so you may wish to make those arrangements prior to being screened for the study.
Step 2: Randomization
After screening, your treatment will be randomly assigned (like a coin flip). You may receive placebo, or ocrelizumab. You will not be able to decide which treatment you will receive. Neither you nor anyone on your study team will know which treatment you are receiving until after the study has ended.
Step 3: Treatment and Monitoring
Once your treatment is randomly assigned, you will begin your study treatment (placebo or ocrelizumab). Study treatments will occur every 6 months for 18 months, and you will be followed in the study for a total of 4 years. You will see the study neurologist every 6 months, and your MRI will be monitored. You will also fill out surveys periodically to let the study team know about your overall health. The study team will take blood at each visit.
Data from one lumbar puncture (spinal tap) is required for all study participants at the beginning of the study. Looking at the spinal fluid helps our study scientists get an accurate picture of whether your immune system is showing any signs of being over-activated around the brain and spine, something that cannot be learned by just studying the blood. This is key to understanding how MS develops. People who have had a lumbar puncture done previously, as part of a workup for possible MS, may not need to have another procedure done, if they can provide the results of their original lumbar puncture. If they wish to contribute additional spinal fluid to help increase the scientific impact of the trial, they may do so. Any study participants who are willing to donate spinal fluid more than once, will have the option of having additional lumbar punctures at year 2 and year 4. Studying multiple spinal fluid samples over time will help the study team identify biomarkers that improve our understanding of the immune changes that lead to MS and help identify additional risk factors for developing the disease.
If you were to develop MS while participating in the study, your participation in the study would end and the study team would help connect you to a local neurologist so that you could begin treatment for MS.
If you qualify for the study and are interested in participating, please find your nearest participating location and reach out to the local study team. They will review the study with you in much more detail, including possible risks and potential benefits.